Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics...

Prof. Dr. Georges De Moor, the Eurorec Institute , 1 /12/ 2005, Brussels

Belgian Health Telematics Syposium 2005

Quality Labelling and Certification of

Electronic Health Record systems (EHR s)

Georges J.E. DE MOOR, M.D., Ph.D.

Belgium

EUROREC



Definitions (1)

Electronic Health Record (EHR)

Repository of information regarding the health status of a subject of care, in computer processable form.

(ISO TR 20514:2004)

The EHR is the primary source of data and information in Health

Information Networks (HINs)

Goals:

- Supporting continuing, efficient and high quality integrated healthcare

- Ability to share patient health information between authorized users



EHRs: TRENDS (1)– transmural– virtual– multidisciplinary and interactive

AdministrativeRecords

Patient Health Diaries

MedicalRecords

NursingRecords

! Integration with other health care software applications ...!

EHRs become



EHR: TRENDS (2)

-Medical and Bio-Medical data -Security: Privacy Enhancing Techniques-Semantic interoperability: Ontologies-Added value of EHRs: Decision Support Systems-TeleHealth-GRID Technology: HealthGrid

“The PHENOME meeting the GENOME in the EHRs of the Future”



EuroRec

– The « European Institute for Health Records »

– A not-for-profit organization, established April 16, 2003

– Mission: the promotion of high quality Electronic Health Record systems (EHRs) in Europe in Primary and Acute Hospital - Care settings

– Federation of national ProRec centres in Europe



EUROREC: ORGANIZATION (1)

EUROREC

PROREC - CENTRES … (Complementarity / Languages)

(Economy of scale / Synergy)

Healthcare

Authorities

…

Users

(Clinicians, Citizens)

EHRs -

Vendors

Purchasers,

Payers

“Think Globally, but act locally”



EUROREC: GOALS

– Support to ProRec centres

– Inform users of current trends in EHRs and express their needs

– Help public authorities to define and implement strategies

– Defend the EHRs-industry (ROI)

– Promote research, education and development in EHRs

– Foster international co-operation (with US, Canada, Japan, Australia…)



ProRec CENTRESCentres

BelgiumBulgariaDenmarkFranceItalyGermanyIrelandRomaniaSloveniaSpain

Applicants

NorwayGreeceHungaryPortugalPolandSwedenThe NetherlandsUnited KingdomSlovakia

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



HISTORY of EU-PROJECTS (1)

WIDENET : Offering World-Wide Services through an International Network of Health Record

centres (CEU, FP5,IST-14203, 2000-2003)

PROREC : Promotion Strategy for the European HC Record

(CEU, FP4, HC 1110,1996-1998)

QREC : Quality Labelling and Certification of Electronic Health Record systems in Europe (CEU, FP6, IST-27360, 2005-2008)



HISTORY of EU-PROJECTS (2)

PROREC First PROREC centres established and

cooperation between all stakeholders

{ Extension of the PROREC network

WIDENET (additional PROREC centres created) Establishment of EUROREC (June 14, 2003)

{ QREC Harmonisation of EHRs-Certification Delivery of EuroRec Services



European Conferences on Electronic Health Records

1997, Paris1998, Rotterdam1999, Sevilla2001, Aix-en-Provence2002, Berlin2003, Dublin2004, Brussels

PROREC

WIDENET

QREC



EUROREC: FUNDING

– Membership fees

– Annual conferences

– Services (cf. business plan)

– E.C. projects funded: CERTFE, QREC, RIDE,...



The European eHealth Area (2004)

– Electronic health cards, common approach to patient identifiers, standardisation of electronic health record architecture, secure access to personal health information;

– Health information networks between points of care (with broadband connectivity where relevant);

– Online health services to citizens, quality criteria for websites...

This EU action was endorsed by the EU Health Ministers in June 2004. Developing Electronic Health Records was one of the key policy priorities, with as targets:



The E-Europe Action Plan (2005)

– By the end of 2005: EU member states must define national and regional e-health strategies (deployment of e-health systems, use of electronic health records, interoperability and re-imbursement of health services)

– By the end of 2006: identification of interoperability standards for health data messages, electronic health records, taking into account best practices and relevant standardisation efforts

– By the end of 2009: EU member states and the EC will set the baseline for standardised provision of e-health services in clinical and administrative settings

E-Health was identified as one of the EC priorities, with as deadlines:



Interoperability: general definitions

• ISO 2002:12 : Interoperability refers to the ability of two or more systems (computers, communication devices, networks, software and other information technology components) to interact with one another and exchange information according to a prescribed method in order to achieve predictable results

• CEN/ISSS 2005 : Interoperability is a state which exists between two application entities when, with regard to a specific task, one application entity can accept data from the other and perform that task in an appropriate and satisfactory manner without the need for extra operator intervention

• NAHIT (US) :Interoperability is the ability of different information technology systems, software applications and networks to communicate, to exchange data accurately, effectively and consistently, and to use the information that has been exchanged (March 09,2005)



Interoperability: types

• Technical interoperability• Organisational interoperability• Functional interoperability• Syntactic interoperability• Semantic interoperability• Political interoperability• Legal interoperability• Social interoperability• Inter-standard interoperability

• Many references (IDABC/EIF 2004, CEN/ISSS 2005, NAHIT 2005, TMA 2004, Miller 2000, ETSI 2005:3, LISI …)



QREC: FP6-IST4

Results of the 4th Information Society Technology (IST4)

Call for proposals under the EU’s 6th Research

Framework Programme (FP6):

– 276 new research projects

– With EUR 1 billion in EU funding

QREC-project on « Quality Labelling and Certification of EHR systems in Europe » is a Specific Support Action (SSA) with EUR 1.3 million in EU funding.



QREC: Main Objective

To develop formal methods and to create a mechanism for the certification of EHR systems in Europe

EuroRec Institute is coordinating partner QREC has 12 partners and 2 subcontractors



QREC: Coordination with Health Authorities

The coordination with healthcare authorities will be done through the collaboration with the eHealth ERA consortium and its European Health Care Authorities (HCA) Ministries Group that is co-ordinating with the national e-Health roadmap activities within the EU-Framework Programme.

Both platforms (EuroRec and eHealth ERA) will follow the necessary bottom-up and top-down approaches for the adequate assessment of needs and for the optimal choice of methods for EHRs certification in Europe.



EHR & interoperability

Biomedical informatics

HealthGrid

Deployment

Applied/Industrial R&D

Basic research

5 years 10 years 15 years

Decision Support Systems

Support to eHealth “Action Plan”

Health info networks & services

Personal Health Systems (wearables)

General issues:EHR, Security, Interoperability

I

II

III



Implementation

I

eHealth ERAeHealth ERA

I2HEALTHIdentification

doctors/patientMessages/requests

I2HEALTHIdentification

doctors/patientMessages/requests

Certification EHRSSA

Certification EHRSSA

TMA BridgeInterop. approach

TMA BridgeInterop. approach

RIDEInteroperability

RIDEInteroperability

SHARE Healthgrid

SHARE Healthgrid

SYMBIOMATICSBMI ERA Pilot

SYMBIOMATICSBMI ERA Pilot

STEPVH CA

INFOBIOMEDINFOBIOMED

BIOPATTERNBIOPATTERNSEMANTIC MININGSEMANTIC MINING

Semantic HealthInteroperabilitySemantic HealthInteroperability

II III

Short time research Long time research



QREC: ORIGIN

Several EU-member states (Belgium, Denmark, UK, Germany, …) have already proceeded with quality labelling and certification schemes, but they differ in scope, in legal framework under which they operate, in policies, in organization, in the choice of quality conformance criteria for benchmarking and testing…

These differences could represent a risk of further market fragmentation: harmonization efforts should help to avoid this!



EHRs Certification: the case of Belgium

– Early 1998: PROREC Belgium develops a quality labelling system for EHRs in ambulatory setting (333 Quality Criteria defined)

– Belgian Ministry of Public Health and Social Affairs establishes a national Health Telematics Committee, and implements the EHRs certification process in Belgium (May 3,1999):

– the conformance criteria list is reduced in size (100)

– the certification is a voluntary one, but is incentivized by legislation and budgets: GPs are actually paid to use certified systems (about 750 EURO per physician per year)

– The conformance testing (initially organized on a yearly basis) is now being conducted (since 2005) on a permanent basis



Stakeholders / Benefits

INDUSTRY

Standards / Certification

OPENS UP the MARKET & REDUCES RISKS

QUALITY & SAFETY EFFICIENCY & COST SAVINGS

CLINICIANS, PATIENTS, PUBLIC HEALTH

HEALTH AUTHORITIES



EHRs Certification: EXPECTED IMPACT

– to reduce EHRs investment risk for buyers

– to foster availability, accesibility, interoperability and portability of the patient records no matter where the patients are located or travelling

– to stimulate confidence and increased investment in EHRs

– to guarantee better return on investment (ROI) for vendors

– cost savings in healthcare

– improvement in quality of care and safety of patients

– to encourage patients to play a greater role in managing their own health information

– to provide valuable population health information



EN 13606: Five Parts

- 1. Reference Model (stable since 2004)- 2. Archetype Interchange Specification (*)- 3. Reference Archetypes and Terms Lists- 4. Security Features - 5. Exchange Models

(*) EN 13606 has adopted the OpenEHR archetype methodology



Definitions (2)

Archetype (in eHealth):

A uniquely identified, reusable and formal expression of a specific health concept.

Expressed by means of an Archetype Definition Language and composed of descriptive data, constraint rules and ontological definitions.

Archetypes can be specializations of other archetypes.



QREC: Core Tasks (1)

1. Study of current EHRs « Quality Labelling andCertification » -systems (State-of-the-Art Report)

2. Assay of the requirements amongst all stakeholders across Europe, covering both current and planned EHRs certification activities (Survey)

3. In-depth analysis of the ways to classify and profile EHR systems (based on “functional profiles” and other aspects)

4. Comparison of various possible EHR certification systems



QREC: Core Tasks (2)

5. Definition of a model (a common European template) with harmonized guidelines and procedures for EHRs certification

6. Benchmarking process manual for EHRs certification

7. Business plan for EHRs certification (cf. sustainability of services)

(Extra: harmonization of terms and concepts ( an iterative process) to be used, resulting in a general glossary)



QREC: Main WorkPackages

WP 1: Consortium Management, Project Co-ordinationand Quality Assurance

WP 2 : EHR systems Quality Labelling and Certification Development

WP 3 : Resources for EHR Interoperability

WP 4 : Benchmarking Services

WP 5 : Communication and Dissemination Activities



QREC: WP 1

WP 1 : Consortium Management, Project Co-ordination and Quality Assurance

T1.1 Consortium ManagementT1.2 Project Co-ordinationT1.3 Quality Assurance



QREC: WP 2

WP 2 : EHR systems Quality Labelling and Certification Development

T2.1 State of the Art Report on existing EHRCertification Schemas

T2.2 Pan-European Requirements AssayT2.3 Labelling Terminology and Functional Profiles for

EHRs to be certifiedT2.4 Comparison and Harmonisation of Certification

Guidelines and ProceduresT2.5 Model Certification Guidelines and Procedures

including Legal IssuesT2.6 Plan for Validation of Guidelines



QREC: WP 3

WP 3 : Resources for EHR Interoperability

T3.1 Register of Conformance Criteria and GuidanceDocuments

T3.2 Inventory and Register of EHR Archetypes andGuidelines for their Use

T3.3 Register of Health Coding Systems in Use in EuropeT3.4 Inventory of Relevant Standards for EHR systemsT3.5 Register of XML Schemas and Open Source

Components for EHR systems



QREC: WP 3/ T3.3

T3.3 Registration of Health Coding Systems in Use in Europe

Implementation of the European Standard EN 1068

EuroRec has applied to act as a Registration Authorityand has been mandated by CEN/TC 251



QREC: WP 4

WP 4 : Benchmarking Services

T4.1 Benchmarking Services Manual for QualityLabelling and Certification of EHRs

T4.2 Business Plan (for new certification related services)



QREC: WP 5

WP 5 : Communication and Dissemination Activities

T5.1 EHR TutorialsT5.2 Project Website Development and MaintenanceT5.3 LiaisonT5.4 Conferences



EUROREC: Communication and Dissemination (1)

Fostering a harmonised implementation of high quality EHRs will require promotion, awareness and organization of educational events, hence :

– EuroRec Website and associated services based on trustworthy resources (to help purchasers, vendors and end-users)

– Tutorials on EHRs and Certification

– Workshops and Annual Conferences:

– Liaison (with US, Canada, Japan, Australia…)



EUROREC (QREC): Communication and Dissemination (2)

– Conferences :

– EuroRec 2006 Conference (in Bulgaria)– ? Together with HIMSS & others in October 2006 in EUROPE– EuroRec 2007 Conference and Global EHRs Certification Summit (in Slovenia)– Eurorec 2008 Conference (in Romania)



EUROREC’s wish to liaise (example: with the US)

– Standards :

– ANSI-HISB (Healthcare Informatics Standards Board)– HL7 (CDA / Care Record Summaries)– ASTM E31.28 Electronic Health Record SC (Continuity of Care Record)

- Certification : - CCHIT (Certification Commission for Healthcare Information Technology) - NAHIT (National Alliance for Healthcare Information Technology) - AHIC (American Health Information Community)



EHR- Interoperability and - Standards

- CEN EN 13606: EHRCOM:2004, Message based standard- GEHR/ OpenEHR: Archetype concept based- ISO/ TC215’s EHR- related standards- HL7 Version 3: RIM and CDA based message protocols- ACR-NEMA’s DICOM standard- IHE’s XDS Integration Profile , eb- XML based- JAPAN’s MML, Medical Mark-up Language

“All these standards vary in scope and content !...”



EN 13606: Five Parts

- 1. Reference Model (stable since 2004)- 2. Archetype Interchange Specification (*)- 3. Reference Archetypes and Terms Lists- 4. Security Features - 5. Exchange Models

(*) EN 13606 has adopted the OpenEHR archetype methodology



EHRcom (EN 13606): Basic Building Blocks

- 1. EHR: the EHR for one person

- 2. Folders: high level organisation e.g. per episode, per clin.specialty

- 3. Compositions: a clinical care session,encounter or document

- 4. Sections: clinical heading reflecting workflow & consultation process - 5. Entries: clinical statement about observations,evaluations,instructions

- 6. Clusters: nested multi-part data structures

- 7. Elements: leaf nodes with single data values, e.g. body weight

- 8. Data values: instance values,e.g. coded terms, measurements with units



ISO/ TC 215’s EHR Related Standards

– ISO TR 18307:2001 Interoperability and compatibility in messaging and communication standards (a list of fundamental principles and objectives)

– ISO TS 18308:2004 Requirements for an Electronic Health Record Architecture (EHRA) (a list of requirements, not the architecture)

– ISO TR 20514 EHR, definition, scope and content (a pragmatic categorization of Electronic Health Records)



Harmonization Efforts

CEN/ TC 251 EHRCOM

Convergence

OpenEHR Archetypes HL7 CDA, RMIM...



Future?...

– The e-Health communities have started to interact across global networks

– Make sure that the standards correspond with the real needs of the health communities over the world and that they will be supported by the industry



Thanks for listening!

http://www.eurorec.org

[email protected]

Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics...

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