the eurorec repository of functional ehr requirements - gerard freriks

2012 - Gerard Freriks, EuroRec, ProRec.nl

EHR-Qᵀᴺ Polska 2012

The Eurorec repository of Functional

EHR Requirements

(Lodz, 29 November 2012)

Gerard Freriks EuroRec

http://www.ehrqtn2012.evenea.pl/





Gerard Freriks

• Trained as General Practitioner

• Health IT since 1971

• ProRec-NL board meber

• former convener of CEN/tc251 WG1

• former EuroRec Board Member

• EN13606 Association Board Member

• ERS B.V. Director






Topics

– EHR and ISO RM/ODP Viewpoints

– EuroRec Association

– EHR Functional Requirements

• Repository

• Tooling

– Implementations

– Conclusions






Topics

– EHR and ISO RM/ODP Viewpoints – EuroRec Association


• Repository

• Tooling

– Implementations

– Conclusions






6

MIE2012 - Village of the Future

M. Rigby/J. Hofdijk






All stakeholders across the EU have recognized that the Electronic Health Record is: -a key tool for the documentation of the provision of safe, high quality and effective care;

-and a critical factor for clinical research.

Electronic Health Records (EHR)




8

© EN13606 Association

EHR and standards

8 SemanticHealthNet Dipak Kalra

HISA

13606

Continua

...

SNOMED

WHO

LOINC

...

ContSys

...

PMAC ...

9

© EN13606 Association

EHR - Privacy

9

ACL ACL ACL

ACL

ACL

ACL Trust

Flexibility



Common

Trusted

Facilities






Trust

Payload Semantic Stack

Web Services

C++, Java, ... Windows, Linux

Hardware Platforms

FUNCTIONAL

Requirements






Topics


– EuroRec Association – EHR Functional Requirements

• Repository

• Tooling

– Implementations

– Conclusions






EuroRec (http://www.eurorec.org )

• The « European Institute for Health Records »

• A European not-for-profit organisation (April 16, 2003)

• Mission: the promotion of high quality Electronic Health Record systems (EHRs) in Europe

• Federation of National ProRec Centres (incl. all types of stakeholders)




http://www.eurorec.org



“ Differences in languages, cultures and HC-delivery/funding systems ”

Austria

Belgium

Bulgaria

Denmark

France

Italy

Germany

Ireland

Romania

Slovenia

Spain

Slovakia

Serbia

The Netherlands

United Kingdom

Established ProRec Centers

Cyprus

Czech Republic

Greece

Hungary

Norway

Poland






Clinicians: care… (access to medical records, e-prescription, care pathways…

administrative simplifications !…)

Researchers: clinical trials, disease management studies,

post-marketing surveillance, health economics…

Health Authorities: pharmacovigilance, healthcare management,

quality assessment, utilisation review…

Data-brokers & industry: research, marketing, promotion…

Third Party Payers: billing, reimbursement…

Academics: education…

IT-vendors: software development

Regulators: legislation

Patients: their role in the future…?

eHealth Stakeholders






Clinician

Clinical Trials & Research

Safety and Adverse Event

Registers

EHR (EMR, EPR…)

Decision Support Systems

Marketing

Billing

Knowledge Mgmt

Platforms

Privacy Enhancing Techniques

Patient

PHR

TRUST

Healthcare Management

Secondary use of (medical) data






EuroRec: History of EC Projects

- MediRec (1994-95), Medical Records and Quality

- ProRec (1996-98), Promotion Strategy for EHRs in Europe

- Widenet (2000-03), Establishing EuroRec’s Network

- RIDE (2008-10), Semantic Interoperability (partner)

- EHR-Implement (2008-10), Political, Social and Economical aspects when implementing national EHRs systems

- QREC (2006-08), Quality Labeling and Certification of EHRs in Europe

- EHR-Q-TN (2009-2011), Thematic Network

- Antilope (to start 2012- 2014)

-...






Topics



– EuroRec

EHR Functional Requirements

• Repository

• Tooling

– Implementations

– Conclusions






Rationale (Why Certification is Essential)

– Assure compliance to national rules and standards.

– Increase quality of the products through coherent and

pre-tested functionality.

– Leverage exchange of health (care) related data and

interoperability of systems.

– Improve patient safety in care.

– Have a reliable data source for secondary use.






EHRs Quality Criteria:

just a few Business Cases

• An e-Health programme wishing to implement quality labelling or certification as to ensure consistent EHR system functionality regionally or nationally

• A purchaser wishing to procure an EHR system

module

• A vendor/developer wishing to document his

system or to (re-) develop an EHR system module or wishing to interface a given module of his system across multi-vendor systems






Benefits for the Stakeholders

Industry

EHRs - Quality Labelling / Certification

Market ( R.O.I.)

Quality and Safety Efficiency of HC Delivery Systems

Health Services Management

Patients, Clinicians

Public Health Health Authorities






• Administrative simplification

• Electronic billing

• Care pathways and disease management projects

• Electronic prescription

• Interaction with validated databases

• Secure medical data exchange (summary records!)

• Interoperability, operability and portability

• ...

A growing number of strategic eHealth projects

are or become certification dependent, e.g.:






Pressure

New functions

New instruments

€ 1

2

3

4

Certification: a powerful weapon…






How to Manage Certification?

EuroRec has Multiple Options:

1. Authority: Government (or mandated subcontr.) vs. Non Gov.

5. Self-certification by Industry (also an option!)

• National based vs. Pan European (or joint, cf. specific/generic)

• Mandatory vs. voluntary (with or without incentives)

• Formal audit/testing vs. self-assessment (or pre-test assessment)

• Scoring/rating scheme: pass/fail or more graded approach

• Scheme review rate (1,2,…n year cycles)

• Quality Assurance vs. Quality Improvement focus






• Assure compliance to national rules and standards.

• Increase quality of the products through coherent and pre-tested functionality.

• Leverage exchange of health (care) related data and interoperability of systems.

• Improve patient safety in care.

• Have a reliable data source for secondary use.

•Existing “national” certification

• Foreseen within 1-2 years

• Considered

“National” Certification in Europe






Applicable standards

Stakeholder Applicable ISO/IEC Standard

Accreditation Body ISO/IEC 17011:2004 ISO 9000:2000 ISO/IEC 17000:2004 VIM:1993

Certification Body ISO/IEC Guide 65

Conformity Assessment Body ISO/IEC 17025:2005






Recommendations

by the EHR-QTN Consortium






“ If quality labelling and certification of EHR systems is to become

generalised, then it needs

endorsement at the highest competent levels

e.g. by the EU Commission, the responsible Member States Ministries, the

Healthcare Providers Organisations and the specialised industry.”

See the Belgrade Declaration on www.eurorec.org

Belgrade Recommendations





http://www.eurorec.org/





(summary)

1. Create and harmonise the legal and regulatory framework stimulating national and regional authorities to enforce the use of quality labelled and certified applications.

2. Certification bodies should be accredited and compliant to international standards, more precisely ISO 17020.

• Strengthen the European scale pioneering initiatives (EuroRec / I.H.E.) in order to keep certification on the agenda and invest in maintenance and expansion of the actual descriptive statement and profiles.

• Address the issue of personnel shortage in health informatics in general and more specifically in health informatics quality assessment.








(summary)

5. Third party assessment is the most suitable procedure for quality

labelling and certification in the still immature market of the EHR systems.

6. The incentivised model seems the most promising, surely for self-employed healthcare professionals.

• Promote equivalence of certificates across Europe by validating at European level both the functional descriptive statements of EuroRec and the IHE profiles.

• Consider the possibility to create a cross-border “Register of Quality Labelled or Certified Clinical Software”, offering information about the products and documentation about the certification process.






Topics



– EuroRec: EHR Functional Requirements

• Repository

• Tooling

– Implementations

– Conclusions






EuroRec’s Workflow






Typology of EHR System Statements

• Source Statements/ Referenced Statements (RS)

– faithfully extracted from existing original EHR system specifications and test plans

– translated if necessary

• Fine Grained Statements (FGS) (at present: n>1700)

– usually derived from source statements

– made more generic, decomposed, reworded, corrected

• Good Practice Requirements (GPR) (n~150)

– recomposed from FGS into the more common useful building blocks

– may enhance or extend the scope of FGS: “push the boat out a bit”

• Generic Test Criteria

– derived from FGS and/or GPR

– formally worded as testable functions






Typology of Indexes

Multiple indexing of each statement to maximise the likelihood of finding

all relevant statements when searching via the indices

Business Functions (50 in 8 subcategories)

Care Settings (18 in 3 subcategories)

Component Types (18 in 4 subcategories)

•C0 EHRS functional component

•C1 EHRS infrastructure component

•C10 EHRS Interoperability component

•C11 Security management component

•C2 Knowledge resources

•C20 Knowledge: terminology

•C21 Knowledge: ontology

•C22 Knowledge: archetype

•C23 Knowledge: template

•C24 Knowledge: data set

•C25 Knowledge: guideline

•C26 Knowledge: algorithm

•C3 Directory services

•C30 Directory: patients

•C31 Directory: personnel

•C32 Directory: equipment

•C33 Directory: health service directories

•C34 Directory: service resources

•C35 Third parties

•C4 Profiling or authoring tool

•C5 Documentation, support etc.

•C6 EHR system functional component

•B0 Generic or ubiquitous

•B01 Regional healthcare network (specific distribution)

•B02 Virtual or telehealth

•B03 Personal health

•B04 Community and home care

•B05 Health, wellness and prevention

•B06 Occupational health

•B07 Public health

•B1 Health care enterprises

•B10 Long-term care (institution)

•B11 General practice

•B12 Secondary care (hospital)

•B13 Tertiary care centre (specialist hospital)

•B14 Domain specific

•B15 Profession specific

•B2 Secondary uses

•B20 Research and knowledge discovery

•B21 Education

•B22 Health service and planning

•A0 EHR data (record) management

•A00 EHR data entry

•A01 EHR data analysis

•A02 EHR data content

•A03 EHR data structure

•A04 EHR data display

•A05 EHR data export/import

•A09 EHR generic data attributes

•A1 Clinical functions

•A10 Clinical: medication management

•A11 Clinical: long-term illness management

•A12 Clinical: health needs assessment

•A13 Clinical: care planning and care pathways

•A14 shared care

•A15 Clinical: alerts, reminders and decision support

•A16 Clinical: workflow and task management

•A17 Clinical: patient screening and preventive care services

•A2 Administrative services

•A20 Appointments and scheduling

•A21 Patient consents, authorisations, directives

•A22 Patient demographic services

•A23 Certificates and related reporting services

•A24 Patient financial and insurance services

•A3 Care Supportive services

•A30 Supportive care service requests (orders)

•A31 Supportive care service reporting (results)

•A32 Laboratory services

•A33 Imaging services

•A34 Diagnostic and therapeutic services (other): ECG/EEG etc.

•A35 Pharmacy services

•A4 Analysis and reporting

•A40 Screening and preventive health

•A41 Care setting reports

Component Types

Care Settings

Business

Functions






Good Practice Requirements - Links






EuroRec Languages (non-exhaustive list)

• English (default language) • Bulgarian • Danish • Dutch • French • German • Italian • Romanian • Slovakian • Slovenian • Serbian






The EuroRec Composer ™ To compose user defined, re-usable and exchangeable baskets of Fine Grained Statements.

The EuroRec Certifier ™ To format a EuroRec Basket content to obtain the basic layer for the certification of EHR systems. This is done by adding structure and attributes to the selected Fine Grained Statements (e.g. mandatory, optional...)

The EuroRec Documenter ™

To document EHR systems and their functions, enhancing their understanding and comparability by using the EuroRec statements.

The EuroRec Procurer ™

To list and describe, for purchase purposes, required functionalities and product characteristics using EuroRec statements.

The EuroRec Scripter ™

To produce and link Test Scenarios to EuroRec Baskets for Certification,

Documentation and/or Procurement purposes.

EuroRec Use Tools






• National or Regional Healthcare Authorities (quality labelling)

• EHR System providers (self assessment/ product documentation)

• Health IT purchasers (procurement)

• Health IT professional users

• Health IT research and education

EuroRec stakeholders

(Users of the EuroRec tools)






Test

Procedures

EuroRec

Baskets

Certification Documentation Procurement

Test

Scenarios

Test Criteria

Sets

EuroRec

Repository

of

Statements

Composer

Procurer

Documenter

Certifier

Scripter

EuroRec Use Tools






EuroRec at your Service !

1. Developing & maintaining a central repository with quality criteria

7. Developing tools: certification, procurement and product doc.

• Providing guidance and assistance to all stakeholders

• Assisting Authorities in introducing / adopting certification

• Training and accreditation of surveyors (European level)

• Set-up of certification session (incl. scenario scripting/operations)

• Validation of clinical archetypes (clinical models)

• Continous & total Q.A. of processes and procedures






13 mei 2008






EuroRec Seal

• To have a “base” level set of functions

that can be accredited across Europe.

• This will greatly appeal to the supplier industry and allow for

more early stage accreditation of systems across national

boundaries.

• Harmonisation of the certification will favour harmonisation of

products.

• Develop a strong, growing and profitable EHR supplier industry

that can be competitive globally.






Content of the Seal (1)

• Not all EHR functions can - at present - be harmonised across the European Community:

– Specific regulations (incl. HC reimbursement systems);

– Linguistic and cultural issues;

– Differences in available services (e.g. drug- and other databases in use);

– Even sometimes different options regarding evidence based medicine (EBM) issues ! (cf. decision support modules).

• First versions of the EuroRec seal & criteria will therefore mainly focus on what is really essential and thus be related to “ generic ” aspects. e.g. “the trustworthiness of the content of an EHR”.






• The first set of selected criteria will:

– not be too specific, e.g not related to very particular functions;

– correspond with what is considered essential (e.g. security, medication management, ....)

• Fair chance that a large number of existing EHR products will conform to the chosen criteria.

Content of the Seal






The GPR with most selected FGS






Topics




• Repository

• Tooling

– Implementations – Conclusions






Austria

Ireland

United Kingdom

Belgium

Czech Republic

Hungary

Greece

Germany

France

Estonia

Denmark

Bulgaria

Croatia

Cyprus

Italy

Luxembourg

Netherlands

Norway

Poland

Portugal

Romania

Serbia

Slovakia

Slovenia

Spain

Seals

EHR-Q TN 28 Partners 25 Countries

23 EuroRec

Quality Seals




http://nl.wikipedia.org/wiki/Afbeelding:Flag_of_the_Czech_Republic.svg

http://nl.wikipedia.org/wiki/Afbeelding:Flag_of_Slovakia.svg



Topics

– Introduction Semantic Interoperability

– Introduction EHR

– EHR and Quality

• Functional quality

• EuroRec Quality Labeling

– Conclusions






Conclusions

- EuroRec provides: • European Functional requirements

at the Enterprise level

• Tooling support

• Quality Labeling

• 23 Seals awarded

– Adopt the Belgrade Declaration




the eurorec repository of functional ehr requirements - gerard freriks

Health & Medicine