Quality Labelling and Certification of Electronic Health Record systems (EHR s)

1. Quality Labelling and Certification of Electronic Health Record systems (EHR s) Georges J.E. DE MOOR, M.D., Ph.D. Belgium EUROREC

2. Definition 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 • Enabling to share patient health information between authorized users

3. Administrative Records Medical Records Nursing Records Patient Personal Health Records TRENDS in EHRs (1) EHRs become • transmural / virtual • multidisciplinary and interactive • intelligent ! Integration with other health care software applications ...!

4. TRENDS in EHRs (2) • Medical and Bio-Medical data • Security: Privacy Enhancing Techniques • Semantic Interoperability: Ontology based approaches • Added value of EHRs: eg. Decision Support Systems • Grid Technology: HealthGrid “The PHENOMES will meet the GENOMES in the EHRs of the Future”

5. EuroRec • The « European Institute for Health Records » • A not-for-profit organization, established April 16, 2003 • Mission: the promotion of high quality Electronic HealthRecord systems (EHRs) in Europe • Federation of all the national ProRec centres in Europe

6. EUROREC: ORGANIZATION (2) President : Georges De Moor (Belgium) Secretary General : François Mennerat (France) Vice-President (1) : Rolf Engelbrecht (Germany) Vice-President (2) : Kieran Hickey (Ireland) Treasurer : Louis Schilders (Belgium) Deputy-Treasurer : Knut Bernstein (Denmark)

7. EUROREC: GOALS • Support 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 internationalco-operation (with US, Canada, Japan, Australia…)

8. ProRec CENTRES Applicants Norway Greece Hungary Portugal Poland Sweden The Netherlands Slovakia United Kingdom? Centres Belgium Bulgaria Denmark France Italy Germany Ireland Romania Slovenia Spain “ Differences in languages, cultures and HC-delivery systems ”

9. WIDENET : Offering World-Wide Services through an International Network of Health Record centres (CEU, FP5, IST-14203, 2000-2003) QREC : Quality Labelling and Certification of Electronic Health Record systems in Europe (CEU, FP6, IST-27360, 2005-2008) HISTORY of EU-PROJECTS (1) PROREC : Promotion Strategy for the European HC Record (CEU, FP4, HC 1110, 1996-1998)

10. EUROREC PROREC - CENTRES … (Complementarity / Languages) … Healthcare Authorities Users (Clinicians, Citizens) EHRs - Vendors Purchasers, Payers EUROREC: Organisation (Economy of scale / Synergy)

11. { Extension of the PROREC network WIDENET (additional PROREC centres created)Establishment of EUROREC (June 14, 2003) { QREC Harmonisation of EHRs-Certification Delivery of new EuroRec Services HISTORY of EU-PROJECTS (2) PROREC First PROREC centres established and cooperation between all stakeholders

12. European Conferences on Electronic Health Records PROREC WIDENET QREC 1997, Paris 1998, Rotterdam 1999, Sevilla 2001, Aix-en-Provence 2002, Berlin 2003, Dublin 2004, Brussels 2006, GENEVA (WOHIT06)

13. EUROREC: FUNDING • Membership fees • Annual conferences • Services (cf. new business plan) • E.C. Funded projects : CERTFE, QREC, RIDE,...

14. The European eHealth Area (2004) This EU action was endorsed by the EU Health Ministers in June 2004. Developing Electronic Health Records was already then, one of the key policy priorities. EU eHealth area-targets: • 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...

15. The E-Europe Action Plan (2005) E-Health was identified as one of the EC priorities, with as deadlines: • 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 inter-operability 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

16. 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: general definitions

17. 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 …) Interoperability: types

18. 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.

19. QREC: Main Objectives To develop formal methods and to create a mechanism for the quality labelling and certification of EHR systems in Europe, in primary- and in acute hospital-care settings EuroRec Institute is coordinating partner QREC has 12 partners and 2 subcontractors (project duration is 30 months from 1 Jan. 2006 on)

20. 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 several 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.

21. Basic research Biomedical informatics III HealthGrid Applied/ Industrial R&D Decision Support Systems II Personal Health Systems (wearables) Health info networks & services I EHR & interoperability General issues: EHR, Security, Interoperability Support to eHealth “Action Plan” Deployment 5 years 10 years 15 years

22. eHealth ERA III II I SYMBIOMATICSBMI ERA Pilot I2HEALTH Identification doctors/patient Messages/requests SHARE Healthgrid Certification EHR SSA STEPVH CA Semantic Health Interoperability RIDE Interoperability TMA Bridge Interop. approach INFOBIOMED BIOPATTERN SEMANTIC MINING Short time research Implementation Long time research

23. 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 represent a risk of further market fragmentation:harmonization efforts should help us to avoid this!

24. EHRs Certification: the case of Belgium • Early 1998: PROREC Belgium develops a qualitylabelling 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 now reduced in size (100) • the certification is a voluntary one, but is incentivized by legislation and budgets: GPs are actually paid when using certified systems (+/-750 EURO/phys. /year) • The conformance testing (initially organized on a yearly basis) is now being conducted (since 2005) on a permanent basis

25. UK’s NHS Connecting for Health proposal for GP system choice • A multi-step accreditation process as to reach a minimum bar that will be progressively raised over time • Funding from the national programme • New priorities and services being rolled out: 1. Electronic Prescribing 2. GP to GP record transfers 3. Choose and Book services 4. ...

26. Benefits for the Stakeholders Industry Market & R.O.I. Quality Labelling / Certification Quality and Safety Cost Effectiveness Clinicians, Patients, Public Health Health Authorities

27. EHRs Certification: Expected Impacts • to reduce EHRs investment risk for buyers/purchasers • to stimulate confidence and to increas investment in EHRs • to guarantee better return on investment (ROI) for vendors • to induce cost savings in healthcare • to improve the 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 • to foster availability, accessibility, inter-operability andportability of the patient records no matter where the patients are located or are travelling...

28. QREC: WP 1 WP 1 : Consortium Management, Project Co-ordinationand Quality Assurance T1.1 Consortium ManagementT1.2 Project Co-ordination T1.3 Quality Assurance

30. QREC: WP 2 WP 2 : EHR systems Quality Labelling and CertificationDevelopment T2.1 State of the Art Report on existing EHR Certification Schemas T2.2 Pan-European Requirements Assay T2.3 Labelling Terminology and Functional Profiles for EHRs to be certified T2.4 Comparison and Harmonisation of Certification Guidelines and Procedures T2.5 Model Certification Guidelines and Procedures including Legal Issues T2.6 Plan for Validation of Guidelines

31. QREC: Core Tasks (1) • Study of current EHRs « Quality Labelling andCertification » -systems:(State-of-the-Art Report) • Assay of the requirements amongst all stakeholders across Europe, covering both current and planned EHRs certification activities (Survey) • In-depth analysis of the ways to classify and profile EHR systems(Profiling and Indexing) • Comparison of various possible EHR certification systems (Methodology)

32. QREC: Core Tasks (2) • Definition of a model (a common European Template) with harmonized guidelines and procedures for EHRs quality labelling and certification • Benchmarking processManualfor EHRs certification • Business Plan

33. QREC’s short term strategy • Collect high priority criteria from existing systems • Choose a reasonable set of instances • Encode these instances in our formal (indexing) model • Analyze how they can interact with our certification procedures • Warehouse the agreed guidelines and criteria • Streamline and automate the certification procedure • Validate the whole system through pilots

34. QREC: Concrete Results (1) The Quality Labelling system will act as a filter, enabling: Potential buyers to identify their Needs, requirements (including Contexts of Use, EHRs modules,…) and to find Test Plans with Appropriate Scenarios and Criteria against which a number of existing EHRs can be tested; Vendors to check their own systems in order to get a quality label or certification and to plan further development.

35. QREC: Concrete Results (2) The buyers and the vendors will thus become the main “clients” for the certification related services The end users will be helped by clearing house activities of EuroRec (registries, inventories and other services…)

36. 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

37. QREC: WP 3 WP 3 : Resources for EHR Interoperability T3.1 Register ofConformance Criteria and Guidance Documents T3.2 Inventory and Register of EHR Archetypes and Guidelines for their Use T3.3 Register of Health Coding Systems in Use in Europe T3.4 Inventory of Relevant Standards for EHR systems T3.5 Register of XML Schemas and Open Source Components for EHR systems

38. Definition 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.

39. 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 been appointed as the Registration Authority and has been mandated by CEN/BT and /TC 251

40. 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

41. 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,encounteror 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

42. 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 !...”

43. 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 20514EHR, definition, scope and content (a pragmatic categorization of Electronic Health Records)

44. Harmonization Efforts CEN/ TC 251 EHRCOM Convergence OpenEHR Archetypes HL7 CDA, RMIM...

45. QREC and Standards • Although standards are to be considered as the« DNA »of health records, • the QREC certification will not be restricted to (technical) conformance testing against existingstandards(which only are intermediary instruments to reach higher goals , ie optimal management of health) • but QREC’s approach will therefore be pragmatic, focusing on functional criteria directly related tothe quality, safety, security, equity and efficiencyof health(care) services

46. 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 both the industry and the users

47. QREC: WP 4 WP 4 : Benchmarking Services T4.1 Benchmarking ServicesManual for Quality Labelling and Certification of EHRs T4.2 Business Plan (for clearing house activities and new certification related services)

48. QREC: WP 5 WP 5 : Communication and Dissemination Activities T5.1 EHR Tutorials T5.2 Project Website Development and Maintenance T5.3 Liaison T5.4 Conferences

49. EUROREC: Communication and Dissemination (1) Fostering a harmonised implementation of high quality EHRs will require promotion, awareness and organisation of educational events, hence : • EuroRec Website and associated services based on trustworthy resources (to help purchasers, vendorsand end-users) • Tutorials on EHRs and Certification • Workshops and Annual Conferences: • Liaison (with US, Canada, Japan, Australia…)

50. 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)