1. 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

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

3. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 EHRs: TRENDS (1) – transmural – virtual – multidisciplinary and interactive Administrative Records Patient Health Diaries Medical Records Nursing Records ! Integration with other health care software applications...! EHRs become

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

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

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

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

8. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 ProRec CENTRES Centres Belgium Bulgaria Denmark France Italy Germany Ireland Romania Slovenia Spain Applicants Norway Greece Hungary Portugal Poland Sweden The Netherlands United Kingdom Slovakia “ Differences in languages, cultures and HC-delivery systems ”

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

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

11. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 European Conferences on Electronic Health Records 1997, Paris 1998, Rotterdam 1999, Sevilla 2001, Aix-en-Provence 2002, Berlin 2003, Dublin 2004, Brussels PROREC WIDENET QREC

12. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 EUROREC: FUNDING – Membership fees – Annual conferences – Services (cf. business plan) – E.C. projects funded: CERTFE, QREC, RIDE,...

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

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

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

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

17. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 QREC: FP6-IST4 Results of the 4 th Information Society Technology (IST4) Call for proposals under the EU’s 6 th 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.

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

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

20. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 EHR & interoperability Biomedical informatics HealthGrid Deployment Applied/ Industrial R&D Basic research 5 years10 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

21. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 Implementation I eHealth ERA I2HEALTH Identification doctors/patient Messages/requests I2HEALTH Identification doctors/patient Messages/requests Certification EHR SSA Certification EHR SSA TMA Bridge Interop. approach TMA Bridge Interop. approach RIDE Interoperability RIDE Interoperability SHARE Healthgrid SYMBIOMATICS BMI ERA Pilot STEP VH CA INFOBIOMED BIOPATTERN SEMANTIC MINING Semantic Health Interoperability Semantic Health Interoperability II III Short time research Long time research

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

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

24. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 Stakeholders / Benefits INDUSTRY Standards / Certification OPENS UP the MARKET & REDUCES RISKS QUALITY & SAFETYEFFICIENCY & COST SAVINGS CLINICIANS, PATIENTS, PUBLIC HEALTH HEALTH AUTHORITIES

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

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

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

28. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 QREC: Core Tasks (1) 1. Study of current EHRs « Quality Labelling and Certification » -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

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

30. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 QREC: Main WorkPackages WP 1: Consortium Management, Project Co-ordination and 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

31. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 QREC: WP 1 WP 1 : Consortium Management, Project Co-ordination and Quality Assurance T1.1Consortium Management T1.2Project Co-ordination T1.3Quality Assurance

32. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 QREC: WP 2 WP 2 : EHR systems Quality Labelling and Certification Development T2.1State of the Art Report on existing EHR Certification Schemas T2.2Pan-European Requirements Assay T2.3Labelling Terminology and Functional Profiles for EHRs to be certified T2.4Comparison and Harmonisation of Certification Guidelines and Procedures T2.5Model Certification Guidelines and Procedures including Legal Issues T2.6Plan for Validation of Guidelines

33. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 QREC: WP 3 WP 3 : Resources for EHR Interoperability T3.1Register of Conformance Criteria and Guidance Documents T3.2Inventory and Register of EHR Archetypes and Guidelines for their Use T3.3Register of Health Coding Systems in Use in Europe T3.4Inventory of Relevant Standards for EHR systems T3.5Register of XML Schemas and Open Source Components for EHR systems

34. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 QREC: WP 3/ T3.3 T3.3Registration of Health Coding Systems in Use in Europe Implementation of the European Standard EN 1068 EuroRec has applied to act as a Registration Authority and has been mandated by CEN/TC 251

35. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 QREC: WP 4 WP 4 : Benchmarking Services T4.1Benchmarking Services Manual for Quality Labelling and Certification of EHRs T4.2Business Plan (for new certification related services)

36. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 QREC: WP 5 WP 5 : Communication and Dissemination Activities T5.1EHR Tutorials T5.2Project Website Development and Maintenance T5.3Liaison T5.4Conferences

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

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

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

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

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

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

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

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

45. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 Harmonization Efforts CEN/ TC 251 EHRCOM Convergence OpenEHR ArchetypesHL7 CDA, RMIM...

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

47. Prof. Dr. Georges De Moor, the Eurorec Institute, 1 /12/ 2005, Brussels Belgian Health Telematics Syposium 2005 Thanks for listening! http://www.eurorec.org georges.demoor@ugent.be