1. Georges De Moor, MD, PhD « Electronic Health Record systems’ Quality Labelling and Certification And Validation of Clinical Archetypes » Georges De Moor, MD, PhD Gent University, Gent, Belgium EuroRec President (Copenhagen, 5 November 2008)

2. Georges De Moor, MD, PhD EuroRec (http://www.eurorec.org ) The « European Institute for Health Records » A European not-for-profit organisation (April 16, 2003) Mission: the promotion of high quality Electronic Health Record systems (EHRs) in Europe Federation of National ProRec Centres (all types of stakeholders)

3. Georges De Moor, MD, PhD Vienna, 23/10/2007 Established 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. Georges De Moor, MD, PhD Contacts and Liaison BT and TC 251 TC 215 DG INFSO IHTSDO

5. Georges De Moor, MD, PhD The QREC project: Main 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)

6. Georges De Moor, MD, PhD Vienna, 23/10/2007 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. 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… »

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

9. 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

10. Georges De Moor, MD, PhD 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 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

11. Georges De Moor, MD, PhD EuroRec’s Central Repository and Tools EuroRec has installed a central repository of « validated » quality criteria and other relevant materials and has developed tools that can be used to harmonise quality labelling, product documentation and procurement specification of EHR systems. EuroRec will not impose particular certification models or 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. Georges De Moor, MD, PhD EHRs Criteria: just a few Business Cases An e-Health programme wishing to implement quality labelling or certification as to ensure consistent EHR system functionality nationally A purchaser wishing to procure an EHR system module A vendor/developer wishing 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. 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 Health Services Management Patients, Clinicians Public Health Health Authorities

14. Georges De Moor, MD, PhD AuthorityPhysiciansVendors Pressure New functions New instruments € 1 2 3 4

15. 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 - Certification of EHRs is essential for 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. Georges De Moor, MD, PhD Methodology for the Repository Design 1.Typology of EHR system statements (the quality criteria) 2.Generic information model for the repository 3.Design of indices (indexing system, ontology) 4.Planning of the repository management workflow 5.Design of 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

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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

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20. 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

21. Georges De Moor, MD, PhD Good Practice Requirements - Links

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

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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 Baskets for Certification, Documentation and/or Procurement purposes.

26. 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

27. 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

28. Georges De Moor, MD, PhD Other EuroRec Activities and Services 1. An Inventory of Certification Criteria for EHR systems 2. An Inventory of Standards relevant for EHR systems 3. EHR Archetype validation 4. Open Source Components and XML Schemas 5. EHR Tutorials 6. Register of Health Coding Systems in use in Europe 7. Events

29. Georges De Moor, MD, PhD How to Manage Certification? EuroRec open for Multiple Options: 1. Authority: Government (or mandated subcontr.) vs. Non Gov. 2. National based vs. Pan European (or joint, cf. specific/generic) 3. Mandatory vs. voluntary (with or without incentives) 4. Formal audit/testing vs. self-assessment (or pre-test assessment) 5. Scoring/rating scheme: pass/fail or more graded approach 6. Scheme review rate (1,2,…n year cycles) 7. Quality Assurance vs. Quality Improvement focus

30. Georges De Moor, MD, PhD EuroRec at your Service ! 1. Developing & maintaining a central repository with quality criteria 2. Developing tools: certification, procurement and product doc. 3. Providing guidance and assistance to all stakeholders 4. Assisting Authorities in introducing / adopting certification 5. Training and accreditation of surveyors (European level) 6. Set-up of certification session (incl. scenario scripting/operations) 7. Continous & total Q.A. of processes and procedures

31. Georges De Moor, MD, PhD Certification – Step 1 – 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

32. Georges De Moor, MD, PhD 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. Georges De Moor, MD, PhD 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

34. Georges De Moor, MD, PhD 13 mei 2008 Page 34

35. Georges De Moor, MD, PhD Unveiling the EuroRec Seal 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.

36. Georges De Moor, MD, PhD Content of the Seal (1) 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”.

37. Georges De Moor, MD, PhD Content of the Seal (2) 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.

38. Georges De Moor, MD, PhD The GPR with most selected FGS

39. Georges De Moor, MD, PhD EHR Q TN: a new Project Proposal Thematic Network on Quality Labelling and Certification of EHR Systems

40. Georges De Moor, MD, PhD 28 Partners 24 Countries Belgium Austria Bulgaria Slovakia Cyprus Croatia Denmark Estonia France Germany Greece Hungary Ireland Italy LuxembourgNetherlands Norway Poland Portugal Romania Serbia Slovenia Spain United Kingdom Beneficiaries

41. Georges De Moor, MD, PhD 1.Validate and Customise the EuroRec criteria on e- prescription and patient summary in 24 countries 2.Database of stakeholders (incl. EHRs vendors) 3.Inventory of legal issues 4.Local coordination & education 5.Annual EHR-Q TN International Conferences 6.Five Regional EHR-Q TN Conferences EHR-Q TN (Mediteranian, Eastern, Central, Western and Nordic regions) 7.In each country one workshop every year on: Validation of EuroRec Repository (Y1) Tools for certification, product documentation & procurement (Y2) Procedures for EHR Quality Labelling and Certification

42. Georges De Moor, MD, PhD Clinical archetypes are a formal, rigorous and standardised (interoperable) specification for an agreed consensus or best practice representation of clinical data structures (within an electronic health record). They provide a standardised way of specifying EHR clinical data hierarchies and the kinds of data values that may be stored within each kind of entry. An archetype defines (or constrains) relationships between data values within an EHR data structure, expressed as algorithms, formulae or rules. ISO/EN13606 Definition of Archetype

43. Georges De Moor, MD, PhD Patient safety management and the pursuit of evidence based care require computable information that can be linked to and queried by alerting components, decision support and clinical pathway systems. The efficient management of health services and the support of public health and clinical research through audits and population analyses also require EHRs that can semantically be processed. All these purposes of use ideally require that the clinical findings within EHRs are represented and organised consistently across vendor products and communities of use: semantic interoperability.

44. Georges De Moor, MD, PhD The EuroRec Institute is partnering the openEHR Foundation in developing governance practices for archetype development, and the quality criteria and editorial policies by which certified libraries of archetypes can be recognised. As part of the quality labelling and certification of EHR-systems, it may take joint responsibility for the governance of archetypes and templates alongside the openEHR Foundation.

45. Georges De Moor, MD, PhD openEHR Semantic architecture

46. Georges De Moor, MD, PhD When authoring an archetype, additional details need to be provided about each node such as the number of occurrences that are permitted within instances of EHR data, the terminology values that may be used, numeric ranges and measurement units. Schematic diagram of an archetype for adverse reaction (to medication)

47. Georges De Moor, MD, PhD Enterprise viewpoint will contain the use case, i.e. the standardised work process; Information viewpoint contains the Message Information Model; Computational viewpoint is about the choreography of messages in the interaction schemas; Engineering viewpoint is the level where the XML schema is defined. Messages: “ an older way to support semantic interoperability”

48. Georges De Moor, MD, PhD Archetypes and templates can play a key role in semantic interoperability. Archetypes define what is maximally documented in the world about a specific health record entity. An archetype defines a data structure, including optionality and multiplicity, data value constraints, and relevant bindings to natural language and terminology systems. Templates define what in a specific context at a specific point in time, will be stored, retrieved, presented, exchanged and archived. In part, clinical meaning within an EHR will be expressed through the structure of the archetype/template, and in part the meaning will be expressed through codes from coding systems Archetypes and Templates

49. Georges De Moor, MD, PhD A way to view this metaphorically is: Archetypes and Templates codes are the words in a dictionary; the structure of the archetype/template is the grammar; with both codes and archetypes sentences can be formed that make or do not make sense; but archetypes define what makes sense; and templates define what makes sense in a specific context.

50. Georges De Moor, MD, PhD To support semantic interoperability clinical archetypes need to be shared and used consistently by EHR system vendors and their users, so that the EHR data they create is consistently organised. Archetypes therefore need to be shared and managed as a common knowledge asset, and incorporated into the design of clinical applications, rather like a terminology system.

51. Georges De Moor, MD, PhD Given that many archetypes may be needed to cover a given domain, it is also important for them to be mutually consistent and bind to terminology systems in appropriate and consistent ways. This is necessary in order to minimise the diversity of ways in which a given kind of EHR data might be represented.

52. Georges De Moor, MD, PhD Clinical archetypes need to be quality assured, since they will direct the ways in which clinical data are captured, processed and communicated. It is important that the design of individual archetypes is an accurate and faithful reflection of good practice for the clinical disciplines in which each of them might be used. They need to be optimally designed for their purpose, and considered trustworthy within their intended communities of use. Large and comprehensive sets of archetypes are needed that cover whole clinical domains in a systematic and inclusive way, catering for the inevitable diversity of use cases and users but helping to foster consensus and best practice. For these to be endorsed by health systems, implemented by vendors and trusted by end users, these archetypes need to be quality assured and to be published and maintained by reliable certified sources.

53. Georges De Moor, MD, PhD 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