it-014 health informatics committee...hl7 meeting – vancouver, canada (may 2012) it-014 health...

HL7 Meeting – Vancouver, Canada (May 2012)

IT-014 Health Informatics Committee Final Report

HL7 Working Group Meeting 13th - 18th May 2012 (Vancouver, BC, Canada)

Version: FINAL 1.0 Date Issued: 13/07/12 Lead Author: Dr Patricia Williams Collated by: Standards Australia With input from Australian Delegation and other employer funded Australians at the meeting: • Dr Trish Williams Ph.D. (Delegate and Report Coordinator) • Heather Grain (Delegate) • Richard Dixon Hughes (Delegate) • Grahame Grieve (Delegate) • Dr Hugh Leslie MB BS, FRACGP, FACHI (Delegate) • Dr David Rowed, MB BS, BEng, FRACGP (Delegate) • Dr Vincent McCauley MB BS, Ph.D. (Delegate) • Nat Wong (Mentor Position Delegate) • Dr Andy Bond (NEHTA) • Dr Stephen Chu (NEHTA)


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CONTENTS 1 Executive Summary ...................................................................................................................... 8

1.1 Introduction ..................................................................................................................... 8

1.2 Objectives of the Meeting ............................................................................................... 8

1.2.1 Relevance to NEHTA programs .............................................................................. 10

1.3 Meeting Logistics ........................................................................................................... 10

1.4 Recommendations Arising from the Meeting ............................................................... 13

1.5 Funding Sources Summary and Australian Attendance ................................................ 26

1.6 Australian Leadership Positions .................................................................................... 27

1.7 Acronym List .................................................................................................................. 28

2 Detailed Recommendations Arising from the Meeting......................................................... 37

2.1 Advisory Council ............................................................................................................ 38

2.2 Affiliate Agreement Task Force (AATF) and HL7 Intellectual property ............................ 40

2.2.1 Finalisation and Execution of Updated Affiliate Agreement ..................................... 40

2.2.2 Licensing of HL7 IP for Use in Australian Standards Publications .............................. 42

2.3 Affiliate Due Diligence Committee ................................................................................... 44

2.4 Architecture Review Board (ArB) ...................................................................................... 47

2.4.1 Project #365: Service Aware Interoperability Framework (SAIF) ............................... 47

2.5 Arden Syntax ..................................................................................................................... 48

2.6 HL7 Board.......................................................................................................................... 51

2.6.1 General Business ........................................................................................................ 51

2.6.2 CEO Report.................................................................................................................. 52

2.7 CDISC / BRIDG .................................................................................................................... 54

2.8 Clinical Decision Support (CDS).......................................................................................... 54

2.8.1 Project #507: Context Aware Information Retrieval (Infobutton) SOA Implementation Guide .......................................................................................................... 57

2.8.2 Project #875: Context-aware Knowledge Retrieval, Knowledge Request, Rel 2 ....... 57

2.8.3 Project # 876 URL-Based Implementations of the Context-Aware Information Retrieval (Infobutton) Domain, Release 4 ............................................................................. 58

2.8.4 Project #184: Virtual Medical Record (vMR) for Clinical Decision Support ................ 59

2.8.5 Project #259: Order Set Publication Standard ........................................................... 60


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2.8.6 New Project Proposal: Implementation Guide for CDS .............................................. 61

2.8.7 New Work Activity: Immunisation Evaluation & Forecasting Logic Specification ..... 62

2.8.7.1 Cross Paradigm Interoperability Implementation Guide for Immunizations. ..... 63

2.8.8 openCDS...................................................................................................................... 64

2.8.9 New Project: Services and Capabilities of Clinical Information Systems (notably EHRs) to enable Service Oriented Decision Support. ...................................................................... 65

2.9 Clinical Interoperability Council (CIC) ................................................................................ 66

2.10 Clinical Statement (CS) .................................................................................................... 67

2.11 Collaborative Based Community Care (CBCC) ................................................................. 68

2.11.1 Project (new): Data Segmentation for Privacy ............................................................. 69

2.11.2 Other Non-Project Workgroup Discussions and Presentations .................................. 73

2.11.2.1 Meaningful use .......................................................................................................... 73

2.11.2.2 EHR Metadata project ............................................................................................... 74

2.11.2.3 Consent Management: A Scalable Nationwide Approach ........................................ 74

2.12 Conformance and Guidance for Implementation and Testing (CGIT) ............................ 75

2.12.1 Project #630: HL7 Vocabulary Binding Syntax .......................................................... 76

2.12.2 Project #874: V2 code table versioning and alignment to V3 vocabulary model .... 77

2.12.3 Project: V2.8 Conformance Proposals ...................................................................... 78

2.12.4 Project: V2.9 Conformance Proposals ...................................................................... 79

2.12.5 Project Modelling Workbench (MWB) – Maintenance ............................................ 79

2.12.6 Project #825: V2 XML Encoding Rules release 2 ....................................................... 80

2.13 Detailed Clinical Models .................................................................................................. 80

2.14 Education & Marketing .................................................................................................... 81

2.14.1 Project #865: HL7 Certification PROGRAM ENHANCEMENT ................................... 82

2.14.2 Education Strategic Plan ........................................................................................... 84

2.14.3 Other comments ....................................................................................................... 84

2.15 Electronic Health Records (EHR) .................................................................................. 86

2.15.1 Project #819: EHR-S Functional Profile for Health Information Exchange Metadata ............................................................................................................................................... 87

2.15.2 Project #688: EHR System Functional Information Model (EHR-S FIM) ................. 88

2.15.3 Project #881: Patient Care Allergies and Intolerances DAM .................................... 89

2.16 Electronic ServicES ........................................................................................................... 90

2.16.1 Project #877: Develop HL7 Ballot Site Education Tutorial........................................ 91


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2.16.2 Project #150: New HL7 Web Site .............................................................................. 92

2.17 HL7 Fresh Look Task Force ............................................................................................... 93

2.17.1 Defining Long-term Interoperability Directions ....................................................... 93

2.17.2 Other comments ....................................................................................................... 94

2.18 HL7 Collaboration with other SDOs ................................................................................. 95

2.19 Health Care Devices ......................................................................................................... 96

2.20 Implementation Technology Specification (ITS) .............................................................. 97

2.21 Infrastructure and Messaging (Inm) ................................................................................ 97

2.22 International Council ....................................................................................................... 98

2.22.1 Attendance and quorum ....................................................................................... 98

2.22.2 New Affiliates ........................................................................................................ 98

2.22.3 e-Vote for Approval of Revised Affiliate Agreement ........................................... 98

2.22.4 Election of International Council officers and representatives ............................. 99

2.22.5 HL7 Board Report ................................................................................................. 99

2.22.6 Affiliate Due Diligence Committee ..................................................................... 101

2.22.7 CTO and TSC Representatives Report ................................................................. 102

2.22.8 HL7 Education ..................................................................................................... 103

2.22.9 Marketing and Communcations plan for INTERNATIONAL COUNCIL ................ 104

2.22.10 E-Health in South Africa .................................................................................... 104

2.22.11 SemanticHealthNet ........................................................................................... 105

2.22.13 Special Interest Topic – Affiliate Political Realities ........................................... 105

2.22.14 Regional reports ............................................................................................... 106

2.22.15 IHIC 2012, Vienna Austria ................................................................................. 107

2.22.16 IMATF (International Membership & Affiliation Task Force) .......................... 108

2.22.17 HL7 Around the World ...................................................................................... 108

2.23 International Membership & Affiliation Task Force (IMATF) ............................... 113

2.23.1 Review of Alternative Models for International Membership ............................ 113

2.23.2 Survey of Membership/Customer Classes and their Rights ................................ 115

2.23.3 Survey of Membership/Customer Classes and their Rights ................................ 116

2.24 ISO/TC215 WG2/HL7 Data Communciations and DICOM ..................................... 117

2.25 Joint Initiative Council (JIC) Liaison ........................................................................ 118

2.25.1 HL7/IHE Health Story Implementation Guide Consolidation (#728) .................. 118


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2.25.2 Diagnostic Imaging Reports in HL7 CDA and DICOM SR Format – Cross-SDO Project ............................................................................................................................. 120

2.25.3 Epsos ................................................................................................................... 121

2.25.4 CTS Project 2 ....................................................................................................... 121

2.25.5 TIGER Project ...................................................................................................... 122

2.25.6 LOINC .................................................................................................................. 122

2.25.7 NCPDP ................................................................................................................. 124

2.25.8 IHTSDO ................................................................................................................ 125

2.25.9 IHE ....................................................................................................................... 126

2.26 Mobile Health ................................................................................................................ 128

2.27 Modelling and Methodology (MnM) ............................................................................. 131

2.27.1 Project #219: Core Principles and Properties of HL7 Version 3 Models (joint with Vocabulary WG) ............................................................................................................... 131

2.27.2 Project #823: Fast Health Interoperability Resource (FHIR) ............................... 132

2.27.2.1 Vocabulary implications of FHIR ...................................................................... 133

2.28 Patient Care ................................................................................................................... 136

2.28.1 Project #675: Allergies and Adverse Reactions .................................................. 137

2.28.2 Project: Harmonisation of the Patient Administration Encounter Model .......... 139

2.28.3 Project #813: Care Provision D-MIM to normative ballot .................................. 140

2.28.4 Project #320: Detailed Clinical Models ............................................................... 141

2.28.5 Project (new): Care Plan Initiative project 2011 ................................................ 142

2.28.6 Other discussions ................................................................................................ 144

2.28.6.1 CDA Release 3 .................................................................................................. 144

2.28.6.2 GS1 Presentation of Patient ID ........................................................................ 145

2.28.6.3 Fast Healthcare Interoperability Resources (FHIR).......................................... 146

2.29 Pharmacy ............................................................................................................... 148

2.29.1 Patient Medication Queries (for supporting creation of Medication Profile) project ............................................................................................................................. 148

2.29.2 V3 Nutrition Order Clinical Message .................................................................. 150

2.29.3 Other presentations ........................................................................................... 151

2.29.3.1 FHIR ................................................................................................................... 151

2.30 Physicians Group ................................................................................................... 153

2.31 Policy Advisory Committee (PAC) .......................................................................... 155


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2.32 Public Health Emergency Response....................................................................... 155

2.33 Publishing ............................................................................................................... 156

2.34 Regulated clinical research information management (RCRIM) .......................... 156

2.34.1 Project #528: BRIDG as DAM ............................................................................. 158

2.34.2 Project #372 Clinical Trial Registration and Results (CTR&R) ............................ 160

2.35 Security .................................................................................................................. 162

2.35.1 Project #646: Security and Privacy Ontology ..................................................... 162

2.35.2 Project (New): Data Segmentation and its Role in Access Control – Labelling and Tagging ............................................................................................................................ 163

2.35.3 Review of International Progress, Standards and Industry Bodies ..................... 163

2.35.4 Other Non-Project Workgroup Discussions ........................................................ 166

2.35.4.1 Conformance and guidance for Implementation and Testing Work Group on HL7 conformance methodology ...................................................................................... 166

2.35.4.2 Modelling facilitator ......................................................................................... 167

2.35.4.3 Interim election of 4th co-chair ....................................................................... 167

2.35.4.4 Teleconference organisation ........................................................................... 167

2.35.4.5 Security Cookbook Tutorial ............................................................................. 167

2.36 Services Oriented Architecture .............................................................................. 169

2.36.1 Project #863: Cross- Paradigm Interoperability Implementation Guide for Immunization ....................................................................................................................... 170

2.36.2 Project #838: Medication Statement Service PROFILE........................................ 172

2.36.3 Healthcare and Community Services Provider Directory Service (HCSPD) ......... 174

2.36.4 Project #783: hData Record Format ................................................................... 174

2.36.5 Project : RLUS ...................................................................................................... 175

2.36.6 Project (NEW) : SOA Service ONtology ............................................................... 175

2.36.7 Project #200: Privacy Access and Security Services (PASS) ................................. 176

2.36.8 Project : Data Segmentation - S&I Framework and ONC initiative .................... 177

2.36.9 New Project (SOA/Patient Care): Patient Care Services Coordination Project ... 178

2.36.10 Other Items ....................................................................................................... 179

2.37 Structured Documents ........................................................................................... 180

2.37.1 Project #477: CDA R3 .......................................................................................... 181

2.37.2 Project #756: Health Quality Measure Format (HQMF) Implementation Guide (Co-sponsored by CDS) .................................................................................................... 181


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2.37.3 Other discussions ................................................................................................ 182

2.37.3.1 Ownership of OIDs ............................................................................................. 182

2.38 Templates .............................................................................................................. 184

2.38.1 Project #829: HL7 Templates Registry Business Process Requirements Analysis 185

2.38.2 HL7 Template ITS Pilot ........................................................................................ 186

2.39 Vocabulary ............................................................................................................. 187

2.39.1 Vocabulary Facilitators ....................................................................................... 188

2.39.2 Terminology Binding (joint with Structured documents and CGIT) .................... 190

2.39.3 Project #324 & #839: Common Terminology Services Release 2 (CTS 2) – Normative (#324) and HL7 Common Terminology Services Release 2 (CTS2) Implementation Guide (#839) ......................................................................................... 192

2.39.3.1 Alignment of CTS 2 with the HL7 core principles of vocabulary....................... 193

2.39.3.2 OMG PIM/HL7 traceability matrix .................................................................... 193

2.39.3.3 Conformance profile for HL7 CTS 2 .................................................................. 194

2.39.3.4 UML representation of MIF vocabulary ........................................................... 194

2.39.3.5 Functional and informational model clarification ........................................... 194

2.39.4 Project #806: Development of policies and procedures of an HL7 terminology authority .......................................................................................................................... 195

2.39.5 Project #644: HL7 Evaluation of the IHTSDO Workbench tool ........................... 199

2.39.5.1 Migration process ............................................................................................ 201

2.39.5.2 Harmonisation .................................................................................................. 201

2.39.5.3 Synchronisation Mode ...................................................................................... 201

2.39.6 Project #849: HTinfo – implementation guide for using terminologies in hl7 artefacts – release 2 ........................................................................................................ 201

2.39.7 Tooling /Vocabulary Joint Meeting..................................................................... 204

2.40 CIMI – Clinical Information Modelling Initiative .................................................... 206

2.40.1 Benefits of CIMI to International and Australian e-Health .................................. 209


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1 EXECUTIVE SUMMARY

1.1 INTRODUCTION HL7 is an international organisation with its origins in the USA, and an expanding group of international users participating in its standards development processes. HL7 provides international standards for inter-system and inter-organisation messaging, for decision support, clinical text documents mark-up, user interface integration, EHR/PHR systems functionality as well as a health data model and message development methodology. It produces global health informatics standards through a process of collaboration, which involves its local affiliate, HL7 Australia.

HL7 standards are the dominant health-messaging standards in the USA, Canada, Germany, Holland, Finland, Japan, Korea, Tai wan, New Zealand, and Australia and are being adopted as health-messaging standards by many other countries.

The May 2012 HL7 International Working Group Meeting was held in Vancouver, British Columbia, Canada with activities scheduled over 6.5 days. The main activities ran from Sunday, 13 to Friday, 18 May with some important additional leadership meetings scheduled on Saturday, 12 May. On weekdays formal meetings are scheduled from 8am to 5pm however, some meetings are scheduled from 7am and go as late as 10pm on some days.

At this HL7 working group meeting there were 310 registrants with 190 US delegates and 120 non-US delegates. The countries represented were Argentina, Australia, Austria, Canada, Chile, China, Congo, Croatia, Czech Republic, France, Germany, Great Britain, Greece, India, Israel, Italy, Japan, Korea, Netherlands, Norway, New Zealand, Puerto Rico, Singapore, Spain, Taiwan, Unites States of America and South Africa.

It should be noted that the HL7 International standards work is not structured as "Work Items" that are put forward to the HL7 body for approval, rather most projects arise from the work within the many domain and specialist committees. However, these proposed projects need to be well-defined and documented and require approval by the respective Steering Division and the Technical Steering Committee to ensure appropriate internal (HL7) and external (international standards development organisations) harmonisation.

This report summarises the committee proceedings, issues and actions for consideration by Australia from this HL7 International Standards and Education Meeting.

1.2 OBJECTIVES OF THE MEETING HL7 meetings are true working meetings, not conferences, with many experts and individual groups meeting to develop, discuss and improve HL7 standards, processes and implementation guides and to determine the most effective way to meet the needs of the stakeholders – both those present at the meeting and those in the wider community of interest. While HL7 engagement with stakeholders in other forums is also strong (through regular, often


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weekly teleconferences), the ability to influence the work program, outcomes and strategic direction requires physical presence at working group meetings.

The overarching objectives are to benefit the Australian health system and wider community by:

• Improving Australian capacity to implement health informatics standards and eHealth systems by expanding local knowledge and expertise based on international best practice;

• Promoting free trade and its benefits to health ICT (by lowering the cost of integrating and implementing local health information systems, many of which are imported, and by reducing costs to Australian exporters) – both these outcomes require Australian requirements to be embedded into global standards so that they can be adopted in Australia, rather than having different standards across domestic and international markets; and

• Improving Australian health information systems by facilitating a standards-based approach to development and implementation, and achieving interoperability between systems.

Other more specific objectives for Australian engagement in international standardisation via HL7 International include:

• Monitoring and influencing HL7’s strategic positioning as a global Standards Development Organisation (SDO), encouraging its collaboration with other international and global SDOs and assessing and contributing to the strategic positioning of its key products (HL7 V2.x, V3, CDA, EHR, etc.) so as to encompass Australia’s health information interchange and related requirements;

• Negotiating the inclusion of Australian healthcare messaging requirements into HL7 V2.8, CDA and V3 specifications for:

Patient administration;

Diagnostics (pathology, radiology); and

Collaborative care (e.g. Electronic Discharge Summaries and e-Referrals, so that Australian requirements become a formal part of these standards).

• Negotiating the inclusion of Australian health sector requirements into the HL7 Standards so that Australian EHR developments are supported by the upcoming HL7 and related ISO EHR Standards;

• Negotiating the harmonisation of ISO, HL7 and CEN Standards to achieve progressive inter-SDO eHealth standards harmonisation with the long-term goal of a unified set of global health informatics standards;

• Monitoring, and influencing as necessary, new initiatives to standardise clinical data content so as to improve Australia’s ability to unambiguously and safely exchange semantically interoperable clinical data;


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• Assessing and influencing HL7’s work on service oriented architectures (SOA), as required by Australia’s national direction setting, and negotiating the inclusion of Australian health sector requirements in particular, those described by National eHealth Transition Authority (NEHTA) into service specifications being jointly developed by HL7;

• Assessing and influencing the positioning, development, implementation, utility and effectiveness of CDA (including CDA Release 3), to support Australia’s interest in CDA in its national eHealth program;

• Assessing, exploring and proposing approaches to the embedding and transportation of archetypes in HL7 V2.x messages for referral, diagnostic results and collaborative care to support Australian interest in the use of archetypes for the exchange of clinical information; and

• Progressing the international harmonisation of common data types and vocabulary for healthcare information that will meet Australia’s identified requirements.

Additional Australian interests are pursued opportunistically as and where formally agreed upon by the community and to support specific objectives that are required for the development of Australia’s national eHealth agenda and other national interests.

1.2.1 RELEVANCE TO NEHTA PROGRAMS

NEHTA has endorsed a range of Australian Standards derived from international standards work by including them in the National eHealth Standards Catalogue. As the implementation of NEHTA’s domain-specific initiatives are based on many of these standards, it is important that Australia continues to be involved in the international forums that develop, manage and maintain these, and other potentially relevant, health informatics standards.

1.3 MEETING LOGISTICS

The table below shows the meeting schedule for all of the meeting groups. Most US based meetings have greater than 60 separate working groups and committee meetings. In addition to the working groups listed, members also attended tutorials and project specific workshops e.g. Fast Health Interoperability Resource (FHIR).

The Australian delegation is denoted as following in the table below:

AB – Andy Bond HL - Hugh Leslie SC – Stephen Chu

DR - David Rowed MA- Meya Achdiat TW - Trish Williams

GG - Grahame Grieve NW - Nat Wong VM - Vince McCauley

HG - Heather Grain RDH - Richard Dixon Hughes


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Working Group Sat Sun Mon Tue Wed Thu Fri Affiliate Agreement Task Force (AATF) and access to HL7 IP

Affiliate Due Diligence Committee RDH

Anatomic Pathology

Architecture Review Board (ArB)

AB GG

AB

GG

Arden Syntax

Board of Directors’ Meeting RDH

GG

Clinical Decision Support DR DR

GG MA

Clinical Interoperability Council HL

Clinical Statement SC

Co-Chair Information Session RDH

Community Based Collaborative Care

TW MA

Conformance and Guidance for Implementation/Testing VM VM VM

Detailed Clinical Models HL HL HL HL HL HL

Education & Marketing HG

RDH HG

Electronic Health Records

RDH HL NW RDH

TW NW RDH

Electronic Services NW

Emergency Care

Foundation Task Force HG

Fresh Look Taskforce

AB NW MA

HL7 Activities with other SDOs

RDH TW HG MA

RDH

Health Care Devices GG GG Implementation Technology Specification GG

Infrastructure and Messaging

International Council

TW HG NW RDH VM SC DR MA

RDH

International Membership & Affiliation Task Force (IMATF) RDH RDH


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Working Group Sat Sun Mon Tue Wed Thu Fri Joint Initiative Council (JIC) liaison TW RDH

Laboratory

Mobile Health (mHealth)

RDH VM GG MA AB

TW

Marketing Council Modelling and Methodology (MnM) GG GG GG HG

Orders and Observations DR

Patient Administration NW GG

NW NW NW

Patient Care

HL SC DR

HL SC

GG HL SC MA

HL SC

Patient Safety

Pharmacy

SC SC MA VM GG NW SC

Physicians DR

Policy Advisory RDH

Public Health Emergency Response

GG DR

MA

Publishing MA Regulated Clinical Research Information Management (RCRIM)

NW NW NW

RIMBAA GG

SAIF Architecture AB

Security TW

MA TW TW

VM TW

Services Oriented Architecture

AB GG VM DR

AB VM DR

TW VM

AB DR

VM

Structured Documents

GG VM VM DR

HG HL NW MA

NW RDH

Templates

HL AB GG RDH SC

Terminfo Project / Terminology HG

Tooling HG HG VM


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Working Group Sat Sun Mon Tue Wed Thu Fri US Government Projects ** This WG has officially been disbanded **

Vocabulary

HG HG HG HG VM DR MA

HG

CIMI – Clinical Information Modelling Initiative

GG & HL – present at the 3 day meeting in San Francisco 10, 11, 12 May RDH – by videoconference from Vancouver Fri 11th May

Tutorials are also offered and these are of great value both to new comers and to older hands to bring them up to date on generic changes made that may not be discussed in their individual committee areas. At this meeting 34 tutorial sessions were held concurrently with 61 work group and task force meetings.

The number of concurrent sessions makes it difficult for a small delegation to effectively follow all the issues and to influence change. It is noted that delegates funded by their employer, or individually, to international meetings have no obligation to work with or relate information back to the Australian delegation, though some have done so in the past. It is clearly desirable that there be a cohesive Australian position.

Given the participatory nature of the HL7 committee work, it is vital that Australians are present and participate in the committee work. Intensive work is done in the committees and often 2 or 3 Australian subject matter experts are required to get the Australian requirements into the consensus-based processes. In most cases, beforehand preparation of "Australian positions" on the matters to be worked on is not effective, as the discussions and views often substantially change during the consensus-building process. Most of the work done in committee is "leading edge" standards development work that often cannot be locally previewed, assessed and commented on beforehand. As a result, the selection process of the funded participants focuses on their expertise and interests as well as their ability to effectively communicate complex technical issues and achieve the desired outcomes for Australia in a collaborative consensus-based committee environment.

As is customary, the Australian participants met on a daily basis to plan and monitor its involvement, identify any additional sessions and/or activities that should be covered and to identify emerging issues - particularly those that are relevant to the Standards Australia IT-014 and/or NEHTA work plans. Australian participants also coordinate their activities through Skype.

1.4 RECOMMENDATIONS ARISING FROM THE MEETING The principal issues/actions and recommendations identified by the Australian delegation at the May 2012 HL7 Meeting are summarised in this section. The alignment to the IT-014 Committee Structure is also listed.


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Topic Issue / Action / Recommendations for Australia Recommended for Action by

Advisory Council input

HL7 Advisory Council comprises of a select group of senior executives that provide strategic input to the HL7 Board and the HL7 executive team. The council has been an important influence on HL7 becoming more professional organisation and provides access to the thinking of major stakeholders about HL7 and the environment in which it operates. Richard Dixon Hughes has been Co-Chair of the Council since January 2010.

Action: HL7 Australia and other Australian interests to advise Richard Dixon Hughes of any matters of potential general strategic importance to HL7 International that might usefully be the subject of advice from the Advisory Council to the HL7 Board.

HL7 Australia

IT-014

Others as appropriate

Affiliate Agreement Task Force (AATF)

As version 14 of the affiliate agreement was negotiated, agreed and executed by all parties in April 2012, the AATF has concluded that for the time being, it’s task and has been disbanded.

Action: HL7 Australia to continue to monitor the adequacy of the HL7 affiliate agreement and to advise International Council of any required changes in future revisions.

Action: IT-014 Secretariat to remove "Affiliate Agreement Task Force (AATF)" from the delegate responsibility lists and report template for future delegations.

HL7 Australia

IT-014 Secretariat

WGM Report Coordinator

Affiliate Agreement Task Force (AATF):

Use of HL7 IP in Australian Standards

HL7 Australia and Standards Australia to complete the update and renewal of their agreement to support the continued use of HL7 International IP in the production and publication of Australian implementation guides as Australian Standards (and related publications).

Action: HL7 Australia and Standards Australia to finalise drafting and continue with the negotiation of a suitable affiliate agreement for 2012 thru 2013 and other arrangements with the aim of facilitating the continued availability of HL7 materials in Australia under reasonable commercial terms and allowing the continued publication of HL7 Implementation Guides as Australian Standards.

HL7 Australia

Standards Australia (General Counsel)

Affiliate Due Diligence Committee

Continuing support by L7 Australia of the work of the Affiliate Due Diligence Committee (ADDC) through Richard Dixon Hughes as an active member.

Action: HL7 Australia to note and monitor progress with ADDC activity at HL7 International

HL7 Australia

Richard Dixon Hughes

Architecture Review Board (ARB):

Service Aware Interoperability Framework (SAIF)

The development of a capability model for SAIF will allow greater realisation of maturity of interoperability.

Action: Share NEHTA interoperability capability and maturity work with ARB.

NEHTA


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Arden Syntax:

Version 2.9

Arden Syntax is a mature standard, commercially deployed, and whose uses include immunization scheduling where it is being used in more advanced research programs.

Action: IT-014-13 should review Arden V2.9 and consider its applicability in Australian CDS systems. It should also review the 3.0 version of Arden currently under development and take part in its ballot. It should include Arden in the projects being considered for funding for CDS projects, and for possible use in an Australian Immunisation project.

IT-014-13

HL7 Board West Wireless Health Institute is a significant philanthropic enterprise dedicated to lowering the cost of healthcare through the development of innovative technology, with a strong focus on mobile communications, body area networks and the like.

Action: Richard Dixon Hughes to put West Wireless Institute and HISA Digital Hospital Design SIG in contact with each other.


(Completed)

CBCC/Security:

Data Segmentation for Privacy

The data segmentation for privacy is a framework that is being cited by several HL7 workgroups including CBCC/SEC and SOA.

Action: Monitor the use of the S&I Framework across the HL7 workgroups for potential application to the Australian environment.

IT-014

CDS: Clinical System capabilities to enable Services Oriented CDS operation

CDS requires the ability for applications and component services from specialised vendors and knowledge authors to integrate with larger point-of-care systems. One Australian proposal to IT-014-13 seeks to address this problem and will benefit from the work of this project.

Action: HL7 Delegates to ensure that this progresses to an HL7 informative document. The project be used as a key input resource to the relevant proposed IT-014-13 project

IT-014-13

HL7 Delegates involved in CDS

CDS:

FHIR

RIM modelling has not satisfied many of CDS requirements and FHIR has the potential to address these from the start. CDS requires models for application data and process integration as well as for clinical and biological phenomena. Models need to be simple and readily understandable by vendors and knowledge authors from outside HL7, where FHIR is significantly aimed.

Action: Include CDS information resource requirements for Australia as part of the IT-014-13 projects currently proposed. Liaise with the FHIR development team and monitor progress. Suggest CDS-based FHIR resources for initial development as part of the HL7 international work.

IT-014-13

Australian FHIR project lead


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CDS: Immunisation Evaluation and Forecasting

Immunisation is difficult for GPs and vaccination teams to tailor to patients’ needs when they drift off schedules. There are significant groups of children who are not adequately immunised. CDS can aid immunisers in achieving target immunity.

Action: IT-014-13 should review Australian Immunisation CDS availability and needs as recognised by GPs, Immunisation Registries, and State Jurisdictions providing immunisation recommendations including exception advice. Participation in the international work should be offered to these groups. IT-014-13 should consider immunisation logic and service interfacing for a specific new project which could leverage the multiple immunisation CDS projects at HL7 and openCDS.

IT-014-13

Standards Australia

CDS: Implementation Guide for CDS

There are multiple overlapping standards for CDS from HL7 and other organisations, with a non-obvious path for implementers and knowledge authors commencing product development or selecting from among components. IT-014-13 has a project proposal which involves development of roadmap and gap identification. This project would both resource and benefit from the Australian work.

Action: IT-014-13 should support the proposal, work on its scope statement, and actively participate.

IT-014-13


CDS:

Infobutton Standards for Enhanced Context and URL-based implementation

The Infobutton standards are an implemented, relatively simple solution for applications to obtain increasingly contextually relevant information from EHRs to enable CDS and issue-targeted patient education material.

Action: Review these standards with the CDS community in Australia to assess their applicability to our systems and stakeholder requirements.

IT-014-13

CDS: openCDS

The project is implementation-focussed, open, and provides excellent insight into HL7 CDS standards as well as related SOA and clinical data representation resources.

Action: Work to be reviewed against Australian needs, and be used as a resource in two of the planned Standards Australia CDS projects where it will provide important background resources, and relayed onto other Australian groups as appropriate.

IT-014-13

CDS: Order Set Publication Standard

The Order Set Standard will shortly be available as DSTU and has potential for rationalising the requesting of diagnostic and therapeutic services as well as medications. It thus has benefits for patient care and cost containment.

Action: Review the DSTU from perspectives of GP and Allied Health, expert authors, and government funders then engage other Australian organisations as found appropriate.

IT-014-13


17


CDS: Virtual Medical Record (vMR) for Clinical Decision Support

CDS systems rely on data in EHRs and on inputs and outputs in different formats. Standards for content are required to bridge this gap. An Australian group has been a leader in the development and utilisation of this standard. The vMR forms the basis of one project proposal coming through IT-014-13.

Implications for Australia: This project is important in ensuring our initiatives across messaging, CDA, EHR can be brought together to enable improved care and safety through standardised CDS.

Action: Review specification with view to appropriateness for our needs including its impact, via recent proposals at HL7 and to IT-014-13 involving V2 messaging, on IT-014-06-06 need for clinical content in V2.

IT-014-13

IT-014-06

CDS/SOA: Cross-paradigm interoperability implementation guide for Immunization

Immunisation is monitored and recommended by GP point-of-care systems, but the underpinning knowledge is complex and expectedly difficult for general system vendors to provide. Jurisdictions and health advisory bodies provide guidelines for this and some have in the past provided on-line recommendations including in the problematic areas of catch-ups. A group of standardised services available to point-of-care applications could improve overall achievement of immunisation targets. Australia could benefit from international resources being committed here.

Action: IT-014-13 to consider a project to bring Australian requirements into this work with view to deployment into point-of-care systems, immunisation registries, and knowledge source applications.

IT-014-13

MSIA

Jurisdictions

Immunisation Guideline Authorities

Conformance and Guidance (CGIT):

HL7 Vocabulary Binding Syntax

ISO 17583 draft ‘Health Informatics: Terminology constraints for coded data elements expressed in ISO harmonised data types in healthcare information exchange’ will be circulated shortly for comment.

Action: Distribute draft for Australian comment when available.

NEHTA CCA

IT-014

Conformance Task Force


HL7 V2.8 Conformance Requirements

Significant work has been completed on how conformance requirements for required and optional fields should be specified in HL7 V2. This is also relevant to CDA conformance testing.

Action: Distribute draft material to the NEHTA and the CCA Governance Group.

NEHTA

CCA Governance Group



The final ballot cycle for HL7 V2.8 Conformance Requirements will occur in September.

Action: Prepare and submit ballot responses prior to next WGM in September.

HL7 Australia

Standards Australia


HL7 V2 table content quality review and V3 / CDA harmonisation

Aligning code sets, value sets, and vocabulary models used in V2 and V3/CDA is required to facilitate interoperability. Australia has strong use of V2 and CDA as its key component in the PCEHR.

Action: IT-014-06 need to consider resolution of similar issues.

IT-014-06


18



XML V2 representation HL7 Project 825

“XML V2 representation HL7 Project 825” was recently published and should be distributed to the appropriate Standards Committees and industry.

Action: Notify Standards Committees and industry that this updated document is available.

IT-014-06

MSIA

Education HL7 Australia is considering how to work with New Zealand and possibly Singapore to promote education activities in the region and for their members.

Action: HL7 Australia to progress development of structured HL7 education offerings in collaboration with New Zealand and possibly Singapore.

HL7 Australia

Education and Marketing:

Communication and development of understanding and skills

Australia still has no strategy related to HL7 or Standards Australia products in general. DEEWR Industry Skills Council’s funding to develop competency and skill sets to support certification could be leveraged to develop a strategy.

Action: JSCHIS to consider the possibility of representation on the DEEWR Industry Skills Council.

Action: HL7 Australia to consider how they could add to their existing excellent general information sessions in order to develop more serious certified education programs within the Australian education system and where possible leverage international opportunities and partnerships.

JSCHIS

HL7 Australia

Electronic Health Record (EHR):

HIE metadata

There is a lack of clarity on the purpose of use of the metadata in the EHR and its potential impact on Australian adopted models.

Action: Monitoring and input to the project by Australia from those with knowledge of the Australian EHR format and use is required from both the clinical and security perspectives.

IT-014

NEHTA


EHR-S FIM

The EHR Function and Information Models, the existence of which is little known in Australia, would have value to both Purchasers and Developers.

Action: Increase Awareness of the EHR System Functional Model.

HL7 Australia

MSIA


Allergies and Intolerances

Despite the presence of Australian Co-Chairs driving this project, its visibility to Australian Software Developers is limited at best.

Action: Increase awareness of this Domain Analysis Model.

HL7 Australia

MSIA


19


Electronic Services:

HL7 Ballot Site Education Tutorial

As an International Affiliate, HL7 Australia votes as an entity for all its members. Over the past few years, HL7 Australia has not voted in a number of ballots and there has been some loss of knowledge regarding the balloting process.

As the significant majority of ballots have been related to HL7 Version 3 technology, there has been little interest in the Australian HL7 community in these ballots. Exercising its votes is one of the significant levers that HL7 Australia can use to influence international standards development in the international HL7 stage and requires renewed focus and energy.

Action: Increase knowledge of HL7 International Ballots in Australia.

HL7 Australia


New HL7 Web site

The HL7 Australia website is in need of a significant overhaul. There does not appear to be the level of analytic data available to HL7 Australia to better understand its member’s interests.

Action: Redevelop the HL7 Australia Website.

HL7 Australia

Fresh Look Task Force

The "Fresh Look Task Force" is one of several activities that emerged from the V2/V3/CDA Task Force but is now a separate activity in its own right. It has yet to be separately listed on the Australian delegate task allocation list and have its own section in WGM reports instead of being listed as an incidental inclusion under "V2/V3/V4 Task Force", which ceased to exist over 12 months ago.

Action: IT-014 Secretariat to include "Fresh Look Task Force" as a separate activity in the delegate responsibility lists and report template for future delegations.

Standards Australia


FHIR All rights in the FHIR resources (formerly RfH -Resources for Health) have been donated by Graham Grieve to HL7 in order to provide a simplified technology platform, compatible with current service oriented approaches, for rapid implementation of HL7 (and other) artefacts in the eHealth domain. This is a highly significant development of which all members of the Australian eHealth community should be aware, particularly given its Australian origins. It is time for local awareness in Australia to be raised and engagement in the potential use and development of this resource.

Action: HL7 Australia to raise awareness of FHIR technology and initiate discussion related to its potential application, development and use in the Australian context.

HL7 Australia


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International membership & Affiliation Task Force (IMATF)

The IMATF is considering the medium to long-term membership structure of HL7 and its affiliates. These discussions overlap the HL7 Board consideration of its forward business plan and potentially impact the role of HL7 Australia and the benefits currently received by its members and the Australian eHealth community.

Action: HL7 Australia to continue engagement on the HL7 membership model through IMATF with a view to ensuring Australian stakeholders can continue to obtain HL7 membership benefits cost-effectively and have their interests in HL7 represented locally and at the global level.

HL7 Australia




Richard Dixon Hughes has been asked to lead a study into comparative membership structures across the affiliates and assist in proposing new categories for licensing intellectual property.

Action: Richard Dixon Hughes to finalise and issue survey of affiliate membership classes and privileges for IMATF.


International membership & Affiliation Task Force (IMATF) Review of licensing classes

Richard Dixon Hughes to complete analysis of potential HL7 licensing classes.

Action: Richard Dixon Hughes to assist Diego Kaminker (Argentinian Board Member) with development of revised licensing classes to put forward for use in the HL7 IP policy, membership agreements and affiliate agreements.



While mobile health has not yet emerged as a priority for Australia, there is a considerable and growing international interest in its many facets, which is relevant to HL7 as a member of the global eHealth community. Australian interest in health devices is growing and this is an area that may be impacted by developments in mHealth standardisation. Australia should encourage collaboration and harmonisation of mHealth standards and interoperability of mHealth applications with each other and with mainstream applications including EHR and PHR systems.

Action: IT-014 and HL7 Australia to monitor progress of mHealth and developments in mHealth standards more generally with a view to ensuring Australian interests are informed and to encourage collaboration between HL7 and other groups seeking mHealth Standards.

IT-014

HL7 Australia

Modelling and Methodology (MnM):

FHIR

Australia needs to consider whether a position on FHIR is required.

Action: Consider this at the next HL7 Australia meeting.

HL7 Australia


FHIR – Vocabulary Requirements

Action: Australian HL7 stakeholders should consider the impact and requirements for terminology binding specification to meet Australian needs.

HL7 Australia

Patient Administration:

GS1

There is limited awareness of the GS1 Patient ID proposal/standard among Australian Medical Software Developers.

Action: Increase awareness of GS1 Patient Identifiers.

HL7 Australia

MSIA


21



GS1

There is no MOU between HL7 Australia and GS1.

Action: Recommend that HL7 Australia explore an MOU with GS1.

HL7 Australia

Patient Care:

Allergies and Adverse Reactions

Sharing of Allergy/Intolerance information is critical for good patient care and safety. This work will enable sharing of this information in a standardised and computable way that enables true interoperability.

Action: Australian delegates to HL7 should continue to be involved in steering this work to make sure that it fits with the needs of the Australian health community.

Standards Australia

HL7 delegates

Patient Care: Allergies and Adverse Reactions

This project is of interest to IT-014-06-04, IT-014-06-06 and the newly established IT-014-13.

Action: Australia, in particularly NEHTA and the relevant IT-014 subcommittees and working groups, should continue to provide leadership and contribution to the completion of this very important project.

IT-014

IT-014-06-04

IT-014-06-06

IT-014-13

NEHTA Patient Care:

Harmonisation of the Patient Administration Encounter Model

While Australia is not using HL7 V3 models, it is useful to follow this issue as encounter models are an important part of any health IT system.

Action: Continue to observe the outcome of the HL7 V3 models issue.

Standards Australia

Patient Care:

Detailed Clinical Models

Clinical modelling is a vital activity for Australia to be involved in. The HL7 DCM approach at this time is flawed and is likely to be subsumed by the CIMI work. FHIR also bears watching in this area.

Action: Australia should continue to watch developments in CIMI for clinical modelling approaches. The HL7 work should be observed.

Standards Australia

Patient Care:

Care Plan Topic

While the HL7 V3 output from this work is unlikely to be used in Australia, the DAM is likely to be a useful piece of work to inform modelling in this area.

Action: Australia should continue to monitor this work item.

Standards Australia

Patient Care:

Care Plan Project

The Care Plan project work has important relevancy to IT-014-06-06 and IT-014-13.

Action: Australia, through NEHTA and relevant IT-014 subcommittees and working groups, should continue to lead and contribute to the development of a care plan structure and exchange standards. Jurisdictional participations will also be important and useful.

IT-014

IT-014-06-06

IT-014-13

NEHTA

Pharmacy:

Patient Medication Queries

Action: This project is of significant interest and importance to Australian ehealth agenda. NEHTA and IT-014 subcommittees and working groups, IT-014-06-04, IT-014-06-06 and IT-014-13, should monitor the progress of this project and actively contribute to the development of the models and infrastructures.

IT-014

IT-014-06-06

IT-014-13

NEHTA


22


Pharmacy:

V3 Nutritional Order Clinical Message

Australia currently does not have an ehealth work program on nutrition assessment and orders. NEHTA has received contacts from the Dietician Association of Australia (DAA) on the use of the International Dietetics and Nutrition Terminology (IDNT) to support nutrition assessment and order. NEHTA will introduce the DAA members to work currently being done and planned by the HL7 Nutrition group.

Action: Australia will need to keep a close watch on the development of nutrition models and contribute where appropriate.

IT-014

NEHTA

Physicians Group:

Exposure and New Membership

The Physicians Group is new and not well known to Australian Physicians. By focussing on standards compliance in meeting physician needs, application deployments will better serve the care process capabilities of deployed health IT.

Action: Advice Australian Medical colleges of the existence of the group and its potential for their members to invite their submission of needs to the delegation, and their ability to be part of this if appropriate.

IT-014 (to its relevant member organisations)

RACGP National e-Health Steering Committee (DR is member and will action this)

Physicians Group:

Addressing Australian needs, Delegate involvement

Physicians need to be more active in requirements development and the Physicians Group can address the needs of Australian physicians if they bring requirements to HL7.

Action: All the physician delegates to be strongly encouraged to attend this new WG meeting at the next HL7 meeting. Standards Australia to add Physicians Group to HL7 Delegates Allocation List.

Standards Australia

HL7 Physician Delegates

RCRIM:

BRIDG as a DAM

Australia does not appear to have active participation in the development of the BRIDG model.

Action: Increase Awareness of BRIDG and CDISC more generally in Australia.

HL7 Australia

MSIA

ANZCTR

RCRIM:

CTR&R

There is no known Australian participation in this project. Does Australia leverage International initiatives in the registration of Clinical Trials?

The Australian equivalent to the US ClinicalTrials.gov and European EudraCT sites is ANZCTR – Australian New Zealand Clinical Trials Registry (www.anzctr.org.au).

Action: Inform ANZCTR of this project, and invite and encourage participation.

NEHTA

DoHA

ANZCTR

Security Workgroup:

Security and Privacy Ontology - Project No: 646

This ontology is at present quite immature and requires wider consideration for its international application and specifically for Australia.

Action: Increased review and engagement by IT-014-04 members on this and subsequent ballots.

IT-014-04

Security:

New Co-Chair

Dr Patricia Williams, member of the Australian delegation, was appointed new Co-Chair of the Security WG.

Action: For noting as Australian leadership engagement.

IT-014


23


SOA:

Cross Platform Interoperability Implementation Guide for Immunisation.

Sponsor SOA, co-sponsor with PHER, ArB.

Output from this project is likely to be useful in the Australian context.

Action: Keep the clinical decision support community updated with approach and progress to inform Australian CDS projects.

IT-014-13

SOA/Pharmacy:

Medication Statement Service

The proposed Medication statement service will be balloted in the September 2012 Ballot cycle.

Action: Ensure relevant groups are aware of ballot, and comments are submitted.

HL7 Australia

IT-014-06-04

NEHTA Terminology Services

SOA:

Healthcare and Community Services Provider Directory Service (HCSPD)

Endpoint Location Service (ELS) is to be published through the OMG.

Action: Australia should support the ELS work in the OMG.

NEHTA

SOA:

SOA Service Ontology

SOA is currently working with NEHTA, Canada Infoway and Kaiser Permanente to develop use cases, structure and content of the SOA Service Ontology.

Action: NEHTA to continue to be involved in the development of the ontology content.

NEHTA

SOA: Patient Care Services Co-ordination Project

Care planning and specialised modules for clinical care support can be optimally delivered to, and integrated within, point of care deployments through a SOA framework. Australian delegates have been working through SOA and Patient Care for a general solution to this but have been hampered by lack of resources. Resourced supporters have now come forward for a care co-ordination solution that also includes services for specific components of the care process. This project has the potential to accommodate much if not all of our requirements. The RACGP is revisiting functional specifications for primary care which in new developments would be service oriented.

Action: Ensure that the Project Scope Statement is sufficiently broad to accommodate the needs already identified by the Australian delegation for point-of-care clinical services specification and involve local stakeholders in the project.

IT-014-06-06

IT-014-13

MSIA

RACGP

SOA:

PASS

There should be revision of the PASS DSTU scope to include data tagging and labelling (data segmentation).

Action: When scope is available for discussion, Australia to review to ensure it is sufficiently international to be relevant for future use in Australia.

IT-014


24


Structured Documents:

HL7/IHE Consolidated CDA Implementation Guide

There is a proposed new work item for a CDA document type specific to patient entered data. This is relevant to the PCEHR.

Action: Contribute to new work item in view of Australian current work and experience in this area.

NEHTA

IT-014-06-06

Structured Documents: Health Quality Measure Format (HQMF) Implementation Guide

This is relevant to CDS in population-based applications and knowledge development that also affects pro-active care and resourcing. EHR systems need to be appropriately structured to represent quality measures, especially to support queries around these.

Implications for Australia: This will provide input to EHR requirements for quality and CDS.

Action: Monitor the project to gain a clearer picture of how process and outcome–based quality measures are query able when represented in EHRs and used for CDS.

IT-014

IT-014-13

Templates:

HL7 Template ITS Pilot

The Template ITS pilot project should be of interest to Standards Australia IT-014-06 subcommittees and PCEHR program group developing template services.

Action: Increase awareness of this project, and Australia to consider for potential contribution.

IT-014

IT-014-06

NEHTA

Vocabulary:

Vocabulary Facilitators

Action: HL7 Australia to advise Vocabulary Work Group member for Australia of national requirements for facilitators.

Action: HL7 Australia to consider how we manage these requirements in Australian Standards production.

HL7 Australia

Vocabulary:

Development of Terminology Authority for HL7

As the development of a terminology authority for HL7 offers the ability to use more standardised and accessible terminological content for HL7 purposes, both nationally and internationally, this item is considered to be important to all organisations.

Action: Australia to support the development of a terminology authority and IT-014 to monitor work in this area.

HL7 Australia

IT-014

Vocabulary: Use of IHTSDO workbench for HL7 Content

Action: Ongoing contribution and reporting is required to ensure that HL7 Australia and IT-014-06 are aware of progress in this area.

HL7 Australia

IT-014-06

Vocabulary:

Common Terminology Server 2

Action: Consider how these updates and international trials impact Australia's potential use of this work.

NEHTA


25


Vocabulary/SOA:

Clinical Terminology Service (CTS2)

The French have deployed a Terminology (view only) Service for their Medicines terminology using CTS2. Their approach is documented at:

http://wiki.hl7.org/index.php?title=File:Phast_STS_brief_description_May14_2012.pdf

Action: Australia to review this work as it may provide information for an Australian approach to deployment of AMT.

NEHTA Clinical Terminology

IT-014-06-04

IT-014-02

Vocabulary:

Development of Terminfo use cases

Action: Consider whether Australia wishes to actively contribute to use case development.

Action: IT-014-06-05 to consider any specific issues related to existing standards that might require modification or which could provide input to the use cases.

Action: Consider whether Australia can contribute any information from our existing implementation guides.

NEHTA

IT-014-06-05

Vocabulary/Tooling: National Library of Medicine Request Submission System

Action: Raise awareness of this tool within HL7 Australia community and IT-014-02 through circulation of web address.

Standards Australia

Vocabulary:

Terminology Binding

Action: Consider the impact of these issues of binding syntax in CDA documents under development and published in Australia.

NEHTA

IT-014-06

Clinical Information Modelling Initiative (CIMI)

Clinical modelling is of vital importance to the eHealth program in Australia.

Action: Australia to continue to be involved and support the work of the CIMI group.

NEHTA

Standards Australia




26

1.5 FUNDING SOURCES SUMMARY AND AUSTRALIAN ATTENDANCE

Eleven Australians attended as representatives for the duration of this HL7 meeting, nine of whom were in the formal ‘delegation’. The funding source for these delegate numbers is indicated in the table below.

DOHA provided funding assistance for the following delegates:

Heather Grain

Patricia Williams

Vince McCauley


Hugh Leslie

Graham Grieve

David Rowed

Nat Wong

Meya Achdiat

Funding Source Number Change from Previous meeting

Full funding by employer: Private 0 -2

Full funding by employer: States/Territories or National Initiatives (NEHTA) 2 -4

Funding assistance – DOHA through Standards Australia contract 9 +1

Total: 11 -5

There was a team of delegates from NEHTA who attended the HL7 meeting and these NEHTA delegates are listed below:

• Andy Bond

• Stephen Chu


27

1.6 AUSTRALIAN LEADERSHIP POSITIONS The table below lists leadership positions held by Australians at the HL7 meeting in May 2012.

Attendee Position (held at the meeting)

Funding Source Work Group or Committee

Heather Grain Co-Chair Invited Member

Standards Australia via the DoHA Funding Agreement

Vocabulary Policy Advisory Committee

Grahame Grieve

Co-Chair Co-Chair Member


Structured Documents Modeling and Methodology Architecture Review Board

Hugh Leslie

Co-Chair Standards Australia via the DoHA Funding Agreement

Patient Care


Co-Chair Non-Voting Member Chair HL7 Australia Invited Member Invited Member Nominated Chair-elect


Advisory Council to the Board of HL7 International HL7 International Board of Directors International Council and Affiliate Chairs Meetings, Affiliate Agreement Task Force (AATF), International Membership & Affiliation Task Force (IMATF) Affiliate Due Diligence Committee (of HL7 International Board) Policy Committee (of HL7 International Board – invited by HL7 Chair) Joint Initiative Council (JIC) for Health Informatics SDO Harmonisation

Vincent McCauley

Co-Chair (newly elected)


Service Oriented Architecture

Trish Williams Co-Chair (newly elected interim)


Security

Andy Bond Member ARB NEHTA ARB Stephen Chu Co-Chair NEHTA Patient Care


28

1.7 ACRONYM LIST

Abbreviation Meaning ACCC Australian Competition and Consumer Commission

ACMA Australian Communication and Media Authority

ACSQHC Australian Commission on Safety and Quality in Health Care

ACT Action

ACTUG Australian Clinical Terminology Users Group

ADA-JDA Australian Design Award James Dyson Award

ADL Archetype Definition Language

AG Advisory Group

AGDA Australian Graphic Design Association

AHIEC The Australian Health Informatics Education Council

AHIMA American Health Information Management Association

AHMAC Australian Health Ministers' Advisory Council

AHML Australian Healthcare Messaging Laboratory

AIDA Australian International Design Awards

AIHW Australian Institute of Health & Welfare

AIIA Australian Information Industry Association

AMT Australian Medicines Terminology

ANSI American National Standards Institute

ANZCTR Australia New Zealand Clinical Trials Registry

ArB Architecture Review Board

AS HB Australian Handbook

AS/NZS Australian/New Zealand Handbook

AS/NZS ISO International Standards adopted by Australia and New Zealand

AU Australia abbreviation in the Int'l comment form

AWI Approved Work Item

BAU Business As Usual

BCA Building Codes of Australia

BRS Business Requirements Specification

BRIDG Biomedical Research Integrated Domain Group

BRIDG is a collaborative effort of CDISC, the HL7 RCRIM WG, the (US) National Cancer Institute (NCI), and the US Food and Drug Administration (FDA).

Cal-X The California Exchange (Cal-X) is a data and information exchange to support healthcare, medical, public health, and homeland security needs in a collaborative, shared, secure, and cost-effective manner.

COPOLCO Consumer policy committee [ISO]

CASCO Conformity Assessment


29

Abbreviation Meaning CBCC Community Based Collaborative Care [HL7 Workgroup]

CCD Continuity of Care Document

CCHIT (US) Certification Commission for Health Information Technology

CD Committee Draft (third stage in developing an ISO or IEC standard)

CDA Clinical Document Architecture

CDC Centre for Disease Control (US Government agency)

CDISC Clinical Data Standards Interchange Consortium

CDS Clinical Decision Support [HL 7 Workgroup]

CDV Committee Draft for Vote

CEN European Committee for Standardization (Comité Européen de Normalisation)

CENELEG European Committee for Electrotechnical Standardisation

CEO Chief Executive Officer

CGIT Conformance and Guidance for Implementation and Testing Committee

CIC Clinical Interoperability Council [HL7 Workgroup]

CIMI Clinical Information Modelling Initiative

CIS Clinical Information Systems

COAG Council of Australian Governments

COM Comment

conHIT2011 European Health Informatics Conference 2011

ContSys System of Concepts for Continuity of Care

COR Corrigendum [to a Standard]

CRM Customer Relationship Management

CTO Chief Technical Officer

CTR&R Clinical Trials Registration and Results

DAFF Department of Agriculture, Fisheries and Forestry

DAM Domain Analysis Model (comprehensive model of a domain) [HL7]

DAM Draft Amendment [Standards Australia]

DCM Detailed Clinical Model

DCOR Draft Corrigendum

DEVCO Developing country matters

DIA Design Institute of Australia

DICOM Digital Imaging and Communications in Medicine

DIISR Department of Innovation, Industry, Science & Research

DINZ Design Institute of New Zealand

DIS Draft International Standard (fourth stage in developing an ISO or IEC standard – the main opportunity for public input)

DMP Dossier Médical Partagé (Shared Medical Record) (France)

DoHA (Australian Government) Department of Health and Ageing


30

Abbreviation Meaning DSTU Draft Standards for Trial Use (HL7 and ANSI)

DTR Draft Technical Report [ISO and Standards Australia]

DTS Draft Technical Specification [ISO and Standards Australia]

EC European Commission [the administrative arm of the EU]

ECCF Enterprise Compliance and Conformance Framework

EEC European Economic Community

EFMI European Federation of Medical Informatics

EHR Electronic Health Record

EHR-FM EHR Functional Model

EHRS or EHR-S Electronic Health Record System

ELGA Austrian CDA Implementation Guide in Development

ELS End Point Location Service

EMEA European Medicines Agency

EN European Standard (Européen Norm)

ENA Energy Networks Association

EPM Enterprise Project Management

epSOS European Patients Smart Open Services.

A European initiative (23 countries) to exchange pharmacy and EHR information including prescriptions, across the EEC using IHE profiles and local standards. See www.epsos.eu

ETP Electronic Transfer of Prescriptions

EU European Union

EudraCT European Union Drug Regulating Authorities Clinical Trials

FCD Final committee draft

FDAM Final Draft Amendment

FDIS Final Draft International Standard (for vote to publish) [ISO]

FHIR Fast Health Interoperability Resources [HL7]

FRS Functional Requirements Specification

FYI For your information

GCM Generic Component Model

GDP Gross Domestic Product

GP General Practitioner

GS1 An international SDO – primarily in the supply-chain domain

GVP Good Pharmacovigilance Practices

HCD Health Care Devices Committee

HDF HL7 Development Framework

HI Health Identifiers

HIE Health Information Exchange

http://www.epsos.eu/


31

Abbreviation Meaning HIMSS Healthcare Information and Management Systems Society

HISC Health Informatics Standing Committee

HITSP Health Information Technology Standards Panel

HL7 Health Level Seven (International)

HL7 ELC HL7 E-Learning Course

HPI Healthcare Provider Identifier

HPI-I Healthcare Provider Identifier for Individuals

HPI-O Healthcare Provider Identifier for Providers

HQMF Health Quality Measure Format

HSSP Healthcare Services Specification Project [joint HL7/OMG]

IC International Council (HL7)

ICD10AM The Australian NCCH modification of ICD-10 code set for the coding of diseases and procedures

ICD10-AM International Classification of Diseases, Version 10, Australian Modification

ICD9CM International Classification of Diseases 9 Clinical Modification

ICH International Conference on Harmonisation (of Technical Requirements for Registration of Pharmaceuticals for Human Use)

ICHPPC International Classification of Health Problems in Primary Care

ICNP International Classification for Nursing Practice

ICOGRADA International Council of Graphic Design Associations

ICPC2+ International Classification of Primary Care 2

ICSID International Council of the Societies of Industrial Design

ICSR Individual Case Safety Report [related to Medicines/Devices]

ICT Information & Communications Technology

IDA International Design Alliance

IDEA Industrial Design Excellence Awards

IDMP Identification of Medicinal Products

IDSA Industrial Design Society of America

IEC International Electrotechnical Commission (an international SDO)

IEEE Institute of Electrical & Electronic Engineers (US) (also an SDO)

IF International Forum of Design

IFI International Federation of Architects/ Designers

IG Implementation Guide

IHE Integrating the Healthcare Enterprise

IHI Individual Healthcare Identifier

IHTSDO International Health Terminology Standards Development Organisation

IMATF International Membership and Affiliation Task Force

InM Infrastructure and Messaging [HL7 Workgroup]


32

Abbreviation Meaning IP Intellectual Property

IS International Standard

ISO International Organization for Standardization

ISO/CS ISO Central Secretariat

ISO/TC 215 ISO Technical Committee (Health Informatics)

IT Information Technology

IT-014 Standards Australia Committee IT-014 (Health Informatics)

ITS Implementable Technology Specifications

ITTF ISO/IEC Information Technology Task Force

ITU-T International Telecommunications Union – Standards Division

IXS Identity Cross Reference Service

JI Joint Initiative on SDO Global Health Informatics Standardization

JIC Joint Initiative Council (responsible for governance of the JI – with current members being ISO/TC215, CEN/TC251, HL7 International, CDISC, IHTSDO and GS1)

JIDPO Japanese Industrial Design Promotional Organisation

JSC-HIS Joint Standing Committee on Health Informatics Standards

JSON Java script Object Notation

JTC Joint Technical Committee

JTC 1 ISO/IEC Joint Technical Committee 1 Information Technology

JWG Joint Working Group

KPI Key Performance Indicator

LB Letter Ballot

LIC Low Income Country

LMIC Low and Medium Income Countries

LOINC Logical Observation Identifiers Names and Codes

LPO Local PCEHR Officer

MBS Medical Benefits Scheme

MBUA Member Body User Administrators (Person who maintain the ISO Global directory in each country)

MDA Model Driven Architecture

MIC Medium Income Country

MM Maturity Model

MnM Modelling and Methodology [HL7 Workgroup]

MOR Monthly Operational Report

MOU Memorandum of Understanding

MSIA Medical Software Industry Association

MT Maintenance committee (IEC)

NASH National Authentication Service for Health


33

Abbreviation Meaning NATA National Association of Testing Authorities

NEHIPC National E-Health and Information Principal Committee

NEHTA (Australian) National E-Health Transition Authority

NH&MRC National Health and Medical Research Council

NHCIOF National Health Chief Information Officer Forum

NHIN (US) National Health Information Network

NHISSC National Health Information Standards and Statistics Committee

NHS (UK) National Health Service

NIH (US) National Institutes of Health

NIST National Institute of Standards and Testing (USA)

NMB National Member Body [of ISO or CEN]

Normapme European Office of Crafts, Trades and Small and Medium sized Enterprises for Standardisation

NP New Work Item Proposal (current ISO/IEC abbreviation)

NPACC National Pathology Accreditation Advisory Council

NPC National Product Catalogue

NQF National quality (measures) framework

NSO National Standards Office

NWIP New Work Item Proposal (obsolete ISO/IEC abbreviation – see "NP")

O&O Orders and Observations [HL7 Workgroup]

OBPR Office of Best Practice Regulation

OCL Object Constraint Language

OHT Open Health Tools Foundation (www.openhealthtools.org)

OID Object Identifier

OMG Object Management Group

ONC Office of the National Coordinator for Health Information Technology (within US Department of Health and Human Services)

OSI Open Systems Interconnection

OTF Organisation Task Force [ISO TC 215]

OWL Web Ontology Language

PA Patient Administration [HL7 Workgroup]

PACS Picture Archive Systems

PAS Patient Administration Systems

PBS Pharmaceutical Benefits Scheme

PC Patient Care [HL7 Workgroup]

PCEHR Personally Controlled Electronic Health Record

PDAM Proposed Draft Amendment

PDF Portable Document Format


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Abbreviation Meaning PDTR (Proposed) Draft Technical Report

PHDSC Public Health Data Standards Consortium

PHER Public Health and Emergency Response [HL7 Workgroup]

PHM Powerhouse Museum

PHR Personal Health Record

PHTF Public Health Task Force

PIM Platform Independent Model

PIP Practice Incentive Payment

PIR Post Implementation Review

PKI Public Key Infrastructure

PM Project Manager

PMBOK Project Management Body of Knowledge

PMO Project Management Office

PMP Project Management Plan

PMS Practice Management System

PMTL Project Management Team Leader

PoC Point-of-Care

PSM Platform Specific Model

PSS Project Scope Statement [HL7]

PSUR Periodic Safety Update Report

PWG Pharmacy Working Group [HL7 Workgroup]

RACGP Royal Australian College of General Practice

RCPA Royal College of Pathologists Australia

RCRIM Regulated Clinical Research Information Management [HL7 Workgroup]

RFID Radio Frequency Identification

RHIO (US) Regional Health Information Organisation

RIM Reference Information Model

RIMBAA RIM Based Application Architecture

RIS Radiology Information Systems

RLUS Resource Locate Update Service (HSSP)

RMIM Refined Message Information Model

RM-ODP Reference Model of Open Distributed Processing

RO Responsible Officer

SA Standards Australia

SAIF Services Aware Interoperability Framework

SC Subcommittee

SD Structured Document [HL7 Workgroup]

SDO Standards Development Organisation


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Abbreviation Meaning SHIPPS Semantic Health Information Performance and Privacy Standard

SIG Special Interest Group

SKMT Standards Knowledge Management Tool

SLA Service Level Agreement

SMB Standards Management Board (IEC only)

SME Subject Matter Experts

SMTP Simple Mail Transfer Protocol

SNOMED Systematised Nomenclature of Medicine

SNOMED CT Systematised Nomenclature of Medicine- Clinical Terms

SOA Service Oriented Architecture

SOAP Simple Object Access Protocol

SP3 Standards Professional Project Practitioners

STC Technical Steering Committee

T3SD Technical and Support Services Steering Division

TC Technical Committee

TCM Traditional Chinese Medicine

TCP/IP Transmission Control Protocol/Internet Protocol

TEAM Traditional East Asian Medicine – This term, though inadequate is used to represent Traditional Chinese Medicine, Traditional Korean Medicine, Traditional Japanese Medicine.

TF Task Force

TM Traditional Medicine

TMB Technical Management Board (ISO only)

TOGAF The Open Group Architecture Framework

TR Technical Report (an informative ISO or IEC standards publication)

TS Technical Specification (a normative standards publication having a lower level of consensus than a full international standard)

UAT User Acceptance Testing

UCUM Unified Code for Units of Measure [Regenstrief Institute]

UHI Unique Healthcare Identifier

UML Unified Modelling Language

UN United Nations

VMR Virtual Medical Record

VOC Vocabulary Committee [HL7 Workgroup]

W3C World Wide Web Consortium

WCM Web Content Management

WD Working Draft (second stage in developing an ISO or IEC standard)

WG Working Group or Work Group

WGM Working Group Meeting


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Abbreviation Meaning WHO World Health Organization

WI Work Item

WTO World Trade Organisation

XDS (IHE’s) cross enterprise Data Sharing protocol

XML Extensible Markup Language


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2 DETAILED RECOMMENDATIONS ARISING FROM THE MEETING

The following sections detail the meetings that were attended by members of the Australian delegation. Each section is structured as follows:

1. Working group title and acronym

2. Working group description

3. Progress at this meeting

a. General progress

b. Current projects. For each project

i. Project title and HL7 project number if applicable.

ii. Project objective or topic summary

iii. Project activity and issues at this meeting

iv. Actions for Australia


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2.1 ADVISORY COUNCIL

WORKING GROUP DESCRIPTION

The Advisory Council comprises a select group of individuals that provides strategic input to the HL7 Board. Individuals are selected for service on the Advisory Council based on their personal experience and their ability to work with others to provide useful strategic advice to the Board.

Most members of the Advisory Council are senior executives from industry, the health sector, and government and are not involved with HL7 Working Group Meetings (WGMs). The Advisory Council does not meet at WGMs but has a meeting most months by teleconference with a face-to-face meeting at the annual HL7 Board retreat, which is held in July/August each year.

In recent times, the Advisory Council has provided advice and feedback on a variety of topics, including pathways for revenue growth; engagement with major stakeholder groups including government, the health IT industry and clinicians; linking with industry to improve communications and marketing; being more business-like in the protection and management of intellectual property; and strategic planning - including review of HL7 vision, mission, objectives and processes for developing and maintaining the strategic plan and roadmap. It played a key role in moving HL7 to a more professional standards development organisation with a full-time CEO and CTO.

PROGRESS AT THIS MEETING

Richard Dixon Hughes has been Co-Chair of the Council since January 2010 and is the first person from outside the United States to perform the role. In this capacity he also participates in face-to-face meetings of the HL7 Board. At the May 2012 meeting he held discussions with the CEO of HL7 about topics on which advice from the Council might be of assistance to the HL7 leadership.

At the previous board retreat in July 2011, the Advisory Council reviewed emerging developments likely to impact HL7 and provided feedback on the elements and alternative approaches proposed as part of the new HL7 business plan approved in principle by the Board in December 2011.

Key themes featured in recent Advisory Council discussions have included:

• Measures for continued implementation of the HL7 business plan (and its focus on membership growth).

• How HL7 can more effectively communicate in a dynamic and strategically challenging competitive e-Health standards environment, including:

- Exploring means of connecting with HL7's wider stakeholder community to ensure the relevance and growth of HL7 International – with Advisory Council members among those surveyed by research consultants; and


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- Outreach to the clinical research, pharmaceutical and biotech industry sectors.

• Advising on the new "HL7 Care Connected" logo for use as a splash screen by health IT system suppliers that are members of HL7 and use HL7 standards – and donation of the skills to produce the logo (through Epic).

• Competition and collaboration between SDOs and the potential impacts on HL7 in light of changing needs.

• Promotion of mobile health as an emerging area of focus and advising on the position of HL7 in relation to other groups that have developed or are interested in mobile health standards.

• Recent discussions at Advisory Council meetings have also examined the impact of the proposed standards and regulations for the second stage of the ARRA/HITECH "Meaningful Use" regime in the United States (colloquially known as "MU2"). One of the aspects revealed in AC discussions has been the potential impact on clinicians and the potential for HL7 to work with them in seeking to resolve these issues during public comment on the proposed regulations.

• The new information strategy issued by the Department of Health in England on 21 May and its broader lessons for those involved with health information issues. While the main thrust is returning control over information management and systems to local health authorities, standards for interoperability is one of areas to remain part of the country-wide purview of the NHS. More detail on the UK strategy is available at: http://informationstrategy.dh.gov.uk/.

The Advisory Council is now preparing for its next main activity being the face-to-face meeting at the annual HL7 Board retreat in July/August.

ACTIONS FOR AUSTRALIA


Advisory Council input

HL7 Advisory Council comprises of a select group of senior executives that provide strategic input to the HL7 Board and the HL7 executive team. The council has been an important influence on HL7 becoming more professional organisation and provides access to the thinking of major stakeholders about HL7 and the environment in which it operates. Richard Dixon Hughes has been Co-Chair of the Council since January 2010.

Action: HL7 Australia and other Australian interests to advise Richard Dixon Hughes of any matters of potential general strategic importance to HL7 International that might usefully be the subject of advice from the Advisory Council to the HL7 Board.

HL7 Australia

IT-014


http://informationstrategy.dh.gov.uk/


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2.2 AFFILIATE AGREEMENT TASK FORCE (AATF) AND HL7 INTELLECTUAL PROPERTY

WORKGROUP DESCRIPTION

The affiliate agreements between HL7 International and its affiliates set out the rights and obligations of HL7 International and its affiliates and provide the legal basis under which affiliate organisations are able to operate as the HL7 affiliate in a territory, make use of HL7 International intellectual property and extend privileges of HL7 membership to their own members.

The Affiliate Agreement Task Force (AATF) was formed at the January 2011 HL7 meeting in Sydney when, after nearly 12 months of prior negotiation, the affiliates rejected the terms proposed by HL7 International for renewal of the affiliate agreement for 2011 and 2012. Aspects relating to management, control and licensing of intellectual property were of particular concern.

The AATF has been responsible for drafting a revised affiliate agreement acceptable to both HL7 International and its international affiliates. The AATF reports to the International Council and has a significant overlap of membership and interest with the International Membership and Affiliation Task Force (IMATF), which operates on a longer-term timeframe and is reported separately.

HL7 Australia has been active in the AATF since its formation and is represented at its meetings by Richard Dixon Hughes in his role as HL7 Australia Chairman.

2.2.1 FINALISATION AND EXECUTION OF UPDATED AFFILIATE AGREEMENT

PROJECT SUMMARY

In January 2011, affiliate agreements previously in place for 2009 and 2010 were extended by one year to the end of 2011, with the intention that a revised agreement would be completed by mid-2011, ready for exchange later that year for commencement on 1 January 2012 for the 2-year period 2012 through 2013.

The AATF aimed to develop and agree upon a single common set of broadly applicable terms and conditions for renewal of the affiliate agreement. A proposed Version 12 (v12) of the affiliate agreement was discussed at length at the September 2011 WGM after which it was finalised and put to a vote of the international affiliates.

Although the vote technically passed (16 affirmative, 9 negative, 2 abstain and 7 not voting), the comments submitted and the strength of the “No” vote indicated that a significant proportion of the affiliates would have problems executing v12 as circulated. Further review and editing by HL7 attorneys had also not yet been completed.


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Therefore, at its December 2011 meeting, the HL7 Board of Directors resolved to offer affiliates a further 120-day extension to their affiliate agreements (until 30 April 2012), allowing time for the AATF to propose further changes to address the 21 comments received from affiliates and for finalisation of HL7 International's legal input.

Prior to the January 2012 WGM, the AATF discussed the comments submitted by the affiliates and the legal input and prepared a revised version 13 (v13) of the affiliate agreement along with a disposition of comments, which were then discussed at considerable length at the January WGM. The main areas of change were:

• Increased affiliate control over translations;

• Exclusive rights of an affiliate in a territory may be withdrawn but only if HL7 International gives 90-days’ notice of exceptional circumstances;

• Definitions of licensing categories aligned with those in the HL7 IP Policy – with affiliates to map their membership categories to those in the IP Policy;

• Allowing the affiliate to limit the right of HL7 International and other affiliates to distribute co-owned material developed by the affiliate within the affiliate's territory;

• Absolute requirement to track downloads reduced to making reasonable efforts to track downloads;

• References to licensing terms, IP policy and other external documentation validated and updated where necessary;

• Some wording made consistent throughput the agreement; and

• Recognition that some individual instances of the agreement may vary to accommodate specific conditions (e.g. organisational structure of the Canadian Standards Collaborative; and existing provisions related to personal liability of affiliate office bearers in Luxembourg).

During the remainder of January and into early February 2012, the AATF progressively incorporated further changes sought by members of the AATF and those affiliates with concerns. Many legal drafting issues were also rectified to ensure that the agreement accurately reflected the position that had been agreed between the affiliates and HL7 International.

On 20 February, an updated v14 of the agreement was circulated to affiliate chairs for a 3-week acceptance period with ballot closing on 16 March. The ballot passed with 24 affirmative and no negative votes. There were 7 comments, which were reconciled with the assistance of the AATF resulting in version 14b of the agreement, which was recommended to the Board of Directors of HL7 International and approved by them at their meeting on 2 April 2012. There were two issues, one relating to the period of notice for changes of HL7 rules and the other relating to the rights of members, in case of termination, are to receive further consideration in subsequent revisions.

Copies of the approved final version 14b of the affiliate agreement for 2012-2013 were circulated to be executed on behalf of each affiliate and returned to HL7 International on or by 30 April 2012 (the day on which the extension on the previous agreements expired).


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HL7 Australia, along with other affiliates, has now executed the updated agreement.


With version 14 of the affiliate agreement having been negotiated, agreed and executed by all parties in April 2012, the AATF has successfully concluded its task and has been disbanded, at least for the present.

Consideration of further changes to the affiliate agreement for subsequent years will be discussed at the International Council and will need to be informed by any changes in the HL7 business plan including any changes driven by the work of the International Membership and Affiliation Task Force (IMATF).



Affiliate Agreement Task Force (AATF)

As version 14 of the affiliate agreement was negotiated, agreed and executed by all parties in April 2012, the AATF has concluded that for the time being, it’s task and has been disbanded.

Action: HL7 Australia to continue to monitor the adequacy of the HL7 affiliate agreement and to advise International Council of any required changes in future revisions.

Action: IT-014 Secretariat to remove "Affiliate Agreement Task Force (AATF)" from the delegate responsibility lists and report template for future delegations.

HL7 Australia

IT-014 Secretariat


2.2.2 LICENSING OF HL7 IP FOR USE IN AUSTRALIAN STANDARDS PUBLICATIONS

PROJECT SUMMARY

For over a decade, HL7 Australia has had a collaborative arrangement with Standards Australia (SA) under which Australian implementation guides are produced by IT-014 and published as Australian Standards® publications which are subsequently made publically available under the publishing agreement between Standards Australia and SAI Global.

Australian implementation guides contain limited amounts of HL7 International material and seek to supplement, rather than replicate, the underlying HL7 standards to which they frequently refer.

This long-standing collaborative arrangement between HL7 Australia and SA is based on requirements for the use of HL7 International intellectual property that are derived from principles set out in earlier versions of the HL7 International organisational member license and the affiliate agreement.


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As part of due diligence for accelerating the production of e-Health standards under the national eHealth program, Standards Australia requested HL7 Australia to obtain confirmation from HL7 International that these arrangements are acceptable to HL7 International and for the agreement between HL7 Australia and Standards Australia to be updated and renewed in light of changes to the affiliate agreement.

The main issues have been the terms under which HL7 Australia may utilise HL7 intellectual property, distribute it to its members and allow it to be used in the development of local HL7 implementation guides by Standards Australia that are subsequently published as Australian Standards® under arrangements with SAI Global. Some of these matters are explicitly covered in the affiliate agreement, while the practices surrounding publication of Australian Standards®

needed to be addressed by exchange of letters between HL7 Australia and HL7 International.


At previous WGMs in September 2011 and in January 2012, Richard Dixon Hughes had meetings with Chuck Jaffe (CEO) and Mark McDougall (Executive Director) about the proposed exchange of letters, the affiliate agreement and related IP issues (including the arrangements for publication of Australian Standards®).

From these meetings a form of words was agreed and the exchange of letters between HL7 International and HL7 Australia took place in March 2012 including agreement as to an appropriate copyright notice for inclusion in Australian Standards.

The final step, currently being arranged, is a letter of agreement between Standards Australia and HL7 Australia updated to reflect v14 of the affiliate agreement and the conditions agreed between HL7 Australia and HL7 International for licensing of HL7 IP for use in Australian Standards publications. Standards Australia is presently working on the required letter.

The current state of arrangements and thanks for their collaboration were conveyed to HL7 International.



Affiliate Agreement Task Force (AATF):

Use of HL7 IP in Australian Standards

HL7 Australia and Standards Australia to complete the update and renewal of their agreement to support the continued use of HL7 International IP in the production and publication of Australian implementation guides as Australian Standards (and related publications).

Action: HL7 Australia and Standards Australia to finalise drafting and continue with the negotiation of a suitable affiliate agreement for 2012 thru 2013 and other arrangements with the aim of facilitating the continued availability of HL7 materials in Australia under reasonable commercial terms and allowing the continued publication of HL7 Implementation Guides as Australian Standards.

HL7 Australia

Standards Australia (General Counsel)


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2.3 AFFILIATE DUE DILIGENCE COMMITTEE WORKING GROUP DESCRIPTION

The Affiliate Due Diligence Committee (ADDC) assists HL7 International by reviewing applications to establish an HL7 affiliate. This includes receiving and considering applications, conducting enquiries and making a recommendation to the HL7 Executive Committee, who then forward their recommendation on to the Board of Directors for final approval. The constitution of the ADDC is prescribed in the HL7 General Operations Manual and comprises two Board Members, two representatives of the international affiliates and one HL7 staff member (Diana Stephens, Membership Officer). Its role is to:

• Maintain the criteria for approval and documentation to be submitted by organisations applying to become HL7 affiliates in a country (or more formally, a "territory");

• Maintain information on "How to Become an Affiliate" and publish it on the HL7 web site and, as appropriate, through other channels including direct presentation;

• Review each application to become an HL7 affiliate for a territory and make the necessary enquiries to ensure that the application addresses and meets the criteria for approval;

• Serve as the primary contact point for applicants – particularly in relation to any aspects needing to be revised or strengthened before an application is ready to be approved. This often involves collaboration with the Mentoring Committee, which assists countries seeking to form an HL7 affiliate; and

• Make recommendations to Executive Committee for approval or denial of each application.

Richard Dixon Hughes is a recently-appointed member of the ADDC. In addition to face-to-face meetings at each WGM, the ADDC has conference calls each month and more frequently when required to progress particular matters.


The Affiliate Due Diligence Committee (ADDC) met at the WGM to further the business of considering current applications and to progress its other business.

Richard Dixon Hughes attended as a member of the ADDC.

PROJECT ACTIVITY/ISSUES AT THIS MEETING

The following current projects were addressed by the ADDC at this meeting:

1. Status of HL7 Mexico: Although approved and now operating as an affiliate, the renewed HL7 Mexico had yet to participate in a WGM and there was a change of chair shortly after formation. They are in contact with HQ seeking support to have an education/certification program and are still on the watch list until it is clear that they are functioning as an independent organisation actively engaging with the broader HL7


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community and their stakeholders. Some of the issues to be resolved include implications of the Government's long-standing mandate of HL7v3, the standing of HL7 localization in Mexico and the influence of commercial interests in required HL7 certification programs.

2. Petition from Malaysia: The committee assessed the petition and considered it appropriate to proceed to the next step in the process, namely interviews. Diego and Supten are conducting interviews of the petitioners with the aim of completing them before the next ADDC meeting on 12 June. The hope is that all approvals will be in place to welcome Malaysia as an affiliate in time for the Baltimore Plenary in September.

3. Petition from the Philippines: The petition was reviewed by the committee but needs broader engagement from a wider community of interest before it can be recommended for progression to the next stage. Follow up will be carried out by Catherine Chronaki as chair of the ADDC.

4. Review of the “How to form an Affiliate" slide deck: In continuing its review of the slide deck and comments received, the committee felt that it focussed on too much history and did not articulate early and strongly enough the value and benefits of forming a local affiliate. ADDC members are all to provide further comment and suggestions and advice has yet to be obtained from the Marketing Council.

5. Other topics addressed included tracking the status of the following on-going activities/projects:

a) Obtaining information on prospects for formation of further affiliates in Latin America. With a representative of the recently formed HL7 Puerto Rico present as an observer, potential common interests of LATAM and Caribbean countries were discussed including a need throughout the region to be able to share health record information with each other and with some agencies in the US (notably CMS and VA for recipients of various US welfare and health care entitlements).

b) Obtaining information on prospects for formation of further affiliates in the Asia Pacific region, Eastern Europe and Africa.

c) Status check on activities and health of HL7 Sweden.

d) Status check on activities and health of HL7 China. This was addressed by the sizeable Chinese delegation at this WGM and a presentation by HL7 China to the Affiliate Chairs meeting on the Thursday.

e) Review of templates used for affiliate reporting and how to use it to establish "Affiliate of the Year “ (Richard Dixon Hughes to progress).

f) Draft orientation program for new affiliates to be developed to run perhaps annually (Diana Stephens and Catherine Chronaki to progress).


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Topic Issue / Action / Recommendations for Australia Recommended

for Action by

Affiliate Due Diligence Committee

Continuing support by L7 Australia of the work of the Affiliate Due Diligence Committee (ADDC) through Richard Dixon Hughes as an active member.

Action: HL7 Australia to note and monitor progress with ADDC activity at HL7 International.

HL7 Australia



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2.4 ARCHITECTURE REVIEW BOARD (ARB)


The HL7 ArB seeks to define a coherent architecture for HL7 work that outlines the relationships among the HL7 work products and how they relate to other standards and components of local implementations. This architecture includes the Business Architecture by which these work products are produced and managed through their life cycle, the governance that will be enacted on these work products, and the scope of the standardization effort itself.

The following is a HL7 ARB wiki site: http://www.hl7.org/special/committees/arb/index.cfm CURRENT PROJECTS

At this meeting, the ArB was starting to work on deciding what comes next. At the behest of the TSC, ArB had focused on the SAIF project. This is now largely complete and the ArB is considering the original scope of the board and deciding what to do next.

2.4.1 PROJECT #365: SERVICE AWARE INTEROPERABILITY FRAMEWORK (SAIF)

PROJECT OBJECTIVE

A complete version of the SAIF Book i.e. the canonical definition of the Behaviour, Information, Conformance and Compliance, and Governance Frameworks will be produced for submission to Informative Ballot in the next ballot cycle. “Canonical definition” means the basic concepts, relationships, and grammars necessary to specify the multi-dimensional, multi-perspective aspects of a given component (service, message, document, system, etc.) in the context of that component participating in an instance of Working Interoperability. There is engagement required to open the broad interoperability community for refinement and synchronization.


• Prior to Vancouver, SAIF added a set of conformance criteria to SAIF for determining the requirements for Implementation Guides (IG).

• SAIF projects continue developing within HL7 but are now being applied in the context of FHIR.

• Discussions on how definitions of artefacts such as Domain Analysis Models (DAM) are strictly or loosely applied across HL7. If a DAM doesn’t include all necessary elements, can it still be called a DAM?

http://www.hl7.org/special/committees/arb/index.cfm


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• Capability model for SAIF will allow greater realisation of maturity of interoperability. NEHTA to share work on capability and maturity from Interoperability Framework.

• Thomas Erl tutorial on SOA governance provided to HL7, free to co-chairs. Further work needed on refining the governance model for HL7 in light of its volunteer work force.



Architecture Review Board (ARB):

Service Aware Interoperability Framework (SAIF)

The development of a capability model for SAIF will allow greater realisation of maturity of interoperability.

Action: Share NEHTA interoperability capability and maturity work with ARB.

NEHTA

2.5 ARDEN SYNTAX WORKING GROUP DESCRIPTION

See also report on CDS WG, Arden being a CDS standards technology.

This Working Group develops and maintains the Clinical Decision Support Arden Syntax standard and works closely with the CDS Working Group, having common Co-Chairs, shared meetings and work which overlaps in projects, research, and exploratory activity. The Working Group’s main deliverable, Arden Syntax is a normative HL7 standard that is actively maintained, developed, and re-balloted. It is implemented in at least four commercial systems and several academic and open source developments. The Working Group has strong involvement from the commercial vendors.

The Arden Syntax standard was originally an ASTM standard developed outside of, but brought into, the organisation several years ago. It was first developed in the late 1980’s with considerable resources from IBM. It is now one of several overlapping standards for CDS but the only one maintained by a separately dedicated WG, the others being maintained by the CDS WG. Arden Syntax provides a formal machine processable language for CDS and uses of Medical Logic Modules (MLMs) that can be independently authored, distributed and deployed over differently provided systems. In the early stages its developers famously articulated the difficulty in inter-application clinical data access as The Curly Braces Problem named after the format through which Arden accesses external data. This is not a specific Arden problem and is more widely recognised now. It is important for standards development generally in CDS as well as in SOA, and EHR. Arden can also interface to GELLO-written applications.


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The projects of the Arden WG are each for the development of the next version of the syntax. Version 2.8 work is complete as is Version 2.9 that is about to be submitted for publication. Work is commencing on Version 3.

Version 2.8 of the standard recently passed ballot and version 2.9 has been developed to incorporate fuzzy logic and more detailed XML representations. It is in preparation for publication, ballot reconciliation for version 2.9 having been finalised at the meeting.

Three of the four vendors (one of which was the main driver of the 2.9 version) voted in favour of the new version with one abstaining for reasons of which the WG is unaware.

Version 2.9 incorporates fuzzy logic and redefines the operators to accommodate this. It also has more comprehensive XML representation. It is backward compatible meaning that MLMs authored under older versions will run correctly under newer versions. Arden system vendors have a considerable task to upgrade to version 2.9.

There is ongoing analysis of branching logic statements in a fuzzy logic and parallel processing environment, in particular around some of the operators. It was agreed to maintain the text of the balloted version but to add more examples. After a July conference call, version 2.9 will be finalised and submitted for publication. Work will now proceed on Arden version 3.0.

Future activity was discussed with the Australian delegate requesting the publication of an informative document providing a roadmap of CDS standards, their suitability for different tasks and their overlap. It was suggested that this would fit into a CDS Implementation Guide project that has been requested in the past but never developed. This was again discussed at a later meeting of CDS and will be the subject of initial planning at a conference call in July as well as being on the Agenda for the September WG meeting.

Immunization Decision Support was also worked through at the Arden-CDS-PHER joint meeting. It was agreed that the Arden group would work on the Arden implementation of some of the CDC rules to illustrate Arden capability and to validate output artefacts in the CDC project. Details of this joint meeting are reported in the CDS section of this report, and further details of the Immunization Cross Paradigm project are also reported in the section covering SOA, the main sponsor of that part of the CDS Immunization work.


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Arden Syntax:

Version 2.9

Arden Syntax is a mature standard, commercially deployed, and whose uses include immunization scheduling where it is being used in more advanced research programs.

Action: IT-014-13 should review Arden V2.9 and consider its applicability in Australian CDS systems. It should also review the 3.0 version of Arden currently under development and take part in its ballot. It should include Arden in the projects being considered for funding for CDS projects, and for possible use in an Australian Immunisation project.

IT-014-13


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2.6 HL7 BOARD


The HL7 Board is the principal governing body for HL7 International. It has four face-to-face meetings each year (three working group meetings and an annual Board retreat) and holds regular teleconferences in the other months.

The Board comprises of 14 voting members; the Chair, Vice-chair, Treasurer, Secretary, seven directors at large (including three appointed by the CEO), two directors elected by Affiliates and the Chair of the Technical Steering Committee (TSC).

The senior executive team (CEO, CTO end Executive Director) are non-voting members of the Board and the Advisory Committee external Co-Chair is an invited non-voting participant.

The CEO report, CTO report and Treasurer's report are standing items on the Board agenda and general governance issues arising from these reports are also discussed in this section.

As the Advisory Council external Co-Chair, Richard Dixon Hughes participated in the meeting as a non-voting member of the Board.


2.6.1 GENERAL BUSINESS

General business addressed during the Board meeting included the following:

1. Health AppWorks Initiative: The presentation slide pack provided by Robert A. Greenes, MD, PhD on this collaborative activity, which is aimed at the health sector more effectively leveraging the current explosion in self-contained apps, was noted. The presentation outlined the reasons for the move toward app technologies, the challenges and need for interoperability and outlined a proposed collaboration of major health care, academic and government organisations to address these issues. The group convened by Arizona State University and Mayo Clinic is establishing an "App Interop Initiative" and is approaching HL7 to see how it can best leverage HL7 efforts in this regard. The need for engagement with the mHealth Work Group was noted.

2. The appointment of Jamie Ferguson as the Board's nominee to the Nomination Committee was confirmed. The Nominations Committee has the task of ensuring that there are appropriately qualified candidates for office bearer and Board director positions.

3. Presentation by Aaron Goldschmidt on the West Wireless Initiative.

4. FHIR presentation by Grahame Grieve.

5. CTO/TSC report, delivered by Austin Kreisler (topics all discussed elsewhere and by others).

6. Treasurer's report. Financial position continues to improve. This WGM is looking acceptable but revenues and costs are both down with a slight deficit likely.


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7. Trifolia: Discussion of commercial and governance issues arising from Lantana's donation of CDA templates and use of their Trifolia tool for maintenance of an HL7 templates repository. The questions were debated in the context of proposals for HL7 to:

• provide read only access to HL7’s repository of CDA templates at no cost as provided through the Trifolia tool; and

• embark on a pilot that allows WGs to use the Lantana developed Trifolia template tool for building HL7 CDA templates.

2.6.2 CEO REPORT

In his report to the Board, the CEO, Chuck Jaffe, elaborated on the following current issues and expanding on points touched on in his regular CEO report:

• Resolution of IP Licensing Issues with umbrella bodies, mainly with US federal government agencies and associated bodies - FDA, CDC, AHRQ etc. each with a different distribution and licensing model.

• Progress with H-Rex, the licensing of HL7 v2.5.1 to some 2800 state/local public health agencies across the United States. The licensing will be arranged and managed through the Public Health Institute (PHI). There are discussions with WHO and the UN under which the program may become international.

The public health Institute is a non-profit public health foundation with an international constituency incorporated in the USA as a charitable organisation. It will act as the intermediary to provide funding and logistics to public health authorities (including State and local departments of health within the US). It will also provide ongoing support for licensing HL7 materials for authorities under the H-Rex program. There is a September to November timeline for technology rollout and implementation among health departments

• Recent activities in Europe and the European Office.

• Discussions among US and international regulatory agencies to improved pharmacovigilance.

• Marketing and outreach. The PCI marketing and communications initiative has focused on the following:

- HIMSS messages around utilisation of HL7 IP

- the caregiver initiative

- communications and marketing plan

- membership and IP analysis

- innovations in education


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- broader Stakeholder outreach: how to reach



HL7 Board West Wireless Health Institute is a significant philanthropic enterprise dedicated to lowering the cost of healthcare through the development of innovative technology, with a strong focus on mobile communications, body area networks and the like.

Action: Richard Dixon Hughes to put West Wireless Institute and HISA Digital Hospital Design SIG in contact with each other.


(Completed)


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2.7 CDISC / BRIDG In HL7, work on the BRIDG model is progressed via the Regulated Clinical Research Information Management (RCRIM) Work Group. Its progression as a joint standard was a major topic of discussion at the meeting of the ISO/TC 215 Health Informatics committee, which was held in the same venue during the previous week.

ISO/TC 215 is pursuing measures that will, if accepted by ISO, allow the CDISC BRIDG standard to be published as an ISO standard with its detailed content being regularly updated by CDISC by following an approach similar to that used for DICOM. Under this approach, ISO publishes a head standard that defines processes for maintaining, referencing and claiming conformance with detailed content, which is maintained by the developing organisation (CDISC or DICOM) on an external website.

For further information and actions relating to progression of BRIDG as an ISO standard, please refer to the report of the Australian delegation to the May 2012 ISO/TC 215 committee meeting, also held in Vancouver, BC, Canada.

2.8 CLINICAL DECISION SUPPORT (CDS)


The CDS WG develops communication standards (including documents, services, messages), information models (including Virtual Medical Record (vMR), support tools, an expression language and knowledge representation formalisms, around Clinical Decision Support. This is both patient-centric for alerts, reminders and care optimisation as well as population-based for quality assurance and surveillance. The WG identifies the controlled vocabularies and develops the feeder and response communications for interactions with CDS systems. It works closely with the Arden Syntax WG (common Co-Chairs) which develops a specific knowledge formalism now implemented in deployed systems and this section of the report should be read in conjunction with that of Arden Syntax. The WG also collaborates closely with HL7 clinically focussed groups whose stakeholders use CDS and which also develop standards useable by, or closely aligned with those of, CDS. These include Patient Care, Orders and Observations, Clinical Genomics, and CDA/Structured Documents (documents and messages for Referral, Patient Care Provision, Lab Orders and Results, Guidelines and Protocols which form bases of standardised feeders, outputs, and control of CDS systems). The group has also developed a CDS Services standard in collaboration with HL7 SOA and the OMG HSSP project. The WG membership mainly comprises vendors with working applications, and clinicians associated with academia or industry. There is currently no V3 facilitator.

With its end-points of care optimisation, quality and safety, CDS is arguably the raison d’être of Health IT and of prime importance to the Australian community. It is however not well-


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represented in our local standards community where our implementations are ad-hoc and not safely interoperable but still widely used in clinical practice especially Primary Care.

The WG is open to suggestions for new work and the Australian delegation has, at this and the last meeting, been successful in having the group favourably consider two projects which address our needs and which will closely follow and facilitate our projects in IT-014-013.

This HL7 WG will be increasingly important for Australia with the formation IT-014-013 which can take more of our needs to HL7 as well as benefit from work already conducted and influence future directions of HL7 CDS.

Additional information can be located at:

http://wiki.hl7.org/index.php?title=Clinical_Decision_Support_Workgroup


Further work took place on Immunisation CDS in joint meetings with Arden Syntax and PHER. Immunisation is being looked at for CDS both within the SOA-CDS Cross-Paradigm Immunisation Project and also jointly with CDC members. This addresses both knowledge representation and cross platform services, the latter working with SOA.

Work progressed on the two projects of the Infobutton Standard and finalisation work is in progress for the previously delayed Order Sets Standard which has been done jointly with Patient Care. Other joint work included further work on Health Quality Measure Format (HQMF) Implementation Guide with Structured Documents WG.

Work on other projects was held back due to limitation of attendance by project leads, but will continue by teleconference and at the next WG meeting in September.

Of particular importance is the work item commenced at the last meeting, with strong support from the Australian delegates, on Services and Capabilities of Clinical Information Systems (notably EHRs) to enable Service Oriented Decision Support.

In response to a request from the Australian delegate, the WG, with Arden, is embarking on a new project for an overview and Implementation Guide to CDS intended to help developers, and knowledge authors select from the different and often overlapping HL7 standards when implementing CDS applications.

The WG invited Grahame Grieve to discuss FHIR and look at possible CDS-based resources where it was noted that RIM based modelling has not delivered for many of CDS needs and there is possibility of FHIR satisfying these if CDS requirements are worked out as part of the new modelling. CDS has come from outside mainstream HL7 and FHIR aims to engage to such breadth. Modelling for CDS involves knowledge around clinical phenomena and process as well as the established health IT priorities on patient specific event recording and communication. Candidate areas for initial resource development were explored and appear most likely be around Arden Medical Logic Modules (MLMs) with the “Curly Braces” problem, the Virtual Medical Record (vMR) and GELLO handling of resources as object types.

http://wiki.hl7.org/index.php?title=Clinical_Decision_Support_Workgroup


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CDS:

FHIR

RIM modelling has not satisfied many of CDS requirements and FHIR has the potential to address these from the start. CDS requires models for application data and process integration as well as for clinical and biological phenomena. Models need to be simple and readily understandable by vendors and knowledge authors from outside HL7, where FHIR is significantly aimed.

Action: Include CDS information resource requirements for Australia as part of the IT-014-13 projects currently proposed. Liaise with the FHIR development team and monitor progress. Suggest CDS-based FHIR resources for initial development as part of the HL7 international work.

IT-014-13

Australian FHIR project lead

CURRENT PROJECTS The following projects are discussed in this section:

1. Project #507: Context Aware Information Retrieval (Infobutton) SOA Implementation Guide

2. Project #875 Context-aware Knowledge Retrieval, Knowledge Request, Release 2

3. Project # 876 URL-Based Implementations of the Context-Aware Information Retrieval (Infobutton) Domain, Release 4

4. Project #184: Virtual Medical Record (vMR) for Clinical Decision Support

5. Project #259: Order Set Publication Standard

6. New project proposal: Implementation Guide for CDS

7. New work activity: Immunisation Evaluation and Forecasting Logic Specification

- Cross Paradigm Interoperability Implementation Guide for Immunizations

8. openCDS

9. New Project: Services and Capabilities of Clinical Information Systems (notably EHRs) to enable Service Oriented Decision Support.


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2.8.1 PROJECT #507: CONTEXT AWARE INFORMATION RETRIEVAL (INFOBUTTON) SOA IMPLEMENTATION GUIDE PROJECT OBJECTIVE

Context Aware Information Retrieval or Info Button is a SOA and modular Implementation Guide based on the earlier Infobutton Standard (Project 265), Infobutton URL-based Implementation Guide (Project 130), and HL7 Decision Support Services (DSTU). Infobutton is a balloted normative standard which has both strength and weakness in its simplicity, ease of use and implementation. It has so far mainly addressed content but is now addressing the recognised need for development of a modular and services-based component approach. Additional information can be located at:

http://www.hl7.org/Special/committees/dss/projects.cfm?action=edit&ProjectNumber=507


This project is now in DSTU for review until May 2013. Issues focussed around the new Infobutton projects # 875 and #876 that are detailed below.

2.8.2 PROJECT #875: CONTEXT-AWARE KNOWLEDGE RETRIEVAL, KNOWLEDGE REQUEST, REL 2 PROJECT OBJECTIVE

This is an enhancement of the earlier release of the normative standard, Context-Aware Knowledge Retrieval, Knowledge Request. Additional information can be located at:

http://www.hl7.org/implement/standards/product_brief.cfm?product_id=208

The Context-Aware Knowledge Retrieval (Infobutton), Knowledge Request specification provides a standardised knowledge request mechanism to act on knowledge resources such as Health Record systems to aid at the point of care by delivering both relevant clinical information and patient-centered education materials, relevant to the clinical context.

The Release 2 project was approved after the previous meeting and addresses use cases requested by implementers. These include the ability to specify additional patient clinical attributes and geographical locations of interest, specification of a health care payer as the performer or information recipient of an Infobutton request, and clarification of description of the modeling. Additional information can be located at:



http://www.hl7.org/implement/standards/product_brief.cfm?product_id=208



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The project was reviewed at a joint meeting with SD and later worked on by the CDS WG. The model extensions required from implementation experience with release one were worked through and include observation class, code-value attribute pairs with LOINC code use.

The project will be worked on over the following months and is expected to be ready for ballot as DSTU in September 2012 and publication in May 2013.

2.8.3 PROJECT # 876 URL-BASED IMPLEMENTATIONS OF THE CONTEXT-AWARE INFORMATION RETRIEVAL (INFOBUTTON) DOMAIN, RELEASE 4 PROJECT OBJECTIVE

This project is to develop as an implementation guide to specify URL-based implementations of the Context-aware knowledge retrieval (Infobutton) standard and will be an HL7 Informative Document. It will support implementations that use URLs as communication protocols with the ultimate goal of enabling a stepwise transition from URL-based implementations to a services-oriented approach. Release 4 of this implementation guide reflects changes made to its normative parent specification, Context-aware Knowledge retrieval, Knowledge Request Standard. It also includes clarifications regarding the use of coded attributes and provides a quick reference of code systems used in the implementation guide. Additional information can be located at:



This project was worked through in conjunction with project #875 (see previous) on which it is dependent and addressing the same content issues but with a specified URL-based interaction model.

It is working to the same time plan as #875 and is due to be ready for DSTU ballot in September 2012, with publication ready for submission in May 2013.



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CDS:

Infobutton Standards for Enhanced Context and URL-based implementation

The Infobutton standards are an implemented, relatively simple solution for applications to obtain increasingly contextually relevant information from EHRs to enable CDS and issue-targeted patient education material.

Action: Review these standards with the CDS community in Australia to assess their applicability to our systems and stakeholder requirements.

IT-014-13

2.8.4 PROJECT #184: VIRTUAL MEDICAL RECORD (VMR) FOR CLINICAL DECISION SUPPORT

PROJECT OBJECTIVE

The objective of this project is to create HL7 vMR data models capable of supporting scalable, interoperable CDS. The vMR uses only the CDS-essential EHR abstractly specified data. It is thus independent of implementation technologies including HL7 V2, V3 messaging and V3-CDA. It encourages CDS at the point of care by reducing costs and response turnaround time. It eliminates the need for EHR vendors to maintain proprietary CDS structures and messages. It is of great value to emerging clinically focussed applications addressing patient outcomes and community needs.

vMR is being further developed with more Implementation Guides and Template specs for standard data models: CCD; Care Plan of PC; and for priority tasks of CDS e.g. Drug–Drug interactions, vaccine advice, Family History Risk Analysis and Genomics. Transformations are being developed between standard models and it is moving to more alignment with HL7 work. Additional information can be located at:



The project was reviewed jointly with Orders and Observations WG. Its current status is as follows: • Release of its DAM is published and GELLO IGs are available. • Actively being used by efforts including open CDS (also implements DSS Services). • Aligned to proposed Meaningful Use stage 3 (DSS using vMR as CCD could be applied to

vMR).



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CDS: Virtual Medical Record (vMR) for Clinical Decision Support

CDS systems rely on data in EHRs and on inputs and outputs in different formats. Standards for content are required to bridge this gap. An Australian group has been a leader in the development and utilisation of this standard. The vMR forms the basis of one project proposal coming through IT-014-13.

Implications for Australia: This project is important in ensuring our initiatives across messaging, CDA, EHR can be brought together to enable improved care and safety through standardised CDS.

Action: Review specification with view to appropriateness for our needs including its impact, via recent proposals at HL7 and to IT-014-13 involving V2 messaging, on IT-014-06-06 need for clinical content in V2.

IT-014-13

IT-014-06

2.8.5 PROJECT #259: ORDER SET PUBLICATION STANDARD

PROJECT OBJECTIVE

This project is to develop a Special instance of a structured document standard and associated implementation guidelines for the publishing and sharing of interoperable order sets for clinical system vendors to deploy for CDS at point of care. It is really a knowledge document not an instantiated order set. Additional information can be located at:



This project had stalled after delays in the ballot reconciliation and outside demands (coupled with inability to attend WGs) on the project leadership but it has been restarted recently and is almost finalised. Its models have been adjusted in readiness for release as DSTU as agreed at the last meeting.

At this meeting, given the recent progress, the co-sponsor Patient Care agreed to keep it on its work program as the standards is required for care planning.

The group reviewed the few remaining gaps prior to publication as DSTU. Members have agreed to work on inclusion of order codes and some minor documentation additions noting the expected availability of help from the original project lead.



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CDS: Order Set Publication Standard

The Order Set Standard will shortly be available as DSTU and has potential for rationalising the requesting of diagnostic and therapeutic services as well as medications. It thus has benefits for patient care and cost containment.

Action: Review the DSTU from perspectives of GP and Allied Health, expert authors, and government funders then engage other Australian organisations as found appropriate.

IT-014-13

2.8.6 NEW PROJECT PROPOSAL: IMPLEMENTATION GUIDE FOR CDS PROJECT OBJECTIVE

To produce a roadmap of the CDS standards from HL7 and elsewhere in order to provide a better understanding of these multiple approaches. It will highlight different methodologies, areas of overlap, and suitability for different types of CDS and application environments. It will be of benefit to vendors, developers, users and people new to CDS. The deliverable would be a formal HL7 Informative Document.


This was proposed by the Australian delegate in response to needs noted in Australia where CDS has recently become part of the national standards process. The WG discussed the proposal noting the multiple solutions available from HL7 as well as from other organisations. There is a recognised lack of obvious solutions for given sets of needs and there are overlaps of functionality even among the HL7 standards.

There was WG support for this project and it has been accepted for further development by teleconference in July and then at the September meeting.


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CDS: Implementation Guide for CDS

There are multiple overlapping standards for CDS from HL7 and other organisations, with a non-obvious path for implementers and knowledge authors commencing product development or selecting from among components. IT-014-13 has a project proposal that involves development of roadmap and gap identification. This project would both resource and benefit from the Australian work.

Action: IT-014-13 should support the proposal, work on its scope statement, and actively participate.

IT-014-13


2.8.7 NEW WORK ACTIVITY: IMMUNISATION EVALUATION & FORECASTING LOGIC SPECIFICATION

PROJECT OBJECTIVE

This project aims to support vaccinators in achieving “paths to immunity” for healthy children in age range birth to 18 years across different jurisdictions that have varying protocols. It also supports the using of different vaccine preparations that target the same disease yet have different schedules and may need to be switched during a course. This is a very complex situation when there is deviation from a standard schedule. One in four children in the US are not fully immunised.

The process has two phases: • Evaluation: to assess immunity: and • Forecast: Equivalent to an immunisation Care Plan.

It outputs status and targets in concepts including ‘valid’ and ‘preferred’ according to whether on-protocol or in variance from it and analyses in terms of target vs. administered doses.

Modelling has been in UML and RuleSpeak (business rule expression guidelines) is followed in the protocols.


Led by the CDC member, Eric Larsen, the group worked through this project, which is not yet a CDS formal project, with view to assessing it for joint work and observing CDS’s existing commitment to immunisation as a priority area.

The process was reviewed noting its use of what was described as a “thin process model” using chained decision tables and flow-charts to arrive at output recommendations.


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The issues to be addressed include allowable time ranges of immunisations, splitting combined vaccines by antigen while managing the logic flow separately for each but combining for recommendation output.

The application of Arden Syntax was considered to be of value and the project’s knowledge and logic deliverables will be published on the CDC website.

This joint work will be taken forward in teleconference with CDS and CDC members participating. A formal HL7 CDS project could be developed depending on the group’s assessment.

2.8.7.1 CROSS PARADIGM INTEROPERABILITY IMPLEMENTATION GUIDE FOR IMMUNIZATIONS.

Both CDS and Arden Syntax, in joint meetings with PHER, reviewed progress and set further activities for the SOA Cross Paradigm Interoperability Implementation Guide for Immunizations, project ( #863).

CDS, with PHER are co-sponsors of the SAIF-framework project that is described in the SOA section of this report. This was worked on in common with the CDC immunisation Evaluation and Forecasting Logic Specification project and immunisation use cases have been incorporated. Semantics of Business Vocabulary and Business Rules (SBVR) is used and RuleSpeak is under consideration.

The project is factoring out common material from a large and perhaps challenging number of multiple platforms and models to develop a common information and common behavioural model. Arden Syntax was assessed in relation to this program and considered to fit into the solution architecture. The CDS vMR can provide the common information model with the EHR-S FM Services providing the common behavioural Model. The CDS component of the project will progress by teleconference until the next meeting.



CDS: Immunisation Evaluation and Forecasting

Immunisation is difficult for GPs and vaccination teams to tailor to patients’ needs when they drift off schedules. There are significant groups of children who are not adequately immunised. CDS can aid immunisers in achieving target immunity.

Action: IT-014-13 should review Australian Immunisation CDS availability and needs as recognised by GPs, Immunisation Registries, and State Jurisdictions providing immunisation recommendations including exception advice. Participation in the international work should be offered to these groups. IT-014-13 should consider immunisation logic and service interfacing for a specific new project that could leverage the multiple immunisation CDS projects at HL7 and openCDS.

IT-014-13

Standards Australia


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CDS/SOA: Cross-paradigm interoperability implementation guide for Immunization

Immunisation is monitored and recommended by GP point-of-care systems, but the underpinning knowledge is complex and expectedly difficult for general system vendors to provide. Jurisdictions and health advisory bodies provide guidelines for this and some have in the past provided on-line recommendations including in the problematic areas of catch-ups. A group of standardised services available to point-of-care applications could improve overall achievement of immunisation targets. Australia could benefit from international resources being committed here.

Action: IT-014-13 to consider a project to bring Australian requirements into this work with view to deployment into point-of-care systems, immunisation registries, and knowledge source applications.

IT-014-13

MSIA

Jurisdictions

Immunisation Guideline Authorities

2.8.8 OPENCDS PROJECT OBJECTIVE

This is not currently a formally initiated project of the CDS WG but has direction and cross-collaboration with CDS members and uses HL7 artefacts. It will further inform HL7of needs in the CDS standards and provides a valuable tying together of diverse CDS standards as well as facilitating system design and deployment.

It is a multi-institutional collaborative effort to develop open-source, standards-based CDS support tools and resources that can be widely adopted to enable CDS. A reference Implementation of HL7 CDS standards is being developed in this project led by HL7 CDS Co-Chair, Dr Kensaku Kawamoto. The project has over 20 collaborating organisations from industry, academia and health service providers. Internally, it uses the HL7 vMR that is built on the RIM and includes the HL7/OMG DSS Service. Data mappers work between the vMR and CCD as well as to other standard representations. The project is also building around open tools for terminology (including SNOMED) support (Apelon), knowledge and rule authoring, and domain specific language creation.

This project provides an excellent insight into HL7 CDS standards and tools as well as the related standards it employs. It is an excellent starting point for Australian groups progressing from ad hoc approaches to mature standardised decision support applications and should be promoted here. Additional information can be located at:

http://www.opencds.org/


There was no progress on this project at this meeting.

http://www.opencds.org/


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CDS: openCDS

The project is implementation-focussed, open, and provides excellent insight into HL7 CDS standards as well as related SOA and clinical data representation resources.

Action: Work to be reviewed against Australian needs, and be used as a resource in two of the planned Standards Australia CDS projects where it will provide important background resources, and relayed onto other Australian groups as appropriate.

IT-014-13

2.8.9 NEW PROJECT: SERVICES AND CAPABILITIES OF CLINICAL INFORMATION SYSTEMS (NOTABLY EHRS) TO ENABLE SERVICE ORIENTED DECISION SUPPORT.

PROJECT OBJECTIVE

This project is to identify and prioritise the services and capabilities required from clinical information systems (CISs) to enable service oriented CDS.

It was accepted as a high priority new project on the suggestion of, and with strong support from, the Australian delegates at the previous CDS meeting. Work followed in weekly teleconferences and a comprehensive report has now been produced which has been submitted to AMIA.

The Work Group reviewed the literature, hosted multi-stakeholder discussions, and consulted domain experts. Ten CIS services and eight capabilities were identified as of top priority using an agreed methodology.

The project lead was unable to attend the WG so formal acceptance by the WG is pending. The project needs to be framed into a TSC-acceptable proposal and then formatted for presentation as an HL7 ballot able document, which at this stage would be informative.


The technical work and research is complete but the formal project application and documentation work has had to be held over. The next stage is TSC approval for the work to be presented as an HL7 Informative Document. This should take place via teleconference before and at the next meeting.


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CDS: Clinical System capabilities to enable Services Oriented CDS operation

CDS requires the ability for applications and component services from specialised vendors and knowledge authors to integrate with larger point-of-care systems. One Australian proposal to IT-014-13 seeks to address this problem and will benefit from the work of this project.

Action: HL7 Delegates to ensure that this progresses to an HL7 informative document. The project be used as a key input resource to the relevant proposed IT-014-13 project

IT-014-13


2.9 CLINICAL INTEROPERABILITY COUNCIL (CIC) In Vancouver, due to the overlap in work group meetings, it was not possible for Australia to be represented at this meeting.


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2.10 CLINICAL STATEMENT (CS) WORKING GROUP DESCRIPTION

A Clinical Statement is an expression of a discrete item of clinical (or clinically related) information that is recorded because of its relevance to the care of a patient. Clinical information is fractal in nature and therefore the extent and detail conveyed in a single statement may vary. To be regarded as a clinical statement, a concept must be associated with a patient in a manner that makes clear:

• Its temporal context;

• Its relationship to the patient;

• In the case of an observation, its mood and presence, absence or value; and

• In the case of a procedure, its mood and status.

This clarity may be achieved by:

• Explicit representation; or

• Implicit application of defaults ONLY where explicitly modeled rules state the appropriate defaults.

This group maintains a close working relationship with other HL7 WGs including EHR, Patient Care, Pharmacy, MnM, Structured Documents, and Vocabulary. Additional information can be located at:

http://wiki.hl7.org/index.php?title=Clinical_Statement_Work_Group


This WG met for two quarters/sessions on Thursday during the Vancouver WGM.

The first session was a joint meeting with patient care during which two change requests from Patient Care WG were reviewed and discussed as follows:

• Add proposed Causative Agent (CAUS) participation from Observation to Agent choice box: There is a need to be able to express suspected or validated causative agent(s) that is/are considered to have or potentially has/have trigger the onset of adverse reactions (observation) on exposure.

• Include ReasonCode and ActivityTime attributes in Encounter in Clinical Statement (CS): This change request arises from harmonisation work on Encounter class done by Patient Care and Patient Administration WGs. Patient Care has many use cases that use the Clinical Statement model. The Encounter Class in CS does not have ReasonCode and ActivityTime attributes which are essential.

http://wiki.hl7.org/index.php?title=Clinical_Statement_Work_Group


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After short discussions, CS WG considered that these two change requests were valid. The action plan is for CS WG to make these changes to the CS model in advance of the September 2012 ballot.

The second session was a joint meeting between CS WG and Pharmacy WG. This session was dedicated to discussions on alignment of the CS model and pharmacy models including the Pharmacy D-MIM, Medication Order, Medication Dispense, Medication Administration and Medication Statement. The alignment requirements were generated from comparative analysis of the CS model and the pharmacy models by one of the pharmacy WG members. The analysis identified a number of inconsistencies in the modelling approaches. Consequent alignment discussions identified a number of changes for CS WG to implement before the next WGM in September. The Pharmacy WG agreed that a number of items would require further analysis and clarification by its members. They will be discussed in post Vancouver WGM conference calls. Further information, decisions and any further change requests identified by the Pharmacy WG will be communicated to CS WG for action.

2.11 COLLABORATIVE BASED COMMUNITY CARE (CBCC)


The CBCC WG facilitates development and use of HL7 standards that support and integrate the provision of HHS (health and human services) in community and non-acute care residential settings. It engages experts and other stakeholders to identify, clarify, and validate (by consensus) information system requirements with an emphasis on privacy protection. As such it works closely with the Security WG on projects that involve the privacy and security of data transmitted for community based projects.

The concept of HHS includes health promotion, disease prevention, assisted living, home health, long-term custodial care, hospice, community health centres and day treatment centres, as well as office-based behavioural and physical health care services. HHS may also include other human services and skill training for consumers to the extent that these other services affect needs for and outcomes of health care services e.g. parenting and other basic occupational skills training.

The CBCC WG is currently focused on following domains:

1. EHR functional profiles: long term care and behavioural health

2. Human services directory domain model

3. Referral and Patient Care chapters in V2 & V3

4. Long term or social care domain model terminology

5. Composite Privacy Consent Directive message format and vocabulary


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6. Personal Health & Human Service Record Systems (PHHSRs) profiles: functional and content domains

This WG was set up at the request of Australia to address communication needs coming to IT-014-06-06 from Department of Human Services (Victoria) and NSW Health covering their HL7 V2 work on community based projects including Rapid and CHIME. This included messaging in Mental Health, Aged Care, Home Nursing, Allied Health, as well Social and Community Support.

Its agenda has been diverted by the needs of US authorities working in CBCC to have a unique privacy and security model to control access to “sensitive” data in CBCC systems. Re-invigoration of the original agenda is more than ever of high importance to Australia’s delivery of cost-effective, multi-disciplinary management of complex and chronic disease and related social welfare.


http://wiki.hl7.org/index.php?title=Community-Based_Collaborative_Care


The meeting focussed on discussion and ongoing work with data segmentation, meaningful use and consent which are major items of work being addressed across the US health sector and federally funded. Since coverage of the whole of the CBCC meetings was not possible, the project listed below are those that intersect with the Security WG. CURRENT PROJECTS

The following projects are discussed in this section:

1. Project (new): Data Segmentation for Privacy

2. Other non-project workgroup discussions and presentations

2.11.1 PROJECT (NEW): DATA SEGMENTATION FOR PRIVACY

The term “data segmentation” refers to the process of sequestering from capture, access or views certain data elements that are perceived by a legal entity, institution, organisation, or individual as being undesirable to share. This basic definition however, does not account for the multiple permutations of segmentation in the health care context i.e. granularity, nor does it adequately capture the varied considerations required for development of segmentation policy.

A US national project called “The Data Segmentation for Privacy Initiative (DS4P)” is based on the Data Segmentation for Electronic Health Information Exchange Whitepaper from Office of

http://wiki.hl7.org/index.php?title=Community-Based_Collaborative_Care


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National Coordinator for Health Information Technology (ONC), produced to support the Standards and Interoperability (S&I) Framework. Additional information can be located at:

http://wiki.siframework.org

The Standards and Interoperability (S&I) Framework is to enable the implementation and management of disclosure policies that originate from the patient, the law, or an organisation, in an interoperable manner within an electronic health information exchange environment so that individually identifiable health information may be appropriately shared for:

1. Patient treatment and care coordination

2. Third party payment

3. Analysis and reporting for operations, utilisation, access quality and outcomes

4. Public health reporting

5. Population health, technology assessment and research

The purpose of this initiative is to enable the implementation and management of varying disclosure policies in an electronic health information exchange environment in an interoperable manner with the goal to produce a pilot project allowing providers to share portions of an electronic medical record while not sharing others, such as information related to substance abuse treatment, which is given heightened protection under the law.

PROJECT SUMMARY

Data segmentation, also referred to as data tagging, data labelling and metadata tagging, is important to Security as it relates to Privacy Metadata and the issue of interpretation of the Confidentiality Code between organisations. The initiative is to address issues of determination of which part in the health record should be protected by jurisdictional or organisational policy or by regulation e.g. substance abuse info and vet affairs providers for three specific conditions. For instance if you have a document that has protected information and non-required protection, how does a system identify and manage this? Also, what occurs when this information is passed on to another organisation? How do you define this for the receiving organisation i.e. using the metadata used in the transportation of information? On a national basis, the progress to date has been to identify use cases and now scoping requirements being undertaken.

http://wiki.siframework.org/


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PROJECT ACTIVITY/ISSUES AT THIS MEETING The project update included a refined outline of the project. The project is now broken up into the following areas:

1. What does consent look like?

2. How would you manage in an HIE using centralised management (how to carry CDA consent directive)?

3. How would you analyse the data to tag it appropriately and what are those tags? Sensitivity codes are fundamental to this;

4. How do you push clinical data with rules?

5. How do you publish and discover using rules? Additional information can be located at: http://wiki.siframework.org/file/view/DS4P_Agenda_SR_20120403.pdf

The US Data Segmentation pilot is still in a test environment (sandbox). Optimally, the government will mandate the requirements (providing the tool free) to allow vendors to meet the US confidentiality requirements (42CFR Part 2). The pilot is testing the S&I requirements.

The following gives an indication of how the S&I is leveraging the standards to meet the requirements. The User Stories are building blocks to define the requirements for Information Exchange, Consent Management and System Requirements. There are common requirements across S&I that are related to patient identity, provider identity (Healthcare Provider Directory Initiative), data encryption, integrity, authentication (system), audit, logging, and document exchange. In addition there are standards that have been selected to support and define the building blocks. There are:

• Information Exchange

- Document exchange standards IHE XDS, IHE XDR, IHE XCA; Content profile OMG hData REST Binding for RLUS

○ Document/Standards – Disclosed data content – consolidated CDA templates (US Realm) CCD, CDA R2; HL7 hData Record Format V1 DSTU

• Consent Management

- Document exchange standards - IHE XDS, IHE XDR, IHE XCA; Content profile OMG hData REST Binding for RLUS

- Document/Standards - Consent directives - HL7 consent directive CDA IG based on CDA R2; BPPC content profile IHE ITI Vol. 3, based on CDA R2

http://wiki.siframework.org/file/view/DS4P_Agenda_SR_20120403.pdf


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- Terminology Standards - Privacy metadata (for codes for confidentiality, obligation/condition, purpose); Protected diagnosis, document types, clinical data encoding (LOINC, SNOMED-CT, ICD-9, ICD-10); Provider classification - 42 CFR Part provider

• System Requirements

- Document Submission Metadata Standards (in support of Document Exchange Standards for IHE XD*, XCA); IHE XDS Metadata, IHE XCA metadata, IHE XDM Metadata. The CDA Header – part of the CDA-based documents and will be analysed there and it relies heavily terminology standards

- Terminology Standards - Privacy metadata (for codes for confidentiality, obligation/condition, purpose); Protected diagnosis, document types, clinical data encoding (LOINC, SNOMED-CT, ICD-9, ICD-10); Provider classification - 42 CFR Part provider

- Analysis Models - Domain Models: HL7 Security Domain Analysis, FHIM Functional Models: HL7 EHR System Functional Model

The privacy policy means that the data identified carries the privacy metadata to provide the confidentiality level, information source and the consent required for disclosure/re-disclosure. Subsequently, the Business Process Data Segmentation Process describes the request parameters, how this request is processed, and what decisions are made. Protected diagnosis is one evaluation criteria, as is payment type, and facility type. What is needed is the ability to identify if the data meets any of the criteria to meet policy or consent directive. The criteria are drawn from the clinical information itself and use the value sets/coding (e.g. LOINC codes, SNOMED-CT, HL7) system to identify the data items that need protection.

The mapping of the data segmentation process to the EHR Functional Requirements has also been undertaken. Further, the consensus on codes is difficult with the 42 CFR Part 2 protected information needing a consensus on policy. The modelling demonstrates that algorithms could run if you have the correct inputs, outputs and rules but does not define how it should be done. The approach tries to redact to a minimum set of requirements and rules to facilitate and meet the US 42 CFR Part 2 requirements. S&I Framework is US centric but the premise for the process could be extrapolated to other jurisdictions and realms. The code lists could be extended for this and compensate for changes over time.


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CBCC/Security:

Data Segmentation for Privacy

The data segmentation for privacy is a framework that is being cited by several HL7 workgroups including CBCC/SEC and SOA.

Action: Monitor the use of the S&I Framework across the HL7 workgroups for potential application to the Australian environment.

IT-014

2.11.2 OTHER NON-PROJECT WORKGROUP DISCUSSIONS AND PRESENTATIONS

2.11.2.1 MEANINGFUL USE

PROJECT SUMMARY AND UPDATE

The US is going into the second stage of meaningful use to certify their health records using a financial incentive program. The proposed regulations were released last month. These were the regulations to stipulate the requirements for an EHR to be certified. Phase 2 expands the number of requirements and has added a number of standards. In the area of privacy and security, there are no dependencies with the privacy and security standards and the meaningful use metrics. For security they define standards that the EHR has to meet to be certified and that the users have to use the standards (these facilities provided) correctly as defined to be certified. EHR systems have to meet the standards.

In summary, the new requirements include that providers are required to allow a consumers view, download and transmit their EHR to third parties. The proposed regulation stipulates that the transport mechanism meet the security requirements for instance using secure email protocols. Another aspect is secure messaging with the expectation that the EHR will be required to facilitate secure messaging including integrity checking using hashing. Auditable events and ensuring integrity have no changes between stage 1 and 2. One new criterion relates to amendments to the data i.e. the provider amending the patient record. There is no standard for this but rather an operational function defined to support this. Additionally, the auto logoff session for an EHR remains the same as does the criteria around emergency access. Encryption has a new requirement to encrypt data at rest. This encryption is as defined by NIST. Further, the integrity that the EHR has the ability to verify (according to the standard) that the record has not been altered using a hashing algorithm at a min level of SHA-1. Accounting for disclosure has not changed, EHR is able to record audit detail of disclosure of the data to outside the organisation.


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2.11.2.2 EHR METADATA PROJECT


The EHR metadata project, as listed under the EHR WG, was discussed. Both the CBBC and Security WGs raised concerns regarding the level of over granularity and specificity that is being proposed. This will be discussed further at the joint Security/EHR session at the Plenary WG meeting in September.

2.11.2.3 CONSENT MANAGEMENT: A SCALABLE NATIONWIDE APPROACH


A presentation was given by a representative from Mitre Research on “Consent Management: A Scalable Nationwide Approach” project that is addressing better handling of consent. This is driven because it is seen as a critical success factor in the US for the National Health Information Network (NwHIN, previously NHIN). Its objective is to establish infrastructure to manage patient consents nationwide. Further, it is looking at how to meet the requirements of the HIPAA/ARRA/HITECH Privacy Act, how to build trust and obtain patient and provider acceptance of electronic exchanges, and to facilitate “meaningful use”.

The scope of the project includes how to comply with the US special protections in 2012 federal law such as 42CFR and 38CFR e.g. how to support research and other secondary use cases; how the patient can expresses their own desires for information sharing; to implement generalized (reusable) consents on intuitive categories; the creation of defaults and overrides and mix-ins of state rules, provider rules; to create standards for health transactions; and to support an open market for competing consent products.

The challenge is to address how complicated policies can be written such that they can be implemented across institutions using current enforcement mechanisms. This is envisaged as creating rule-sets that can capture the needed rules (long term, late binding of data to policy) and can be incrementally simplified. This includes evaluation assertions of request purpose, treatment relationship, and professional qualifications that give someone authority to see patient data such as clinicians, physicians and other healthcare stakeholders.


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2.12 CONFORMANCE AND GUIDANCE FOR IMPLEMENTATION AND TESTING (CGIT)


The Conformance and Guidance for Implementation and Testing WG supports all conformance activities of users of the HL7 standards. This includes the localisation of HL7 standards to suit specific real-world situations, the creation of implementation guides, and the mechanism to specify, interpret, and test conformance to HL7 standards.


http://wiki.hl7.org/index.php?title=Implementation_and_Conformance


Discussion continues around differentiating conformance requirements for sender and receiver systems in HL7 Standards. This has been the practice in relevant IHE profiles for some time and normative guidance in the standard based on that experience would be useful to the entire standards community. This will be a continuing area of debate over the next few meeting cycles as documentation is prepared for the HL7 V2.9 ballots.

It was noted that project 825 “V2 XML Encoding Rules release 2” was completed, sent to publication in November 2011 and published 11 May 2012. It is available for download at the following location:

http://www.hl7.org/search/viewSearchResult.cfm?search_id=234259&search_result_url=%2Fdocumentcenter%2Fpublic%2Fwg%2Fxml%2FXML%5FEncoding%5FRules%5Ffor%5FHL7%5Fv2%5FMessages%20Rel2%20v04%2Edoc

The current USA HL7 V2 testing process that is in development was discussed. It is to be deployed by October 2012 as part of the “Meaningful Use” requirements. Initially it will comprise static message testing with specified vocabulary requirements using a large pool of test messages. Currently the requirements are still to be finalised especially in the area of microbiology. Terminology to be used is LOINC except for microbiology where SNOMED will be used for organism names V2.51 (US Realm specific) and V2.71 (International) will be supported. The target is to support V2 from pathology laboratories to EHRs. NIST is currently working to determine and specify receiver responsibilities in terms of rendering and display.

Some concerns have been raised as to the level of understanding of HL7 V2 by Certification organisations.

The USA does not have a display segment in their HL7 V2 laboratory messages, as does Australia, and this is making specification of rending requirements more complex. There is no mechanism for modifying related display elements when showing pathology e.g. at present patient DOB and sex are not required to be displayed but should be for pathology.

http://wiki.hl7.org/index.php?title=Implementation_and_Conformance

http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=825





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CURRENT PROJECTS


1. Project #630: HL7 Vocabulary Binding Syntax

2. Project #874: V2 code table versioning and alignment to V3 vocabulary model

3. Project: V2.8 Conformance Proposals

4. Project: V2.9 Conformance Proposals

5. Project Modelling Workbench (MWB) – Maintenance.

6. Project #825: V2 XML Encoding Rules release 2

2.12.1 PROJECT #630: HL7 VOCABULARY BINDING SYNTAX PROJECT OBJECTIVE/ TOPIC SUMMARY

This joint project with Vocabulary will define how Vocabularies and Termsets are specified in HL7 V2 and V2 models and at runtime including the conformance specification and testing required.


This project is now partly being taken forward at TC215 WG2 as an ISO document “Health informatics: Terminology constraints for coded data elements expressed in ISO harmonized data types used in healthcare information interchange (ISO 17583)”. Dr Vincent McCauley has been nominated as the Australian National expert for this document.

A draft of ISO 17583 was prepared and comments provided during the working group meeting. Further work is required in the area of conformance assessment and this will occur out of cycle. Changes to the ISO draft will be incorporated into the HL7 project.




HL7 Vocabulary Binding Syntax

ISO 17583 draft ‘Health Informatics: Terminology constraints for coded data elements expressed in ISO harmonised data types in healthcare information exchange’ will be circulated shortly for comment.

Action: Distribute draft for Australian comment when available.

NEHTA CCA

IT-014

Conformance Task Force


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2.12.2 PROJECT #874: V2 CODE TABLE VERSIONING AND ALIGNMENT TO V3 VOCABULARY MODEL

PROJECT OBJECTIVE

This project is attempting to align code sets, value sets and vocabulary models used in V2 and V3/CDA to facilitate interoperability. This is a joint project of Vocabulary and Conformance and Guidance for Implementation/Testing.


The project will review all the published versions of the V2.1 - 2.7 tables (5-600 of them) and content to determine what kind of an object it is; a value set or value set and code system, how many versions of the code system there are, and check the quality of what is in the table. Progressive review has been undertaken and the results are identified in the Tables Decision document (currently at number Table 356).

There are a number of places where the content of the database offered to the user community are different from what is in the published standard and the reasons for such variations have been identified. There were tables (tabulated values) with duplications in the data entry, not by actual duplication but by use of "" marks, which is not useful for those using the tables computationally. There is a case of Null as an entity that can be used to populate the value of a table and an even more significant problem related to the use of Yes/No values. The meaning of yes/no is totally dependent upon the question to which it is applied. Consideration was given to whether to have a single yes/no code system as a first case and recommend that these fields be made more specific in future e.g. rather than, is the person a smoker Yes/No, the value domain is really smoking status and the value is smoker or non-smoker.

This is the first systematic review and the intent is to include fixes for the identified error areas in V2.8 ballot. There are some issues with this strategy as the complete table review and suggested fixes might not make the ballot by September, meaning that the fixes may be applied after the 2.8 ballot is finalised. There is a need for an engagement plan to ensure that all relevant working groups understand what is happening, but also to get contribution and consideration from those groups.

The use case for this work is to support cooperating systems across the V2/V3 boundary and the objective is to fix the problems and discrepancies found.

While the work group review is undertaken, decisions on what has to be added to the V3 ballot will be made by the work group.

It was discussed that if you are carrying version 2, as captured and sent by a version 2 communicating system, and you are carrying it in a translation entry, such as a CDA document, how you indicate the namespace for that code system with this OID as it was captured in version 2. It is suggested that multiple tables will be represented in 1 code system in V3.


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Publishing will meet jointly with Vocabulary at the September meeting to address this issue more fully. There are a large number of HL7 V2 tables that need to be included and the work is progressing slowly due to limited resources.




HL7 V2 table content quality review and V3 / CDA harmonisation

Aligning code sets, value sets, and vocabulary models used in V2 and V3/CDA is required to facilitate interoperability. Australia has strong use of V2 and CDA as its key component in the PCEHR.

Action: IT-014-06 need to consider resolution of similar issues.

IT-014-06

2.12.3 PROJECT: V2.8 CONFORMANCE PROPOSALS

PROJECT OBJECTIVE

This project specifies the conformance requirements for HL7 V2.8 (Chapter 2B).


This project was balloted in the last ballot cycle. Reconciliation of the received ballot comments was completed at this WGM. In particular, there was further discussion as to how required/optional fields and their associated conformance requirements should be represented. It was noted that a conformance requirement of RE (Required but may be empty) is not satisfied by two double quotation marks in a field (,“”,). This should be interpreted by a receiving system as “delete any value in this field”. However a requirement of just R is satisfied.

A further final ballot for the V2.8 Standard will occur in September and editing for the Chapter 2B inclusion in that ballot is underway to reflect the persuasive comments disposal from the previous ballot.


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Significant work has been completed on how conformance requirements for required and optional fields should be specified in HL7 V2. This is also relevant to CDA conformance testing.

Action: Distribute draft material to the NEHTA and the CCA Governance Group.

NEHTA

CCA Governance Group



The final ballot cycle for HL7 V2.8 Conformance Requirements will occur in September.

Action: Prepare and submit ballot responses prior to next WGM in September.

HL7 Australia

Standards Australia

2.12.4 PROJECT: V2.9 CONFORMANCE PROPOSALS

PROJECT OBJECTIVE

This project specifies the conformance requirements for the next version of HL7 V2 (V2.9) and in particular updates or additions to Chapter 2B.


No specific additional work was performed at this WGM on this project.

2.12.5 PROJECT MODELLING WORKBENCH (MWB) – MAINTENANCE

PROJECT OBJECTIVE

Maintenance of the Modelling Workbench tool to deal with issues as notified and update for new version of HL7.


This project has been placed on hold.


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2.12.6 PROJECT #825: V2 XML ENCODING RULES RELEASE 2

PROJECT OBJECTIVE

Update the standard that describes the rules for the encoding of HL7 V2.x messages in XML for transmission.


Final document was published.




XML V2 representation HL7 Project 825

“XML V2 representation HL7 Project 825” was recently published and should be distributed to the appropriate Standards Committees and industry.

Action: Notify Standards Committees and industry that this updated document is available.

IT-014-06

MSIA

2.13 DETAILED CLINICAL MODELS Detailed Clinical Models is not an HL7 working group. It is an idea that has been worked on mostly in Patient Care and has found a lot of interest in various other working groups. It is referenced in several work group reports.


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2.14 EDUCATION & MARKETING WORKING GROUP DESCRIPTION

The HL7 Education WG ensures the quality and availability of education and learning deliverables provided by HL7 International and nurtures a community of HL7 educators.

The objective of the Education WG is to allow all those involved in delivering HL7 education and learning services to develop the quality and availability of education and learning deliverables.


The Education Work Group with Marketing discussed the increasing needs for quality-based education. This need was highlighted through reports where many countries have identified workforce skill shortfalls required to support e-Health projects and other related requirements for information sharing around the world.

HL7 has largely considered education as a marketing tool and a revenue generation activity but this attitude is changing as the need for sound education and the need to support educational activities around the world have become clearer.

There are still issues related to the quality of what is offered. Many tutorials are presented by highly experienced and valued members of the community but people with little knowledge of how to develop quality training materials, nor how to assure or assess whether those attending actually learn anything of value to them in their workplace.

It is acknowledged that there is a difference between the training needs of those who work in HL7 and those who work in healthcare in general and not in the standards themselves. The following meeting in September will continue the discourse on this and consider the courses and competencies required for both groups. Specific consideration will be given to those requiring knowledge of mobile health and discussion will take place on HL7 tutorials in mobile health and if these are required.

In addition, discussions on the succession planning and rolling faculty using backup tutors who must be “agreed as competent” and who would be expected to deliver tutorials periodically. All tutorials at the September meeting will be asked to resubmit their tutorial outline and lesson plan (using the template developed by Heather Grain). This template is based upon metadata required by Australian Department of Education, Employment and Workplace Relations (DEEWR). Further, Heather Grain has been asked to provide two tutorials on basic tutorial design and presentation at the next Working Group Meeting in September.

The US Office of the Coordinator has identified the need for health IT workforce development. The core requirements for specific work environments and courses that support the development of those skills are published on the Office of the Coordinator web site. The process includes a course on networking and information exchange. This material came


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originally from Duke University, developed by Ed Hammond, and includes version 3 and CDA. However, it is quite old and requires review and update for broader use.

The potential to have additional tutorial days available at WGMs was presented and Friday was offered as a day which would suit many and not interfere with the work of the meeting. Marketing members will determine what action to take with the materials available to them.

A presentation was given by Erica Franke of NextGen who was interested in what HL7 might be able to do to support their needs. NextGen run a free university program backed by universities in the US and Canada as a compliment to “emergency physician in training” which includes some local training and some training through a Moodle site. Though their courses are online the student can interact with a mentor who is “local”. There is the potential to use existing ambassador program materials for this and leverage the programs both for this purpose and for broader HL7 use. Erica is employed by the University of British Columbia and a number of universities in Africa and South America are also involved. Further information can be located at:

www.nextgenu.org

Webinar on the Ambassador program was very well received and attended. The questions received were very useful and helpful. 90% of the people on the webinar were totally new to the HL7 environment with most having never been to a meeting or previous webinar.

Countries have identified the need for a trusted source for receiving local training and mentoring to help develop capacity and workforce that is suitably HL7 trained. There is a need to identify the skills needed for different jobs in the community.

CURRENT PROJECTS

2.14.1 PROJECT #865: HL7 CERTIFICATION PROGRAM ENHANCEMENT

PROJECT OBJECTIVE

This project will enhance the HL7 certification program by taking into account the process used for certification as well as the actual certification testing. Enhancements include:

• Other HL7 International Educational opportunities e.g. e-Learning, HL7 International Summits or WGM tutorials;

• Educational events organised by HL7 Affiliates or other organisations e.g. workshops, conferences, e-learning, etc.;

• The certification candidates work experience with HL7 products; and

• The certification candidate involvement in HL7 International or Affiliate Workgroups e.g. Co-Chair, member, etc.

http://www.nextgenu.org/


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The certification program will also take into account the roles and skill levels needed to work with HL7 standards in healthcare-related organisations at different areas of responsibility. The project will:

• Establish a table of competencies categories, subcategories and skills, related to HL7 standards or products;

• Establish areas of responsibility/job roles related (using, developing, making decisions) to HL7 standards/products;

• Establish a framework mapping the roles to the competencies;

• Define the name of the levels of certification;

• Define and/or investigate existing skill metrics (i.e. how to acquire credits for certification) and create the policies;

• Evaluate the current HL7 and HL7 Affiliate offerings in terms of specific skills acquisition and create the corresponding Quality Assurance mechanisms;

• Define the process for the certification program management e.g. HL7 Staff chores, HL7 Affiliate chores (options include certifying people and/or course) and define the process for post-certification continuing education (CE); and

• Launch the new certification program.


This work aims to improve the current certification process and, in particular, move towards a more competency based approach that would support affiliates and educational organisations offering competency certification. This process includes identification of current activities and affiliate requirements.

The results of Affiliate requirement collection was reviewed, though in many cases more information was provided by the members present than had been obtained from the Affiliates. The review identified that many Affiliate countries do not understand their national workforce needs, their educational processes and the potential impact of a lack of education. Germany identified the need for high level (PHD) programs, while most other countries were far more interested in quality assured vocational, or short programs. All were keen to have certification that clearly specifies the skills of those certified and, where certification is built, around industry requirements for implementation. The processes used within HL7 international around certification were considered and further clarification of the process requirements will be an ongoing activity.

MnM will be updating the RIM certification instrument and processes. The general policy is that people who work on the certification exam will be involved in testing the exam and will be granted certification for their efforts. The group who develop the certification examination must be from more than one part of the world. The need to be clear about what a person is certified to do was reiterated and acknowledged as an important requirement.


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Education and Marketing:

Communication and development of understanding and skills

Australia still has no strategy related to HL7 or Standards Australia products in general. DEEWR Industry Skills Council’s funding to develop competency and skill sets to support certification could be leveraged to develop a strategy.

Action: JSCHIS to consider the possibility of representation on the DEEWR Industry Skills Council.

Action: HL7 Australia to consider how they could add to their existing excellent general information sessions in order to develop more serious certified education programs within the Australian education system and where possible leverage international opportunities and partnerships.

JSCHIS

HL7 Australia

2.14.2 EDUCATION STRATEGIC PLAN

PROJECT OBJECTIVE The project is reviewing the educational WG group strategic plan for HL7.


The Education WG’s strategic plan was discussed with the Marketing WG and each WG has been asked to identify the scope of the skills required by the HL7 community members as well as the broader community.

Other areas discussed were quality and evaluation processes where it was agreed that all tutorials for September will be required to provide updated template information which will be reviewed for quality and reported upon at the September meeting, and resource management. To be enforced next year, it will now be a requirement that each person teaching an HL7 tutorial must have completed Heather Grain’s “How to prepare and deliver an HL7 tutorial” if they want to deliver a tutorial for HL7.

2.14.3 OTHER COMMENTS

From the strategic perspective there is a strong need for HL7 to complete, endorse and progress implementation of its Education Strategy. Through oversight and development of well-structured and appropriate HL7 education and learning content through resource appropriate pathways across a range of requirement categories including:

• To raise awareness and basic understanding of HL7 (hence the link with the Marketing Council);


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• To provide more advanced understanding and support for self-study by health informatics professionals (IT personnel and clinicians) to allow them to understand and apply HL7 standards at a strategic level and participate in HL7 standards work (traditionally the role of the HL7 tutorial programs);

• To equip health IT professionals and paraprofessionals with a range of structured skills needed to understand and correctly implement standards; and

• To provide deeper understanding of HL7 processes, information structures and standards as part of the professional education of health informatics professionals.



Education HL7 Australia is considering how to work with New Zealand and possibly Singapore to promote education activities in the region and for their members.

Action: HL7 Australia to progress development of structured HL7 education offerings in collaboration with New Zealand and possibly Singapore.

HL7 Australia


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2.15 ELECTRONIC HEALTH RECORDS (EHR) WORKING GROUP DESCRIPTION

The goal of the Electronic Health Record (EHR) Technical Committee is to support the HL7 mission of designing standards to support the sharing of electronic health records. It will accomplish this goal through contributing to the creation and promotion of appropriate and necessary standards including the definition of a high-level architecture to support the interoperability requirements among EHR Systems. The goal of the EHR Fresh Look Task Force is to support the HL7 mission of developing standards for EHR interoperability. The Fresh Look Task Force will contribute to this goal by creating and promoting appropriate and necessary standards which include:

• Functional Requirements for Electronic Health Records (EHR) and systems (EHRS);

• Functional Requirements for Personal Health Records (PHR) and systems (PHRS);

• Definition of a high-level framework to support the interoperability requirements and life cycles; and

• Identification of existing and emerging information requirements and other HL7 artefacts.


http://www.hl7.org/Special/committees/ehr/index.cfm

http://wiki.hl7.org/index.php?title=EHR

PROGRESS AT THIS MEETING Progress at this meeting is defined under each current project below.

CURRENT PROJECTS


1. Project #819: EHR-S Functional Profile for Health Information Exchange Metadata

2. Project #688: EHR System Function and Information Model (EHR-S FIM)

3. Project #881: Patient Care Allergies and Intolerances DAM

http://www.hl7.org/Special/committees/ehr/index.cfm

http://wiki.hl7.org/index.php?title=EHR


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2.15.1 PROJECT #819: EHR-S FUNCTIONAL PROFILE FOR HEALTH INFORMATION EXCHANGE METADATA The scope of this project is to create a US Realm EHR Functional Profile describing the functions for an EHR system to support metadata required for patient demographics, provenance (source and type of data), and security and privacy in support of health information exchange.

PROJECT OBJECTIVE

Review of the Metadata profile is being developed based on EHR-S FM R2 using the new EHR Trust Infrastructure Conformance Profile.


There is currently a comment only ballot out until 25 May after which reconciliation of comments will need to be undertaken jointly with EHR, Security and CBCC. The metadata section has been reviewed with another WG in HL7 (subcommittee DS4P project). A framework to analyse the metadata was reviewed and involved the patterns for analysing data (such as the lifecycle events in the record as a language for triggering events). The process of the review included noting who performed the action; the entry of the action; move from who to organisation; action moves into what, what action was taken; moves to when the action occurred; move across to the where, physical location recorded; move across to the why, what was the reason the action was taken (who, what, when, how, why – with additional criteria added for each). This tool was seen as useful in explaining why it was chosen as metadata by member however, there were fundamental modelling problems raised with the metadata. The purpose of the metadata should be considered more closely as a driver for the analysis of metadata requirements. This may require some scope changes to the project. In addition, when exchanging metadata there are other requirements in regards to the communication properties.

The difficulty with record management in the healthcare industry is that there is no authoritative body who states that this EHR is the model that is to be used. Therefore, this is problematic in defining and implementing triggers as these are embedded in the lifecycles that have to do with exchange.

The project, from the Security workgroup’s perspective is that there appears to be a misunderstanding of the purpose of the metadata. It was suggested that there were two fundamental aspects that needed advancement in the project. These relate to the purpose of the metadata for health information exchange requirements in consideration of who was going to use it and for what purpose. It is currently medical records focussed but does not include the whole breadth of HIE metadata. It was suggested that the structure based on IHE to document the XDS metadata project be looked at as a solution to drive the project.

There was additional discussion (outside the joint meeting) that the EHR functional model requirements needs to be independent to any other structural definitions of the EHR i.e. needs to be applicable to other conceptual models e.g. openEHR.


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Additional concerns were raised by the security workgroup that the EHR glossary definitions are diverging and require consistency. The Security WG is needed to give input into this.




HIE metadata

There is a lack of clarity on the purpose of use of the metadata in the EHR and its potential impact on Australian adopted models.

Action: Monitoring and input to the project by Australia from those with knowledge of the Australian EHR format and use is required from both the clinical and security perspectives.

IT-014

NEHTA

2.15.2 PROJECT #688: EHR SYSTEM FUNCTIONAL INFORMATION MODEL (EHR-S FIM)

PROJECT OBJECTIVE

The EHR WG describes this project as producing a set of Conceptual Information Models called EHR-S “data profiles”. Each EHR-S data profile corresponds directly with an EHR-S function profile. Pairs of EHR-S function profiles and data profiles can be used to define business objects, which can be composed into software components, capabilities, applications, systems and their information exchanges e.g. messages, documents and/or services. The superset of EHR-S data profiles is called the EHR-S Information-Model.

The objective of this Project is perhaps more succinctly articulated by Steve Hufnagel and Nancy Orvis as:

“The EHR-S FIM vision is that analysts, engineers or testers can efficiently compose and refine the architecture and workflow agnostic EHR-S FIM into interoperability specifications, which meet their System Acquisition, Implementation or Test needs.”


A Prototype has been developed for immunisations and more recently for orders management. The FHIR 80/20 rule has influenced the selection of attributes in the prototype. The philosophy has been that the artefact is a requirements model and an Analyst can use the model to do an initial review for product capability.

These models are essentially sets of conformance criteria and purposely try to avoid the concept of workflow.


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Version 1.1 is now an ISO Standard. ACTIONS FOR AUSTRALIA



EHR-S FIM

The EHR Function and Information Models, the existence of which is little known in Australia, would have value to both Purchasers and Developers.

Action: Increase Awareness of the EHR System Functional Model.

HL7 Australia

MSIA

2.15.3 PROJECT #881: PATIENT CARE ALLERGIES AND INTOLERANCES DAM

PROJECT OBJECTIVE

This Project is intended to complete the Domain Analysis Model and update the RMIM for Allergies and Intolerances. It is sponsored by the Patient Care WG and Co-Sponsored, among others, by the EHR WG.

PROJECT ACTIVITY/ISSUES AT THIS MEETING Further information on this project can be located in clause 2.28.1 of this report.




Allergies and Intolerances

Despite the presence of Australian Co-Chairs driving this project, its visibility to Australian Software Developers is limited at best.

Action: Increase awareness of this Domain Analysis Model.

HL7 Australia

MSIA


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2.16 ELECTRONIC SERVICES WORKING GROUP DESCRIPTION

The Electronic Services Work Group is appointed by the Technical Steering Committee (TSC) to oversee and prioritise HL7 headquarters’ electronic services with a mission of optimising all forms of electronic interaction with HL7.org.

Electronic services comprise interactions with HL7.org either via the internet or e-mail that includes, but are not limited to:

• Hosting a web site (http://www.hl7.org) that provides useful information to the public while serving the needs of the HL7 members;

• Maintaining list servers to facilitate member interaction; and

• Providing and supporting electronic balloting including the availability of electronic ballot materials.

It should be noted that Electronic services do not comprise the interchange of HL7 messages or other specifications.


The WG convened for two quarter sessions. The first session was aimed at the development of a tutorial for Ballot Training Material. The second session reviewed access to the website by different groups of users. It was a deliverable of Project #877 “Develop HL7 Ballot Site Education Material” and was instigated after the Electronic Services WG received feedback that the Ballot Website was difficult to use.

The ES WG lists a number of current projects including:

1. Project #877: Develop HL7 Ballot Site Education Tutorial 2. Project #803: HL7 Tooling Dash Board Project 3. Project #802: HL7 Tooling Communication Plan and Execution Project 4. Project #801: HL7 Tooling Strategy and Process Revision 5. Project #799: HL7 Strategic Initiatives Dashboard Project 6. Project #150: New HL7 Web site

There were no WG updates for the HL7 Strategic Initiatives Dashboard, however WG “Health” was publicised during the morning Plenary Sessions, and various WG recognised for meeting their project deliverables.


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CURRENT PROJECTS


1. Project #877: Develop HL7 Ballot Site Education Tutorial

2. Project #150: New HL7 Web Site

2.16.1 PROJECT #877: DEVELOP HL7 BALLOT SITE EDUCATION TUTORIAL

PROJECT OBJECTIVE

The intent of this project is to develop a tutorial on how to use the HL7 Ballot site. This tutorial will be developed in English.


This project was discussed at the ES WG session that, due to the overlap in work group meetings, no Australian delegate was able to attend, however the ES WG did deliver an education session on using the “HL7 Ballot Website” during this WGM.




HL7 Ballot Site Education Tutorial

As an International Affiliate, HL7 Australia votes as an entity for all its members. Over the past few years, HL7 Australia has not voted in a number of ballots and there has been some loss of knowledge regarding the balloting process.

As the significant majority of ballots have been related to HL7 Version 3 technology, there has been little interest in the Australian HL7 community in these ballots. Exercising its votes is one of the significant levers that HL7 Australia can use to influence international standards development in the international HL7 stage and requires renewed focus and energy.

Action: Increase knowledge of HL7 International Ballots in Australia.

HL7 Australia


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2.16.2 PROJECT #150: NEW HL7 WEB SITE

PROJECT OBJECTIVE

The goal of this project is to develop a new HL7.org website and has been segmented into a number of releases. Release 1 was a new “Creative Look and Feel”. Release 2 focused on key components of “WGM Registration and HL7 Membership”. Future releases will expand the scope of “WGM Registration and HL7 Membership”.


There was a discussion of page access to the HL7.org website by different audience groups. This review considered the pages that were most widely viewed and, by association, of most interest to visitors. The audience groups were categorised into “Members”, “Non Members”, “Affiliates”, “Anonymous”, and “Co-Chairs”.

Access by International Affiliates, such as Australia, dominated access to the HL7 Standards at 38% of audience page views. This reflects strongly on affiliate membership entitlements that provide free/included access to the HL7 Standards material. Access to the HL7 Standards across all audience types was highest (17%), followed by “Conference Call Information” and “About HL7”.




New HL7 Web site

The HL7 Australia website is in need of a significant overhaul. There does not appear to be the level of analytic data available to HL7 Australia to better understand its member’s interests.

Action: Redevelop the HL7 Australia Website.

HL7 Australia


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2.17 HL7 FRESH LOOK TASK FORCE


The Fresh Look Task Force is one of several initiatives that emerged from the v2/v3/CDA task force. It is now a separate and very different activity with a focus on identifying potential longer-term innovation projects for trial by HL7 and has been meeting regularly at recent WGMs. The earlier v2/v3/CDA task force completed its work and was disbanded over 12 months ago.

PROGRESS AT THIS MEETING In the absence of the usual chair of this WG, Ed Hammond led the discussions. The progress

at this meeting is detailed under current projects.

CURRENT PROJECTS

2.17.1 DEFINING LONG-TERM INTEROPERABILITY DIRECTIONS PROJECT OBJECTIVE

This task force has recently been established to look at long-term (five years +) interoperability concerns and to help HL7 standards easier to implement.


The discussion at the meeting has identified a need to look at broader semantic interoperability issues than what is currently addressed by HL7. Many of the concerns raised are addressed as part of the NEHTA Interoperability Framework 2.0 and, more recently, the e-Health Interoperability Framework standard being developed by the Interoperability Tiger Team. In fact, many of these concerns are addressed by the HL7 SAIF framework and it appears that the FLTF is not fully aware of this HL7 ARB initiative. There needs to be a consistent way of expressing relationships between this task force, CIMI and SAIF so that SA members are aware of these different initiatives. It may be of value to pay more attention to various ONC projects under Standards and Interoperability, which was also presented at this meeting.

Additional information can be located at: http://www.siframework.org/.

The discussion at the meeting was led by Ed Hammond and focused on what HL7 should be doing 5 years in the future. A number of issues were canvassed. Some of the dominant themes were as follows:

• Simplifying Message Transport

• Provenance and Tagged metadata

http://www.siframework.org/


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• Convergence of Clinical Care and Clinical Research

• Big Data

• Growing interest in Apps and Devices

There were also some interesting views expressed by a number of HL7 International Affiliates including:

• HL7 Singapore expressed the view that HL7 would be irrelevant once the Message Transport issues were resolved. Their belief is that it then becomes all about Data Analytics. HL7 Singapore expressed the sentiment that they did not see an ROI on the participation of their personnel at HL7 WGMs, and felt that HL7 International should merge with CIMI.

• HL7 Canada was highly focused on the IAMTF meeting to follow. Given HL7 Canada’s investment in HL7 Version 3, they are evaluating whether it’s participating or investing in these HL7 Initiatives. Canada also indicated that it would no longer be participating in ISO WG3 and more generally carefully considering its participation in various SDOs.

2.17.2 OTHER COMMENTS

As a separately constituted group that meets regularly at WGMs, the Fresh Look Task Force should be reported under its own heading in this and future reports.



Fresh Look Task Force

The "Fresh Look Task Force" is one of several activities that emerged from the V2/V3/CDA Task Force but is now a separate activity in its own right. It has yet to be separately listed on the Australian delegate task allocation list and have its own section in WGM reports instead of being listed as an incidental inclusion under "V2/V3/V4 Task Force", which ceased to exist over 12 months ago.

Action: IT-014 Secretariat to include "Fresh Look Task Force" as a separate activity in the delegate responsibility lists and report template for future delegations.

IT-014 Secretariat



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2.18 HL7 COLLABORATION WITH OTHER SDOS


This is an open forum, convened by the TSC, to consider matters proceeding across the various SDOs. Reporting has been reduced with a view to providing more opportunity for discussion and feedback. For information on this please refer to Section 2.25.


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2.19 HEALTH CARE DEVICES WORKING GROUP DESCRIPTION

The Health Care Devices working group facilitates the integration of health care device information at the enterprise level by:

• Establishing standardised version 2.x and version 3 content to support health care device interoperability at the enterprise level;

• Harmonising device data models between HL7 and other organisations including ISO/IEEE 11073;

• Harmonising and coordinating device terminology usage within HL7 components;

• Support revision and harmonisation of the Clinical and Laboratory Standards Institute (CLSI ) Point of Care Test (POCT) and laboratory automation standards; and

• General coordination and harmonisation between HL7 and other national and international organisations involved in health care device informatics and interoperability.


http://wiki.hl7.org/index.php?title=Health_Care_Devices_(DEV)_WG

http://wiki.hl7.org/index.php?title=DEV_WGM_Agenda_January_2012


Health Devices met with the FHIR project team to discuss the relationship between FHIR and their needs for healthcare devices. Two principle areas of interest where discussed:

• How to define what a device is; and

• How devices receive and emit data.

The working group committed to developing some test resources for FHIR to see what they would look like and evaluate whether this would be a useful approach.

In Vancouver, due to the overlap in work group meetings, it was not possible for Australia to be represented further at this meeting.

http://www.11073.org/

http://wiki.hl7.org/index.php?title=Health_Care_Devices_(DEV)_WG

http://wiki.hl7.org/index.php?title=DEV_WGM_Agenda_January_2012


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2.20 IMPLEMENTATION TECHNOLOGY SPECIFICATION (ITS) WORKING GROUP DESCRIPTION

The ITS SIG supports the HL7 mission through the development of Implementable Technology Specifications and Messaging Protocol guidelines e.g. ebXML, Webservices, MLLP to be used when putting the HL7 information specifications to use.


http://wiki.hl7.org/index.php?title=ITS_WG


During this meeting, the ITS committee spent two quarters reviewing the technical underpinnings of the FHIR project. One quarter was devoted to issues associated with the representation of resources, and the other with the definition of the REST interface. The following outcomes were noted:

• Due to a series of issues around JSON, it will not be a primary representation of the resources but an informative representation will still be described.

• The specification should describe an adjunct usage of FHIR for exchanging profiled resources to suit local requirements.

• The REST specification for RLUS/hData and FHIR should be aligned. The alignment of this was completed during the meeting.

In Vancouver, due to the overlap in work group meetings, it was not possible for Australia to be further represented at this meeting.

2.21 INFRASTRUCTURE AND MESSAGING (INM)


The mission of the Infrastructure and Messaging WG is to provide the infrastructural support required in order for systems to exchange domain content as specified by HL7.


In Vancouver, due to the overlap in work group meetings, it was not possible for Australia to be represented at this meeting.

http://wiki.hl7.org/index.php?title=ITS_WG


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2.22 INTERNATIONAL COUNCIL WORKING GROUP DESCRIPTION

The International Council is a body that comprises the chair of each national HL7 affiliate, led by the two HL7 directors elected by the HL7 affiliates and provides a forum within HL7 for discussion of international aspects of HL7's activities and for resolutions relating to the needs of the national affiliates. It provides a forum for the HL7 International Affiliates (like HL7 Australia) and other interested HL7 members to discuss and communicate issues regarding the international development, adoption, application and implementation of the HL7 standard. Previously called the Affiliates Council this meeting considers international advances and issues of the HL7 organisations around the world.

The International Council recommends to the Board of Directors actions and policies on behalf of the International Affiliates and advises the Technical Steering Committee and Board of Directors on matters relating to areas of standardisation that are relevant to the International Affiliates. This group supports the HL7 mission to create and promote its standards by helping to assure that the needs, issues and other input of the HL7 International Affiliates are recognized and effectively acted on by the HL7 organization. In summary the role of the International Council meeting is to update the international community on the board and its nominated group activities.


http://www.hl7.org/special/committees/international/index.cfm

http://wiki.hl7.org/index.php?title=International_Council

GENERAL SESSION OF THE INTERNATIONAL COUNCIL

2.22.1 ATTENDANCE AND QUORUM There were 67 people registered for the International Council Meeting, 24 out of 38 HL7 affiliates were represented by their chair or a proxy for voting. This was a near record attendance which provided a comfortable quorum.

2.22.2 NEW AFFILIATES

The most recent affiliate, HL7 Puerto Rico and its Chair Julio Cajigas were welcomed by the International Council. HL7 Mexico has also been admitted as an affiliate, with a few operational details still being confirmed following a recent change of Chair shortly after formation.

2.22.3 E-VOTE FOR APPROVAL OF REVISED AFFILIATE AGREEMENT

The motion for International Council approval of the revised (v14) Affiliate Agreement for 2012 and 2013 was passed in March with 7 comments but without any negative ballots. Some minor

http://www.hl7.org/special/committees/international/index.cfm

http://wiki.hl7.org/index.php?title=International_Council


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changes were made to accommodate most of the comments and the resulting agreement was subsequently approved by the Board and circulated to affiliates for execution prior to 30 April, which had been done by all those present.

2.22.4 ELECTION OF INTERNATIONAL COUNCIL OFFICERS AND REPRESENTATIVES

The following results of recent ballots for elections to International Council positions were noted:

• International Council Co-Chair (HQ Liaison) for the balance of 2012 – Philip Scott (UK) was elected to replace Robert Stegwee, who had resigned because of his increased commitments to CEN as its new Chair and to his work.

• International Council representative to the TSC for the balance of 2012 – Georgio Cangioli (Italy) was elected.

• International Council representative to the Finance Committee of the Board – Diego Kaminker (Argentina) was elected for 2012 - 2013, filling the vacancy left when Michael Van Campen took up his position as HL7 Treasurer for 2012 - 2013.

2.22.5 HL7 BOARD REPORT

The CEO, Dr Chuck Jaffe, welcomed the delegates to the International Council on behalf of the Board of HL7 and presented a short report, which addressed the following key points:

• Current business plan activities are aimed at fostering development of HL7 and also collaboration with other SDOs.

• Following requests from the affiliate chairs for more information on the HL7 Business Plan (including the confidential aspects), the Board of HL7 has agreed to the full business plan documentation being shared on a strictly confidential basis with the affiliate chairs to allow more detailed discussion and consideration of its impact on activities such as the IMATF. This took place in closed session of the Affiliate Chairs meeting on the following Thursday.

• Director of Education: The Board and senior executive team are pleased that Mollie Brennan has been appointed to this new role and will commence on 5 June. Unfortunately she was unable to attend the Vancouver WGM. Her role will include liaison with the Education Committee, progressing the HL7 education strategy, and implementing the education components of the overall HL7 business plan.

Australian delegates are pleased that HL7 appears to be moving toward more professional management of its education activities and the completion of the education strategy. This is an area for Australia to continue monitoring in conjunction with its own needs to address HL7 education needs in Australia.


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• Caregiver Membership: This is a new category of membership with an annual fee of US$100 which is open to any front-line clinical practitioner interested in working with HL7 on requirements for use of HL7 standards in clinical practice. Caregiver members have rights to access and read HL7 standards and participate in HL7 activities. While numbers are presently low, the gradual progression toward MU2 and MU3 meaningful use in the US is focussing more care givers on the need for better information standards to support them in achieving higher levels of clinical utility from their information systems.

• Establishment of the HL7 Mobile Health (mHealth) Work Group: The decision to form this workgroup arose after numerous queries from other organisations concerned about ensuring interoperability of emerging mobile health applications and the associated need for appropriate frameworks and standards. Webinars attracted several hundred people expressing various levels of interest and a core group has held five or six meetings to plan a charter for the new work group

The large number of interested groups already addressing the application of mobile technologies in health care has raised the importance of collaboration, harmonisation and the need to avoid duplication of effort and competing standards. Within HL7, some have questioned whether HL7 standards used for mHealth need to be any different from those used with other underlying technologies. These are all issues to be considered and the mHealth WG provides a valuable forum for this to occur within HL7, a forum that currently seems to have strong support from the various industry groups including Continua and IHE.

The first face-to-face meetings for mHealth were held at this WGM and reported on separately in this report.

• Marketing the business plan: Marketing consultants (PCI) are assisting HL7 to develop commuted targeted communication and engagement strategies to promote the organisation and assist it in realising its business plan by expanding membership and innovating to meet emerging needs in its marketplace. Stakeholder consultation will take place by means of telephone interviews to explore these questions and issues such as bundling and unbundling of membership and IP access/usage rights. The consultation will be international and is expected to include some affiliates and their members.

• The following "Care Connected" logo is now available for use on the "Splash Page" of EHR systems:

Following strong encouragement from suppliers represented on the Advisory Council. HL7 has been working on having a splash page logo that can be used by EHR system suppliers to promote their membership of HL7 and use of HL7 standards. The logo


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may also be licensed by members of affiliates in good standing. HL7 International particularly thanks Carl Dvorak and design department at Epic for donating their time to develop the logo and make it available to HL7. The logo may be licensed for use free of charge. Australian suppliers wishing to use the logo should contact HL7 Australia to make the necessary arrangements

• HL7 Europe: Kai Heitmann was thanked for his effort in compiling the 32 page second edition of the HL7 Europe "Newsletter". This was an important contribution to a successful HL7 presence at the e-Health week in Europe, which focussed on the economics of interoperability. Further details of activities in Europe are reported on in a later part of the International Council section.

• HL7 in Genomics: There is a growing body of work moving beyond interoperability to leverage the many genomics developments around the world.

• Trifolia: HL7 is the beneficiary of a library of CDA templates for reuse and the use of the Trifolia tool, generously offered without charge by Lantana (Liora Alschuler and Bob Dolin's consulting firm). HL7 is still working through the associated licensing, governance and potential commercial issues.

• FHIR: HL7 is very grateful to Grahame Grieve (Australia) for donating his library of implementation resources to the HL7 community to provide a development platform for HL7 specifications. The FHIR resources are to be hosted on HL7 website and, under terms of the donation, will be an open source.

There is great interest throughout the HL7 community on the potential for FHIR to become the most likely technology to underpin easier, more consistent HL7 implementation moving forward. It is designed to deliver the richness of expression required while also being able to be understood by the current generation of IT implementers. Free tutorials were provided during this WGM.

• Outreach to the pharma industry: This is being pursued in collaboration with CDISC and includes outreach to regulatory bodies and those seeking to connect clinical research and clinical care.

• JIC: The CEO indicated that he would be commenting further on JIC activities later in the week. Constructive interaction between SDOs is critical and he is looking forward to further advances in this regard. He suggested that the model of the SCO (SDO Collaborative Organization) as used in the US may be one that other countries find useful on a local or regional basis.

2.22.6 AFFILIATE DUE DILIGENCE COMMITTEE

The countries that currently have lapsed are as follows:

• HL7 Brazil – missing dues, reports:

• HL7 Chile – missing dues, reports; and


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• HL7 Switzerland – missing dues.

New applications have been received from HL7 Philippines and HL7 Malaysia, and expressions of interest from Slovenia, Denmark, Bangladesh.

As affiliate application needs some assistance, the “How to become an HL7 Affiliate” document is to be updated by the Affiliate Due Diligence Committee. This is an important document for all new affiliates and was originally created by Klaus Veil in 2009.

The Affiliate Due Diligence Committee is currently assessing petitions from Malaysia and the Philippines. Further discussions are continuing between HL7 HQ and the recently formed HL7 Mexico following a change in HL7 Chair and the need for agreement on allowed roles and use of HL7 IP in relation to HL7 training and certification. Work also continues on improving materials. For further details on the activities if this committee, see the Affiliate Due Diligence Committee section of this report.

2.22.7 CTO AND TSC REPRESENTATIVES REPORT

Austin Kreisler, Chair of TSC, provided the CTO/TSC report for John Quinn who was unable to attend the WGM due to illness. The following are among the points noted:

• Project status and approvals: TSC project backlog continues to grow but has slowed a little. There are currently 252 active projects, down from 257 at the last WGM due to project completions, review and closure of inactive projects and despite new projects being approved nearly every week. He noted that HL7's goal is to get projects done successfully and warned that projects will not be approved by TSC if the requirements for the Project Scope Statement are not met, particularly in relation to active support and leadership of projects. These disciplines accord with those of other SDOs working in the domain including ISO/TC 215's proposed position and Standards Australia IT-014.

Numbers since last WGM compared with the previous period:

- New Project approvals : 29 (-7)

- Projects withdrawn: 10 (+5)

- Publication approvals : 8 (+1)

- Ballots: 40 (+21)

- Working Groups (WG) dissolved: 1

- New WG in process of being established: 1

• Government projects WG was shut down with its remaining project transferred to EHR.

• Georgio Cangioli was welcomed as the replacement International Council representative on the TSC and thanked for his early contributions to its deliberations.

• SAIF Architecture Program remains a strong current focus for the ArB and TSC with the intention on making it clearer how HL7 will use SAIF CD in conjunction with those working on SAIF. It is aiming to roll out across organisations and HL7 is developing a plan on how HL7 will use SAIF CD. One issue is how to move this project forward, however many of the same


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people are also working on FHIR and it is becoming a resource issue. Another project within this architecture is a Cross-Paradigm Interoperability implementation guide for immunisations (SAIF, HL7, IHE & OMG). INM Wrappers R2 is looking at the message infrastructure to support SAIF. SAIF Pilot project to manage the interdependencies between all the projects is the SAIF architecture program.

• Tooling WG: There continues to be a call for participants as there remains a desperate need for more workers to help the tooling WG progress and the delivery of required HL7 tooling. Some may be undertaken as contract work but this is subject to availability of funds.

There are some 8 active tooling projects across the HL7 platform. The ‘HL7 Tooling Challenge’ to be funded by Sparx is scoped but currently on hold. These projects include:

- Tooling Strategy: Where active, different elements are being trialled. Funding being sought to complete.

- Tooling Communication Plan and Execution: Funding being sought to complete project

- Tooling Dashboard - EHRS-FM Profile designer: Planning for funding request in progress - Model Automated Exchange (MAX): Funding to be sought - Templates Interchange Pilot: Funding to be sought - HL7 participation in OHT HEART Project: Funding to be sought - Gforge replacement project: Project on hold, current service provider to be

reviewed

• Sparx Systems sponsorship of modelling initiative: Communication seems to have lapsed in relation to the sponsorship of the modelling competition. Richard Dixon Hughes followed up with the Sparx Systems ambassador during the WGM to ensure that Sparx was aware that there was a perception that communications had lapsed and it is understood that steps were taken to respond to the TSC concerns.

• FHIR: Leveraging the potential capabilities of FHIR is a high priority area for HL7 and the TSC is supporting its introduction and encouraging people to get involved by taking the free tutorials and discuss how its use may be progressed. It is recognised that there are issues and these need to be worked through in an informed manner. FHIR artefacts are now hosted by HL7 URL: http://www.hl7.org/implement/standards/fhir/

2.22.8 HL7 EDUCATION

The development of the strategic plans has been deferred temporarily until the newly appointed HL7 Director of Education commences in June 2012. The HL7 e-Learning Course has been very successful across the world with 250+ students taking up the International Edition, 60 students in HL7 Canada (affiliate run), 14 students in HL7 Pakistan (run from hl7elc), and 90 students in Latin America. In addition, HL7 India and HL7 Austria ran an edition this year, and HL7 Italy and HL7 Brazil will run editions, translated into Portuguese, in the coming year.

http://www.hl7.org/implement/standards/fhir/


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2.22.9 MARKETING AND COMMUNCATIONS PLAN FOR INTERNATIONAL COUNCIL

This is being developed because of the perception that HL7 is only comprised of the HQ, US members and everyone else. The challenge is to highlight the breadth and value of the activities that the international affiliates undertake. There has been stakeholder analysis on the various committees and other stakeholders including the Board, HQ staff, Policy Advisory Committee, Marketing Council and Education Committee. This was presented to promote discussion on the topic and to see how the International Council wants to progress this. It was suggested that the barriers to achieving some things are also a fundamental issue and should be included in the analysis.

Philip Scott (UK), newly elected Co-Chair of the International Council, provided a provocative presentation on marketing of HL7 from the international perspective and in light of an environment where many perceive the image and relevance of HL7 (along with ISO and CEN) as "proprietary" standards developers. This is in comparison to other organisations that are seen to be working with stakeholders to provide interoperability solutions, groups such as IHE, Continua and international pilot projects. These perceptions are found in key stakeholder groups, suppliers, national programs and major purchasers of health information technologies.

It is noted that, because of the size and growth of the global investment in health and health information systems, HL7 operates in an extremely aggressive marketplace and needs to adapt to this reality while being a mainstream collaborator.

Emeritus Chair, Ed Hammond, suggested that that any barriers to acceptance of HL7 need be identified, addressed and resolved sooner rather than later.

2.22.10 E-HEALTH IN SOUTH AFRICA

Dr Rosemary Foster provided an inspiring presentation on the healthcare system in South Africa, its use of health information systems and its incremental e-Health strategy that aims to support NSDA Negotiated Service Delivery in the federated system with strong provincial interests. The strategy covers public and private sector health and welfare activities. The country has significant problems with AIDS (25% of the World's AIDS sufferers live in South Africa) and the associated problems with tuberculosis.

With an organised e-Health program underway there is a moratorium on ad hoc systems acquisition and development. There is a lot of vendor scepticism to overcome following failed national contracts some years ago but these issues are recognised and are being overcome.

Prospects are again looking good for the potential to form an HL7 affiliate in South Africa which may provide a springboard for other HL7 activities in those Southern and Central African countries with a natural connection with South Africa.


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The current scenario in South Africa is that there is a coordinating role of the DoH through the NHIS/SA Committee. The objectives are to draw together the varying levels of e-Health maturity across the country. There are several tiers of public health disease recording and a new e-health strategy has been developed and due for release imminently. In South Africa the focus has been on resource constraints and therefore, mobile telephony has a strong foothold as mHealth has been recognised by a significant potential driving force. The Negotiated Service Delivery Agreement (NSDA) has four targets that form the basis of its e-Health national strategy and e-Health is seen as “enabling a long and healthy life for all South Africans”. For instance, anti-retroviral is a major target for the improvement in healthcare for South Africa. The establishment of the organisation of the standards to support the development of the e-Health and national electronic health record system will need support and advice from the rest of the community.

2.22.11 SEMANTICHEALTHNET Charlie McKay (UK) presented briefly on the Semantic HealthNet Project being carried out in the EU within the Calliope framework. Relationships to other activities including epSOS IHE profiles, EC Health InterOp framework, CIMI, ContSys are points for further consideration. The EU project started in Dec 2010 and HL7 is a collaboration partner. It looks at health failure related to public health use cases to create a virtual organisation to deliver EU Healthcare Interoperability. It is a three year project and relates to several other projects including, Calliope, epSOS, European Interoperability Framework and EU eHealth Governance Initiative. There are several SDOs and universities involved and the HL7 input included coherence across the CDA templates. The challenges are seen as the coordination between the various collaborators and the IP. The value to HL7 is to build on the engagement with EU policy and the project is looking at managing the diversity of and complexity of specifications.

2.22.13 SPECIAL INTEREST TOPIC – AFFILIATE POLITICAL REALITIES

There were three perspectives presented by France, Australia and the United Kingdom. Each presentation provided an outline of the political structure of the standards environment in that country. These presentations included the models of funding. The key part of each presentation was the integration of the national coordination of standards and how this links to the national agendas on e-health.

Nicolas Canu (France), Richard Dixon-Hughes (Australia) and Philip Scott (UK) gave presentations outlining the structure and organisation of e-Health activities within their countries' political environments, the role of their HL7 affiliate and some of the challenges and successes.

Key themes emerging from all three presentations were that:

• HL7 affiliates operate in complex national environments, often within competing national and provincial interests;


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• Local collaboration and active engagement at an appropriate level with national e-Health programs and organisations such as IHE, Continua and national standards bodies is essential for an HL7 affiliate to realise its potential;

• HL7 affiliates are not usually in a position to set national agendas but need to respond positively to initiatives and opportunities as they arise. Key roles include facilitating knowledge of HL7 and providing access to HL7 resources within the country; and

• There is not necessarily a single model for the most effective state of a mature HL7 affiliate; however the effective HL7 affiliate will be an organisation that has engaged at many levels with the broader e-Health initiatives within its country.

2.22.14 REGIONAL REPORTS 2.22.14.1 LATIN AMERICAN AFFILIATES (LATAM)

This region includes the countries of Uruguay, Argentina, Brazil, Colombia, Mexico, and Chile. In 2012 a key milestone was that the HL7 LATAM Newsletter was released from the group. Other progress includes the production by Uruguay of the Medical Certification CDA R2 Guide which includes LOINC/ICD-10 encoded entries, the translating of the HL7 ELC into Portuguese by Brazil, the appointment of Pablo Ceballos, as the new Mexican Chair, and the appointment of new Argentinian Chair, Fernando Campos and the countries active perusal of government and university outreach. There were no updates from Chile or Colombia. 2.22.14.2 EUROPE

Europe now has 19 Affiliates. The major project currently is the “Digital Agenda for Europe 2020: Standardisation and eID”. This is designed to address sustainable health systems, deliver quality care, and unlock market potential. The relevant aspects of this from HL7 Europe’s perspective are in relation to the following four actions:

• Action 21: Propose legislation on ICT interoperability

- As part of the review of EU standardisation policy, propose legal measures on ICT interoperability to reform the rules on implementation of ICT standards in Europe.

• Action 24: Adopt a European Interoperability Strategy and Framework

- Promote interoperability by adopting in 2010 a European Interoperability Strategy and European Interoperability Framework

• Action 77: Foster EU-wide standards, interoperability testing and certification of e-Health systems by 2015 through stakeholder dialogue

• Action 83: Propose a Council and Parliament Decision on mutual recognition of eID


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Visibility and engagement with the European Commission has been a major focus and has included the following activities:

• Updating of the website “HL7.eu”;

• Production of the Europe Newsletter 2011-2012;

• Numerous academic engagements;

• EC e-Health stakeholders’ group engagement; and

• Contribution to the European Interoperability Platform.

In addition there has been participation in EU funded or co-funded projects such as Semantic Healthnet (as a partner), e-health Governance Initiative (as a partner), IT Future of Medicine (as an associate partner), and epSOS cross border e-Prescription (as an observer).

Informal discussions were held throughout the week on the formation of other regional umbrella groups, particularly in the Asia-Indo-Pacific region. Australia indicated its support for the desire of Japan, Korea, China, Taiwan and possibly Hong Kong to form an Asian grouping, it has been suggested that Australia may be offered observer status in such a group.

Australia, New Zealand and Singapore see that they may form the nucleus of another regional collaboration in the South Asia Pacific area, possibly including HL7 Malaysia and HL7 The Philippines.



FHIR All rights in the FHIR resources (formerly RfH -Resources for Health) have been donated by Graham Grieve to HL7 in order to provide a simplified technology platform, compatible with current service oriented approaches, for rapid implementation of HL7 (and other) artefacts in the eHealth domain. This is a highly significant development of which all members of the Australian eHealth community should be aware, particularly given its Australian origins. It is time for local awareness in Australia to be raised and engagement in the potential use and development of this resource.

Action: HL7 Australia to raise awareness of FHIR technology and initiate discussion related to its potential application, development and use in the Australian context.

HL7 Australia

2.22.15 IHIC 2012, VIENNA AUSTRIA

The International HL7 Interoperability Conference, IHIC 2012 will be held in Vienna, Austria on 20-21 September 2012 immediately after the ISO/TC 215 meeting.

The conference provides an opportunity for submission of academically referred papers as well as sharing of implementation experience.


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2.22.16 IMATF (INTERNATIONAL MEMBERSHIP & AFFILIATION TASK FORCE)

The International Council noted that the IMATF was meeting for a total of 1.5 days at this WGM and is continuing to assess the policy implications, strengths and weaknesses of the two preferred organisational models for international membership and participation, both being variations of the federated model.

The relationship of a more federated structure to the HL7 Business Plan and its overall palatability to the wider HL7 organisation will be discussed with HL7 leadership likely to increase over coming months. It was also noted that the affiliate chairs would be briefed on the details of the HL7 Business Plan in a closed session to ensure that they can consider this in relation to the work of the IMATF. While the IMATF has some agreement on a general direction which includes a continuing role for local affiliates, the Task Force was not yet ready to report in further detail until the potential consequences and the feasibility of the preferred approaches are identified and worked through. Work is proceeding with a view to a final report and recommendations at the September 2012 WGM.

Further information on the activities of the IMATF at this WGM is reported in the IMATF section of this report.

2.22.17 HL7 AROUND THE WORLD 2.22.17.1 HL7 ARGENTINA

In May this year, a HL7 full-day workshop was held with another workshop scheduled for June. HL7 Argentina is pursuing university collaboration to undergraduate students and two international editions of e-Learning are running in Argentina. There is a newly elected board as of April 2012 and the membership is slowly increasing with 24 members. HL7 Argentina is approaching the government for adoption of HL7 v2.x XML involving personnel and organisation registry for SIISA project in the Argentina Integrated healthcare system. 2.22.17.2 HL7 AUSTRALIA

There has been a 60-70% increase in membership over the last few years. With the advent of the new PCEHR and e-Health system the focus has been on supporting the national initiatives. This has been achieved by licensed publication of HL7 implementation guides through Standards Australia IT-014; working with NEHTA & IT-014 to support fast-track health informatics (HI) standards; and national participation on Australian Health Informatics Education Council (AHIEC) and the Joint Standing Committee Health Information Standards (JSCHIS). Proactively there are more educational events to be run towards the end of the year which focus on practical needs from national e-Health program, CDA services (1 day in July & 1 to 2 days in November), and certification testing. Also a renewal and update of the publishing agreement with Standards Australia is underway. There will be a greater focus on electronic


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services and marketing, and a push for greater technical engagement in the standards/ballots by HL7 Australia in the coming months. 2.22.17.3 HL7 AUSTRIA

Membership is currently at 35 organisational members and 18 individual members. Activities include an annual conference with 80 attendants and 12 speakers, the running of the second e-learning course with 20 participants which received very positive feedback, positive ballots for CDA implementation guides for ELGA (National EHR) for the Austrian Realm (and in German), development an interactive reference style sheet, and Schematron-Rules for CDA IG. The 13th International HL7 Interoperability Conference (IHIC) will be held in Vienna 27-28 Sept and is positioned as an interface between science, research and the real world.

2.22.17.4 HL7 BOSNIA & HERZEGOVINA

No verbal report was given by HL7 Bosnia & Herzegovina. PowerPoint is available if required.

2.22.17.5 HL7 CANADA

Infoway Standards Collaborative is the singular standard organisation for HL7 Canada, ISO TC215, IHTSDO and IHE Canada. HL7 Canada has 550+ members.

Activities are the continued HL7v3 implementations underway in multiple domains including pharmacy, lab and patient care and tooling for v3 implementers’ work is underway. Two partnership meetings are held each year where the standards collaborative and the ten domains based groups meet.

Other news includes that the PAN-Canadian standards have been approved as a Canadian Draft for Use and that the HL7 v3 Claims message for Physio-Chiro and Vision Care e-Claims and other numerous CDA implementations are underway.

2.22.17.6 HL7 CROATIA

Membership is 15 organisations and 9 individual members. HL7 Croatia is planning to run the first of its certification session and there is a new website www.hl7.hr. There is a request for support of ISHEP 2012 to fund the HL7 speakers ($1.5).

2.22.17.7 HL7 CZECH REPUBLIC

No verbal report was given by HL7 Czech Republic. PowerPoint is available if required.

2.22.17.8 HL7 FRANCE

A new government means that changes are expected in the way the projects are conducted with the new regime. France now has DP (prescription records) and there are now +20M active

http://www.hl7.hr/


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records with DMP +100,000. This means that this is a major implementation of CDA. Now all documents for the DMP project have been translated into English for other countries to use. Interop Santé , the interoperability for hospitals R2 was released in May.

2.22.17.9 HL7 GERMANY

Operationally, several implementation guides have been balloted. Marketing is an important factor for Germany and “Europe HL7 News Journal” is available in four countries.

2.22.17.10 HL7 INDIA

It was reported that a new not-for-profit registered for HL7 India.

2.22.17.11 HL7 ITALY

Membership now includes 35 organisations (3 research institutions and 29 companies) and 15 individual members. HL7 open days have been conducted and they will start e-learning courses in September. Greater collaboration with universities is being pursued and known as the HL7 Academy.

2.22.17.12 HL7 JAPAN

Japan recently held its 41st e-Health Event.

2.22.17.13 HL7 KOREA

No verbal report was given by HL7 Korea. PowerPoint is available if required.

2.22.17.14 HL7 LUXEMBOURG

No verbal report was given by HL7 Korea. PowerPoint is available if required.

2.22.17.15 HL7 NEW ZEALAND

Membership remains similar to last year. They have major support from Ministry of Health but people resourcing is an issue. HL7 Version 2 continues to be used for Messaging. Regional repositories for shareable data based on IHE are being developed and CDA is being used for new interoperability initiatives. A Vendor toolkit was created to support these initiatives and has proven to be successful.


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2.22.17.16 HL7 NORWAY

Established in 2010, membership is now at 16 members and is a 50/50 split between organisation and individual. There are a number of services in production in v3 and they have held a number of workshops and educational events. Norway is conducting ongoing work with establishing a CDA national standard and expressed interest in HL7 certification. Harmonisation of national standards and HL7 is being sought.

2.22.17.17 HL7 SINGAPORE

There have been two cycles of HL7 Certification and a number of networking events and training sessions. The issues for HL7 Singapore are still providing value for money to its members and what is a sustainable business model, together with committee overload, and marketing to vendors who are not engaging. The Chair of HL7 Singapore reflected “we have moved from communication to information and knowledge. This requires a shift from interoperability to co-operability and analytics”.

2.22.17.18 HL7 SWITZERLAND

Membership remains the same with 55 organisations and 1 individual. Four projects are running including Lab, CDA-CH Body, and Collaboration. IHE Suisse is having a connectathon in Europe in 2012.

2.22.17.19 HL7 TAIWAN

Several activities planned for 2012-2013 in relation to ICD-10 and privacy protection and law adoption as part of meaningful use.

2.22.17.20 HL7 THE NETHERLANDS

The Netherlands has steady membership with 215 organisational member and 556 individual members and expects further growth. New activities include the CCR/CCD initiative to support the creation of a Dutch Implementation Guide and new workshop within the HL7 University. They are also trying to engage the membership into brainstorming as to what they want and what needs to be done strategically. 2.22.17.21 HL7 PUERTO RICO

Some funding from government has set up a Health Information Network (HIN) based on HL7. Puerto Rico is seeking assistance with this development and implementation.


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2.22.17.22 HL7 UK

HL7 UK consists of 160 memberships, 2 benefactors, 105 organisations and 53 personal/students. There has been slow growth of the NHS ITK project but more activity is expected in 2013. Strong activity in Education in v2, v3 and ITK was reported due to academic outreach, a planned summer school with two universities, and road shows to Manchester, Birmingham and London. This month will see the new information strategy from the government.

2.22.17.23 HL7 USA

In the US the key projects that are HL7 related or of interest include:

• Meaningful Use – Phase 2

• Translational Medicine (CTSA)

• Clinical Research/Clinical Trials

• Mobile Devices

• Big Data

• Visualisation

• Clinical Effectiveness Research

• Population Health

• Health Surveillance

• Medical Home

• Health independent living for the aging

• Infectious disease

• Telemedicine

• Imaging

• Patient Monitoring

• Apps for smart phones

• Data mining

• Natural Language processing

With the prediction of access to 3 billion health records around the world, new ways are needed to visualise data.


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2.23 INTERNATIONAL MEMBERSHIP & AFFILIATION TASK FORCE (IMATF)


The International Membership and Affiliation Task Force (IMATF) was convened following the May 2011 WGM to examine alternative membership models and their impact on the relationship between HL7 International, its international affiliates and various classes of HL7 membership around the world.

The IMATF is considering the medium and longer-term membership structure of HL7 and its affiliates, including the desire of HL7 International to become a more unitary organisation, whether there should continue to be affiliates and, if so, what role they should play.

The IMATF has taken up some of the themes that arose in the former One Member One Vote (OMOV) task force. The work of the IMATF still has some way to go but is germane to developing the broader HL7 business model, the nature of HL7 membership and the use of HL7 intellectual property.

HL7 Australia has been active in the IMATF since its formation and is represented at its meetings by Richard Dixon Hughes in his role as HL7 Australia Chairman.


The main activity of the IMATF at this meeting was to progress the impact analysis and consider relationship to the HL7 Business Plan. Results of this work were shared through the Affiliate Chairs sessions of the International Council and will be taken forward through teleconferences of the IMATF in coming months. The plan is to complete the IMATF's work by the September 2012 WGM.

As Chairman of HL7 Australia, Richard Dixon Hughes has agreed to continue Australia's involvement with the IMATF, which is also relevant to his other Board-level roles in HL7 International.

CURRENT PROJECTS

2.23.1 REVIEW OF ALTERNATIVE MODELS FOR INTERNATIONAL MEMBERSHIP

BACKGROUND

By the conclusion of the Working Group Meeting in September 2011, the IMATF had defined four potential models for global membership engagement within HL7 as well as a set of 20 criteria to be used in evaluating them. The four potential models are as follows:


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National representation

The basic feature of this model is that governance of HL7 as a global enterprise is organised through national representative bodies similar to CEN (for the European region), ISO or IHTSDO. Individuals or organisations would belong to a national member body, with some arrangement to allow participation by those that come from a country that does not have a national body. Under this model, it is assumed that those in the USA would be represented by a national body. This model has been strongly advocated by some of the European affiliates as the only model acceptable to them.

Single membership

This is a purely unitary model in which all Individuals, organisations and others from around the world would join HL7 International as “equal” members of the global organisation. The only form of membership for the purposes of receiving member benefits (including access to IP), payment of fees and participation in HL7 governance processes would be through HL7 International itself and while local affiliate organisations might continue in some form, they would not be the principal means by which members engage with HL7.

Single membership with registration in one or more realms

This option entails a unitary membership model in which all members belong to HL7 International but are registered to participate in the activities of one or more realm-based affiliates that have been recognised by HL7. This model differs from single membership in that it assumes each member be registered with at least one Affiliate and a US Affiliate would likely be required to cater for the needs of US members.

Status Quo

As today, individuals and organisations obtain various levels of member benefit by joining either an affiliate or HL7 International or both (and without the requirement to form a US Affiliate).

In meetings during October and November 2011, the IMATF reviewed and refined 20 assessment criteria and used a scoring scheme to assess the extent to which each of the models addressed the overall requirement for an appropriate organisation structure for HL7 as a global activity. On the basis of this analysis, option 1 (National representation) and option 3 (single membership with realm-based registration) appeared to offer by far the greatest potential to address the identified requirements. Option 2 (single global membership) was clearly the least acceptable with option 4 (status quo) falling between the two extremes. A decision was taken at the January 2011 WGM to discontinue consideration of options 2 and 4. It is recognised that options 1 and 3 have a lot in common, being different variants of a federated model.

Having reached this point, the IMATF is examining the more detailed implications of these two models (and potential combinations of them) in terms of:

• Standards Development including needs for both universal and realm-specific versions, and managing consistency, realm localisation and translation;


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• Governance including voting, representation and "ownership" of the HL7 organisation;

• Membership including singularity and variations in the membership models and categories, local membership rights and benefits (particularly access to and use of IP), international membership rights and benefits;

• Finances including flow of funds, harmonisation of membership categories and determination of fee structures, principles for equity across realms e.g. capacity to pay, reasons for variances and graduated payment scales;

• Legal and constitutional including relationships between realms and international;

• Affiliate role including continuity and changes to rights and obligations as noted in the affiliate agreement;

• Balance of interest, US vs. realm vs. universal;

• Products & services and impacts on tooling, education and implementation material; and

• Processes and organisation including conduct of HL7 WGMs, running the organisation vs. running the realm.




The IMATF is considering the medium to long-term membership structure of HL7 and its affiliates. These discussions overlap the HL7 Board consideration of its forward business plan and potentially impact the role of HL7 Australia and the benefits currently received by its members and the Australian eHealth community.

Action: HL7 Australia to continue engagement on the HL7 membership model through IMATF with a view to ensuring Australian stakeholders can continue to obtain HL7 membership benefits cost-effectively and have their interests in HL7 represented locally and at the global level.

HL7 Australia



2.23.2 SURVEY OF MEMBERSHIP/CUSTOMER CLASSES AND THEIR RIGHTS

BACKGROUND

Richard Dixon Hughes is leading an activity with help from Michael Van Campen and Hans Buitendijk to establish an inventory of membership classes used by existing Affiliates. This is to enable the IMATF to understand current practices better including categories, fees, benefits, voting, and IP access.


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A draft of the survey has been prepared, circulated and reviewed at previous meetings. A revised version was discussed at this meeting and with a few changes approved for trial among volunteers from IMATF, after which it would be again updated in light of any feedback or comment and circulated to all affiliates.

The IMATF expressed its support for the work to date and looked forward to the next stages.



Richard Dixon Hughes has been asked to lead a study into comparative membership structures across the affiliates and assist in proposing new categories for licensing intellectual property.

Action: Richard Dixon Hughes to finalise and issue survey of affiliate membership classes and privileges for IMATF.


2.23.3 SURVEY OF MEMBERSHIP/CUSTOMER CLASSES AND THEIR RIGHTS

BACKGROUND

Diego Kaminker (with assistance from Richard Dixon Hughes on the legal aspects) is to determine how to change the IP Policy and associated documentation to accommodate a minimum of 3 classes of categories of rights for IP, namely:

• View/personal use (as per current "individual" memberships and HL7 Canada free membership);

• Reproduce/distribute/incorporate for internal purposes only while not producing products for external sale nor distributing extracts to external parties (as required for use of HL7 in German hospitals); and

• Rights to reproduce/distribute/incorporate within and outside the organisation (to the level allowed by current corporate/organisational membership).


International membership & Affiliation Task Force (IMATF) Review of licensing classes

Richard Dixon Hughes to complete analysis of potential HL7 licensing classes.

Action: Richard Dixon Hughes to assist Diego Kaminker (Argentinian Board Member) with development of revised licensing classes to put forward for use in the HL7 IP policy, membership agreements and affiliate agreements.



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2.24 ISO/TC215 WG2/HL7 DATA COMMUNCIATIONS AND DICOM


ISO/TC 215/WG2 (Data Communication) and DICOM WG 10 (Strategic Advisory) have developed a tradition of meeting jointly at the January HL7 WGM each year that the HL7 WGM is held in North America, with a view to strengthening harmonisation and cooperation with each other and with HL7 International and IHE.

DICOM WG 10 and TC 215/WG2 held separate meetings during the first quarter, after which their delegates participated in a joint meeting hosted by TC 215/WG2.


This joint meeting is an annual event which occurs in conjunction with the January WGM and therefore was not held at the May 2012 WGM.

ISO/TC 215 met in the same venue the week before the HL7 WGM and significant proposals by WG 2 of interest to HL7 were progressed and supported by TC 215 with Australian assistance in crafting appropriate resolutions.

These measures include continuing discussions with ISO to progress the possibility that jointly balloted HL7 documents may be published by ISO in the original HL7 format and allow them to be maintained in a timelier manner.

Other measures include support for ISO publication of the CDISC BRIDG standard by following an approach similar to that used for DICOM, where ISO publishes a head standard that defines processes for maintaining, referencing and claiming conformance with detailed content, which is maintained by the developing organisation (CDISC or DICOM) on an external website. ISO approval has been explicitly sought for CDISC to adopt this approach, with a further discussion to occur around the general principles that might be used to maintain other documents using a similar approach.


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2.25 JOINT INITIATIVE COUNCIL (JIC) LIAISON


The JIC is a grouping of Standards Development Organisations (SDO’s) whose aim is to enable common and timely health informatics standards and was constituted to undertake projects that cross SDO boundaries. Currently the participating SDOs are ISO/TC 215, HL7, CEN/TC 251, CDISC, IHTSDO and GS1. Other SDOs may be invited to participate as appropriate to the work and domain of the Joint Initiative and that meet specific criteria as identified by Joint Initiative Council.

It is now the second year under the chairmanship of Bron Kisler of CDISC with Lisa Spellman having taken on the Secretariat.

Additional information can be located at: www.jointinitiativecouncil.org

PROGRESS AT THIS MEETING The progress at this meeting is detailed under the current projects below and focuses on the

updates of the current projects and liaisons.

CURRENT PROJECTS

2.25.1 HL7/IHE HEALTH STORY IMPLEMENTATION GUIDE CONSOLIDATION (#728)

PROJECT OBJECTIVE

This project will take a series of existing CDA implementation guides for various types of clinical documents and consolidate them into a single publication as a DSTU. These publications include IGs for the following types of clinical notes:

• Continuity of Care Document

• History & Physical

• Consult Note

• Operative Note

• Procedure Note

• Diagnostic Imaging

• Discharge Summary (CRS R2)

http://www.jointinitiativecouncil.org/


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• Progress Note

• Unstructured Documents

The Project will review and reconcile related IHE Templates but will not address IHE CDA Templates that do not overlap with the HL7 Implementation Guides listed above, although that could be considered for future collaboration. Where a Health Story document is appropriate as an attachment, the attachment requirements will be reviewed as part of the scope of this project. However, it will recognise that some attachment requirements e.g. the need for the CDA to point to a billing identifier may not be part of the consolidated guide, but could be part of a supplemental attachments guide. The project will not introduce a review of content of these notes and will be limited to the following objectives:

1. Reconciling discrepancies among the guides (HL7, IHE, HITSP)

2. Disambiguate current templates: should clarify not add requirements or expand scope

3. Updating to meet regulatory requirements (C32, C83 where they overlap with the implementation guides listed here)

4. Adopting consistent publication format/style for conformance statements

The project will not introduce new templates, where not required per the objectives above. However, additional scope was added in February 2012 that outlined that the project will review, update, and add new templates to the Consolidated CDA Templates DSTU. New section and entry-level templates will provide guidance to implementers for more consistent implementations. For example, the current Functional Status section describes functional statuses and then references generic Problem and Result Observations. This project will add more detailed functional status templates and will be scoped to elements that support transitions of care in the CMS Continuity Assessment Record and Evaluation (CARE) assessment tool. The ballot will be scoped to the new and updated templates and the SDWG agreed upon errata. The project will not introduce a review of content of existing document-level templates. The entire DSTU will not be re-balloted

The consolidation of the guides will resolve ballot comments made on individual publications over the past several years and will resolve the minor discrepancies that exist among the guides. The project will make it easier for implementers by providing a single source of documentation where the reuse between document types is made clear. The project will update all guides to use a consistent and current style of conformance statement and terminology binding and will ensure uniformity through publication out of a single template database. Finally, the project will create a unified and simplified platform to support US Realm requirements for these types of clinical documents and provide a strong basis for further enhancement.


A presentation given by Lantana outlined the project on CDA consolidation. The driver being the US Meaningful Use citation for CDA and collaboration between Lantana Health Story with


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IHE and S&I Framework. This resulted in a single ballot process but there was a lack of MoU between the groups. Currently it is unclear how this collaboration will continue.

Several activities have occurred since the last meeting including Health Story hosted Health Story demonstration at the HIMSS12 Interoperability Showcase. At this demonstration, twelve Health Story vendor members worked together to apply HL7 CDA in a transition of care use case that was provided to Health Story by the American College of Physicians. There was also significant promotion at this event by HL7, IHE and the ONC S&I Framework collaboration to advertise the work of the Consolidation Project. Several follow-up articles in national publications featured the work of Health Story and HL7.

Other activities have included three industry educational webinars promoting the use of HL7 CDA; supported IHE in exploring options for HL7 CDA testing in the next Connectathon; recruited Health Story vendor members to participate in another demonstration of HL7 CDA at the HIMSS Government HIT Conference this June in Washington DC; coordinated a response to the call for public comments on the proposed ruling for Stage 2 meaningful use requirements, commenting on references to clinical documentation and the use of Consolidated CDA; and recruitment for participation in Health Story from the consumer engagement community, enriching Health Story by enabling patients to contribute to their own health stories.

2.25.2 DIAGNOSTIC IMAGING REPORTS IN HL7 CDA AND DICOM SR FORMAT – CROSS-SDO PROJECT

PROJECT OBJECTIVE

This project is looking at the harmonisation of the HL7 CDA and DICOM SR formats. DICOM is involved in HL7 Structured Documents, HL7 Imaging Integration, DICOM WG20 and Health Story. The basis of this collaboration between HL7 & DICOM is a MoU. This has resulted in first HL7 CDA R2 Diagnostics Imaging Report and Implementation Guide. The new DICOM Part 20 documents were balloted and published separately adhering to HL7 processes that provided flexibility in balloting process. The cooperation with HL7 was positive and resulted in a set of more mature standards.


This was developed in conjunction with HL7 Structured Documents, HL7 Imaging Integration/DICOM WG20 and the Health Story Project. The project results include an HL7 CDA R2 Diagnostic Imaging Report (DIR) IG; new DICOM Part 20 “Transformation of DICOM to and from HL7 Standards”; and Annex A “SR Diagnostic Imaging Report Transformation Guide”. In addition, these documents were balloted and published.

• Relevant DICOM Activities - Web Access to DICOM Persistent Objects (DICOM WG27):


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- DICOM approved Suppl. 148 Web Access to DICOM Persistent Objects (WADO) by means of Web Services final text in August 2011. This supplement deals with retrieval of persistent DICOM objects such as images and reports, corresponding to the evolution of the existing HTTP-based WADO to Web Services. Both native DICOM and rendered images can be retrieved as well as total or partial metadata of the object without the image pixels. DICOM WG27 is working on further WS*-based and RESTful WADO services.

2.25.3 EPSOS

PROJECT OBJECTIVE

Currently there are 23 countries involved, 20 EU and 3 other, which provide cross-country interoperability in relation to pharmacy. This has been achieved by HL7 working closely with ISO, WHO, CEN, and others. IT has highlighted that several different competences and experiences need to be harmonised. Unfortunately, standards are seen as a ‘magic book’ approach e.g. they are seen as alternatives instead of working on synergies. A common cross-SDO reference framework may assist in promoting these synergies.


The epSOS project is looking at the lessons learned which include the requirement of a classification for the project artefacts on differently layer viewpoints which may assist the cross-SDO harmonisation.

2.25.4 CTS PROJECT 2

PROJECT OBJECTIVE

The CTS2 Project has arisen because of terminology limitations. The project, adopted by Vocabulary WG, looked at terminology maintenance including clear roles for each of the SDOs involved. It will be a HL7 balloted artefact with OMG owning the platform independent model. Challenges for this though include the separation of ownership of artefacts between HL7 and OMG. An early concern was raised that in the event that the Technical Specification developed by the OMG does not meet the requirements, what would happen? OMG has existing infrastructure in terminology. The overall experience is that it has been a successful process. This has provided a workable process as a means for HL7 to ballot their requirements in one Technical Specification in the future.


The Common Terminology Services R2 derived from the original CTS project has some limitations in version management and brings maintenance and versioning to the fore. HL7


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developed requirements in a service functional model with collaboration with HSSP and therefore, provides the HL7 requirement for that service. It is an HL7 ballot artefact and OMG holds the ownership of the service artefacts.

It took longer to develop than intended. Some of the challenges were in the ownership between artefacts. Also, there was confusion and concern on matters on implementation changes did not meet the exact requirements from OMG to the HL7 requirements. The result has been an implementation model rather than a conceptual model that was originally envisaged.

2.25.5 TIGER PROJECT

PROJECT OBJECTIVE

Technology Informatics Guiding Education Reform Initiative (TIGER) has a mission to advance the integration of health informatics to transform practice, education and consumer engagement. This is to enable nurses and interprofessional colleagues to use informatics and emerging technologies to make healthcare safer, more effective, efficient, patient-centered, timely and equitable by interweaving evidence and technology seamlessly into practice, education and research fostering a learning healthcare system.


Pat Van Dyke reported that this group initially started by Linda Fischetti and sponsored by Ed Hammond, continues to meet for a Tuesday morning breakfast at each Working Group Meeting. Its focus is on Nursing Education opportunities at this WGM. Several of the attendees currently teach informatics and have a desire to create and offer nursing informatics classes for HL7. We will also continue to explore methods of introducing HL7 into the curriculums of nursing schools and nursing organisations.

2.25.6 LOINC

PROJECT OBJECTIVE

Logical Observation Identifiers, Names and Codes (LOINC) is a public use set of codes and names for electronic reporting of clinical laboratory test results in particular. LOINC provides a standard way of identifying observations using approximately 41,000 observation terms. Nearly 31,000 of these terms are used for laboratory testing. LOINC codes allow you to merge clinical results from multiple sources into a single database, allowing results to be automatically sent to the appropriate place and improving patient care and clinical research. It has been adopted by some large commercial laboratories for use in HL7 result messages and is used by some US federal agencies with healthcare interests. While initially created specifically for HL7 messaging, its use has expanded to Digital Imaging and Communication in Medicine (DICOM) ultrasound


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messages and Clinical Data Interchange Standards Consortium (CDISC) pharmaceutical industry messages.

PROJECT ACTIVITY/ISSUES AT THIS MEETING HL7/LOINC Activity

Submitted by: Ted Klein Conference call was held between Ted Klein and Dan Vreeman at 9:00AM on April 12, 2012. Several items were discussed that should be pursued:

1. Structured documents source reference in the REFERENCES table in RELMA: this should be a project to fill in this information for those LOINC codes in the CDA implementation guides.

2. Ask StructDoc to please complete and fill in the missing flags in the ‘DOCUMENT vs. SECTION vs. BOTH’ field in RELMA for all LOINC codes that are referenced in CDA Implementation Guides.

3. Collaborative work with NLM for the linkage to SNOMED codes that are in answer lists for particular codes: can NLM maintain and distribute value sets of SNOMED codes (similar to how CDC does it with PHINVADS for instance) and with a URI or some technical API reference link from the HL7 value set to the NLM distribution, and also from a particular code in RELMA to the value set of the answer list of SCT codes. This would be useful to the community, and represents a 3-way activity between LOINC, HL7, and NLM.

4. Access via ‘click’ from HL7 tooling (ballot, RoseTree, RMIM Designer) on a value set containing LOINC codes that passes a search string to the web search form and brings up a search result window with the codes that are in the value set in the LOINC web search form. Dan to look into passing the flag for displaying deprecated codes, and will supply the syntax guide for passing a search string to the web search form.

5. Issue of IP and copyright notice relative to the display names associated with codes in third-party published documents – what should the policy and statement be? Ted suggested that people be encouraged to show both local and standard display terms, but if they show only local term, then explicitly state that they are doing so in the copyright notice, and direct readers to the source of truth from LOINC for the ‘standard’ display names.

6. Might there be interest on the part of the Education WG at HL7 to have a 1/2 day LOINC tutorial at a WGM or Ed Summit?


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2.25.7 NCPDP

PROJECT OBJECTIVE

National Council for Prescription Drug Programs (NCPDP) and HL7 are collaborating on a mapping project is to help streamline the implementation of e-Prescribing. They have completed the first phase of a standards coordination project to facilitate electronic prescribing messaging capabilities between prescribers and pharmacies and payers. The first deliverable is a mapping guidance document which provides a consistent mapping that can be used to improve patient safety and enable semantic interoperability between e-prescribing standards by NCPDP and HL7.

PROJECT ACTIVITY/ISSUES AT THIS MEETING NCPDP HL7 activity

Submitted by: Margaret Weiker

• NCPDP WG2 – Product Identification has a task group, The Structure Product Labelling Activities Task Group that tracks the activities of the SPL, offers suggestions to improve access and usability of the FDA Structured Product Label and Electronic Drug Listings, and monitors the work of the Guiding Coalition for feedback to the WG. This task group met during the WG meeting. The Coalition has sent seven letters to the FDA and is working on letters regarding Marketing Categories, Inner/Outer NDCs and Identifiers, and Freeness. Two letters, SPL Validation Dates and Fee Definition Update, were reviewed and approved at this meeting. They continue to collaborate with the HL7 SPL Leadership Team/SPL Working Group regarding issues with “Last Marketing Date/Marketing End Date”, “June/December Updates of the SPL” and the “SPL Validation Process”. The process whereby the Billing Unit Standard can be added to the SPL Indexing Files has been defined and the letter of agreement between NCPDP and the FDA was approved by NCPDP and has been sent to the FDA for review.

• NCPDP WG11 – e-Prescribing and Related Transaction has a task group, NCPDP/HL7 Pharmacist Functional Profile Task Group that discussed analysing the functional profiles for NIST testing for meaningful use in the future. They are also reviewing the HL7 release 2 changes to the Pharmacist/Pharmacy Provider Profile.

- NCPDP WG14 - Long Term and Post-Acute Care (LTPAC) has 1 task group that interfaces with HL7

• Automation in LTPAC Task Group – This task group reported they are in the process of creating a white paper on the use of the HL7 messages in pharmacy. The first draft of the white paper is being reviewed.


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2.25.8 IHTSDO

PROJECT OBJECTIVE

The International Health Terminology Standards Development Organisation (IHTSDO) is an international not-for-profit organization based in Denmark. IHTSDO owns and administers the rights to SNOMED CT and related terminology standards. The purpose of IHTSDO is to develop, maintain, promote and enable the uptake and correct use of its terminology products in health systems, services and products around the world, and undertake any or all activities incidental and conducive to achieving the purpose of the Association for the benefits of the members.

PROJECT ACTIVITY/ISSUES AT THIS MEETING IHTSDO HL7 activity

Russ Hamm reported that the following activities have been ongoing between HL7 and IHTSDO:

• Technical Architecture of the IHTSDO Workbench:

IHTSDO recently completed a review of the technical architecture of the IHTSDO Workbench. HL7 participated in interviews towards this effort, providing feedback on both architectural and usability aspects of the Workbench. Recommendation from the technical architecture review includes:

- Refactor existing code to create a core terminology data model API

- Develop a new terminology-specific data model API

- Refactor existing code to create a discrete data access layer

• Mapping of H7 Vocabulary to the IHTSDO Workbench:

HL7 is currently investigating use of the IHTSDO Workbench to manage the HL7 vocabulary artifacts, and is progressing on a project to map the HL7 vocabulary to the IHTSDO Workbench data model. In addition, HL7 is investigating the feasibility of setting up their own extension namespace of SNOMED CT to maintain SNOMED CT content specific to HL7 structures. It is likely that HL7 would use the IHTSDO Workbench to maintain their SNOMED CT extension.

• Availability of the IHTSDO Workbench to HL7 Members:

The “Member’s Release” of the IHTSDO Workbench has been released and is available on the IHTSDO hosted Collabnet site. The Member’s release is based off the Migration Release, which is the version that IHTSDO has been using for developing the latest version of SNOMED-CT. This version should be considered by HL7 as the “starting point” for Workbench development activity and is available to HL7 members through the IHTSDO.


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2.25.9 IHE PROJECT OBJECTIVE

There have been long-term discussions with IHE and HL7 on how IHE work can be balloted through HL7. The intention is to create a simplified process and one central place for implementers. IHE has the ability and tools to develop the guides, taking existing HL7 work to support these tools. Currently there exist issues with backward compatibility i.e. a new set of templates that are not backward compatible. There are also differences in approach to what Health Story has done to what HL7 and IHE have done. Moreover, the issues around governance are not clear. Lastly, the issue of timing (adopting CDA Consultation) and fitting it all together was reported. It will start with the 1.2 release as baseline.

PROJECT ACTIVITY/ISSUES AT THIS MEETING IHE Liaison Report

Submitted by: Keith Boone

Patient Care Coordination:

• PCC is using the HL7 Infobutton Standard and the URL Implementation Guide to update the HITSP T81 Retrieval of Medical Knowledge transaction to support IHE requirements. It uses the Atom format as the standard for responses, similar to what HL7 did with Infobutton DSS Implementation Guide. It is to be published for public comment in early June.

• PCC is also developing three workflow profiles based on the IHE XDW profile to support e-Referral, Telehome Monitoring, and Tumor Board which are not presently using HL7 standards.

ITI Infrastructure:

• ITI is developing a white paper on the exchange of Critical Results, with the anticipation of future profile development. They are looking at HL7 Version 2.5, 2.7.1 or 2.8 and adopting (or pre-adopting) the R40, R41, R42 trigger events with the ORU to communicate critical findings.

• ITI is also developing a profile to support Patient Encounter Location Query, using HL7 Version 2. Development is principally being handled through IHE-J.

• It is also developing a profile supporting the exchange of documents for mobile health, and has been looking at hData and other standards to support communication of clinical documents (e.g., CDA) between mobile devices and application portals. To be published for public comment in early June.

Quality, Research and Public Health:

• QRPH is working on several CDA templates in support of Early Hearing Screening, Birth Summaries, and Clinical Research.

http://www.hitsp.org/ConstructSet_Details.aspx?&PrefixAlpha=3&PrefixNumeric=81


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Cardiology:

• IHE Cardiology has developed CDA templates for Catheterization (CATH).

• They are presently working on a profile supporting Electrophysiology reporting using CDA.

Eye care:

• Eye care has developed General Eye Evaluation Content Profile, using an HL7 CDA document to record a patient’s general eye examination. It consists of an evaluation of the physiological function and the anatomical status of the eye, visual system and its related structures. It is planned to be released as a Draft for Trial Implementation in May.

• They are currently developing three clinical documents related to Cataract Surgeries. Cataract Pre-Operative Note, Cataract Operative Note and Cataract Post-Operative Note. Expected to be published for public comment late in 2012.

Radiology:

• Radiology is developing a white paper on the management of reporting templates. While this does not reference HL7 standards, it does address a topic of interest to Structured Documents with respect to the "Definition" of a document.

Laboratory:

• The Laboratory Analytical Workflow (LAW) profile improves interoperability between in vitro diagnostic testing systems and health informatics systems by reducing complexity and variability in the exchange of information related to patient and QC test orders and to the result thereof. LAW supports the workflow of lab test work order steps and their results between analysers and automation managers. LAW will be tested at the 2012 EU Connectathon. It uses HL7 2.5.1.

• The Laboratory Clinical Communications (LCC) profile is to standardise and electronically capture common laboratory – provider communications around order modifications and result verification and interpretation. LCC is in progress and uses HL7 2.5.1.

Patient Care Devices:

• Asynchronous Data Query (ADQ) is a profiling project within the IHE Patient Care Device domain to provide messages for a system to request device data from a repository containing device data. An HL7 query is used to specify the particular data that is desired.


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2.26 MOBILE HEALTH


The Mobile Health (mHealth) WG was formed in response to strong interest from a broad cross-section of potential stakeholders and those who participated in a series of webinars and preliminary teleconferences on the topic.

Subject to further refinement as the result of recent discussions at the May 2012 WGM, the initially proposed mission and charter of the group are:

The Mobile Health workgroup supports the HL7 mission by creating and promoting health (information technology) standards for mobile health device communications used in the practice of medicine, wellness, and public health

The goal of the Mobile Health (mHealth) Work Group is to support the HL7 mission of developing standards for mobile health services, data and information interoperability, security and integration in mobile and wireless healthcare and public health systems to reduce costs, improve quality and delivery, guide informed-decisions and promote individual and population health

Additional information can be located at: http://www.hl7.org/Special/committees/mobile/index.cfm


The first meeting of the WG discussed the scope and coverage of the group. It is looking at a focus on “how to capture health data from a device and transmit the data to populate the patients EHR or PHR”.

Mobile Tracks: • Governance (legal policy, regulation) • Infrastructure • Security • Communication platform (phones, tablets, pads etc.) • Applications • Research

There is a recognition that this group crosses or needs input from other technical workgroups in HL7 including ITS, CGIT, InM, MnM, RIMBA, SEC, SOA, Templates, and Vocabulary. It is aware that it must not duplicate work already done in the space from within HL7 and industry partners. At present the focus appears to be from the device to the record, however the definition should be wider than and bi-directional.

At this first mHealth WG there was over 60 people present and much of the discussion focussing on the following areas:

http://www.hl7.org/Special/committees/mobile/index.cfm


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• Defining the mission, goals and specific objectives of the group, and differentiating those aspects that distinguish "mobile health" from use of health care devices in a mobile fashion

• Perceived interoperability challenges between apps on mobile devices and with other applications tied to specific health care delivery and/or EHR/PHR platforms

• The need to recognise others already working in the area and seek ways to bring HL7 capabilities and content (e.g. CDA) to the table without duplicating existing standards (e.g. those produced by Continua)

• Other HL7 working groups with interests intersecting those of the mHealth group include:

- Health Care Devices

- EHR (including PHR)

- Patient Safety

- RCRIM

- CIC

- ArB

• Proposed (formal or informal) relationships with groups outside of HL7 include:

- ISO TC 215 Health Informatics

- Health and Human Services (HHS), Assistant Secretary for Planning

- Office of National Coordinator (ONC)

- Certification Commission for Health Information Technology (CCHIT)

- Healthcare Information and Management Systems Society (HIMSS)

- American Health Information Management Association (AHIMA)

- eHealth Initiative (eHI)

- Mobile industry (Apple, Verizon, Google, AT&T, Microsoft, Intel etc.)

- Government (FDA, FTC, ONC, FCC, GAO, AHRQ) (EU, AU, Asia, Africa, WHO)

- Continua Health Alliance, ASTM, mHealth Initiative

- Industries (Verizon, AT&T, Google, Apple)

http://www.hl7.org/Special/committees/healthcaredevices/index.cfm




http://www.hl7.org/Special/committees/patientsafety/index.cfm

http://www.hl7.org/Special/committees/patientsafety/index.cfm


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While mobile health has not yet emerged as a priority for Australia, there is a considerable and growing international interest in its many facets, which is relevant to HL7 as a member of the global eHealth community. Australian interest in health devices is growing and this is an area that may be impacted by developments in mHealth standardisation. Australia should encourage collaboration and harmonisation of mHealth standards and interoperability of mHealth applications with each other and with mainstream applications including EHR and PHR systems.

Action: IT-014 and HL7 Australia to monitor progress of mHealth and developments in mHealth standards more generally with a view to ensuring Australian interests are informed and to encourage collaboration between HL7 and other groups seeking mHealth Standards.

IT-014

HL7 Australia


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2.27 MODELLING AND METHODOLOGY (MNM)


The Modelling and Methodology Committee is responsible for creating and maintaining the HL7 message development methodology and facilitating its use, and maintaining a Reference Model that reflects the shared models that are developed and used by the HL7 Functional Committees. It is responsible for the RIM and the v3 modelling process in general. MnM has been called the template of v3.

Additional information can be located at: http://www.hl7.org/Special/committees/mnm/overview.cfm

http://wiki.hl7.org/index.php?title=Modelling_and_Methodology


At this WGM, MnM worked on the following items:

• Ballot reconciliation for core principles and RIM

• Data types planning

• FHIR work

• V3 modelling questions (Condition, Act relationships)

V3 is a mature specification with most of the work completed. The work that is still happening is around corner cases. Accordingly, most of the energy in MnM is focused on the FHIR project.

CURRENT PROJECTS

2.27.1 PROJECT #219: CORE PRINCIPLES AND PROPERTIES OF HL7 VERSION 3 MODELS (JOINT WITH VOCABULARY WG)

PROJECT OBJECTIVE

This project seeks to develop an infrastructure standard that will supplement the RIM, Data Types and Vocabulary documents. When completed, the document will be maintained as a “sibling” to the “Refinement, Constraint and Localization” standard, and cross-referenced from and to the HDF. Version 3 is predicated on HL7's ability to develop specifications (CDA, Messages, SOA).

http://www.hl7.org/Special/committees/mnm/overview.cfm

http://wiki.hl7.org/index.php?title=Modelling_and_Methodology


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This document needs to go back to ballot, largely for MnM based comment disposition. It has no outstanding issues related to Vocabulary however, the Vocabulary WG has one word to change and their activity will be complete.

There are also issues related to Structured Documents, particularly the structures and processes related to terminology binding used in CDA that reflect the state of binding knowledge some years ago. These need to be updated to reflect the requirements identified through the core principles development process.

2.27.2 PROJECT #823: FAST HEALTH INTEROPERABILITY RESOURCE (FHIR)

PROJECT DESCRIPTION

This is a new project launched by a group of HL7 insiders and has had the endorsement of the Fresh Look task force. The project aims at developing a new HL7 standard that leverages the best bits of both v2 and v3. The project lead is Grahame Grieve.

The draft standard and additional information can be located at:

http://www.hl7.org/fhir

http://wiki.hl7.org/index.php?title=FHIR

http://www.hl7.org/special/committees/projman/searchableprojectindex.cfm?action=edit&ProjectNumber=823

PROJECT OBJECTIVE

The Fast Health Interoperability Resource (FHIR) is a new contribution from Grahame Grieve (Australian delegate) for the ongoing debate about a future direction for HL7. It combines both granular and aggregated clinical concepts along with an XML-focussed, RESTful and/or SOA exchange format. HL7 workgroup committee is considering approving FHIR as a standard for rapid adoption of RIM and CDA R3 standards.

FHIR defines a set of "Resources" that represent granular clinical concepts. The resources can be managed in isolation, or aggregated into complex documents. This flexibility offers coherent solutions for a range of interoperability problems.

The simple direct definitions of the resources are based on thorough requirements gathering, formal analysis and extensive cross-mapping to other relevant standards. A workflow management layer provides support for designing, procuring, and integrating solutions.

Technically, FHIR is designed for the web; the resources are based on simple XML, with an http-based RESTful protocol where each resource has predictable URL. Where possible, open Internet standards are used for data representation.

http://www.hl7.org/fhir

http://wiki.hl7.org/index.php?title=FHIR




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This project is targeted at Green field sites and offers an alternative approach to CDA as it simplifies the data into more manageable XML structures.


• FHIR appears to meet HL7’s general organisational requirements, and enthusiasm is still increasing.

• FHIR will be balloted at the upcoming September cycle as a draft for comment with a focus on the underlying infrastructure.

• The infrastructure is looking increasingly solid and reliable and is starting to be tested in practice.

• There are public servers available for testing.

• There will be a connectathon to test implementations prior to the September meeting.

• The Technical Steering Committee is laying down the foundations for the FHIR governance structures required. Nascent variations of these groups are working on internal collaboration processes.

• Many domain committees are starting to consider how FHIR impacts their work, and/or creating FHIR resources.

• The FHIR marketing effort needs to refocus away from an internal focus towards the customers of HL7 i.e. why is it a good idea? What impact will it have? Already committed users of V3 are starting to assess these impacts.

2.27.2.1 VOCABULARY IMPLICATIONS OF FHIR

There are data types within FHIR that deal with coded values. These have a degree of correspondence to the data types in ISO and in the abstract data types. There are 4 data types used in FHIR including:

Code:

Code that corresponds to CS - a constrained type of string - a code (a single item, no display string). You can send code and code system and put is defined elsewhere, or you have code and here's the set of codes. It is an ‘on the fly’ definition of a pick list as there is no other place to find the list. This encourages the use of existing, defined code systems as often as possible. This is a requirement of anatomical pathology

There was concern raised about the volume this adds to the wire load e.g. if you were selecting 5 elements from 25, you would send the answer 5 times (for each of the choices) and each of those 5 times would include not only the answer, but also the 25 possible answers i.e. 125 elements.

Code systems can now be uniform resource identifiers (URI). So rather than a URID or OID you can now specify a URI as your code system. By loosening the requirement to register all


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code systems we make it much easier for the community but might also encourage a level of anarchy. The URI needs to be able to link to the definitions of the codes. A jurisdictional mandate for the concept binding in that realm saying that these code systems should be registered appropriately, but that one-off's and limited use would find the suggested approach practical.

Coding:

Coding in FHIR includes the code (equivalent to a CV) code system, and text originally captured. So value set and value set version definitions are not expected to be required for over 80% of the content. This appears within codeableconcept. These are expected to be representations of the same concepts. You would repeat the element whose type is coded. If you wanted to create ValueSet as a FHIR resource, one of its properties would be expansion with the type of coding and have one or more repetitions but this is not intended to be done this way. CodeableConcept may be bound to a concept domain.

Resources:

In FHIR there are a number of things that are reused consistently, such as people and documents. One of the things in the infrastructure that will need to be constrained is terminological resources. For CS type elements that are specific to a resource.

FHIR also operates on a principle of minimal tooling and uses less customised tooling where ever possible. The code systems are defined and used directly in resources and maintained in a .csv file.

A sample of address is:

Code Definition

Part part of an address line (typically used with an extension that further defines the meaning of the part)

Line A line of an address (typically used for street names and numbers, unit details, delivery hints etc.)

City The name of the city, town, village or community or delivery centre

State Sub-unit of a country with limited sovereignty in a federally organized country

Country Country ISO 3166 3 letter codes can be used in place of a full country name

Zip A postal code designating a region defined by the postal service

Dpid A value that uniquely identifies the postal address (often used in barcodes)

This structure only handles flat code systems. Each resource has been modelled. The binding is currently documented but rendering is being prepared.

When FHIR goes out to ballot, resources will be included in the package. FHIR requires strong governance and HL7 V2, V3, and other groups such as OpenEHR will be encouraged to identify that are domain specific in order to evaluate what is in the resource and what does not. There may be issues related to resolution of negative ballot comments. This might require


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considerable education of the voting community to understand the 80/20 requirements and why they are important.

Terminology Binding:

The notes section includes terminology bindings, expressed in text. Bindings need to be sufficiently machine readable so that tooling support to help with automated conformance testing can be straight forward for someone to build. FHIR is specifically targeting two different user communities, the people who roughly have to know what's going on but also the users that have to know precisely what's going on because they have to build it. The objective is to provide a mechanism that meets both of these issues. All concepts that exist in vocabulary now will still exist but not all are exposed, such as coding strength.

MnM asked the Vocabulary WG to look at the four data types and evaluate the 80/20 requirements. It is important to consider all the use cases and to determine the elements likely to be used by 80% of the use cases. Vocabulary is also to consider processes for quality and process governance for resources. This includes identification of the following:

• How the content will be managed and held in the resources of FHIR; and

• How to ensure good terminology practices are followed in what HL7 produces given the need for introducing alternative mechanisms which are less rigorous than currently required in harmonisation.

It is expected that there are likely to be 300+ of these standard resources.

MnM also asked Vocabulary to look at the terminologies referenced in the data types and to review the FHIR documentation and identify any questions or issues and feed back to the FHIR group. The two work groups will meet jointly again at the next face to face meeting to progress this work further.




FHIR

Australia needs to consider whether a position on FHIR is required.

Action: Consider this at the next HL7 Australia meeting.

HL7 Australia


FHIR – Vocabulary Requirements

Action: Australian HL7 stakeholders should consider the impact and requirements for terminology binding specification to meet Australian needs.

HL7 Australia


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2.28 PATIENT CARE


The Patient Care Technical Committee (TC) was formed as a Special Interest Group (SIG) in 1993. A small group of individuals were brought together with the objective of assessing the current HL7 specification and bringing forward recommendations for extensions to support a variety of activities related to direct patient care. Over a series of meetings and discussions the conclusion was reached that the current HL7 model did not adequately support the needs of the patient care community, particularly in the areas of patient goals, problems, care plans/critical paths, assessments, and histories and physicals. The group developed, as a SIG, a set of new segments and messages, and the decision was made in the fall of 1995 to establish Patient Care as a Technical Committee. A new chapter (twelve) was produced and approved as part of HL7 Version 2.3.

Today the Patient Care Work Group defines the requirements and solutions for communicating information regarding the creation, management, execution and the quality of care provision.

The goal of Patient Care WG is to define the requirements and solutions to support the needs for communicating information regarding the creation, management, execution and the quality of care provision. During the past decade, Patient Care has become more involved in v3 messaging, and the static and dynamic modelling that can be used and reused in different HL7 formats. For instance the core of patient care work is the Care Provision D-MIM, deploying the clinical statements and dynamic model, which was established as Draft Standard for Trial Use in 2007.

The last twelve months has seen Patient Care heavily involved in working on the Detailed Clinical Models approach to clinical content.

Additional information can be located at: www.hl7.org/Special/committees/patientcare/index.cfm

http://wiki.hl7.org/index.php?title=Patient_Care_WG


• Stephen Chu was re-elected as Patient Care WG co-chair.

• Patient Care WG held a 3-day out-of-cycle ballot preparation meeting after the January 2012 WGM in Europe (the Netherlands) to prepare four sets of topics which were submitted for May 2012 normative level ballot:

- Care Provision (Patient Care D-MIM) - Care Record - Care Record Query - Care Transfer

http://www.hl7.org/Special/committees/patientcare/index.cfm

http://wiki.hl7.org/index.php?title=Patient_Care_WG


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• Ballot reconciliation meetings were held during the Vancouver WGM PC meeting sessions. Negative comments were addressed.

CURRENT PROJECTS


1. Project #675: Allergies and Adverse Reactions

2. Project: Harmonisation of the Patient Administration Encounter Model

3. Project #813: Care Provision D-MIM to normative ballot

4. Project #320: Detailed Clinical Models

5. Project (new): Care Plan Initiative project 2011

2.28.1 PROJECT #675: ALLERGIES AND ADVERSE REACTIONS PROJECT OBJECTIVE

This topic is about harmonising a number of different models that are in use or are being considered in various parts of the world. Leading up to the working group meeting there were presentations of models from the US, Canada, and Australia as well as discussions about how these things should be represented. This ongoing work is now looking at developing a DAM to ensure that all requirements are met in the redevelopment of the current DSTU package contents include the allergy/intolerance model.

The current Allergy/Intolerance topic DSTU expires in June 2012. It is agreed that the best option is to request for the DSTU to be extended for another 2 years while the group continue to work on the Domain Analysis Model (DAM) to determine and model the requirements thoroughly, assess the adequacy and currency of the current DSTU, and to consider the merit of deprecating the DSTU in favour of an update Health Concern and Concern Tracking models. A DSTU extension request document was reviewed and edited with further revision and has now been completed. The final version has been approved at the subsequent conference call endorsed by the PC Co-Chairs and has been submitted to TSC for processing. HL7 HQ has confirmed that the extension approval will only be for 12 months.

A quick review was given on progress on the Allergy/Intolerance works done (including various detailed clinical models from Australia (NEHTA), Canada, US VA and Intermountain Health Care. The Australian model was considered one of the best models.

It was suggested that two tracks should be considered for this topic: (a) allergy/intolerance as condition, and (b) allergic/intolerance adverse reactions as observations, evaluation and tracking. This will be discussed in further conference calls. Medications, foods, and environment factors should be considered as trigger factors.


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The Clinical Statement Model group has an outstanding change request to include representation of adverse reaction causative agents in this model. The group has requested detail requirement to be submitted to support accurate modelling. This will be discussed in the first conference call after the WGM. A project proposal with supporting storyboards will need to be developed to satisfy this request.

It is agreed that the next step is to develop a set of use cases to comprehensively capture requirements for these topics. The goal is to develop the allergy/intolerance and adverse reaction DAM for informative ballot before May 2013.


The project team is co-led by Stephen Chu and Hugh Leslie from Australia and Elaine Ayres from US. This project is relatively well supported by international participants from Australia, Canada, Europe and US. Fortnightly conference calls have been organised between WGMs.

International information models on allergy/intolerance and adverse reaction were presented by contributors from Intermountain Healthcare and VA/DH (part of the Federal Health Information Model) of US, Australia, Canada and UK. A list of use cases has been identified as priority deliverables after the January 2012 WGM. Eight use cases covering allergy list, observed reactions to medications, new food allergy, vaccine allergy/reactions, unable to differentiate trigger of adverse reaction. Three of these use cases were reviewed and approved by the project group.

Debates over the differentiation between allergy and intolerance are continuing during the meeting at the Vancouver WGM and continuing on email. A US member of the group who re-ignited the debate has been tasked to produce documentations (use cases, definitions and pathophysiologic mechanism) as informative framework to direct further discussions. Once the documentations are available, a conference call will be schedule to discuss the issues and bring the matter to satisfactory closure.

The project team presented work done to the EHR WG a joint EHR/PC joint meeting. Alignment of EHRS functional requirements with the work done by PCWG on this topic was discussed intensively. EHRWG agreed to collaborate closely with the project team on this work.

Post May 2012 WGM work plan for this project include progressing to complete all identified use cases and begin to create activity and interaction diagrams and [information] class diagrams before September WGM.

A lot of work has been done leading up to the WGM on story boards and use cases for the proposed DAM. The group has been meeting fortnightly to progress this work and at the working group meeting, this progress was discussed and displayed. This work is being supported strongly by Canada, Australia and the USA at this time.

The goal is to develop the allergy/intolerance and adverse reaction DAM for informative ballot before May 2013.


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In addition, Patient Care met with the FHIR team to consider the impact on FHIR on PC work. The outcome of which is that the FHIR team is going to develop a resource based on the Assessment Scale as a demonstration of what this would look like. Other interactions were considered, but nothing formal was adopted.



Patient Care:

Allergies and Adverse Reactions

Sharing of Allergy/Intolerance information is critical for good patient care and safety. This work will enable sharing of this information in a standardised and computable way that enables true interoperability.

Action: Australian delegates to HL7 should continue to be involved in steering this work to make sure that it fits with the needs of the Australian health community.

Standards Australia

HL7 delegates

Patient Care: Allergies and Adverse Reactions

This project is of interest to IT-014-06-04, IT-014-06-06 and the newly established IT-014-13.

Action: Australia, in particularly NEHTA and the relevant IT-014 subcommittees and working groups, should continue to provide leadership and contribution to the completion of this very important project.

IT-014

IT-014-06-04

IT-014-06-06

IT-014-13

NEHTA

2.28.2 PROJECT: HARMONISATION OF THE PATIENT ADMINISTRATION ENCOUNTER MODEL

PROJECT OBJECTIVE

The Encounter (ENC) act is a specialisation of the Care Provision (PCPR) Act, and yet there are inconsistencies between the Patient Administration models and the Patient Care models on a number of issues. This proposal seeks to harmonise/address some of these issues.

These issues were initially touched upon during the October 2010 WGM in Cambridge. For further information see also the Requirements for a Universal Encounter model at:

http://wiki.hl7.org/index.php?title=Requirements_for_an_Universal_Encounter_model.


There was no meeting with Patient administration at this meeting.

http://wiki.hl7.org/index.php?title=Requirements_for_an_Universal_Encounter_model

http://wiki.hl7.org/index.php?title=Requirements_for_an_Universal_Encounter_model


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Patient Care:

Harmonisation of the Patient Administration Encounter Model

While Australia is not using HL7 V3 models, it is useful to follow this issue as encounter models are an important part of any health IT system.

Action: Continue to observe the outcome of the HL7 V3 models issue.

Standards Australia

2.28.3 PROJECT #813: CARE PROVISION D-MIM TO NORMATIVE BALLOT

PROJECT OBJECTIVE

The existing Patient Care D-MIM needs to be revised to reflect the lessons learned from current implementations, as summarised in the 2010 CP evaluation. In addition, the four core topics, Care Statement/Clinical Statement Topic, Care Record Topic, Care Record Query Topic, Care Transfer Topic. Four major changes are to be implemented:

1. Replace Care Statement with Clinical Statement CMET (cooperation with CS WG)

2. Apply a templates approach for implementation (cooperation with templates WG)

3. Vocabulary update, in particular Concern class and encounter class

4. Upgrade of all artefacts to Data Types R2

In addition, specific evaluation points, such as additions, meeting specified use cases, and requested and approved changes for settings of attributes, relationships and cardinalities will be remodelled and described.


The revised D-MIM went to normative ballot in May and was successfully passed. It was interesting to note that there were very few negative comments for ballot reconciliation and that there were a very high number of abstentions. It is likely that this ballot holds little interest for most people and that these models are not likely to be used widely. Ballot results are posted here:

HL7 Version 3 Standard: Care Provision; Care Record Topic, Release 1

V3_PC_CAREREC_R1_N1_2012MAY

Normative 1 Apr 06, 2012 - May 07, 2012

Ballot Content: Ballot Site

http://www.hl7.org/v3ballot/html/welcome/introduction/index.html


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Aff. Neg. Abst. NV

Affiliate 6 0 26 1

Consultant 1 1 2 1

Government/Non-Profit 3 0 1 1

Payor 0 0 0 0

Pharmaceutical 1 0 0 1

Provider 14 0 15 3

Vendor 3 0 16 1

Totals 28 1 60 8

% of Votes 28.87% 1.03% 61.86% 8.25%

Quorum 91.75%

Approval 22

2.28.4 PROJECT #320: DETAILED CLINICAL MODELS

PROJECT OBJECTIVE

This project was developed to ballot 5 models as examples of DCMs. DCMs were aimed to be an interim format which could be transformed into other formalisms such as HL7 models and openEHR archetypes. The actual aims of the project are vague and this has caused the activity to falter significantly. There is little understanding or buy in of the project at the TSC or MnM WG which is a high barrier to adoption of a DCM methodology within HL7. The CIMI work is likely to supersede the DCM initiative inside HL7 and this is likely to inform the FHIR work as well.


The Detailed Clinical Model project continues to struggle for various reasons. The first and foremost is that the models being balloted have no foundation in a methodology or technical specification. They are represented in UML but there are many questions about an underlying reference model that has not been seen or adopted by HL7. The models were undergoing ballot but this has stalled recently due to a large amount of criticism of the approach. Prior to the working group meeting, TSC asked that the models be brought forward for ballot or the ballot be withdrawn. Inside the Patient Care WG, it was felt that only two of the models were in


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any shape for ballot and so a proposal was taken to the TSC to request that only these two models be bought forward for ballot. At a meeting at the WGM in Vancouver, the TSC agreed to this approach and two models, namely “weight” and “length” will be bought to ballot as informative.

The models balloted are extremely simple, and are not based on any published methodology so they are very difficult to assess and may not be very useful for HL7 or Australia. The WG has agreed that after the ballot, there will be a discussion about how this work should proceed and how it should fit within the HL7 environment. The CIMI work will undoubtedly inform the further progress of this activity.

It is noted that the ISO DCM (ISO 13972) proposed standard has also been demoted to a technical specification and will be balloted as such.

PCWG developed 10 DCMs that, with the exception of the pressure sore/ulcer DCM, are essentially outputs from the Netherlands. Five of the 10 DCMs were submitted for informative ballot about 12 months ago had attracted significant criticisms in particular due to the lack of clarity in scope, nature, absence of clearly defined methodology and quality criteria. The DCM developers agreed to withdraw the remaining 5 DCMs from ballot process but argued that those 5 that passed informative ballot should be published. TSC raised questions on issues such as scope, nature, and relations to the CIMI work in response to the publishing request. The issues are yet to be resolved.



Patient Care:

Detailed Clinical Models

Clinical modelling is a vital activity for Australia to be involved in. The HL7 DCM approach at this time is flawed and is likely to be subsumed by the CIMI work. FHIR also bears watching in this area.

Action: Australia should continue to watch developments in CIMI for clinical modelling approaches. The HL7 work should be observed.

Standards Australia

2.28.5 PROJECT (NEW): CARE PLAN INITIATIVE PROJECT 2011

PROJECT OBJECTIVE

This was passed as DSTU, Project #105: Care Provision DSTU - Topic Care Plan, several years ago then went dormant. It was resurrected several meetings ago at Patient Care and has project leads from Australia (Stephen Chu) as well as from USA and Canada.

The objective is to develop a Care Plan Domain Analysis Model (DAM) for informative ballot in 2013. The scope includes defining the concepts, requirements including use cases, structure of care plan and interactions for exchange of care plans.


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It is important to Australia as its subject health processes form a key part of Medicare funded primary care and flow-on into allied health, community nursing, and mental health. The processes underpin the shared responsibilities of Collaborative Care both at information content and behavioural or dynamic levels, and inform IT-014-06-06 work on Collaborative Care Communications. Additional information can be located at: http://wiki.hl7.org/index.php?title=Care_Plan_Initiative_project_2011

PROJECT PROGRESS AT THIS MEETING

The care plan working group has continued to meet fortnightly since the September 2011 WGM and again met in Vancouver. Work is progressing on storyboard completion and process models for the DAM. There has been ongoing discussion about plans and proposals for modelling and also a draft of requirements. This project is led by Stephen Chu from Australia, Andre Boudreau from Canada and Laura Heermann Langford from US.

Between January 2012 and May 2013 WGM, a set of use cases covering the following settings had been developed, reviewed and approved by the project group:

• chronic disease/condition management

• Home care

• Perinatal care

• Paediatric immunization

• Stay healthy

The acute condition/care use case is still under development.

A modelling facilitator has begun to develop a set of interaction diagrams based on several use cases with the aim of abstracting the different use-case based diagrams into a common pattern.

NHS Wales is also working on community (nursing) care plan project. One of its members presented the work to the Clinical Interoperability Council (CIC) group and was advised to approach PCWG to seek its inputs. The NHS Wales delegate agreed to seek permission from her organisation to share relevant NHS Wales’s documentations on this topic with the PCWG. The two groups agreed to establish some form of collaboration to share knowledge and experiences on care plan work.

The care plan work has attracted the interest of the SOA group. Two SOA group members participated in the PCWG meeting session on Care Plan topic. The SOA group is planning the development of a SOA implementation guide for community care coordination for healthcare organisations using/implementing care plans. The SOA project will focus on episode of care in which care plans are used and on interactions of providers participating in the care of patient. The scope will exclude intra-organisation coordination but will focus on inter-organisation

http://wiki.hl7.org/index.php?title=Care_Plan_Initiative_project_2011


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coordination. The SOA group will leverage the domain knowledge from PCWG on the behavioural components of care coordination and how they impacts on contents and structure of the care plan.

Both groups agreed that a project scope statement (PSS) would need to be developed. The SOA group will develop the PSS and PCWG will be co-sponsor of the project. ACTIONS FOR AUSTRALIA


Patient Care:

Care Plan Topic

While the HL7 V3 output from this work is unlikely to be used in Australia, the DAM is likely to be a useful piece of work to inform modelling in this area.

Action: Australia should continue to monitor this work item.

Standards Australia

Patient Care:

Care Plan Project

The Care Plan project work has important relevancy to IT-014-06-06 and IT-014-13.

Action: Australia, through NEHTA and relevant IT-014 subcommittees and working groups, should continue to lead and contribute to the development of a care plan structure and exchange standards. Jurisdictional participations will also be important and useful.

IT-014

IT-014-06-06

IT-014-13

NEHTA

2.28.6 OTHER DISCUSSIONS

2.28.6.1 CDA RELEASE 3

An update on progress on CDA R3 development was provided by Structured Document WG member on Thursday Q2. Proposed changes to CDA header was identified and briefly explained. The CDA R3 header will include additional components and Participation CMETs such as subject, participation, informant (assignedDevice), accreditedLocation, etc. to satisfy exchange of financial, veterinary, public/population health, medical device, and credentialing requirements. While the inclusion of financial components is not clinical in nature, it is conceded that they are required to assert entitlement of patient to certain care management programs.

The right hand side of CDA R3 still appears to be on track to include all RIM constructs. However, it is unclear that how the right hand side of the new CDA is to be related to the various domain models developed by other workgroups such as Patient Care and Pharmacy.

It is planned that in late summer 2012, CDA R3 draft will be released for public comment.

An overview of the Trifolia Workbench was given. It is a set of tools for managing CDA templates and metadata. It contains the following resources/components:

• Template Repository: A centralised database for CDA template management.


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• Structured Template Entry Tool: Enter, review, manage and localise/update HL7 CDA templates.

• HL7 CDA Templates: a library of nearly 70 clinical templates from the HL7/IHE Health Story Consolidation Project.

• Publishing Tool: Export templates to share within and outside your organisation.

• Documentation: Manuals to support installation and use.

A stylesheet has also been developed and is available for download (http://ccda-tools.googlecode.com/svn/trunk/xsl/getdb.xsl). It can be used to extract data from the Trifolia workbench database and output into a file containing contents (in xml format) of the template database.

2.28.6.2 GS1 PRESENTATION OF PATIENT ID

Christian Hay of GS1 presented on the topic of Patient ID/Caregiver Identifiers. This was essentially a presentation of the ISO Working Document on Patient ID. This document was approved by the JIC members including ISO in the Spring of 2010. It is expected to be balloted for approval by ISO in August 2012.

The GS1 Patient ID defines a data structure for Patient ID/Caregiver ID. It draws substantially from Heather Grain’s work in this area.

The GS1 approach to Patient Identifiers provides a globally unique reference for a Patient ID and a consistent namespace or identifying Products, People, etc. It is constructed of the following data:

• Location

• Identifying Party

• Instance ID

Where Barcodes are used, the GS1 approach has been described as the best way of doing things as it inherently improves Patient Safety. In particular, it allows barcodes to be scanned in any order, providing Software with the mechanism to differentiate between a Person and a Thing. This provides the potential to eliminate workflow constraints that impose a sequential order on things that are scanned.

In the UK, their National Unique Patient Identifier is embedded in GS1 codes for Subject of Care. The UK mandates that this data is included in all Patient Wrist Bands.

GS1 has an MOU with HL7 International. GS1 also has a relationship with NEHTA. An MOU with GS1 has been proposed with HL7 Australia.

http://ccda-tools.googlecode.com/svn/trunk/xsl/getdb.xsl

http://ccda-tools.googlecode.com/svn/trunk/xsl/getdb.xsl


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GS1

There is limited awareness of the GS1 Patient ID proposal/standard among Australian Medical Software Developers.

Action: Increase awareness of GS1 Patient Identifiers.

HL7 Australia

MSIA


GS1

There is no MOU between HL7 Australia and GS1.

Action: Recommend that HL7 Australia explore an MOU with GS1.

HL7 Australia

2.28.6.3 FAST HEALTHCARE INTEROPERABILITY RESOURCES (FHIR)

Grahame Grieve and Ewout Kramer presented FHIR to the Patient Administration Work Group. After a brief history and description of FHIR, the PA WG was asked to review the following FHIR Resources:

• Person • Animal • Organisation • Agent • Patient

The FHIR group was particularly clear that the PA WG had to undertake this review with priority, as it is the custodian of these resources. It was suggested that considerable pressure would be applied to the WG if sufficient priority were not assigned.

Implementation and Modelling personnel would be made available to the PA WG to fast track this project.

The allocation of Personnel Resource to this WG for FHIR and the emphasis on rapidly delivering Core resource definitions is indicative of both the interest in FHIR, the latent desperate need in many realms for something to overcome the implementation difficulties of HL7 Version 3, and perhaps more tellingly the strength of the FHIR support by the HL7 Executive and leading Informaticians.

As a project originally conceived by an Australian, Grahame Grieve, Australia should embrace FHIR. As much as secondary Work Groups are concerned that their lack of participation will lead to their interests being sidelined, Australia should actively look to increase its pool of Human Capital familiar with FHIR, and seek to leverage these in influencing what is likely to be a new strong emergent standard in the field of Healthcare interoperability.

FHIR can be considered as an initiative established to rapidly develop a set of reusable, easily implementable information model resources to support HL7 v3 implementations. One of its key premises is to develop resources/artefacts that will be used by 80% of all implementers and


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only to include data elements in the artefacts that 80% of all implementers will use. The remaining 20% will be managed as extensions. FHIR publications will focus on what the implementers need and not what modellers or designers need. FHIR has attracted widespread attention and captured significant interest of Vancouver WGM. A number of tutorials and presentations were conducted throughout the WGM. Extensions will need to be published and made available to the public. Extensions will always be published as profiles. Registry infrastructure will be provided for profile publishing.

The FHIR team is seeking inputs from PCWG in two aspects:

• Governance: in determining the scope, definition and design of patterns governing FHIR development and approval; management of extensions ensuring that extensions from different groups are consistent; and

• Engineering: in the definition of the concepts, their contents, prototyping, validation, approval, profiling. The outputs are engineering constructs/artefacts which can be mapped to HL7 constructs (v3 or v2) to support implementations.

PCWG will need to identify suitable clinical concept candidates for FHIR development. Allergy, intolerance and adverse reactions have been proposed. Others potential candidates will need to be identified.

Another joint FHIR/PCWH/Template group meeting session has been planned for the September WGM in Baltimore.


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2.29 PHARMACY


The Pharmacy WG helps to assure that the HL7 messages and models concerning medication related information including prescribing, dispensing, and administering medication address all of the requirements of the many stakeholders and variations in different countries.


http://wiki.hl7.org/index.php?title=Pharmacy_WG


Pharmacy met with the FHIR project team, and agreed to propose a set of pharmacy related resources: prescription, dispense, and medication statement. It appears that immunisation will be a profile of a prescription.

Pharmacy WG submitted two topics for DSTU level ballot:

• Medication Order Release 2

• Medication Dispense and Supply Event Release 2

Ballot reconciliation meetings were held during the Patient Care meeting sessions to address negative comments.

Identification of Medicinal Products (IDMP) Release 1 of the 5 sets of specifications was submitted for second normative ballot under the JIC arrangement. The ISO delegate who usually liaises with the Pharmacy WG on IDMP ballot discussions was not present at this WGM. Therefore, it was decided that the IDMP normative ballot reconciliation will be handled post the WGM through conference calls.

CURRENT PROJECTS


1. Patient Medication Queries (for supporting creation of Medication Profile) project

2. V3 Nutrition Order Clinical Message (New project)

2.29.1 PATIENT MEDICATION QUERIES (FOR SUPPORTING CREATION OF MEDICATION PROFILE) PROJECT

The IHE Pharmacy Technical WG and including the Netherlands and Australia have brought to the attention of Pharmacy WG international work programs on medication history and/or medication profiles as initiatives to support better patient medication management. The Patient

http://wiki.hl7.org/index.php?title=Pharmacy_WG


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Medication Queries project is initiated to support these international work programs and to facilitate alignments of international efforts in this area.

PROJECT OBJECTIVE/TOPIC SUMMARY

This project will define what a medication profile means based on known use cases and will identify the requirements and information structure to support the retrieval and capture of data related to patient medications.

It is anticipated that this may result in modifications to previously balloted and yet to be balloted pharmacy domain topics. It is possible that the requirements will identify the need for new interactions and messages within existing topics and/or will identify the need to ballot existing material.

While this project will focus on medication related information, it is recognised that other information such as labs, observations, etc. may be identified. If so, these requirements will be forwarded to the appropriate HL7 WG.


The Netherlands delegate presented progress work on medication profile project. The presentation generated vigorous exchanges of opinions especially on what would constitute a medication profile. There is no clear definition on this concept from HL7 and other international entities such as IHE.

A number of related concepts were presented from Australian delegate Stephen Chu with the following proposed definitions:

• Medication list • Medication history • Medication record • Medication profile • Medication management plan • Medication review • Medication reconciliation

Stephen Chu proposed that attempts should be made to define these concepts clearly such that the scope and boundaries of medication profile could be clearly identified and the queries required to support the creation of medication profile could be adequately developed.

Furthermore, the Australian delegates suggested that the development of medication queries alone would not be sufficient. Information model(s) and infrastructures including dynamic behavioural models/messages will need to be defined so that the contents of medication profile can be accurately communicated and persisted where necessary.

A project scope statement has been developed. This project will be discussed and progressed through a set of conference calls leading up to the September WGM.


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Pharmacy:

Patient Medication Queries

Action: This project is of significant interest and importance to Australian eHealth agenda. NEHTA and IT-014 subcommittees and working groups, IT-014-06-04, IT-014-06-06 and IT-014-13, should monitor the progress of this project and actively contribute to the development of the models and infrastructures.

IT-014

IT-014-06-06

IT-014-13

NEHTA

2.29.2 V3 NUTRITION ORDER CLINICAL MESSAGE

The Nutrition group has successfully completed the development of a DAM on nutrition management that covers assessment, orders and evaluation. The nutrition order clinical message project is a continuation of the DAM towards the development of implementable artefacts.

PROJECT OBJECTIVE/ TOPIC SUMMARY

The goal of this project is use the Diet and Nutrition Orders Domain Analysis Model work balloted in May 2012 to map the identified domain class model to the RIM and create all necessary version 3 artefacts including an implementation guide to support the exchange of electronic nutrition order clinical messages.

Diet and nutritional supplement orders are an important part of the medical nutrition therapy. They include medically-based diet orders, tube feeding and nutritional supplement orders, dietary intolerances and food allergies, and patient/resident food preferences. Nutrition order messages will support the following types of nutrition orders:

• oral diets including texture modifications;

• oral nutritional supplements;

• enteral formula orders for tube feedings and infant formulas;

• patient food preferences; and

• special meal service orders/instructions.

Currently, there is no accepted controlled vocabulary standard (codes or value sets) for diets. However, the Academy of Nutrition and Dietetics has already submitted many of the terms from the International Dietetics and Nutrition Terminology (IDNT) into SNOMED-CT and seeks to continue to pursue this effort. Therefore, the development of the required Vocabulary Concept Domains has been included as part of the scope of this project.

The Diet and Nutrition Orders DAM also references the allergies and intolerances work in progress within Patient Care (see Project ID 881). This project will be informed by that work


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such that component messages specific to food allergies and food intolerances can be exchanged whenever nutrition orders are exchanged.


The project scope statement was developed and will be discussed further in post Vancouver WGM conference calls.

The nutrition group is working closely with Orders & Observations and Pharmacy WGs on the order message definition, and is working closely with Patient Care WG on allergy/intolerance and adverse reaction contents required to support nutrition orders. It will also work with EHRS and CDSS WGs on CPOE and decision support functional requirements.



Pharmacy:

V3 Nutritional Order Clinical Message

Australia currently does not have an ehealth work program on nutrition assessment and orders. NEHTA has received contacts from the Dietician Association of Australia (DAA) on the use of the International Dietetics and Nutrition Terminology (IDNT) to support nutrition assessment and order. NEHTA will introduce the DAA members to work currently being done and planned by the HL7 Nutrition group.

Action: Australia will need to keep a close watch on the development of nutrition models and contribute where appropriate.

IT-014

NEHTA

2.29.3 OTHER PRESENTATIONS

2.29.3.1 FHIR

PROJECT OBJECTIVE

Develop FHIR Resources for Medications.


The FHIR Group presentation was well received by the Pharmacy WG who has already undertaken some modelling of the resources for which it is custodian.

The WG was less enthusiastic about the prescription resource initially defined by FHIR, and will therefore, review and revise the resource.


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Of the WG meetings that the delegation attended the Pharmacy WG seemed further progressed than other WGs in their acceptance of FHIR, and had begun at least the conceptual development of FHIR resources.

A joint meeting between FHIR and Pharmacy was held. Discussions focused on the type of FHIR resources the Pharmacy WG could development. A draft medication resource was presented by the FHIR group to which comments were sought from the Pharmacy WG.

The Pharmacy WG presented a pharmacy products/models conceptual map which was used to inform the discussions on a proposed medication profile project which included the following:

• Medication order (prescription) including/referencing [medicinal] products, supply instructions and administration instructions.

• Medication dispense including referencing products and supply instructions.

• Medication administration including referencing products and administration instructions.

• Medication statement including referencing prescription, administration and products.

It was agreed that the WG would discuss and plan the development of a number of FHIR resources for the FHIR resources pool. The two groups agreed to hold a joint session during the September WGM.


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2.30 PHYSICIANS GROUP WORKING GROUP DESCRIPTION

This is a new group that held its first official meeting at the May WGM, cover of which was included as a work priority area for the Australian Delegation.

The rationale for forming the separate clinical group was the need to reach out to this target membership that is different from the general clinician attendance at HL7, particularly from the Clinical Interoperability Council. It is noted that physicians in the US, and certainly Australia, work mostly as individuals, or out of small business units where they hold sway over systems to be used. They do not, in general, have the strong medical informatics background of the nursing groups whose representatives attend HL7 and who are more likely to be employed by larger institutions.


Being held at 7am, and not yet widely known amongst its target membership, the meeting had a small attendance which did however, include Don Mon, Chair of HL7 and Charles Jaffe, HL7 CEO, both of whom were enthusiastically supporting and assisting the group. The participating physicians were from USA and Australia.

The rationale for forming the group was reviewed and clarified in the meeting and strategies for reaching the target membership were explored.

There was recognition of the importance of physicians appreciating the role of functional requirement in systems development and the need to support their empowerment and capabilities in specification of their defined needs.

Moreover, there are application issues which impact on our users, most notably workflow integration and user interface inadequacies. HL7 standards could be enhanced or developed as necessary to address these.

Emphasis was on engaging physicians into the HL7 process, offering education programs to familiarise them with HL7 and what HL7 can do for them. Specific priority areas are: EHRs, Usability, Presentation Layers, Workflow support, Clinical Decision Support (CDS), EHR-S Functional Model, Domain Analysis Models (DAMs), and Information Models.

A list server will be created and the HL7 CEO will meet with administration with a view to making approach to HL7 member physicians. The Nursing Informatics WG will continue to be engaged with the group to benefit from their experience.

Teleconferences, with times to suit US and Australia, will be held before the next meeting to develop a high level action plan, reach out for appropriate membership, and focus on the work for the next meeting.


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CURRENT PROJECTS

The group is new and specific projects will be developed as a result of current meeting activities described above. ACTIONS FOR AUSTRALIA


Physicians Group:

Exposure and New Membership

The Physicians Group is new and not well-known to Australian Physicians. By focussing on standards compliance in meeting physician needs, application deployments will better serve the care process capabilities of deployed health IT.

Action: Advice Australian Medical colleges of the existence of the group and its potential for their members to invite their submission of needs to the delegation, and their ability to be part of this if appropriate.

IT-014 (to its relevant member organisations)

RACGP National e-Health Steering Committee (DR is member and will action this)

Physicians Group:

Addressing Australian needs, Delegate involvement

Physicians need to be more active in requirements development and the Physicians Group can address the needs of Australian physicians if they bring requirements to HL7.

Action: All the physician delegates to be strongly encouraged to attend this new WG meeting at the next HL7 meeting. Standards Australia to add Physicians Group to HL7 Delegates Allocation List.

Standards Australia

HL7 Physician Delegates


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2.31 POLICY ADVISORY COMMITTEE (PAC)


The PAC undertakes policy and regulatory review and analysis within the health information technology (HIT) sector with the objective of identifying emerging issues, trends, and problems related to either policy or standards. Topics in scope include HIT legislation, regulation, contracts and contract negotiations, industry consensus, and international coordination. The PAC provides options and recommendations to the Executive Committee (EC) for the resolution of such issues and problems in the form of briefing notes, background documents, discussion papers, and position papers.


http://www.hl7.org/Special/committees/policy/index.cfm


There was brief meeting to develop a strategy to advice on current US Government proposals relating to rights in relation to EHR information exchange.

2.32 PUBLIC HEALTH EMERGENCY RESPONSE


The PHER work group supports the HL7 mission to create and promote its standards by helping to assure that HL7 V2 and V3 models, messages, documents and services address the requirements of the many public health agencies, both governmental and non-governmental.


http://www.hl7.org/Special/committees/pher/overview.cfm



http://www.hl7.org/Special/committees/policy/index.cfm

http://www.hl7.org/Special/committees/pher/overview.cfm


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2.33 PUBLISHING


This Work Group supports the HL7 mission to create and promote its standards by recommending the methodology, format and tools for publishing the HL7 standards according to requirements established by the HL7 board, the Technical Steering Committee, ANSI accreditation and the needs of the HL7 membership.


http://www.hl7.org/Special/committees/publishing/overview.cfm



2.34 REGULATED CLINICAL RESEARCH INFORMATION MANAGEMENT (RCRIM)


The RCRIM Work Group develops standards to improve or enhance information management during preclinical research, clinical research and regulatory evaluation of the safety, efficacy and quality of therapeutic products and procedures worldwide.

The primary areas of interest for this WG are Regulated Products and Regulated Studies. Regulated Products embodies topics such as Product Information (Labeling and Listings). Regulated Studies includes topics such as Clinical Study Data (Study Design, Participation, Data and Reporting), Stability Study, Clinical Trial Laboratory and Clinical Research Filtered Query Service.

The WG has a formal relationship with CDISC established under a MOU with HL7 International.


http://wiki.hl7.org/index.php?title=Regulated_Clinical_Research_Information_Management


The sessions for this WG principally focused on status updates, with a number of sessions dedicated to Ballot Reconciliation. There appeared to be comparatively few sessions either overall or dedicated to progressing project topics.

http://www.hl7.org/Special/committees/publishing/overview.cfm

http://wiki.hl7.org/index.php?title=Regulated_Clinical_Research_Information_Management


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US Realm issues dominate many of the RCRIM sessions, and many of the projects appear to be initiated by Regulatory agencies.

Status updates were presented on the following topics:

• BRIDG

• Janus Clinical Trials Repository (CTR) Project

• Periodic Safety Update Report (PSUR) from Patient Safety (PS)

• CTR&R

The Janus Clinical Trials Repository (CTR) project is an undertaking of the US Food and Drug Administration. It is a US repository of subject level clinical trial data. More information on Janus can be found at the US FDA website:

http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm155327

During a joint session with Patient Safety, an update was presented on changes to the Periodic Safety Update Report (PSUR) process in the European Union. New EU legislation has been the driver of these changes. These changes have been published in “GVP Module VII – Periodic Safety Update Report”. A PSUR is a regulatory requirement for authorised medicines in the EU. They are generated by Companies for each of their products at specified time intervals. Much of the BRIDG modelling for PSUR has been undertaken in the US, but artefact development has occurred more generally in the EU.

There was some interesting discussion regarding the FHIR proposal and the impact that it would have on the RCRIM WG. This was not a scheduled agenda item.

In the FHIR “nomenclature”, the RCRIM WG is a secondary WG. This particular description relates to the focus on the creation and consumption of FHIR resources. Many of the core FHIR resources that RCRIM would need to use are the responsibility of the PA WG. These include resources such as Person, Patient, Organisation and Agent. Within the domain of Clinical Research, there are many more data items required in these resources. Using the FHIR 80/20 rule for implementers, it is highly likely that many of the WG’s data items would need to be defined as FHIR extensions. Given the growing interest in FHIR, the WG expressed both concern and optimism about its relative impact. There was a strong affirmation that the WG could not sit on the sidelines and hope to have any influence on the creation of resources.

There is strong belief that FHIR will greatly simplify the process of implementation. This is in contrast to the complexity of HL7 Version 3. A question was posed by a Pharmaceutical Industry representative and funder of the CTR&R project who asked whether the CTR&R project should be reconceived with FHIR resources, and would this make it quicker and cheaper for implementations to be developed and deployed. The response was that the CTR&R project was too far along in the standards development process and will be submitted for ballot shortly.

The perspective of a significant global funder of Clinical Trial Research highlights the often unexpressed need to make implementations of HL7 Technology simpler. Simpler implementations imply faster and cheaper delivery of technology artefacts. These objectives

http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm155327


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are universally desirable. Australia should consider this international movement, particularly given its significant and complex investment in a national eHealth strategy.

The RCRIM WG has several current projects:

• BRIDG as DAM (Project #538)

• Clinical Trials Registration and Results (Project #372)

• CDISC Content to Message (Project #205)

• Drug Stability Reporting (Project #275)

• Laboratory Result based Adverse Event Assessment Messaging Project

• Medical Product Information (Project #325)

• Periodic Reporting of Clinical Trial Laboratory Data

• Regulation Product Submissions Release 2 and 3 (Project #217, Project #539)

• Structured Product Labelling

CURRENT PROJECTS


1. Project #528: BRIDG as DAM

2. Project #372 Clinical Trial Registration and Results (CTR&R)

2.34.1 PROJECT #528: BRIDG AS DAM

PROJECT OBJECTIVE

Biomedical Research Integrated Domain Group (BRIDG) is a collaborative effort of CDISC, the HL7 RCRIM WG, the US National Cancer Institute (NCI), and the US Food and Drug Administration (FDA). The BRIDG model is a DAM to represent protocol driven biomedical and clinical research. It serves to bridge standards and organisations. The HL7 RCRIM WG adopted the BRIDG model in early 2005. This project aligns BRIDG with HL7 through the HL7 Standards Ballot process.

The RCRIM definition of this project is:

“...to ballot the static components of the BRIDG DAM. The scope of the BRIDG model is Protocol-driven research and its associated regulatory artifacts, i.e. the data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, subject characteristic, or device on a human, animal, or other subject or substance plus all associated regulatory artifacts required for or derived from


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this effort, including data specifically associated with post-marketing adverse event reporting.”


BRIDG 3.1 is now available. It incorporates changes due to the harmonisation of the three following projects:

• Hematopoietic Cell Transplant (HCT) Database Common Data Elements (part 1)

• National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) Human Studies Database (HSDB)

• NCI Case Report Form (CRF) Harmonization and Standardization Initiative (rounds 1 and 2)

Current effort in this project incorporates harmonisation of:

• MD Anderson/NMDP Hematopoietic Cell Transplantation (HCT) Project (part 2)

• Continuing to add bone marrow/stem cell transplant concepts to BRIDG

• CDISC Statistics Domain Analysis Model

• HL7 Clinical Trials Registration & Results (CTRR) R3

• FDA Clinical Trial Repository (CTR) model

The next release of BRIDG is scheduled for August 2012 and will include:

• MD Anderson/NMDP Hematopoietic Cell Transplantation (HCT) Project (part 2) NCI Case Report Form (CRF) Standard Elements (round 3 of 4)

• CDISC Statistics model

• HL7 Clinical Trials Registration & Results (CTTR) R3

BRIDG 3.1 needs to be published by HL7 and is scheduled for September 2012 ballot. The Harmonisation schedule is being worked on to determine harmonisation dates with the project teams. ACTIONS FOR AUSTRALIA


RCRIM:

BRIDG as a DAM

Australia does not appear to have active participation in the development of the BRIDG model.

Action: Increase Awareness of BRIDG and CDISC more generally in Australia.

HL7 Australia

MSIA

ANZCTR


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2.34.2 PROJECT #372 CLINICAL TRIAL REGISTRATION AND RESULTS (CTR&R)

PROJECT OBJECTIVE

The goal of this project is to develop a message type to distribute Clinical Trial Registration data to multiple Registration bodies. More formally, the HL7 RCRIM WG defines the project as the development and maintenance of an HL7 V3 message in support of the global data exchange requirements brought about by the increasing number of national, regional, global and organisational clinical trial registries and trial results databases. In doing so, this effort will provide a mechanism to transport the protocol-related descriptive information needed to register a clinical trial along with the capability to exchange information summarising trial result outcomes. The project is intended to address the exchange of clinical trial-level summary data and will not be used to transport individual patient-related data.


The project requirements have been mapped to BRIDG. Particular project specific data is mapped to the CTRR DAM, a subset of BRIDG.

An RMIM has been developed from the DAM. The RMIM is influenced by the RMIM specification of the BRIDG, but is not a subset of it. The reason was the BRIDG RMIM referenced data elements that weren’t part of the CTRR DAM resulting in some oddities in the RMIM. Six use cases have been developed, one of which, Registration, has been sent to ballot.

The scope of testing is limited to registration of Clinical Trials to ClinicalTrials.gov (a service of the US National Institutes of Health) and EudraCT (European Union Drug Regulating Authorities Clinical Trials).

A number of CTRR Test scenarios have been defined including:

1. Coverage Are all data items from ClinicalTrials.gov and EudraCT adequately accommodated in the CTRR message specification?

2. Round Trip Can data transformed from ClinicalTrials.gov and EudraCT formats into the CTRR message format be returned to their original form?

3. Cross Registry Can data transformed from the ClinicalTrials.gov and EudraCT message formats into the CTRR message format, be transformed into their respective alternate format?

4. Direct Consumption Can ClinicalTrials.gov/ EudraCT registries consume CTRR formatted message?


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5. Direct Production Can Clinical Trial sponsoring organisations produce CTRR formatted messages?

The next steps in the project are:

1. Complete specification/harmonisation of required vocabulary datasets;

2. Complete development of the CTRR testing system;

3. Execute the five CTRR DSTU test scenarios;

4. Create 3.1 of the CTRR DAM based upon BRIDG harmonization results;

5. Update the Source to DAM Mapping using the revised DAM;

6. Update the Dam to RMIM/XSD mapping using the revised DAM;

7. Update the RMIM/XSD mapping using the revised mapping and testing outcomes;

8. Prepare one or more implementation guides for the CTRR message;

9. Ballot the validated CTRR message as an HL7 v3 normative specification; and

10. Ballot the validated RMIM message as an HL7 v3 normative specification.

The Work product is sponsored by Kaiser and others, while the Client is Eli Lilly. It is expected that the project will be submitted for normative ballot in November 2012, with resolution/reconciliation to be completed in January 2013. ACTIONS FOR AUSTRALIA


RCRIM:

CTR&R

There is no known Australian participation in this project. Does Australia leverage International initiatives in the registration of Clinical Trials?

The Australian equivalent to the US ClinicalTrials.gov and European EudraCT sites is ANZCTR – Australian New Zealand Clinical Trials Registry (www.anzctr.org.au).

Action: Inform ANZCTR of this project, and invite and encourage participation.

NEHTA

DoHA

ANZCTR


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2.35 SECURITY WORKING GROUP DESCRIPTION

This group supports the HL7 mission to create and promote its standards by publishing standards for trustworthy communication among all applications and services in HL7’s scope. The Security WG also will lead the convergence and harmonisation of standards for identity and access management among healthcare standards development organisations.

Additional information can be located at: http://wiki.hl7.org/index.php?title=Security


The progress at the meeting revolved around the ballot reconciliation of the Security and

Privacy Ontology, and advice to other WGs that the Security WG supports. Details of specific

projects are given below.

CURRENT PROJECTS


1. Project #646: Security and Privacy Ontology

2. Project (New): Data Segmentation and its Role in Access Control – Labelling and Tagging

3. Review of international progress, Standards and Industry Bodies

4. Other non-project workgroup discussions

2.35.1 PROJECT #646: SECURITY AND PRIVACY ONTOLOGY

PROJECT OBJECTIVE

This project will develop a domain ontology encompassing the healthcare IT security and privacy domains providing a single, formal vocabulary embodying the concepts in each domain as well as concepts shared between the two. The concepts identified and defined in this ontology will be primarily drawn from those concepts contained in the Security and Composite Privacy DAMs. The concepts in this ontology will be extended in order to bridge to standard ontologies in associated domains such as enterprise architecture, clinical care and biomedicine. This project will support modelling and analysis of the unified Security (privacy DAM), and identify areas where reference value sets are needed. Existing terminologies, where applicable, will be utilised and/or extended. Where appropriate terminologies are not available, they will be developed to meet the needs of the models. Concepts covered by security and

http://wiki.hl7.org/index.php?title=Security


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privacy domains that are relevant to this ontology include, but are not restricted to, security and privacy policies, consent directives, and access control.


This work item is currently out for informative ballot for comments. The comment period is still open and therefore no ballot package was available. The reconciliation of comments has been deferred until the weekly teleconferences.



Security Workgroup:

Security and Privacy Ontology - Project No: 646

This ontology is at present quite immature and requires wider consideration for its international application and specifically for Australia.

Action: Increased review and engagement by IT-014-04 members on this and subsequent ballots.

IT-014-04

2.35.2 PROJECT (NEW): DATA SEGMENTATION AND ITS ROLE IN ACCESS CONTROL – LABELLING AND TAGGING

PROJECT OBJECTIVE

A new project was discussed at the SOA/Security joint meeting in regard to data segmentation and its role in access control. This includes data tagging and data labelling and is reflective of the new US Standards and Interoperability (S&I) Framework. More information on this initiative can be located at:

http://wiki.siframework.org/Data+Segmentation+for+Privacy+Homepage

PROJECT ACTIVITY/ISSUES AT THIS MEETING Further information on this project can be located in the SOA WG section of this report.

2.35.3 REVIEW OF INTERNATIONAL PROGRESS, STANDARDS AND INDUSTRY BODIES

Updates from around the world were limited as fewer countries were represented at this session due to conflicting WG commitments and HL7 training.

http://wiki.siframework.org/Data+Segmentation+for+Privacy+Homepage


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PROJECT ACTIVITY/ISSUES AT THIS MEETING Europe:

A report on European activities on secondary use of clinical information was given. The slides from this can be sourced from the Security WG wiki page:


There are several national initiatives and European projects regarding secondary use of clinical information. The newest European project is EHR4CR (EHR for Clinical Research). The project participants represent the European Association of the Pharmaceutical Industry EFPIA (sponsor), Universities and authorities. The project aims at providing principles, methodologies and technical platforms to enable secondary use of clinical data by semantically integrating local, regional and national EHR systems, disease-specific registries, biobanks and other resources of clinical information.

There are 5 objectives of this project including protocol feasibilities, patient recruitment, study execution, adverse event reporting, and in the future, support of personalised care. It references IHE QRPH, uses IHE infrastructure and provides guidance and rules around selection of clinical trial candidates. It should be noted that this is one of the IHE projects calling for the IHE Pseudonymization Handbook. The project is however, finding it challenging to translate one clinical context into another. For example medical observations and lab results might be summarised into a single statement of hypertension.

It was further pointed out that in any discussion on risk, the reality is that de-identification never brings the risk to zero. This project is defining a service that will do the de-identification seamlessly.

US:

The update from the US centred on the S&I Framework and the need for non-repudiation on documents and sub-section signatures. This necessitates identity delegation that is transitory. Further information can be located at:

http://wiki.siframework.org/esMD+-+Charter

http://wiki.siframework.org/file/view/esMD%20AOR%20and%20Digital%20Signature%205-9-2012%20V1.1.pptx

ISO Updates on the following standards were advised as below:

• WG7 HealthCare Devices. Regulation for medical devices includes the maintenance has been extended because of the increasing indistinguishable delineation between hardware and software. The series of standards (80001.x.x Application of risk management for IT-


https://staffmail.ecu.edu.au/owa/redir.aspx?C=eb98b92042564f1db640e4e1ac32483c&URL=http%3a%2f%2fwiki.siframework.org%2fesMD%2b-%2bCharter

https://staffmail.ecu.edu.au/owa/redir.aspx?C=eb98b92042564f1db640e4e1ac32483c&URL=http%3a%2f%2fwiki.siframework.org%2ffile%2fview%2fesMD%2520AOR%2520and%2520Digital%2520Signature%25205-9-2012%2520V1.1.pptx

https://staffmail.ecu.edu.au/owa/redir.aspx?C=eb98b92042564f1db640e4e1ac32483c&URL=http%3a%2f%2fwiki.siframework.org%2ffile%2fview%2fesMD%2520AOR%2520and%2520Digital%2520Signature%25205-9-2012%2520V1.1.pptx


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networks incorporating medical devices) will be expanded to include other guidance standards that will reference other existing standards. This work will be a Joint ISO TC215 and IEC/SC 62A project.

• NWI ISO/NP 82304 - Healthcare software systems - Part 1: General requirements. This

item is a Joint ISO TC215 and IEC/SC 62A project. The scope and renaming of the item was discussed at the ISO meeting.

• TS 14265 Classification of Purposes for processing of personal health information was

published.

• NWIP Components of Education to Ensure Health Information Privacy. Approved to issue a NWIP ballot targeting technical report.

• Health Care Cards Systematic Review:

- 21549-5 Patient Health Card Data - Part 5: Identification Data. Revision of ISO 21549-5:2008 approved to issue a NWIP ballot targeting an international standard.

- 21549-6 Patient Health Card Data - Part 6: Administrative. Confirmed IS0 21549-6.

- 21549-7 Patient Health Card Data – Part 7: Medication. Approved to issue a NWIP ballot targeting an international standard.

• ISO/NP TS 14441, Security & privacy requirements of EHR systems for use in conformity

assessment. Approved publication of the Technical Specification.

• ISO/NP TR 17791, Health informatics – Guidance on Standards Enabling Safety in Health Software. Approved the disposition of the NP ballot comments document. Electronic meetings with experts from SC 62A and TC215 will be conducted to review the current PDTR draft 17791.

• ISO/DIS 27789, Health informatics - Audit trails for electronic health records. Approved

the disposition of the DIS ballot comments and that the project should proceed to FDIS ballot.

• ISO/PWI 29977 Health informatics - Information security management in health using

ISO/IEC 27002. Approved that the above mentioned project be added to the TC215 Program of Work as a Preliminary Work Item.

• ISO 21298: Health informatics – Functional and Structural Roles. Approved to issue a

NWIP ballot targeting an international standard.

• Continuing Work: ISO 22857 Guidelines on data protection to facilitate trans-border flows of personal health data.


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• ISO 16864 Data protection in trans-border flows of personal health information.

• Volunteer from HL7 to join Task Force for new ISO de-identification project. This will look

at the revision/additions based on TS 25237 Pseudonymization.

ANSI-INCITS-CS.1

No report was given at this WGM.

CLTI

Members were asked if anyone is interested in the ITD standards to please join and review.

OASIS

No report was given at this WGM.

IHE

Like HL7, IHE has also de-identified requirements, producing a risk based procedure (heavily based on ISO work and drawing on DICOM) to support profiles that involve the requirement for de-identified data such as clinical trials and public health reporting. The Healthcare Pseudonymization Handbook defines the process for incorporating/defining a profile. Current draft of IHE Healthcare Pseudonimization Handbook can be located at:

http://wiki.ihe.net/index.php?title=Healthcare_De-Identification_Handbook

2.35.4 OTHER NON-PROJECT WORKGROUP DISCUSSIONS

2.35.4.1 CONFORMANCE AND GUIDANCE FOR IMPLEMENTATION AND TESTING WORK GROUP ON HL7 CONFORMANCE METHODOLOGY

HL7 is looking at an overall HL7 (external) accreditation certification and conformance process. It should be noted that this is not the same as the internal Conformance WG project work. There is increasing interest in HL7 being accredited to do certification as it sees it as a profitable activity in the future, and it does not want to leave this to be done externally. Similarly ISO is keen to develop the same sort of process for the ISO standards.

In Europe, there are single centres for certification and it is product based. It is important to clarify the difference between accreditation – being what you are permitted to do, and certification - of products themselves. HL7 is keen to establish itself as an accredited certifying authority and therefore, needs to establish a framework do be able to do the certification process.

https://staffmail.ecu.edu.au/owa/redir.aspx?C=eb98b92042564f1db640e4e1ac32483c&URL=http%3a%2f%2fwiki.ihe.net%2findex.php%3ftitle%3dHealthcare_De-Identification_Handbook


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This is important to the security WG to ensure that the security aspects of the accreditation are included as it is a difficult area currently for all security related standards certification of which there are many in the market place already. The security is complicated in its implementation testing around and integrated into, for instance the EHR. This is further complicated by healthcare workflow and the potential security architectures that would apply.

2.35.4.2 MODELLING FACILITATOR

The Security WG requires a volunteer to be a modelling facilitator. Mike Davis is the facilitator for the group for vocabulary and publishing. This is required as Bernd Blobel is stepping down from this role.

2.35.4.3 INTERIM ELECTION OF 4TH CO-CHAIR

Dr Trish Williams was voted in as new Security Co-Chair (Interim) with the full support of the Security WG.



Security:

New Co-Chair

Dr Patricia Williams, member of the Australian delegation, was appointed new Co-Chair of the Security WG.

Action: For noting as Australian leadership engagement.

IT-014

2.35.4.4 TELECONFERENCE ORGANISATION

The Security WG, with the appointment of the new Co-Chair from Australia, wishes to accommodate widening international contributions by organising a more time-appropriate regular teleconference time that Australia can attend. A poll of times, convenient to international contributions (US, Europe and Australasia) will be undertaken.

2.35.4.5 SECURITY COOKBOOK TUTORIAL

A tutorial on Cookbook was undertaken and a lively discussion with the 4 participants present. John Moercke gave the tutorial on Risk Assessment including the Cookbook and the classic system design aspects of risk assessment. One attendee commented:


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“I attended the security tutorial expecting it to be boring and complicated to consume and was surprised how practically applicable it is! Very friendly presentation with practical tools and discussions”.

The Security WG is going to request that the tutorial in Q3/Q4 Wed is included in the program for Baltimore, Sept 2012.


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2.36 SERVICES ORIENTED ARCHITECTURE WORKING GROUP DESCRIPTION

The Services Oriented Architecture SIG (SOA) supports the HL7 mission to promote and create standards by identifying common architectural "services" and their behaviours and establishing an industry position on the form these services take. The SOA SIG will produce Service Functional Models (SFMs) that will be balloted as HL7 standards declaring the functions and information appropriate to them. The SOA SIG will identify service candidates, prioritise and determine functional boundaries for those services, relating them to existing HL7 content and other relevant standards. These services will promote the interoperability of healthcare systems, including but not limited to EHR systems for inter-product, intra-organisation, inter-organisation, regional, and national efforts.

The SOA standards development process is a joint one with another SDO the Object Management Group (OMG) called the Health Service Specification Project (HSSP).

Further detail about the process, current project status, details of specification and standards, as well as committee minutes and teleconference call schedules are available at:

http://hssp.wikispaces.com/


Progress at this meeting is detailed in each of the current projects below.

CURRENT PROJECTS


1. Project #863: Cross- Paradigm Interoperability Implementation Guide for Immunization

2. Project #838: Medication Statement Service PROFILE

3. Healthcare and Community Services Provider Directory Service (HCSPD)

4. Project #783: hData Record Format

5. Project: RLUS

6. Project (NEW) : SOA Service Ontology

7. Project #200: Privacy Access and Security Services (PASS)

8. Project: Data Segmentation - S&I Framework and ONC initiative

9. New project (SOA/Patient Care): Patient care services coordination project

http://hssp.wikispaces.com/


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2.36.1 PROJECT #863: CROSS- PARADIGM INTEROPERABILITY IMPLEMENTATION GUIDE FOR IMMUNIZATION

PROJECT OBJECTIVE

This is a new joint project with SOA and ArB and co-sponsored by CDS, and PHER.

This implementation guide will explore the Service-Aware Interoperability Framework (SAIF) methodology to show how various HL7, IHE and OMG immunisation-related artefacts can be deployed to satisfy immunisation interoperability use cases. The project will provide feedback to the MnM SAIF Implementation Guide project regarding artefacts and governance necessary to develop this project’s deliverables. It will build upon existing artefacts rather than create anything new. Previous work includes:

• The Practical Guide to SOA in Healthcare Part II: the Immunization Case Study;

• The Immunization DAM;

• V2 immunization messages;

• V3 POIZ messages;

• V3 Care Record document;

• V3 Care Record message;

• vMR; IXS (Service Functional Model and Technical Specification);

• RLUS;

• DSS;

• hData;

• Arden Syntax;

• GELLO;

• IHE profiles including PIX, PDQ, and Immunisation Content; and

• The IHE SOA White Paper.

The scope of the immunisation use case will be limited to use cases specifically related to interoperability, primarily patient identification, immunisation data exchange and decision support (recommendations, adverse reactions, contraindications). Additional information can be located at:

http://hssp.wikispaces.com/Cross+Paradigm+Interoperability+Implementation+Guide+for+Immunization




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Considerable progress has been made out of cycle on this project via weekly conference calls. A development methodology has been agreed and case studies for inclusion recruited from the UK and San Diego Health Information Exchange.

It has become clear that there are similarities with the European Semantic Healthnet project, led by Charlie Mackay from HL7 UK, and a cooperative approach has been agreed. Both projects involve dealing with multiple SDOs and mutual learning’s should prove valuable.

The Project has been divided into the following Sections (steps):

1. Develop a layered Service Architecture

2. Define Case studies and Use cases

3. Develop a Platform Independent Model (PIM)

4. Determine a solution architecture and define its relationship to SAIF

The Project Scope has been refined and Drools (CDS environment) is now out of scope as is FHIR (at least for the present). Semantics of Business Vocabulary and Rules (SBVR) has been added (CDC project).

A Common Information model is to be developed incorporating learning’s and specifications from HL7 V2 immunisation messages and the IHE IC (Immunisation Content profile) comparison and informed by the existing immunisation HL7 Domain Analysis Model (DAM) for immunisation.

Lessons learned so far:

1. Following the documentation trail is difficult. Much of the linkage is via OIDs between different documents that are opaque to humans.

2. There is a need for a Technical risk register

A decision with respect to the Clinical Decision Support (CDS) implementation is being informed by collecting existing examples of immunisation requirements in the decision support language standards Arden and GELLO. The plan is to extract the rules from these implementations and implement them using the Decision Support Service (DSS) SOA Standard. PROFORMA, a CDS rules engine from the UK, is under investigation to implement this within the DSS.

Services, profiles and implementation platforms have been identified and the task now is to choose a consistent set that completely covers the problem domain.

There is a need to find a representation for the PIM to complement the layered service architecture approach. It is unclear what form at present would be best for this.

Work will continue on this project out of session via weekly work item specific conference calls.


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SOA:

Cross Platform Interoperability Implementation Guide for Immunisation.

Sponsor SOA, co-sponsor with PHER, ArB.

Output from this project is likely to be useful in the Australian context.

Action: Keep the clinical decision support community updated with approach and progress to inform Australian CDS projects.

IT-014-13

2.36.2 PROJECT #838: MEDICATION STATEMENT SERVICE PROFILE

PROJECT OBJECTIVE

This new joint project between Pharmacy and SOA WGs aims to provide a service based mechanism for exchange of the HL7 V3 Medication Statement content. This project will create an implementation guide for a medication statement service. It will define the actual content (precise data model and representation approach), its semantics, behavioural model, and service functionality. The IG will address the requirements of both REST services as well as SOAP-based web services. It should be noted that the HL7 Service Functional Model (SFM) for the Retrieve, Locate, and Update Service (RLUS) has a SOAP and REST realisation. SOAP is a family of protocols that create an XML envelope around the payload for transport. REST is an architectural style that is focuses on resources and updates to them. The hData REST Binding for RLUS uses HTTP as the transport protocol.


The Medication statement event query that is the core of this project has all optional parameters including that for patient ID (to support de-identified research data). It was decided that for this project the RMIM would be constrained so that a patient ID would be required.

The Parameters list defined for the medication query statement is as follows:

• prescriptionID

• EncounterID

• AuthorTime

• MedicationCode

• PatientID


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• EffectiveTime

All of these will be supported by the Service implementation. However, it was agreed that there was a need to focus on the primary (initial) project plan with a simple query using a GET mapped to a resource URL (POST). There will be a need to specify a confirmation URL (temporary) and provide the atomic data as the feed once the URL is confirmed. The IHE IT TF metadata model for XDS will be used to investigate what additional metadata may be required but, at present, it was felt that there is no need for extra metadata.

The REST compliant approach will integrate neatly to provide feeds to existing medication lists, provide flexibility, and minimise implementation effort required. The REST approach will be made privacy aware by limiting results on a role basis by data segmentation using confidentiality and sensitivity codes dependent on the request initiator.

Identified issues:

a) A general approach should be adopted where possible rather than specific to this project.

b) The role based security approach may require small changes to the OMG REST specification.

c) The security/privacy possible metadata requirements are being defined elsewhere in a general case (SEC/PHIR). However in this context, probably location and “break glass” at least are needed.

d) There is a need to consider the ramifications of this approach for SAIF as the medication query RMIM predates SAIF.

It was recognised that the security approach adopted and developed here may provide a template and capabilities that can be leveraged by FHIR and that the Medication statement would be a candidate for an initial member of the FHIR resources.

The Pharmacy WG will now develop the use cases to test whether the proposed service implementation is adequate. These are to be provided to SOA.

The project will be balloted by SOA as a DSTU by September. The intent to submit is to be completed by end of June.



SOA/Pharmacy:

Medication Statement Service

The proposed Medication statement service will be balloted in the September 2012 Ballot cycle.

Action: Ensure relevant groups are aware of ballot, and comments are submitted.

HL7 Australia

IT-014-06-04

NEHTA Terminology Services


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2.36.3 HEALTHCARE AND COMMUNITY SERVICES PROVIDER DIRECTORY SERVICE (HCSPD)

PROJECT OBJECTIVE

HCSPD is required to provide an online facility that will enable Practitioners, via a set of parameters, to locate other practitioners and health services to assist in the continuum of care.

This project is an outcome of the Victorian Human Services Directory (HSD) project.


This project has now been renamed at OMG to ServD as it is being developed as a general, not Healthcare specific, Service. The Australian company DCS is currently submitting a response to the OMG Request for Proposal (RFP) using the HL7 Standard that is progressing well. An initial draft was submitted in March and approved by OMG in April. A final document is in preparation with a target of September. It is planned to revise the standard at HL7 to reflect the implementation experience at OMG in mid-2013.



SOA:

Healthcare and Community Services Provider Directory Service (HCSPD)

Endpoint Location Service (ELS) is to be published through the OMG.

Action: Australia should support the ELS work in the OMG.

NEHTA

2.36.4 PROJECT #783: HDATA RECORD FORMAT


This project establishes a simple hierarchical organisational model for clinical content and attaches data provenance meta-data to this information. Through the HSSP collaboration, OMG is working on a submission for a RESTful transport of hData content. The project was originally sponsored by Mitre Corporation, and has some additional videos and historical information at the Mitre Corporation. Additional information can be located at:


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http://www.projecthdata.org/


hData is in finalisation at OMG and open for comment until 21 May. Considerable discussion about security and RESTful services occurred in the context of the Medication statement and FHIR. Gerald Beuchelt, is to be recognised as SOA liaison to FHIR. The hData record Format project is undergoing finalisation at OMG. Final ballot at HL7 is planned for the January 2013 ballot cycle.

2.36.5 PROJECT: RLUS

PROJECT OBJECTIVE

The Retrieve, Locate, Update Service Functional Model (RLUS SFM) is a functional standard defining the capabilities, responsibilities, inputs, outputs, and expected behaviour of a system component capable of querying information and returning data and metadata between systems. RLUS can be used for managing a multitude of information content via a standard access mechanism, promoting consistency within a heterogeneous environment.


An updated version of RLUS was balloted as an HL7 Standard. The Ballot was passed.

2.36.6 PROJECT (NEW): SOA SERVICE ONTOLOGY

PROJECT OBJECTIVE

This project aims to develop a “Health Interoperability Service Ontology” encompassing the description and classification of healthcare-oriented SOA services into a single, formal vocabulary. The concepts identified in this ontology will be derived from several sources, including, but not limited to, the SAIF, the SOA WG Roadmap, and service capabilities identified in the HL7 EHR Functional Model. The concepts in this ontology will be extended to bridge standard ontologies in associated domains such as enterprise architecture, clinical care, and biomedicine.

The project will:

• identify where reference value sets are needed

• collect and/or develop use cases to define the objectives of the Healthcare SOA Terminology work

http://www.projecthdata.org/


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• assess existing SOA ontologies for applicability to meet the needs of the healthcare domain, and recommend the best-fit for HL7

• enhance/extend, or create a taxonomy for healthcare SOA services in the event that an existing body-of-work is incomplete or insufficient

Existing terminologies, where applicable, will be utilised and/or extended. Where appropriate terminologies are not available, they will be developed to meet the needs of the use cases identified.


• Working with NEHTA, Infoway, and Kaiser Permanente to develop Use Cases, structure and content of Ontology.

• Use of Ontology as a run-time vs. design-time capability is an ongoing issue as there has always been an issue with the reality of service discovery.



SOA:

SOA Service Ontology

SOA is currently working with NEHTA, Canada Infoway and Kaiser Permanente to develop use cases, structure and content of the SOA Service Ontology.

Action: NEHTA to continue to be involved in the development of the ontology content.

NEHTA

2.36.7 PROJECT #200: PRIVACY ACCESS AND SECURITY SERVICES (PASS)


The Privacy, Access and Security Services (PASS) project specifications define a set of encapsulated and loosely-coupled, with the ability to compose, service components that can contribute to ensuring the confidentiality and integrity of healthcare information. The goal of PASS is to define a suite of services that will provide a simple interface for all privacy, access control, consent, identity management and other security services that are needed in a service oriented health information architecture.


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The Project lead for this was not able to attend Vancouver and no significant progress occurred. Currently the PASS DSTU is inactive. Following the discussion (as outlined ion section 2.36.8), it was recommended that the Security WG take the lead on the project. This decision will be deferred to Mike Davis, one of the co-chairs of the Security WG, as he would be the lead on the project. It was moved that the PASS DSTU would be revised before Security WG moves it to a normative document and to incorporate into the scope the need of tagging and labelling requirements e.g. S&I Framework. The Security WG agreed to undertake this review and bring additional issues back to SOA prior to or at the next WGM.



SOA:

PASS

There should be revision of the PASS DSTU scope to include data tagging and labelling (data segmentation).

Action: When scope is available for discussion, Australia to review to ensure it is sufficiently international to be relevant for future use in Australia.

IT-014

2.36.8 PROJECT: DATA SEGMENTATION - S&I FRAMEWORK AND ONC INITIATIVE

PROJECT OBJECTIVE

This project is still under discussion.


This is a US realm project. There are a couple of WGs dealing with specific issues in the S&I Framework project, and the project related to SOA and SEC is the Data Segmentation for Privacy WG.

An issue is where you have a comprehensive Continuity of Care CDA; you have issues with privacy where a record contains some sensitive information. The S&I Framework contain the constraints on specific sensitive health conditions. The solutions being sought are not specific for those but to find a way to cater more generally. The group has identified a number of use cases where information needs to be protected but shared.


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The project also incorporates the understanding of the security and sensitivity policies between the organisations with whom the documents are shared. Where you have a holistic healthcare record (in a document), the solution must ensure that the particularly sensitive information is protected and shared according to the rules. One solution is to have one CDA that has the general information that does not need extra protection, and an attached CDA that contains the sensitive information.

The solution is seen as a SOA/SEC based, as it needs to apply as a service to the process of information sharing. The issue is complex because of the componentised architecture of software and accreditation of “systems’”. Please see recommendation on progressing this through the PASS project as outlined in section 2.36.7.

2.36.9 NEW PROJECT (SOA/PATIENT CARE): PATIENT CARE SERVICES COORDINATION PROJECT

This project will look at the services framework, supporting the work done by the Patient Care WG on Care Planning, to satisfy needs that the project supporters have in effecting integration across and within their organisations. Patient Care has completed the storyboards for chronic care conditions and has modelled care plans and their components as specific care concepts. These will form payloads and be subject of interactions in the services specifications. Integration will need to be supported at levels which will need to go to the level of patient controlled and owned resources. There have been related efforts by the Australian delegation over several meetings to initiate a project for grouped functional services from multiple sources that could form or enhance point-of-care applications, initially in Primary Care. SOA, with Patient Care, have endorsed this previous proposal known more briefly as the “Patient Care Services Project” for which a project scope statement has been developed. Progress has been slowed by lack of organisational resource commitment, despite strong recognition of the need for the specification. This project has the potential breadth to include much, if not all, of the earlier Australian Patient Care Services proposal.

For further information please see the Patient Care WG section of this report.


On the instigation of one of the SOA Co-Chairs, the possibility of the project had been discussed out-of-meetings with the three US delegates whose organisations have the need, and Australian delegates who attend SOA, Patient Care and Clinical Decision Support. It was agreed that this should be put to SOA where it was later discussed and agreed that the project should be developed as a SOA and Patient Care sponsored project. CDS should also be considered as a Co-Sponsor, given its work in service oriented application integration and clinical interactions.

A small group, including one of the Patient Care Co-Chairs and SOA and CDS members will meet by teleconference in the weeks following the meeting and draft a project scope statement that will be taken to the September WGM. It is anticipated that it will be drafted by mid-July.


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The CDS delegate, David Rowed, will take up CDS Co-Sponsorship of the project with that WG’s Co-Chairs.



SOA: Patient Care Services Co-ordination Project

Care planning and specialised modules for clinical care support can be optimally delivered to, and integrated within, point of care deployments through a SOA framework. Australian delegates have been working through SOA and Patient Care for a general solution to this but have been hampered by lack of resources. Resourced supporters have now come forward for a care co-ordination solution that also includes services for specific components of the care process. This project has the potential to accommodate much if not all of our requirements. The RACGP is revisiting functional specifications for primary care which in new developments would be service oriented.

Action: Ensure that the Project Scope Statement is sufficiently broad to accommodate the needs already identified by the Australian delegation for point-of-care clinical services specification and involve local stakeholders in the project.

IT-014-06-06

IT-014-13

MSIA

RACGP

2.36.10 OTHER ITEMS There are a number of outstanding existing ballots related to Security. SOA is to provide a list of these to the Security WG.


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2.37 STRUCTURED DOCUMENTS


The structured document WG is a parent technical WG which hosts all technical works on CDA including the CDA standards and implementation guides. Specialisation on the more general CDA standards have been applied to develop domain specific standards and implementation guides including the Continuity of Care Document (CCD), Discharge Summary, Progress Notes, and Healthcare Acquired Infection Report. The WG is also working on delivery of Green CDA and CDA Release 3 specifications. Additional information can be located at:

http://wiki.hl7.org/index.php?title=Structured_Documents

CURRENT PROJECTS

A new work item was proposed to create a CDA document type for patient entered data. The proposal would require an addition to the CDA header data to add a flag as a patient entered document. The proposed sections to be included would be allergies, medications and problems. Optional sections may include History of past illnesses, immunisations, procedures, encounters, payers, social history, family history and pregnancy history. Some issues covered included would the document author ID be the same as the patient ID? It was agreed to take the Project proposal forward as “An implementation guide for how to use CDA for patient authored notes”

Issues to be addressed in the project proposal include:

a. How to indicate that a document is patient authored rather than clinician authored?

b. How to fill the mandatory author ID in the absence of a realm (national) patient identification system?



Structured Documents:

HL7/IHE Consolidated CDA Implementation Guide

There is a proposed new work item for a CDA document type specific to patient entered data. This is relevant to the PCEHR.

Action: Contribute to new work item in view of Australian current work and experience in this area.

NEHTA

IT-014-06-06

http://wiki.hl7.org/index.php?title=Structured_Documents


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2.37.1 PROJECT #477: CDA R3

PROJECT OBJECTIVE

The CDA R3 meeting was primarily focused on the new inclusions to CDA R3 RMIM model. These new inclusions address some of the required Australian CDA Extensions; however it still doesn’t cover all of the required NEHTA extensions. The SD WG has closed the official requirement intake for CDA R3, so any further Australian specific extension that needs to be included in CDA R3 shall be provided as a feedback for the CDA R3 ballot cycles. Australia needs to continue to be involved in the review and development in order to help shape CDA R3. Australia has suggested the WG preclude any further work on CDA R2.1; this is to eradicate the complexity involved in supporting various CDA standards like CDA R2.0, CDA R2.1 and CDA R3.


A discussion was held at the conclusion of the last SD session regarding CDA Release 3. In summary, it was suggested that CDA R3 would probably be done in FHIR.

2.37.2 PROJECT #756: HEALTH QUALITY MEASURE FORMAT (HQMF) IMPLEMENTATION GUIDE (CO-SPONSORED BY CDS)

PROJECT OBJECTIVE

The project aims to create a DAM and an Implementation Guide for HQMF with the goal to provide a standard methodology for implementing performance measurement in clinical information systems to enable current and future measures of meaningful use of EHRs and patient centred measures of health.

Work on HQMF has been done initially with the support of the US National Quality Forum (NQF). HQMF was successfully balloted as a DSTU standard in 2009.

The US Office of the National Coordinator (ONC) has related supporting work under the “Query Health” initiative. This work aims to enable population-based queries across multiple and distributed certified EHRs, to enable large and small providers to undertake population analyses to enhance pro-active patient care and develop resourcing strategies.



http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=756



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The CDS WG met with the SD WG and further worked through HQMF with the aim to go to ballot in September as a DSTU. An IG is being developed to represent QDM in HQMF.

There was an overview of Query Health to see how it was aligning with HQMF, noting collaborative work and resourcing of the project.HQMF is declarative and can be translated into JavaScript, SQL, and XQuery against targets according to models. The group recognised a need for a core language for mathematical expressions that would connect to the RIM-based model. The derivation would not have to be expressed in XML where there are difficulties with the support of standard mathematical symbols. JavaScript, GELLO, mathML, and Arden have been considered. The group wants an extensible core-library with human readability and transparency of the mechanics for clinicians. The ballot will be prescriptive with the solution chosen.

Java Script and GELLO examples have been put together and this work will continue. The project team will be working with ONC to get stakeholder involvement. The Query Health Group will engage through joint calls.



Structured Documents: Health Quality Measure Format (HQMF) Implementation Guide

This is relevant to CDS in population-based applications and knowledge development that also affects pro-active care and resourcing. EHR systems need to be appropriately structured to represent quality measures, especially to support queries around these.

Implications for Australia: This will provide input to EHR requirements for quality and CDS.

Action: Monitor the project to gain a clearer picture of how process and outcome–based quality measures are query able when represented in EHRs and used for CDS.

IT-014

IT-014-13

2.37.3 OTHER DISCUSSIONS

2.37.3.1OWNERSHIP OF OIDS

There was an interesting discussion about ownership of OIDs initiated by a representative from The Joint Commission. They were very concerned about people impersonating their OID. Their concern originated from a problem the CDC encountered when a Third Party used their HL7 OID inappropriately.


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Other Members of the WG pointed out that OIDs are just used for identifying Identifiers and they were not a Digital Certificate and should not be conceived of as having similar properties. Nevertheless, Australia is likely to experience similar confusion around the use or misuse of OIDs in HL7 Messaging.

In Vancouver, due to the overlap in WG meetings, it was not possible for Australia to be represented further at this meeting.


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2.38 TEMPLATES


The Templates WG is primarily responsible for the defining processes for creating and managing HL7 Templates. An HL7 Template is a registered expression of a set of constraints on an HL7 RIM-derived model. The Templates WG is primarily responsible for the evolution of the HL7 templates methodology and resulting standards. In recent years, their work has extended to consider the business requirements for registries and repositories to facilitate location, indexing, storage, use and access to a wider range of modelling artefacts including HL7 templates, openEHR archetypes and UML-based detailed clinical models.

Key aspects to the work of the Templates WG have included and include:

• Development and maintenance of the Templates DSTU;

• Identifying business requirements for a templates registry and development of a pilot implementation; and

• Identifying business requirements for an HL7 templates repository that was envisaged as being a function of a proposed HL7 V3 artefact repository to be developed as part of the HL7 Tooling initiative.


http://wiki.hl7.org/index.php?title=Templates_-_HL7_Wiki

BACKGROUND

An HL7 V3 template is an identified set of constraints on a normative static model.

The HL7 uses the term “template” for expressing two types of models:

• An atomic model (“independent” in the V3 paradigm; roughly equivalent to a CEN13606 and/or ADL archetype).

• A model that is a composition of atomic and/or other compositional templates. This is roughly equivalent to an ADL and/or 13606 template.

This HL7 template definition also parallels the IHC CEM definition that also supports recursion.

The WG released its “HL7 Template Registry Business Analysis Requirements R2” document for comment ballot in January 2012. Ballot reconciliation results appeared to indicate that it has passed comment ballot.

Works of the Template WG are useful to the Australia e-Health community when considering technical approaches and infrastructure to sharing of e-Health specifications including various clinical models specifications as templates.

http://wiki.hl7.org/index.php?title=Templates_-_HL7_Wiki


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The templates WG met with the FHIR project team to consider the relationship between the FHIR project and templates. The following two issues were considered:

• How FHIR handles templates – called “profiles” in FHIR. The current state of play was demonstrated, including a working FHIR template registry; and

• Using FHIR for the new template ITS. This will be considered on an ongoing basis.

Much of the work of the Templates WG occurs in weekly teleconferences that take place between WGMs, with the time at WGMs being largely shared with other WGs and used for strategic presentations and updates.

Activities undertaken include:

• A report on the Templates ITS Pilot PSS progress and status. Discussion and planning of next steps in the project;

• A report on resolution of negative ballots on the Templates Registry Business Analysis Requirements;

• A report on Co-Chair election and vote on interim Co-Chair election. Note that Kai was appointed into the position;

• Discussion of issues raised at the Thursday Q2 meeting, especially concerning Patient Care, Structured Documents and Vocabulary WGs; and

• A discussion involving Grahame Grieve of the relationship between Templates and the FHIR project.

CURRENT PROJECTS

2.38.1 PROJECT #829: HL7 TEMPLATES REGISTRY BUSINESS PROCESS REQUIREMENTS ANALYSIS

PROJECT OBJECTIVE

The objective of this project is to define business requirements for a registry that will be an authoritative source of metadata about HL7 templates being used around the world and similar clinical information models developed using other modelling paradigms e.g. archetypes, CIMs and DCMs. The aim is to assist developers and implementers looking for existing template resources to rapidly locate them by searching on available administrative and classification metadata.

V2 of the specification is influenced by suggestions put forward by Corinne Gower, HL7 New Zealand, and is grounded in application of “ISO/IEC 11179-3 Information technology – Metadata registries (MDR) - Part 3: Registry meta-model and basic attributes”. It seeks to


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provide an agreed approach for tracking template artefacts throughout their life cycle from initial proposal through to active use including roles required for management and adoption.


Negative ballots for this project were resolved.

2.38.2 HL7 TEMPLATE ITS PILOT

This project aims at creating an ITS that supports an interchange format in a canonical form for HL7 CDA templates.


This project is a tightly focused sub-project of the Templates Interchange Format project (Project #272 in Project Insight) to move the work forward in a specific area. The lessons learned from this project will feed back into the wider, larger scope project.

Many groups are creating HL7 CDA templates independently and there is a need to be able to transmit template specifications between groups in a canonical form, to support: knowledge sharing; creating new templates or new versions of templates; and healthcare implementations using templates; and, to support persistent storage. An example is the communication of a template specification between various template definition tools.


This project aims at completing Requirements Analysis including an analysis of MDHT, Trifolia Workbench, DECOR, and Templates Registry Business Process Requirements by the September WGM. The first draft of ITS is scheduled to be completed by November 2012 and ready for DSTU level ballot in May 2013. It is also anticipated that exchanges by two CDA template implementations will be demonstrated in January 2013.



Templates:

HL7 Template ITS Pilot

The Template ITS pilot project should be of interest to Standards Australia IT-014-06 subcommittees and PCEHR program group developing template services.

Action: Increase awareness of this project, and Australia to consider for potential contribution.

IT-014

IT-014-06

NEHTA


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2.39 VOCABULARY WORKING GROUP DESCRIPTION

The Vocabulary WG provides an organisation and repository for maintaining a coded vocabulary that, when used in conjunction with HL7 and related standards, will enable the exchange of clinical data and information so that sending and receiving systems have a shared, well defined, and unambiguous knowledge of the meaning of the data transferred. The purpose of the exchange of clinical data includes, but is not limited to: provision of clinical care; support of clinical and administrative research; execution of automated transaction oriented decision logic (medical logic modules); support of outcomes research; support of clinical trials; and to support data reporting to government and other authorised third parties.

To achieve this goal, they work cooperatively with all other groups that have an interest in coded vocabularies used in clinical computing. Some of the groups that this WG seeks to work closely with include: standards development organisations; creators and maintainers of vocabularies; government agencies and regulatory bodies; clinical professional specialty groups; vocabulary content providers; and vocabulary tool vendors.

The Vocabulary WG activities include:

• Document HL7 vocabulary design and maintain the documentation guidelines on the principles of vocabulary message content and structure over time – the Core Principles project defining the principles of how this should be done is a current major work item nearing completion;

• Maintain OID Registry with approval for new OID requests including current consideration of ISO OID registry metadata standardisation;

• Maintain the V3 Vocab repository – there is current consideration of how IHTSDO and other organisations activities might manage more of the vocabulary registration processes i.e. that HL7 will “use” existing repositories where possible rather than maintain their own;

• Maintain table 0396 (V2 content for registered coding systems) including new requests, changes to existing entries, publishing on HL7 website; and

• Educate stakeholders via tutorials and improved documentation.


http://www.hl7.org/Special/committees/Vocab/index.cfm

http://www.hl7.org/Special/committees/Vocab/index.cfm


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Progress at the meeting is detailed in the specific projects below.

CURRENT PROJECTS


1. Vocabulary Facilitators

2. Terminology binding (joint with Structured Documents and CGIT)

3. Project #324 & #839: Common Terminology Services Release 2 (CTS 2) – Normative (#324) and HL7 Common Terminology Services Release 2 (CTS2) Implementation Guide (#839)

4. Project #806: Development of policies and procedures of an HL7 terminology authority

5. Project #644: HL7 Evaluation of the IHTSDO Workbench tool

6. Project #849: HTinfo – implementation guide for using terminologies in hl7 artefacts – release 2

7. Tooling/Vocabulary joint meeting

2.39.1 VOCABULARY FACILITATORS

PROJECT ACTIVITY

Vocabulary facilitators are individuals who work within WGs and provide terminology expertise to the WG. A number of problems have been identified related to the facilitator system.

There are problems that relate to harmonisation and harmonisation proposals, outside harmonisation which still relate to Vocabulary, where the Vocabulary WG provides advisory input. There is existing documentation on facilitator processes, but these have not been updated recently. There is a need to document facilitator needs to do and update information about the artefacts required for harmonisation. The total list of tasks that involve terminology is quite extensive and was originally listed in the 16 point document. This document needs to be reviewed. An initial review of this document has been undertaken and it identified that it is not clear how the document is intended to be used. Additional information can be located at:

http://wiki.hl7.org/index.php?title=Vocabulary_Facilitator_Responsibilities

The WG identified changes needed which include:

• Remove names associate with training documents; and • Remove how to make submissions for imported vocabularies.

It was agreed that there is a need for a Vocabulary Facilitator Guide which will created over the next few months. One-quarter session was spent obtaining information to support the development of this guide.

http://wiki.hl7.org/index.php?title=Vocabulary_Facilitator_Responsibilities


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A discussion on the role and relevance of a facilitator occurred. The essential issues that will be included in the facilitator document include:

• What is a vocabulary facilitator and relationship to modelling facilitator? • What is the action within your working group? • What is the action externally e.g. harmonisation, OID registries?

The facilitator tasks roles and responsibilities include:

1. Intrinsic (required of the individual): - Attending facilitator meetings. - Participating in development of facilitator training materials documents and

processes. - Participate in development of vocabulary facilitator resources - listed on the

Vocabulary Facilitator Guide wiki. - Identification of training requirements to support facilitators. - To development skills required to achieve the required tasks i.e. keep up to

date with changes. - Attend vocab facilitator meetings. - Attend tutorials at least every X (to be decided) years. - Must subscribe to the vocabulary list. - Must be familiar with parts 4 and 5 of the Core Principles document.

2. Internal domain WG focus - tasks to function as a terminology expert within the working group domain. These will need to be enumerated:

- Act as an expert resource to the domain WG on vocabulary and terminology principles and issues.

- Advice the WG on good vocabulary practice. - Assist the WG with the construction/selection of value sets for coded attributes. - Liaison with the vocabulary WG on behalf of their WG. - Educate the domain WG of the role of the facilitator and be actively involved in

the WG activities. - Coordinate with the WG modelling facilitator on WG items. - Inform the domain WG about licensing and IP issues on proposed terminology

use. - Assist the domain WG with how to bind terminology to their models including:

i. Understanding the implications of binding choices, and relationship to localisation; and

ii. Assist in creation and modification of concept domains.

3. Externally focus, representing your WG to other communities: - Focus on HL7 harmonisation process, working on behalf of the WG e.g. "SDO

interactions, other HL7 organisational bodies, and steering divisions. - External roles attend harmonisation meeting for which you are making a

submission.


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- Prepare harmonisation proposals. - Facilitate communication between WG and external experts and SDO's. - Register OID using HL7 OID registration process (after the domain WG has

determined that registration is required).



Vocabulary:

Vocabulary Facilitators

Action: HL7 Australia to advise Vocabulary Work Group member for Australia of national requirements for facilitators.

Action: HL7 Australia to consider how we manage these requirements in Australian Standards production.

HL7 Australia

2.39.2 TERMINOLOGY BINDING (JOINT WITH STRUCTURED DOCUMENTS AND CGIT)

PROJECT ACTIVITY

In the CDA implementation Guides there are issues arising from the binding syntax designed many years ago. This has now been adopted by the US government and tooling that uses that binding syntax, even though that syntax does not meet the requirements of core principles.

The vocabulary binding section of the guide was presented with vocabulary representatives’ explaining the current status of core principles but noting that the vocabulary section is now stable. This normative specification identifies the requirements for binding but not the syntax of expression as this was considered an implementation detail rather than a high level principle of operation.

The elements needed for model binding include:

• Bind to single or collection of codes (value set assertion) (required) i.e. what you are binding.

• When the binding is to go into effect - effective date (required). • When the binding is no longer to be used - end date (optional).

Code systems are similar to those in CDA documentation. Value Set Assertion is required when you want to allow participants in a community to extend or create subsets to work with local requirements on state or national value domains. This allows publication of a value set formally, but supports the need for additional constraints on the agreed normal set. This is managed through the MAX value set and MIN value set mechanisms and an indication of stability (static/dynamic), and is a local code allowable if the concept you want to use is not in the value set.


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The Core Principles document will be re-balloted. The Vocabulary WG will update the document to include hyperlinks to make optional and other components clearer.

The major issue for consideration at this meeting is how to harmonise the approaches taken by Vocabulary and Structured Documents WGS which vary. The problem of value set stability has been addressed by each group in slightly different ways.

The existing binding syntax project (CGIT and Vocabulary) has considered these elements of the core principles and includes a grammar on how to present this information. Additional information can be located at:

http://wiki.hl7.org/index.php?title=Binding_Syntax

To be conformant to the requirements, certification requires support of all the codes. If you say MAX you must not replace content with a superset. You can build something that can handle all subsets, but not all supersets. MIN and MAX are often the same, but another common pattern is where you have a MAX and the MIN is null. The binding in all guides will preferably not require updating.

Additionally, it was discovered that the Binding Syntax wiki needs to be updated to include effective date and to show that this means “as of the effective date”.

Comments recorded to inform further resolution of the identified issues include:

• The use of a special keyword for stability (e.g. static and dynamic) is entirely up to you, the normative syntax does not require it. If there is a date, it is static stability for that date.

• Where the word STATIC is in the above, perhaps 'resolved as of yyyymmdd?

• If the ValueSet is being defined inline in the Implementation Guide and it is known explicitly to be extensions (an enumerated list), then this phrase about resolved date can probably be omitted.

Other additional comments in the document reviewed included the need to identify more clearly in the documentation the different terms “SHALL”, “SHOULD” and “MAY”. The strength of the binding seems to be a term that might be confused. Use of the term binding intensity was suggested as it indicates that if you do these things you can be certified as compliant. Intensity of the binding will be identified and the number of states required must be established. There are many choices and there is a desire to keep it as simple as possible. An enhancement to binding and coding strength will be considered which will require changes in core principles and CDA documentation to resolve these issues and will add an item of metadata to binding. Binding syntax will be developed after resolution to these issues is agreed.

http://wiki.hl7.org/index.php?title=Binding_Syntax


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Vocabulary:

Terminology Binding

Action: Consider the impact of these issues of binding syntax in CDA documents under development and published in Australia.

NEHTA

IT-014-06

2.39.3 PROJECT #324 & #839: COMMON TERMINOLOGY SERVICES RELEASE 2 (CTS 2) – NORMATIVE (#324) AND HL7 COMMON TERMINOLOGY SERVICES RELEASE 2 (CTS2) IMPLEMENTATION GUIDE (#839)


CTS 2 is a commonly accepted standard for terminology services that enhances the capabilities of the initial CTS specification for sub-setting and mapping, and extends the specification into domains such as terminology distribution, versioning, and classification. The Vocabulary WG sponsors these projects.

The OMG CTS2 Beta Standard is an API based on Resource Oriented Architecture (ROA) and REST approach to modelling. ROA gives a number of advantages including simplicity at a PIM level. This work supports RDF2 and OWL2 for the semantic Web. It is intended to be extensible, not constraining, and help encourage consistency.


http://www.omg.org/techprocess/meetings/schedule/CTS2.html

All materials are freely downloadable and all parts are fully documented from the following location:

http://informatics.mayo.edu/cts2

The original CTS2 documentation has been significantly updated to meet the needs of the health terminology community. In particular, there has been work to align the requirements from the Service Functional Model (SFM) to the platform independent model (PIM) and correct errors in the service functional model, and align the vocabulary with that used in the vocabulary core principles document.

This project is informed by and, in some ways, is dependent upon work being done by Mayo Clinic and Apelon. Delivery milestones are available at:

http://wiki.hl7.org/index.php?title=Common_Terminology_Services_-_Release_2_(Normative):

http://www.omg.org/techprocess/meetings/schedule/CTS2.html

http://informatics.mayo.edu/cts2

http://wiki.hl7.org/index.php?title=Common_Terminology_Services_-_Release_2_(Normative)


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The normative ballot is planned for September 2012. The French national standards group PHAST, joined the CTS2 Finalisation Task Force (FTF) at OMG in December 2011 (along with the MAYO Clinic) and the Task Force has now closed but may still accept further input. The HL7 Normative edition of the CTS2 Standard is going forward in the Vocabulary WG with a ballot target of September 2012. The PHAST group has provided a Standard Terminology Description (STS) document with detailed specifications available in English at:


This document provides a detailed implementation approach by the French National Terminology Group to a real-time medicines terminology viewer Service using CTS2. In addition, PHAST has connected their implementation (SOAP based) to the NCBO BioPortal (REST based). The lessons learned are documented at:

http://extension.phast.fr/CTS2/ListCodeSystemsBP.aspx?path=BioPortal/bCodeSystems

The MAYO group has been refining their CTS2 toolset with a plan to release V2 in the near future. They are in the process of negotiating this being contributed to The Open Health Tools (OHT) process. The French and USA groups are completing harmonisation of their approaches to implementation to provide feedback to the CTS2 HL7 Ballot in September.

2.39.3.1 ALIGNMENT OF CTS 2 WITH THE HL7 CORE PRINCIPLES OF VOCABULARY

The DSTU went to ballot prior to the Core Principles document which resulted in the terminology used being out of sync. A draft has been written that aligns the terminology elements of the SFM with Core Principles. The intention is to produce an incomplete SFM for review and ultimately get feedback from the Vocabulary WG. An iterative review will be undertaken but the question is how the iterations will be presented and how will input be submitted. In answer to this question there is a Google document available (link off main page listed above) that will allow input. The alignment with the Core Principles will be the most challenging as it impacts the entire document. The Google document is available for ad hoc review at any time. Edits will be restricted but approval can be granted to individuals for edit access.

2.39.3.2 OMG PIM/HL7 TRACEABILITY MATRIX

This will document how functional and information (OMG PIM) models align. A document for vocabulary to review will be brought forward after some editing consolidation. A mitigation strategy will be developed to address any gaps identified by this process. Questions raised as to whether this project is aligned with the SAIF program included:

• How is conformance measured?

• What is a valid profile for a CTS 2 implementation?


http://extension.phast.fr/CTS2/ListCodeSystemsBP.aspx?path=BioPortal/bCodeSystems


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These will need to be specified. Furthermore, there seems to be a function missing that accounts for certification for use of a specific licensed terminology. There was extended discussion about functionality and minimal functions needed to declare that you have a valid implementation. Comparison of functions with those being developed by Germany was also discussed. For CTS2, in regards to HL7, there is a profile being developed on how to represent HL7 vocabulary using CTS2. Discussion included what was in and/or out of scope as to what should be included in the SFM. Not only in terms of gaps but also in terms of introduction of details that do not belong in this aspect of the CTS 2 specification.

2.39.3.3 CONFORMANCE PROFILE FOR HL7 CTS 2

Although, the HL7 implementation guide is in development, work of which began at the January 2012 WGM, it has been put on hold due to limitations of resources. Other guides for SNOMED and the UMLS are in the process of being developed. The intent of the HL7 profile is to use these guides, so there is a dependency on this project. It was suggested that a review of the ECCF be undertaken to make sure it is considered in the future development.

2.39.3.4 UML REPRESENTATION OF MIF VOCABULARY

This has evolved into more than a conceptual representation of HL7 vocabulary and has moved into nearly an implementation model. There is a need to look at MIF model vocabulary and see how this might fit into the CTS 2 model for HL7 vocabulary. Additionally, there is a need to ensure that everything that was in the original model can be managed by a vocabulary MIF and there is a vocabulary MIF in UML in the ballot that can be used as a template. A comparison of the MIF and the SFM must be undertaken to determine gaps, mismatches, omissions and additions. Any identified issues must result in a plan to resolve any discrepancies.

2.39.3.5 FUNCTIONAL AND INFORMATIONAL MODEL CLARIFICATION

Identification of functional or structural enhancements that would be needed will be recorded and put into the project plan. A few examples of where this already exists were discussed. These will be documented and placed on the wiki as they are identified. Available resources include:

• DSTU

• OMG Submitter documents

• PHAST documents

• CTS2N work artifacts (the Google document referred to above)

Samples of international work (PHAST – France, and OMG – Germany) are being sought.

Craig Stancil gave an update on the Finalisation task force as part of the workflow for the CTS 2 project. The final specification will be sent to OMG on May 21 and the final publication in


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June 2012. The types of changes that can be made at this stage include omissions, text changes and erroneous implementation guidance.



Vocabulary:

Common Terminology Server 2

Action: Consider how these updates and international trials impact Australia's potential use of this work.

NEHTA

Vocabulary/SOA:

Clinical Terminology Service (CTS2)

The French have deployed a Terminology (view only) Service for their Medicines terminology using CTS2. Their approach is documented at http://wiki.hl7.org/index.php?title=File:Phast_STS_brief_description_May14_2012.pdf

Action: Australia to review this work as it may provide information for an Australian approach to deployment of AMT.

NEHTA Clinical Terminology

IT-014-06-04

IT-014-02

2.39.4 PROJECT #806: DEVELOPMENT OF POLICIES AND PROCEDURES OF AN HL7 TERMINOLOGY AUTHORITY

PROJECT OBJECTIVE This project is to develop the policies and procedures for the establishment and ongoing operation of an HL7 Terminology Authority to administer terminology content in SNOMED CT and define the responsibilities and relationships of HL7 to SNOMED CT and its use.

The purpose of this group is to:

• Manage the integration of SNOMED CT content into HL7 value sets, although other code systems will be under its purview.

• Develop and manage a process and structure to triage and route terminology requests to IHTSDO or other external terminology organisations.

• Define the processes to submit terminology to an external terminology body, and to define the scope of process within HL7.

The need for this work was driven by the requirement to form a single point of contact with HL7 for IHTSDO content management.


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Clarification of what can and cannot be done under the use of SNOMED CT under the Public Good Agreement is required. Questions arose as the WG started to consider the process. These issues and the discussion around them are outlined as follows:

Issue 1:

Does a warning need to go out to users of HL7 standards that if they are using SNOMED CT for value set content for the international balloted international releases that they may only use extensional definitions?

IHTSDO written clarification on distribution of intentional reference sets is required e.g. SNOMED CT concept id of X and all of its subtypes. The definition syntax, as defined in the MIF, is a single xml attribute that says include decedents. In order to resolve a reference set i.e. to build the content required by using a reference set mechanism, HL7 may publish the list of concepts and definitions in a transaction and in an artefact.

Issue 2:

Clarification is also required from IHTSDO in writing on the use of post-coordinated expressions in the Public Good Agreement, distribution under public good of the RefSet representation of intentionally defined HL7 value sets. The problem is that when looking at the public good use policy it seemed to some members of the WG that that if you have an HL7 value set that is, for instance brucella and all its decedents (because we only persist the lead concept and the formalism represents and all its decedents) would this violate the policy or not? In response, David Markwell replied that this is a conflict. The use of the concept of decedents requires the structure and content of SNOMED CT. Therefore value set content would need to be explicitly defined. In the current release of V3 there are 15 to 16 value sets which use SNOMED CT and there is an expectation that more and more of the content will be represented in SNOMED CT over the years.

A written statement of the problem requesting clarification is to be prepared to make the “rules” and “issues” clear. If the rules being distributed require the parsing of the subtype hierarchy and this is a key component of HL7 use case for those who receive material, this case should be made to IHTSDO to consider. Ted Cline indicated that he is concerned that HL7 not 'break the rules' inadvertently or cause problems to our members. There has been push back on international ballots from members who do not want to be forced into a product (SNOMED CT). It was agreed that just the distribution of the definition formalisms would not be a problem for the IP but it raises the question of the usefulness of this to HL7 members who are not members of IHTSDO.

IHTSDO do not actually publish a specification of how you should define reference sets, it is handled inside the workbench. If there was use of that specification it would be excluded from public good use. If used for the organisations operations it might be included under the Public Good Agreement.


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The letter to IHTSDO is to seek specific clarification on the following situations:

a. When the international value sets are distributed referring to SNOMED CT these cannot be resolved to an actual value set expansion without reference to the SNOMED CT value set mechanisms, which cannot be used without a license.

b. Distribution of the definition formalisms that refer to relationships in SNOMED CT, specifically can HL7 distribute the rules to allow expansion as you can't interpret the rules without access to the terminology and therefore can't actually build the value set without access to the terminology.

Legal responsibility is an issue and it is assumed that whoever receives or uses the standard has the legal responsibility to use the terminology content appropriately rather than HL7 having that responsibility. The Vocabulary WG is keen to be assured that HL7 is not violating the agreement.

The letter is intended to make the case for why we don't want to produce the expansion only, including the size of some of them. HL7 do not distribute value set expansions in general and will also mention the issue of post-coordination.

David Markwell's answer to these issues was that distribution of post-coordinated content as a static list was not seen as a problem, but to assess whether what was sent/received would require relationships for validation. The use of post-coordination makes the concept model visible in some ways. You don't have to have the relationships to deal with the content. If you say or you have subtypes you need either the relationships or the detailed content, both of which were outside the scope of public good distribution.

If the members of a reference set (the outcome of applying a reference set mechanism) were published the list of concepts and descriptions may be distributed, though there is a tenuous question of whether that list implies structural relationships.

IHTSDO are undertaking a review of the IHTSDO workbench, David Markwell reported that this technical review is underway and that the selection panel included David Bunker. The first phase was to identify the principles of the architecture work bench. The second phase is based on their requirements and identification of the ideal future architecture and how that varies from what we have now.

Outline of findings of the review include:

• Workbench architecture should be layered, with clean interfaces separating the presentation layer, the business logic layer and the data access layer. Calls should only be made from classes in one layer to classes in the layer immediately below.

• Should be clean separation between different functional modules within the workbench to avoid duplication and provide separation of interest.

• A single well commented interface should be provided into the business logic layer, to enable development of alternative presentation layers.


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• A text-based interchange format (human/machine readable) should be defined based on RF2 to enable exchange of content with other applications.

• The presentation layer should be migrated to a more standard framework.

Next steps include:

• The findings and roadmap from the Architecture Review will be reviewed by the Technical Architecture Review Steering group and the Technical Committee, who will produce a summary report.

• The summary report and the detailed architecture report will be reviewed by the officers, in conjunction with the budget and word plan for 2012 and 2013, and with the Member forum's assessment of priorities in the work plan.

• Officers will build recommendations from the architecture review into the work plan for 2012 and future years, either as cost-neutral elements to existing work items, or as items requiring additional funding.

• Any items requiring additional funding will go to the Management Board for approval.

The timelines are still evolving. While the architecture review has been a major endeavour, there have been changes with the workbench over the last 6 months. Four workbench packages have been identified. Each of these packages is aimed at different groups of stakeholders, to be used as follows:

• International package - authoring and release of the international edition of SNOMED CT by IHTSOD approved terminologists.

• Managed Service Package - maintenance of extension content, for members countries that wish to create and maintain their own SNOMED CT extension.

• Translation package - creation of language translations for member countries that wish to translate SNOMED CT descriptions into their own language.

• General members package - a demonstration release, for those interested in learning more about workbench functionality.



Vocabulary:

Development of Terminology Authority for HL7

As the development of a terminology authority for HL7 offers the ability to use more standardised and accessible terminological content for HL7 purposes, both nationally and internationally, this item is considered to be important to all organisations.

Action: Australia to support the development of a terminology authority and IT-014 to monitor work in this area.

HL7 Australia

IT-014


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2.39.5 PROJECT #644: HL7 EVALUATION OF THE IHTSDO WORKBENCH TOOL

PROJECT OBJECTIVE

This project is to evaluate and map (technical alignment) between the IHTSDO workbench information model and the HL7 vocabulary model, as implemented in the MIF to identify how the vocabulary artefacts in the MIF can be modelled in the workbench. This will provide a mechanism to support a plan to moving forward with the workbench.


The current state of HL7 vocabulary maintenance tooling is a concern. The approach is to consider data sources and the mapping approach. The mapping tables are quite large.

Current state of terminology maintenance tooling:

• Put together with a combination of xml (Vocabulary Maintenance Language) which uses a relational database and JAVA APIs.

• Additionally there are manual merges of material which cannot be automatically maintained.

• There is no current maintenance or upgrade to existing tooling, and this is increasing the number of manual updates to make things happen. This is a high risk strategy.

• The current tool requires significant expertise to use accurately and there are only a handful of people on the planet who can do it and it is still prone to human errors.

In order to identify what is practical and achievable, this project has undertaken a conceptual mapping between the HL7 content and how this would be structured in the Workbench.

Version 2.1.6 of the MIF implementation of HL7 had instance data available and formed the basis of the review. The use of an eConcept was considered. This serves as an idea which has descriptions, annotations and relationships etc. in a way that the workbench understands to be a concept i.e. a building block that the workbench can understand or represent.

The project decision has been made to map to eConcepts and not to RF2 as eConcepts offer a better conceptual mapping for HL7 through the workbench. This also means that it will not be necessary to add SNOMED CT specific information to our existing information. It will be possible to use the workbench to export HL7 content in a representation that is consistent with RF2.

The process that might be used to maintain HL7 content in the workbench was discussed:

• Each HL7 primary terminology object is represented as a concept (concept domain, code system, concept, value set, binding and value set assertion).


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• Mapping focused on representing a HL7 MIF vocabulary elements and attributes as concepts within the IHTSDO workbench.

Auxiliary concepts are essentially a group to support terminology components, such as properties. This separates these from the primary terminology objects so that they don't get confused. The diagram below indicates the metadata created to represent HL7 content as a prototype.

It should be noted that inverse name is the property of a relationship (as each relationship is bidirectional). It was noted that this is not necessarily in the right place in this diagram but as it is only a prototype, areas can be changed.

Some of the existing metadata used in HL7 vocabulary processes may not be required as it may have originated as a mechanism to support the current “broken” elements of our tooling. One of the description types identified is the concept of a description. It was acknowledged that this concept might work better with a different title e.g. print name.

The workbench offers the opportunity to add descriptive text, which was not able to be maintained in the existing tooling.

Value sets are handled similarly to metadata components. HL7 persists value sets with a definition through a value set definition which is a description of what the content of the value set is supposed to be. There are clauses used in the MIF which define the actual codes in the value set. The review found that the clauses in the MIF map very well to the clauses used in the workbench to create a reference set. The workbench actually offers greater functionality then that what was available in the existing HL7 tooling.

An HL7 value set has no underlying structure; it is just a “sack” of concepts. The terminology provides the relationships. There are discussions within IHTSDO as there is not yet a standard for display of relationships and input from the HL7 Vocabulary community on this issue was welcomed by David Markwell.


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2.39.5.1 MIGRATION PROCESS

There is a need to develop a MIF export function for the workbench. HL7 would put content in through the workbench, then export from the workbench and compare the two export files to validate the migration. The current requirement is to use the workbench, the MIF, and Rosetree, as the existing tools that support publication. The change after migration is that data capture will be through the workbench and MIF content is updated through export from the workbench.

2.39.5.2 HARMONISATION

The intent is that vocabulary facilitators will be able to enter their modifications through the workbench and harmonisation will be approval rather than actual entry activities. There will still need to be a quality overview but it is expected that there will be far fewer errors because the tooling will identify many issues and make much clearer the intended use of the concepts concerned.

2.39.5.3 SYNCHRONISATION MODE

The synchronised version creates the build in a manner which is now appropriate for HL7 use so a separate build is not the recommended method. A new project is being considered to actually undertake the migration, harmonisation and synchronisation processes as there is seen to be immediate process improvement and quality control.



Vocabulary: Use of IHTSDO workbench for HL7 Content

Action: Ongoing contribution and reporting is required to ensure that HL7 Australia and IT-014-06 are aware of progress in this area.

HL7 Australia

IT-014-06

2.39.6 PROJECT #849: HTINFO – IMPLEMENTATION GUIDE FOR USING TERMINOLOGIES IN HL7 ARTEFACTS – RELEASE 2

PROJECT OBJECTIVE

This is a DSTU revision to the expired DSTU from Project #468 and is the provision of implementation guidance to support the communication of SNOMED CT and LOINC


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terminology content in HL7 artefacts (including V2 and 3 messages and templates, and CDA documents). This is achieved by the consensus development of guidance relating to: areas of semantic overlap e.g. attributes supported by both models (negation in SNOMED CT, system and method axes in LOINC); areas specific to each technology e.g. constraining appropriate SNOMED CT and LOINC content for V2 and V3 artefacts; areas needing guidance since the previous DSTU; extensions to cover the use of LOINC and use in V2 artefacts; description ID's; display text for post-coordinated expressions; vocabulary binding principles; definitions of intentional value sets where the constraint(s) further limit an existing intentional value set; and others as they emerge. This guidance takes the form of; editorial principles; technical constraints and mappings where these are possible; illustrative examples; and discussion and explanation of open issues.

The Terminfo project sets out to resolve and specify how to represent terminology SNOMED CT in HL7 V3, the terminology content and information model relationships. This work was last updated in 2009 and published as a DSTU and has been used and tested. IHTSDO have also used the original DSTU document and engaged with this work item.

The intent is to beak the work up into management pieces and determines what new sections need to be added. The use of LOINC and other terminological resources will be included. This work will also consider the relationship to V2 and include requirements to support V2 processes. Additional information can be located at:

http://wiki.hl7.org/index.php?title=Terminfo_2

PROJECT ACTIVITY

Initial discussions to inform the development of Release 2 of Terminfo and to provide content to the document are centred on the development of use cases.

The use case for Microbiology was used as an example. The purpose of this use case is to identify guidelines in the domain of microbiology reporting terminology when using LOINC for the observation and SNOMED CT for the result value.

The scope includes V2, V3 and CDA and will cover the LOINC observations used in Microbiology reporting where a coded result value is a recommended option and include recommendations and guidance on the following:

• The sue of interpretation of the result value;

• When to use generic LOINC observations and organism specific observations;

- with each of the generic and organism specific observations guidelines on the type of result value codes should be used and which ones should be avoided

• The use of specimen information;

• The use of method information;

• The use of isolate observations and result value;

• The use of sensitivity observations and result values; and

http://wiki.hl7.org/index.php?title=Terminfo_2


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• Others, as appropriate.

The assumption is that there are open projects at IHTSDO in this area and this work will include collaboration with this IHTSDO associated work.

This use case represents the problem of the need to represent something in more detail than what is represented in LOINC. It was agreed that there is a need for guidance on the level of granularity such as class or method. Whether only to use method lists needs to be considered. LOINC by no means covers the level of detail to cover some of the methods that are needed. Also organisation specific cultures are a rule for that organism class only and cannot be used outside the taxonomic level it is representing in that concept. This clarification is essential and guidance is absolutely needed including guidance on how to use the SNOMED CT code in conjunction with LOINC in scenarios such as this. This is recognised as a difficult area, but also one what if resolved would provide significant utility as solutions to other problems may also fall out of this process.

There have been discussions on the selection of appropriate LOINC representations in different use case situations. There is also a challenge back to the LOINC committee where it has been discussed about the appropriateness of some of the early LOINC codes to support the way they've always reported, as opposed to representing concepts correctly. Concepts such as these are no longer added, but are a known issue with LOINC content. The guidance may be to put the SNOMED CT code in the interpretation and leave the value blank. This may cause some difficulties in the V2 situation. This relates to what things will be maintained in HL7 codes and what should be moved to other external terminological representation. Volunteers were sought to work on any of the areas of development of the Terminfo work item. Canada is providing support to the microbiology use case.

The vocabulary community is being asked to assist and provide information to capture the current understanding, based upon implementation guides that exist. The community can set the scope and approach, but if that approach is in conflict with existing approaches they will not be successful. Therefore, they need to undertake an environmental scan. The focus will be on the guides that are HL7 international artefacts or existing guides from relevant terminology developers or other SDOs. A request for input from LOINC was also included. The review should include a review guides under ballot at HL7 V2.

It is intended that the Terminfo use cases be divided into sections to make each achievable, but this will require clear coordination and harmonisation between workers. There is a need to collect names of people with an interest in a given section.

A new section was added on Organism related observables, observables coded with organism subtypes, observables coded with organism related findings subtypes, and observables coded with organism related situation subtypes would be included.

Specimen information is another additional section. Subcategories include:

• Original specimen vs. derived specimen.

• Original specimen vs. isolated organism.


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• Specimen source (topography) vs. Specimen (substance and morphology) such as (fluid from a cyst on the right arm).



Vocabulary:

Development of Terminfo use cases

Action: Consider whether Australia wishes to actively contribute to use case development.

Action: IT-014-06-05 to consider any specific issues related to existing standards that might require modification or which could provide input to the use cases.

Action: Consider whether Australia can contribute any information from our existing implementation guides.

NEHTA

IT-014-06-05

2.39.7 TOOLING /VOCABULARY JOINT MEETING

PROJECT ACTIVITY

The National Library of Medicine’s terminology request submission tool was reviewed and considerations taken on how it might assist in the management of terminology in HL7 requests and support the harmonisation process. In May 2012 there will be a new release of the tool. Additional information can be located at:

https://uscrs.nlm.hih.gov/main.xhtml

Registration is required but access is free. HL7 will use this tool to support vocabulary request submissions. Changes in this release include UMLs single sign on and HL7 are considering what process we would require in the login interface for requesting HL7 content.

Requests can be created individually or in batches. The batch spread sheet has a wide range of activities, change descriptions, change relationships, add concepts, add parents, add new relationships etc. These are customisable and might be modified for HL7 content.

The screen is customised to the type of request and terminology source. Requests may be saved as a draft and continue to update and gather information and submit when you are ready to do so. This system shows existing requests so that you can add your requirement to an existing request, vote for requests, identify duplicate requests which make management and prioritisation easier.

IHTSDO is considering adoption of this system, which is likely.

This tool is available with no indication of support or commitment of the NLM but here is the possibility of support arrangements being considered.

https://uscrs.nlm.hih.gov/main.xhtml


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Tooling indicated the need to insert authentication mechanisms for HL7 use. HL7 would be likely to be using a service that needs to be hooked up to the membership service. Export to batch import process is provided. This is in RF2 format using the standard RF2 batch loader. The tool exports content to excel based upon the request current on the screen at the time.

If adopted an analysis of all of the elements required to record and process harmonisation and ensure that each element required is recorded and used effectively in the tool. Vocabulary facilitators could be taught how to use this tool in an hour or two and it would be much more likely that they would find it easier to use and that the results would be more accurate.

Conversation from the tool into the actual MIF submission would require mapping of RF2 to VML. This could be done but raises the question if there is great value to the harmonisation process, should this activity be funded? A single trial harmonisation proposal from the next harmonisation will be trialled in the ballot cycle after next.

Each of the fundamental HL7 vocabulary objects have property name and property value tags on them, if we look at the superset of those there are many but they are thinly populated. At the moment the tool does not have field level properties. There are also properties on concept domains, such as deprecated as at release. The tool will not currently hold detailed properties required to support a request. This would be added on to the existing tool.



Vocabulary/Tooling: National Library of Medicine Request Submission System

Action: Raise awareness of this tool within HL7 Australia community and IT-014-02 through circulation of web address.

Standards Australia


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2.40 CIMI – CLINICAL INFORMATION MODELLING INITIATIVE


The Clinical Information Modelling Initiative (CIMI) is an international collaboration that is dedicated to providing a common format for detailed specifications for the representation of health information content so that semantically interoperable information may be created and shared in health records, messages and documents. CIMI has been holding meetings in various locations around the world since July, 2011. All funding and resources for these meetings have been provided by the participants.

CIMI is a clinical information modelling activity that is derived from the HL7 “Fresh Look Initiative Report” chaired by Stan Huff. This group is formed by representatives from international informatics organisations, health care and government agencies including ISO/CEN 13606 Organisation, ISO TC215, HL7, IHTSDO, US ONC, US DOD and VA, US CDISC, Mayo Foundation, Kaiser Permanente, Intermountain Healthcare, Canadian Health Infoway, UK NHS, Australia NEHTA, Dutch NITCIZ (National Institute for Healthcare), Singapore MoH, Sweden, Ocean Informatics, etc. Additional information can be located at:

http://informatics.mayo.edu/CIMI/index.php/Main_Page

PROJECT BACKGROUND

Whilst the CIMI group is NOT an HL7 working group, it is reported on here for three reasons:

1. The meeting was held in San Francisco on the three days prior to the HL7 WGM.

2. The CIMI group is working on outcomes that have a direct bearing on Australian use of detailed clinical models into the future.

3. The CIMI group has commitment from a wide range of standards groups and international programs including (in no particular order):

- Canada Health Infoway - CDISC - HL7 - IHTSDO - Ministry of Health – Singapore - openEHR foundation - NHS Connecting for Health - Veterans Health Administration (USA) - National Institutes of Health (USA) - Department of Defense (USA) - NEHTA

http://informatics.mayo.edu/CIMI/index.php/Main_Page


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- GE Healthcare - Intermountain Health (USA) - Kaiser Permanente - Mayo Clinic - Ocean Informatics - Tolven - And a number of others

At a meeting in London in November 2011, the CIMI group agreed on the following:

1. CIMI specifications will be freely available to all. The initial use cases will focus on the requirements of organisations involved in providing, funding, monitoring or governing healthcare and to providers of healthcare IT and healthcare IT standards as well as to national eHealth programs, professional organisations, health providers and clinical system developers.

2. CIMI is committed to making these specifications available in a number of formats, beginning with the Archetype Definition Language (ADL) from the openEHR Foundation (ISO 13606.2) and the Unified Modeling Language (UML) from the Object Management Group (OMG) with the intent that the users of these specifications can convert them into their local formats.

3. CIMI is committed to transparency in its work product and process.

APPROACH

• ADL 1.5 will be the initial formalism for representing clinical models in the repository.

- CIMI will use the openEHR constraint model (Archetype Object Model: AOM).

- Modifications will be required and will be delivered by CIMI members on a frequent basis.

• A set of UML stereotypes, XMI specifications and transformations will be concurrently developed using UML 2.0 and OCL as the constraint language.

• A Work Plan for how the AOM and target reference models will be maintained and updated will be developed and approved by the end of January 2012.

- Lessons learned from the development and implementation of the HL7 Clinical Statement Pattern and HL7 RIM as well as from the Entry models of 13606, openEHR and the SMART (Substitutable Medical Apps, Reusable Technologies) initiative will inform baseline inputs into this process.

• A plan for establishing a repository to maintain these models will continue to be developed by the group at its meeting in January.


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The previous meeting in January, 2102 in San Antonio had established a number of WGs to further the work of the group. These were the Reference Model wg who were tasked with looking at a candidate reference model for the CIMI models, the Clinical Modelling WG who were tasked with beginning work on developing some models for the CIMI group to look at, and the glossary working group who were tasked with defining terms for the CIMI group.

The San Francisco meeting heard reports back from these groups.

The Reference model task force developed a set of criteria for the required reference model and then looked at different options as starting points with reference to these criteria. Additional information can be located at:

http://informatics.mayo.edu/CIMI/images/a/a7/CIMI_Reference_Model_Taskforce_Report_%2810_May_2012%29.pptx

The task force considered the following established reference models:

• A profile, simplification or improvement of ISO13606-1

• openEHR reference model.

• openEHR / ISO13606-1 model.

• DCM reference model (ISO13972-based).

• EN13606 Association proposal.

Other models, whose features were considered include:

• Parts of Intermountain Healthcare’s Clinical Element Model.

• Federal Healthcare Information Model (US Government FHIM).

• Logical Record Architecture (NHS LRA).

After looking at criteria, the taskforce recommended that the “openEHR reference model” should be the starting point as it met the following:

• Ability to meet requirements - including capturing required information patterns, and semantics.

• Demonstrable computability, implementability and transformability (e.g. to ISO13606, openEHR, DCM, HL7 v2, v3, CDA).

• Existing tooling & infrastructure.

• Existing library of clinical models.

• Existing community (implementation and clinical).

• IP considerations.

• Simplicity.




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• Can support all use cases.

Once the group made a decision, work was started on simplifying the reference model to meet CIMI requirements. This will be ongoing work and will require new tooling and functionality to meet the requirements.

The clinical modelling group was unable to demonstrate much progress, as the reference model has not been finalised. Stan Huff announced that Intermountain was proceeding with mapping their models to the openEHR reference model.

The next CIMI meeting is likely to be co-located with either the ISO meeting in Vienna or the HL7 WGM in Baltimore. There was some preference expressed for a meeting in Europe as the last two meetings had been in North America.

2.40.1 BENEFITS OF CIMI TO INTERNATIONAL AND AUSTRALIAN E-HEALTH

HL7 International community has decided that the next version of CDA (i.e. CDA R3) will include the entire HL7 V3 Reference Model as its model component for the CDA Body. This change will increase tremendously the complexity of CDA and consequently the hurdle to interoperability, implementation and conformance. This is an issue that the Structured Documents WG are very aware of but don’t have a clear view of how to manage it. This is now also complicated by the new FHIR project that is touted as a simpler approach to CDA.

The availability of internationally endorsed isosemantic clinical information models that are readily transformed into HL7 V3 clinical templates together with predefined standard terminology binding will significantly improve the ease of CDA R3 implementation. Interoperability of CDA documents may also be better ensured. Outputs from the CIMI group will make significant contributions to interoperable health information exchange and reuse and lower the costs of interoperability and conformance.

Australia is well placed to take advantage of the CIMI work as the current NEHTA tool chain, and the current work on that tool chain, is based on the openEHR framework that has been adopted almost in full by the CIMI group. This means that Australia can easily benefit from the models that are produced by the CIMI group and can contribute back easily to the CIMI group.



Clinical Information Modelling Initiative (CIMI)

Clinical modelling is of vital importance to the eHealth program in Australia.

Action: Australia to continue to be involved and support the work of the CIMI group.

NEHTA

Standards Australia