1. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Electronic Health Record Systems Certification: the European Perspective Georges De Moor, MD, PhD EuroRec President Portoroz, 5 May 2008

2. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD EuroRec (http://www.eurorec.org ) The « European Institute for Health Records » A not-for-profit organisation, established April 16, 2003 Mission: the promotion of high quality Electronic Health Record systems (EHRs) in Europe Federation of national ProRec centres in Europe

3. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Vienna, 23/10/2007 ProRec Centers Belgium Bulgaria Denmark France Italy Germany Ireland Romania Slovenia Spain Slovakia Serbia UK “ Differences in languages, cultures and HC-delivery/funding systems ”

4. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Vienna, 23/10/2007 Contacts and Liaison BT and TC 251 TC 215 DG INFSO

5. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Vienna, 23/10/2007 EHR systems Settings: primary care, acute hospital care, tertiary care, … Content: summary records, emergency records, discharge records, … Approach: problem-oriented, care pathway- or clinical pathway-oriented, … Context: prevention, diagnostic, therapeutic (care & cure), monitoring, palliation (or combination), research, … Author: medical record (EMR), nursing record, administrative record, patient personal health record (PHR) « The boundaries between EHR systems are fading away… »

6. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Vienna, 23/10/2007 EHR systems: Future Trends Patient-centered (access keeper?) and longitudinal (life-long) Multi-disciplinary / multi-professional Transmural (cf. interoperability) and virtual More sensitive content (biomedical/genetic data) More structured and coded Intelligent (cf. decision support) All stakeholders across the EU have recognized that the Electronic Health Record is a key tool in the provision of safe, high quality and effective care end a critical factor for clinical research.

7. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Vienna, 23/10/2007 EHRs: Secondary Uses (examples) User / Clinician re-use Clinical Trial Safety and Adverse event Register EHR Decision Support Utilisation Review Marketing Billing t2t2 t4t4 t5t5 t6t6 t3t3 Knowledge Mgmt Platform t1t1 (de-identification) Patient

8. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD The QREC project: Objective 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 (1/1/2006-30/6/2008)

9. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD QREC: ORIGIN Several EU-member states (Belgium, Denmark, UK, Ireland, …) have already proceeded since years with (EHRs-) quality labelling and/or certification (more often in primary care) but these differ in scope, in legal framework under which they operate, in policies and organisation, and perhaps most importantly in the quality and conformance criteria used for benchmarking … These differences represent a richness but also a risk: harmonisation efforts should help to avoid further market fragmentation in Europe

10. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Central Repository EuroRec has installed a central repository of validated quality criteria and other relevant materials that can be used to harmonise European quality labelling, product documentation and procurement specification of EHR systems. It will not impose particular certification models or specific criteria on any member country but will foster, via authorized channels, the progressive adoption of consistent and comparable approaches to EHR system quality labelling.

11. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Benefits for the Stakeholders Industry EHRs - Quality Labelling / Certification Market ( R.O.I.) Quality and SafetyEfficiency of HC Delivery Systems Clinicians, Patients, Public Health Health Authorities

12. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Q-REC Rationale –Certification is Essential To assure the quality of EHR systems: patient safety Sharing of information requires a quality assessment of EHR products with a view to ensuring interoperability with other systems because: healthcare information, in particular clinical information, is often scattered over a number of informatics systems the structures of these EHRs may significantly differ from one system to the other, depending on the creator and the purpose. more and more incentives are being given to share patients’ medical data to support high quality care and “continuity of care” in a seamless way. Certification of EHRs is essential for buyers and suppliers to ensure that EHR systems are robust enough to deliver the anticipated benefits as EHR systems and related product quality (data portability and interoperability) are difficult to judge.

13. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD EHRs Criteria: Business Cases A purchaser wishing to procure an EHR system module An e-Health programme wishing to implement certification as to ensure consistent EHR system functionality nationally A vendor/developer wishing to (re-)develop an EHR system module or wishing to interface a given EHR system module across multi-vendor systems

14. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Example Use Cases for the Repository For a given EHR system module, to –browse the functional criteria –query for specific requirements or criteria –extract (download) the full set of criteria for the module to put into a procurement specification to use in order to develop a local test plan for certification for product documentation For a given care setting –identify which modules are relevant –choose which requirements are of greatest local relevance –find certified suppliers that meet these

15. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Methodology for the Repository Design 1.Typology of EHR system statements 2.Generic information model for the repository 3.Design of indices (ontology) 4.Planning of the repository management workflow 5.Design of the web-based user interface requirements Review of other relevant work of this kind –e.g. HL7, CCHIT, ISO TC/215, academic work Learning from early iterations of statement classification Testing of the pilot repository

16. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Repository Workflow

17. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Typology of EHR System Statements Source Statements –faithfully extracted from original EHR system specifications and test plans –translated if necessary Fine Grained Statements (FGS) –usually derived from source statements –made more generic, decomposed, reworded, corrected Good Practice Requirements (GPR) –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

18. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD 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

19. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD List of Good Practice Requirements, with number of Fine Grained Statements included number of EuroRec Baskets with this GPR selected view icon on indexes display icon of links and indexes icon enabling the user to give comments view icon on the translations maintenance icon

20. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD 16. Multilingual Good Practice Requirement Example of Good Practice Requirement in English, Bulgarian, German, Danish, French, Dutch, Romanian and Slovenian

21. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD EuroRec Languages (non-exhaustive list) English (default language) Bulgarian Danish Dutch French German Italian Romanian Slovakian Slovenian Serbian

22. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD EuroRec Use Tools 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. 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.

23. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD For Q-REC repository managers –Manage users and authorisations –Enter or importing statements –Maintain indices –Manage cross-references For Q-REC classifiers –Search for statements using multiple index terms –Index statements –Cross-reference similar statements –Compose new FGS or GPR based on existing statements For end users –Browse statements through EuroRec Profiles –Search for statements using multiple index terms –Export query results –Save personal profiles and searches

24. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD EuroRec stakeholders (possible users of the EuroRec 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

25. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Test Procedures EuroRec Baskets CertificationDocumentationProcurement Test Scenarios Test Criteria Sets EuroRec Repository of Statements Composer Procurer Documenter Certifier Scripter EuroRec Use Tools EuroRec Repository Use Flow

26. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Other EuroRec Services 1. An Inventory of Certification Criteria for EHR systems 2. An Inventory of Standards relevant for EHR systems 3. EHR Archetypes 4. Open Source Components and XML Schemas 5. EHR Tutorials 6. Register of Health Coding Systems in use in Europe 7. Events

27. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD

28. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD A European Seal To have a “base” level set of functions (minimum baseline requirements) that can be accredited across Europe, which 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;

29. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Content of the Seal (1) Not all EHR functions can - at present - be harmonised across the European Community: – Specific reimbursement systems; – Language specific issues; – Differences in available drug- and other databases; – Even sometimes different options regarding evidence based issues ! First set of criteria will therefor mainly focus on what is really essential and thus be related to “generic” aspects of “the trustworthiness of the content of an EHR”.

30. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Content of the Seal (2) The first set of selected criteria will: – not be to o specific, e.g related to very particular functions; – correspond what is considered essential. Fair chance that a large number of existing EHR products will conform to the chosen criteria.

31. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD The GPR with most selected FGS

32. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Important but not selected

33. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD

34. EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD www.eurorec.org Georges.DeMoor@UGent.be I thank you for your attention!