EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 EuroRec ( ) 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

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 ProRec Centers Centres Belgium Bulgaria Denmark France Italy Germany Ireland Romania Slovenia Spain Slovakia Applicants United Kingdom Serbia The Netherlands Poland Norway Greece Hungary Portugal Sweden “ Differences in languages, cultures and HC-delivery/funding systems ”

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 EHRs: TRENDS transmural, virtual multidisciplinary and interactive longitudinal and intelligent Administrative Records Personal Patient Records Medical Records Nursing Records ! Integration with other eHealth applications...! EHRs start to become:

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 Q-REC European Quality Labelling and Certification of Electronic Health Record systems (EHRs) Duration: Contract No: IST SSA Coordinator: Prof. Georges De Moor EHR-Implement National policies for EHR implementation in the European area: social and organisational issues Duration: Contract No: IST SSA Coordinator: Dr. Laurence Esterle RIDE A Roadmap for Interoperability of eHealth Systems in Support of COM 356 with Special Emphasis on Semantic Interoperability Duration: Contract No: IST Coordinator: Prof. Asuman Dogac

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 QREC’s 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/ /6/2008)

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 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

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 Central Repository EuroRec will install a central repository of validated quality criteria and other relevant materials that can be used to harmonise European testing, quality labelling and procurement specification of EHR systems. It will not impose particular certification models or specific criteria on any member country but will foster, via ProRec centres and other channels, the progressive adoption of consistent and comparable approaches to EHR system quality labelling.

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 Q-REC Rationale –Certification is Essential To assure the quality of EHR systems, e.g., patient safety may be at risk due to: system design, specification and functional inadequacies, poor or confusing presentation of clinical relevant information. 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 purchasers 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). To reduce the risk for purchasers and therefore accelerate the adoption of high quality and more interoperable EHRs.

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 The EuroRec Repository: Introduction The Q-Rec repository will comprise several kinds of artefacts relating to the quality labelling and benchmarking of EHR systems: EHR system requirements EHR system conformance criteria EHR system test plan items An inventory of quality labelled (certified) EHR systems An inventory of EHR related standards An inventory of terminology and coding schemes A directory of certified EHR archetype repositories A directory of reviewed open source specifications and components The year 1 priority

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 EHRs Criteria: Business Cases A purchaser wishing to procure an EHR system module An e-Health programme wishing to ensure consistent EHR system functionality nationally A vendor wishing to (re-)develop an EHR system module Developers wishing to interface to a given EHR system module across multi-vendor systems All may be: –seeking design guidance –wishing to obtain quality labelling certification –searching for trustworthy products

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 EuroRec Repository Repository Workflow

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 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

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 EuroRec Repository Repository Workflow

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 Indexing the statements (1) Multiple indexing of each statement –to maximise the likelihood of finding all relevant statements when searching via the indices 1.Business Function (50 in 8 subcategories) 2.Care Setting (18 in 3 subcategories) 3.Component Type (18 in 4 subcategories)

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 Business Function (1) 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

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 A5 Population health A50 Screening and preventive health A51 Disease registries A52 Public health A53 Epidemiology A6 Health system services A60 Healthcare organisation management A61 System maintenance and technical support A62 Education, training, support A63 System configuration of the application A64 Individual configuration of the application A7 Security: privacy and accountability A70 Security: authentication A71 Security: authorisation A72 Security: access control A73 Security: confidentiality and consents A74 Security: version management A75 Security: de-identification services and processes A8 Security: technical A80 Security: backup and integrity validation A81 Security: data retention, availability and destruction A82 Security: audit and override monitoring A83 Security: attestation and non- repudiation Business Function (2)

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 Care Setting 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

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 Component Type 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

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 Some statistics

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 EuroRec Repository Maintenance Tools Creation of Fine Grained Statements Creation of Good Practice Requirements Indexing statements Linking statements Maintenance and update of Fine Grained Statements Maintenance and update of Good Practice Requirements Translation functions Access management Versioning and audit functions Overviews and statistics

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/ From Reference Statements to Fine Grained Statements: selecting the Reference Statement Reference statements frequently include multiple functions. Extract of the Irish 2007 criteria for General Practitioners

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/ From Reference Statements to Fine Grained Statements: editor and linkage and indexing FGS Editor Linking an existing FGS Indexing

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/ Fine Grained Statement: maintenance interface Linked to 4 reference statements Version and translation management Editing area Included in 1 Good Practice Requirement

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/ Fine Grained Statement: similar view of attributes of a FGS Linked to 4 reference statements Included in 1 Good Practice Requirement Applicable indexes Area with comments from outside, if any

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/ Fine Grained Statement View of a Fine Grained Statement with link to the Source Statements and the Good Practice Requirements.

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/ Overview of Good Practice Requirements 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

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/ Good Practice Requirement View Five Fine Grained Statements included The statement The indexes for that Good Practice Requirement Area with comments from outside, if any

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/ Multilingual Good Practice Requirement Example of Good Practice Requirement in English, Bulgarian, German, Danish, French, Dutch, Romanian and Slovenian

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 EuroRec Languages (non-exhaustive list) English (default language) Bulgarian Danish Dutch French German Romanian Slovenian

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 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 Documentor ™ To document EHR systems and their functions, enhancing their understanding and comparability by using the EuroRec statements. The EuroRec Procuror ™ To list and describe, for purchase purposes, required functionalities and product characteristics using EuroRec statements. The EuroRec Scriptor ™ To produce and link Test Scenarios to EuroRec Baskets for Certification, Documentation and/or Procurement purposes.

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 Test Procedures EuroRec Baskets CertificationDocumentationProcurement Test Scenarios Test Criteria Sets

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 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

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/2007 Events at WHIT 2007 Tuesday, 23 October 13:30–14:30 Location: room 1 TL7 - Thought Leader Session EHRs Certification: Global Issues Wednesday, 24 October 11:30–12:30 Location: room 3 ES34 – Integrating IT Leadership to Improve Healthcare Delivery and Performance Certification of EHRs: Criteria, Procedures and Tools EuroRec will present an update on the development of its certification criteria repository, as well as on its recommended procedures, including the use of its EHR profiling tool. 17:15–18:00 Location: product tutorial theatre - booth 1021 Demo of the EuroRec Tools EuroRec EHR certification and documentation New era in certification - Real time demo Thursday, 25 October 09:00–10:00 Location: room 2 ES44 – Integrating IT Leadership to Improve Healthcare Delivery and Performance EHR in Europe: A new paradigm. Archetypes: a Revolution Three new CEN European standards constitute a new paradigm. The Archetype paradigm enables 'plug-and- play' semantic interoperability between EHR systems. Via the process of 'creative destruction' new ICT vendors will enter the market using this new exciting paradigm. These European standards help fulfill the ambitious 2010 goals, as accepted by the European Commission.

EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD – President EuroRec 22/10/ Thank you for your attention!