EuroRec: current standing on EHR certification in Europe

1. EuroRec: current standing on EHR certification in Europe « Electronic Health Record systems’ Quality Labelling and Certification » Georges De Moor, MD, PhD Gent University, Gent, Belgium EuroRec President Georges De Moor, MD, PhD

2. EuroRec: current standing on EHR certification in Europe EuroRec (http://www.eurorec.org ) • The « European Institute for Health Records » • AEuropeannot-for-profit organisation (April 16, 2003) • Mission:the promotion of high quality Electronic Health Record systems (EHRs) in Europe • Federationof National ProRec Centres (all types of stakeholders) Georges De Moor, MD, PhD

3. Belgium Bulgaria Denmark France Italy Germany Ireland Romania Slovenia Spain Slovakia Serbia (UK) Established ProRec Centers “ Differences in languages, cultures and HC-delivery/funding systems ”

4. Contacts and Liaison DG INFSO BT and TC 251 TC 215

5. The QREC project: Main Objective To develop formal methods and to create a mechanism for the quality labelling andcertification 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)

6. 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 • and a critical factor for clinical research.

7. EHR systems « The boundaries between EHR systems are fading away… » 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)

8. 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 and more structured and coded • Intelligent (cf. decision support)

9. Clinical Trial Safety and Adverse event Register Marketing Utilisation Review Knowledge Mgmt Platform Decision Support Patient User / Clinician EHRs: Secondary Uses (examples) EHR re-use t1 t6 (de-identification) t5 t2 t4 t3 Billing

10. QREC: ORIGIN Several EU-member states (Belgium, Denmark, UK, Ireland,France …) have already proceeded since years with (EHRs-) quality labelling and/or certification (more often in primary care)but these differin scope, inlegal framework under which they operate, in policies andorganisation, and perhaps most importantly in the quality andconformance criteriaused for benchmarking … These differences represent a richness but also a risk:harmonisation efforts should help to avoid further market fragmentation in Europe

11. EuroRec’s Central Repository and Tools EuroRec has installed a central repositoryof « validated » quality criteriaand other relevant materials and has developed tools that can be used to harmonise quality labelling, product documentation and procurement specification of EHR systems. EuroRec willnot impose particular certification modelsor specific criteria on any member country but wishes to foster, via authorized channels, the progressive adoption of consistent and comparable approaches to EHR system quality labelling. EuroRec should be considered as a service provider.

12. EHRs Criteria: just a few Business Cases • Ane-Health programmewishing to implement quality labelling or certification as to ensure consistent EHR system functionality nationally • A purchaserwishing to procure an EHR system module • Avendor/developerwishing 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

13. Benefits for the Stakeholders Industry Market ( R.O.I.) EHRs - Quality Labelling / Certification Quality and Safety Efficiency of HC Delivery Systems Health Services Management Patients, Clinicians Public Health Health Authorities

14. New instruments Newfunctions 4 3 1 € 2 Pressure

15. 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 ensuringinteroperability with other systems - Certification of EHRs is essentialfor buyers and suppliers to ensure that EHR systems are robust enough to deliver the anticipated benefits. (EHR systems and related product quality - data portability and interoperability- are difficult to judge!)

16. Methodology for the Repository Design • Typologyof EHR system statements (the quality criteria) • Generic informationmodelfor the repository • Design ofindices(indexing system, ontology) • Planning of the repository managementworkflow • Design of web-baseduser interfacerequirements • 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

18. Typology of EHR System Statements • Source Statements/ Referenced Statements (RS) • faithfully extracted from original EHR system specifications and test plans • translated if necessary • Fine Grained Statements (FGS) (at present: n>1500) • 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

20. 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 • 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 • 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 • 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 • 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 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) Business Functions Care Settings Component Types

21. Good Practice Requirements - Links

23. EuroRec Languages(non-exhaustive list) • English (default language) • Bulgarian • Danish • Dutch • French • German • Italian • Romanian • Slovakian • Slovenian • Serbian

25. 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 (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 Basketsfor Certification, Documentation and/or Procurement purposes.

26. 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

27. Composer EuroRec Baskets EuroRec Repository of Statements Certifier Procurer Documenter Certification Documentation Procurement Test Criteria Sets Scripter Test Procedures Test Scenarios EuroRec Use Tools

28. Other EuroRec Activities and Services • An Inventory of Certification Criteria for EHR systems • An Inventory of Standards relevant for EHR systems • EHR Archetype validation • Open Source Components and XML Schemas • EHR Tutorials • Register of Health Coding Systems in use in Europe • Events

29. How to Manage Certification? EuroRec open for Multiple Options: • Authority: Government (or mandated subcontr.) vs. Non Gov. • 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

30. EuroRec at your Service ! • Developing & maintaining a central repository with quality criteria • 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) • Continous & total Q.A. of processes and procedures

31. Agree - as authority - with the users and suppliers what should be certified. Select appropriate criteria to be validated during a particular certification session: initial certification might be comprehensive; but is later often limited to specific (new/changed) functions. Use the Indexes and Good Practice Requirements as filters. If needed, complete the set with new statements (and send to the EuroRec repository). Result => Basket of Fine Grained Statements Certification – Step 1

32. Structure the Basket: Order Grouping in subsets Define: Essential (mandatory) criteria Optional criteria Criteria “for later” Assign weights to individual criteria and/or subsets Produce certification documentation (for the suppliers & users) Certification – Step 2

33. Define test scripts Link to each script a number of FGS / criteria that will be validated by that script Combine scripts in a test scenario Link one or more test scenarios to a certification session Produce certification forms (to be completed during a certification session…) Certification – Step 3

35. 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. Unveiling the EuroRec Seal

36. 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”. Content of the Seal (1)

37. 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 (2)

38. The GPR with most selected FGS

39. Certification is a powerful weapon: use it! Continuity of certification should be guaranteed (credibility issue) Efficiency: do not (re-) invent the wheel Take advantage of the growing EuroRec repository and of the broadening certification scope (e.g. EHRs in other settings and other software applications) resulting from European investments Align choices & strategies with European and International ones (cf. standards, coding systems ...) Professionalize the certification procedures Build a long term, incremental and consistent certification roadmap which is in harmony with your overall healthcare strategy ...EuroRec is your partner and is at your service ! Some Conclusions