HL7 DevelopmentWho Does it

and How Do They Do It?

Shari DworkinCIHI

June 7, 2001SHIN HL7 Workshop

Presentation Overview

• Who - The Movers and Shakers

– Membership– Working Group– Collaboration

• How - The Evolution of the Standard

– Balloting– v2.x Development– v3 Development– Publications

Who - The Movers and Shakers

MembershipWorking GroupCollaboration

Who are Members of HL7 (.org)• 450 Organizational Members, 2131

Members of HL7 (US) •946 Vendors•641 Providers•256 Consultants•119 Non Profits•13 Payors•18 Pharmacy•60 Affiliates•24 Students•54 Unknown

What Do HL7 Members Do?

• Members develop the standard

– Participation in Working Group Meetings

– Voting on HL7 Ballots– Providing input on listservers and

teleconferences– Informing HL7 Canada of issues or

recommendations regarding the HL7s standard

What is an HL7 Working Group?• The Working Group is the name that

shall be given to those activities related to the production and use of the Standard.

• The Working Group consists of the set of individual Technical Committees and Special Interest Groups which are focused on particular HL7 protocol specification issues and areas.

Taken from HL7 Bylaws

Key to HL7 - The Working Group

• Draws equally from providers, software vendors, and consultants (interested parties)

• Group sets aside their individual interests, rolls up their sleeves and collaborates to get the tough work done

• Most discussions stem from– violent agreement, but failure to see the agreement– passionate beliefs

• Strong facilitators in the working group that help to resolve issues

Hard Work = 12 hours x 5 days x 3 general meetings / year +

12 hours x 3 days x 3 harmonization meetings / year +Active electronic collaboration in between

HL7 TCs and SIGs• Technical Committees (TCs)

– Responsible for the development and maintenance of a section of the standard (usually a chapter)

– Exceptions (Vocabulary, Education, Marketing, Publishing, and International Affiliates)

• Special Interest Groups (SIGs)– Represent a variety of major initiatives in

healthcare– Work in conjunction with TCs to advance the

efforts of HL7

HL7 (.org) Technical Committees

• CCOW• Clinical Decision Support • Control / Query• Data Warehousing• Education• Implementation• International Affiliates• Marketing• Medical Records / Info. Management• Modeling and Methodology

HL7 (.org) Technical Committees (cont’d)

• Orders / Observations• Pt. Admin. / Financial Management• Patient Care• Personnel Management• Publishing• Scheduling and Logistics• Structured Documents• Vocabulary

HL7 (.org) Special Interest Groups (SIGs)

• Arden Syntax• Attachments• Blood Bank• Clinical Guidelines• Clinical Trials• Community-Based Health Services• Conformance• Government Projects• Image Management• Lab Automation

HL7 (.org) Special Interest Groups (SIGs) - cont’d

• Medication• Patient/Provider Messaging• Security and Accountability• Templates• XML

HL7 (.org) Works with Other Key Stakeholders

Collaboration Among Standard Development Organizations

• X12 and HL7 - Claims Attachment and Data Modeling

• DICOM WG20 and HL7 Imaging SIG - Joint Image Management SIG, IHE Demo

• IEEE and HL7 - Merged Activities• HL7 and CEN - Message Development

Framework, RIM and XMl syntax• HL7 and ISO TC215 - Message

Development Framework

So… How does all this lead to a new standard?

How - The Evolution of the Standard

Ballotingv2.x Developmentv3 Development

Publications

Balloting• HL7 (.org) is an ANSI approved

Standards Development Organization

• According to ANSI rules, this means that…

– All new versions of the HL7 standard must undergo a balloting process that is open to all members

Balloting - The 5Ws• HOW does something go to ballot?

– TCs propose new and/or improved content for the standard to HL7 Head Quarters

• WHO votes?– HL7 (.org) have 1 vote– HL7 International Affiliates have up to

8 votes• WHEN do ballots take place?

– 120 day cycle, Three cycles per year

Balloting - The 5Ws (continued)

• WHERE can you vote?– Online - Ballots are available on the

HL7 (.org) site and the HL7 Canada site

• WHY would want to vote?– To influence the standard

Balloting Procedures

• Two Rounds of Balloting

– Technical Committee Ballot

– Membership Level Ballot

• All negative ballots must be addressed

• According to ANSI rules, 90% of ballots must be affirmative

HL7 v2.x Development

• New and/or improved content came from

TCs and SIGs

• Members wrote specific chapters of the

standard without considerations from

other TCs or SIGs

• Content was added as needed, and

under the discretion of the TC or SIG

Limitations of Version 2.x

• No explicit information model• Events not tightly coupled to use cases• Need for controlled vocabularies• No explicit support for security functions• Optionality is troublesome• Lack of harmonization between chapter

domains• Expansion of the standard led to

incoherence

Versions 2.xStrengths

– broad functional coverage– highly adaptable

• IS environments differ•system capabilities

variations– vocabulary independent– least common denominator

technological base

Difficulties– broad functional coverage– highly adaptable

•“Seen one? Seen one.”•vendor capability

mismatch– vocabulary independent– least common denominator

technological base

HL7 Version 3 -

• HL7 “grew up” on the Version 2 series, culminating in 2.4

• But now, HL7 is into Version 3– How is it different?– Why is it important?

HL7 v3 Development - We do it with Models!

Version 3 Goals

• Provide a Message Development Framework based on modeling

• Improve clarity and precision of specification

• Improve adaptability of standards to change

• Work with other standards initiatives, such as DICOM

• Begin to approach “plug and play”

Benefits of V3 to HL7

• Reduces optionality: results in more specific messages

• Uncovers hidden assumptions about application boundaries (for everything there is a reason)

• Facilitates defining clear, fine-grained, conformance claims

• Allows for multiple implementation specifications (XML, CORBA, etc..)

HL7 Version 3 Development Approach

1. Define a consensus reference information model (RIM) that defines the data of interest in the healthcare domain.

2. Assemble the terminology and data types necessary to express the attributes of the RIM

3. Apply the model, vocabulary and types to: messages, patient record DTDs, medical logic modules, component specifications, etc.

4. For any particular application, draw from the RIM to construct an abstract message structure - the Hierarchical Message Description (HMD)

5. For any particular implementation technology, HL7 will define an implementation technology specification (ITS) for mapping the HMD to that technology.

6. When the message (or equivalent) is sent, the HMD is used to marshal the data, and the ITS is used to format the data for communication.

HL7 Version 3 Development Approach

HL7 Modeling

Abstractions:ActivitiesActivities(Use Case (Use Case

Model)Model)

Dispense Medications

Manage Care

Perform Lab Tests

Review Utilization

Objects Objects (Information (Information

Model)Model)

Account Patient Provider Encounter Order

Communication Communication (Interaction and (Interaction and Message Models)Message Models)

ADT Pharmacy

HL7 message

Finance

HAHALL

HL7 message

Version 2.x focused its energies at the communication level and covered the other abstractions only loosely in the specifications.

By demanding analysis of the requirements and information content, Version 3 assures consistency in and enhances the value of the resulting products.

Use Case Model

Information Model

Interaction Model

2-nd Order 1 choice of 0-n Drug 0-1 Nursing

Message Specification

• Captures healthcare requirements• Defines scope for TSC approval

• Specifies data and its semantics• Specifies major state transitions• Specifies vocabulary for domains

• Defines information flows• Defines communication roles• Forms basis for conformance claims

• Defines message contents• Apply constraints to the

information model and vocabulary

HL7 Version 3 Models and Specifications

Reference Model RepositoryReference Model Repository

RequirementsRequirementsAnalysisAnalysis

Use CaseUse CaseModelModel(UCM)(UCM)

DomainDomainAnalysisAnalysis

Information Information Model &Model &

VocabularyVocabulary(RIM)(RIM)

AnalysisAnalysis DesignDesign

InteractionInteractionDesignDesign

InteractionInteractionModelModel(IM)(IM)

MessageMessageDesignDesign

HierarchicalHierarchicalMessageMessage

DescriptionsDescriptions(HMD)(HMD)

ApplicationApplication

2-nd Order2-nd Order 1 choice of1 choice of 0-n Drug0-n Drug

0-1 Nursing0-1 Nursing

Medical logicMedical logic

VariableVariabledefinition for definition for Arden syntaxArden syntax

(AVD)(AVD)

data:data:location_of_actionlocation_of_action := READ LAST := READ LAST MPSLOC ; MPSLOC ; ‘ ‘ {patient{patient location} location}

DocumentsDocuments

Document Document Types forTypes forHL7 PRAHL7 PRA

(DTD)(DTD)

<!ENTITY %DT_MPSLOC<!ENTITY %DT_MPSLOC“MPSLOC.id,“MPSLOC.id, MPSLOC.name?, MPSLOC.name?, MPSLOC.addr?, MPSLOC.addr?, MPSLOC.phon?, MPSLOC.phon?, MPSLOC.emlAdr?"> MPSLOC.emlAdr?">

MessagingMessaging

Message TypesMessage Typesfor use with for use with

XML, ER7, etcXML, ER7, etc(MET)(MET)

TYPE MPSLOC TYPE MPSLOC CONTAINS {CONTAINS {id[id].TYPE IIDid[id].TYPE IIDnm[name].TYPE STnm[name].TYPE STad[addr].TYPE XADad[addr].TYPE XADph[phon].TYPE XTN ph[phon].TYPE XTN email_addressemail_address [emlAdr].TYPE XTN [emlAdr].TYPE XTN}}

HL7 V3 Message Development Lifecycle

C Code c Codea artb bluec color

How do we get to Version 3?

v3 Strategy• Board appointed V3 steering committee

– Woody Beeler (Chair), Wes Rishel, Abdul-Malik Shakir, Mark Shafarman, W. Ed Hammond

• Focus more working group time on Version 3– One day on Version 2.X– 4 days on Version 3

• Emphasize Version 2.x XML encoding for early adopters• Move quickly on first V3 products:

– CDA (Clinical Document Architecture) (Unanimous Approval)

– Version 3 data types– V3 data type XML ITS (Implementable Technology

Specification)

Old and new will coexist.• How will transition happen?

– Never touch a running system!– HL7 v2.x versions will be operational for an

extended transition period (5 to 10 years)– HL7 v2.x will continue to be maintained for

errors and clarification– new features will only go into new versions of

v2 and HL7 v3• New implementations may use HL7 v3 once it

has been balloted• V2 and v3 interfaces will coexist for the extended

transition period.

HL7 v3 Balloting

Legend:

Normative: Content is balloted by general membership and is considered structural component of HL7 standard. Negative ballots MUST be resolved.

Reference: Content is harmonized during HL7 meetings or approved by the HL7 Board. It is not subject to ballot acceptance

Informative: Content is balloted by general membership; however, it is not considered to be a structural part of the standard, only supporting information.

HL7 3.0 Core Publication Structure

V3 Backbone

•Welcome•Introduction•V3 Principles•Quick Start•Getting Started•Glossary

Message Ballot

Framework

ImplementableTechnology

Specifications

XML

Data Types

Data TypesPart I

Part II

Sub-sectionsSection

InfrastructureManagement

Sub-sectionsSection

AdministrativeManagement

Sub-sectionsSection

Health & ClinicalManagement

Vocabulary

Normative

Reference

Informative

Legend:

Reference Information

Model State Machines

Literary Expression

RIM Diagram

V3 BackboneEquivalent to the 2.x Chapter 1

– Introduction

– Principles

– Managing message development

– Quick Start

– Getting Started

– Glossary

– Links to all other documents & content.

V3 Backbone

•Welcome•Introduction•Quick Start•Getting Started•Glossary

HL7 3.0 Section Publication Structure

Sub-sections Domain

CMET

Storyboard

Application Roles

Interaction Category

R-MIM HMD Message Type

Interaction

Trigger Event

R-MIM HMD

StoryboardExamples

Message Type

Normative

Reference

Informative

Legend:

Committee Deliverables

Domain

Storyboard

Application Roles

Interaction Category

R-MIM

Interaction

Trigger Event

R-MIM HMD

StoryboardExamples

Message Type

Design RepositoryVisio files

Domain MDB

Publication FormatPublication in two final formats:• PDF

– appropriate for printing, submission to ANSII and off-line viewing

– Each document available as ‘stand alone’ or will be inter-linked *

• HTML– Appropriate for viewing online– Each document can be downloaded separately *

* Backbone is required

Publication Schedule• June 15th – Deadline for non-Section content• July 9th – Deadline for Section content• July 9th to 13th – Ann Arbour ‘tiger team’ meeting to

convert and test content• July 17th to 19th – Indianapolis meeting to review

content with TCs• August 8th – Committee Ballot opens• October - Reconciliation of negative Ballots• January - Membership Level Ballot• May - HL7 Version 3 Approved Standard

Questions?