The EuroRec Institute: Structure, Activities and new Services Dr. François MENNERAT EuroRec ProRec-France

Bulgariya European initiatives for e-Health The basis Facilitate interoperability to the benefit of the "Mobile European Citizen" Develop the market of applications –Out of the national niches

Bulgariya Principle of free circulation of persons, services and assets Established as early as the first version (Rome Treaty I, 1957) of the Treaties instituting the European Community, now the European Union –Article 8A paragraph 1 (“Citizenship”, later modified according to the Maastricht Treaty) « Every citizen of the Union shall have the right to move and reside freely within the territory of the Member States… » –Articles 48 to 51 (“Workers”) et 52 à 58 (“Right of establishment”)  Free circulation of patients and professionals European initiatives for e-Health The basis

Introduction to EuroRec The European Institute for Health Records

Sofia, Bulgariya The EuroRec Institute European Institute for Health Records Non-profit organisation –founded in 2002 as their Federation by the (then) established ProRec centres (Belgium, Spain, France, and Bulgaria) –registered in 2003 according to the French law Active at the European level with respect to the "subsidiarity principle" Bound to become self-sustainable

Bulgariya The EuroRec Institute Becomes a mainstay of a persistent action of the European Commission services –Directorate General XIII now InfSo - "Information Society and Media" –via successive R&D Framework programmes towards extensive development, implementation and use of interoperable EHR systems –MEDIREC, PROREC, WIDENET projects, and currently Q-REC

Bulgariya Where it all started A series of statements depicting an unsatisfying situation –possibly still partially valid today in several countries

Bulgariya Vendors take usually little care of customers’ actual needs Developers often unaware of current standards and technical specifications Most users unable to formulate their requirements Users often presumptuous with regard to their technical competence Users tend to exaggerate local specificity Users reluctant to spend significant time for education Where it all started

Bulgariya Public authorities with poor or no implementation strategy Public authorities often unaware of technical or functional constraints Public authorities often unaware of market constraints National markets too small for acceptable return on investment etc. Where it all started

Bulgariya MEDIREC –3 rd FPR&D –AIM programme "Advanced Informatics in Medicine" –18 months Concerted Action ( ) –25 partners from 14 countries –"The Lisbon Declaration" at the Final AIM Conference (December 1994) A gradually developing initiative (1)

Bulgariya The Lisbon Declaration 10 consistent recommendations to the Members States and the Commission Recommendation 9 –The effective co-operation between all interested parties including users, professionals, authorities, industry, standardisation bodies and others –at a European level and through a process of managed convergence towards European EHRs –would benefit from the set-up of an appropriate structure based on existing organisations that could promote that mission

Bulgariya PROREC ( Pro motion Strategy for Quality European Health Rec ords) –4 th FPR&D –"Health Telematics" programme –36 months Support Action –5 partners from 5 countries –Practical implementation of item 9 of the Lisbon Declaration A gradually developing initiative (2)

Bulgariya Main achievements of the PROREC project Foundation of 3 ProRec Centres –Belgium, Spain, France Postponement of the planned UK centre Preliminary contacts in Hungary, The Netherlands, Germany, Italy

Bulgariya Registered non-profit organisations Established at the national level Gathering in a balanced way –solution providers –users Developing contacts with all other stakeholders (public authorities, etc.) ProRec centres: the structures

Bulgariya Identify, try and help solve issues opposing or slowing down the process of widely implementing and using high quality EHRs –secure, comprehensive, communicable, interoperable at the national level, as well as throughout Europe ProRec centres: objectives

Bulgariya Rationale behind ProRec centres Take account of local specificity Act at ground level ("Bottom-Up") –think European (the mobile citizen, the market), –act locally (the needs) Bring together and involve field actors: –those who actually use EHRs as their professional tool, –together with those who provide the expected solutions

Bulgariya WIDENET –5 th FPR&D –IST programme ("Information Society Technology”) –36 months Accompanying Measure ( ) –12 partners from 10 countries –Enlarging and strengthening the network A gradually developing initiative (3)

Bulgariya new ProRec Centres –Slovenia, Germany, Italy, Ireland, –Bulgaria, Denmark, Romania And, as a keystone, the foundation of the European Institute for Health Records (The EuroRec Institute) Main achievements of the WIDENET project

Bulgariya The EuroRec Institute ProRec Centre MEDIREC WIDENET PROREC

Bulgariya The EuroRec Institute A non-profit organisation Founded by established ProRec centres (Belgium, Spain, France, and Bulgaria) Developing activities at the European level (subsidiarity principle) Bound to become self-sustainable

Bulgariya Promotion of quality European Health Records Formally established and officially registered –Belgium, Spain, France, Slovenia, Germany, Italy, Ireland, Bulgaria, Denmark, Romania At different development stages –Norway, Cyprus, Greece, The Netherlands, Slovakia, United Kingdom, Portugal, Hungary, Poland, Sweden, etc. The network of ProRec centres

Bulgariya Established Setting up Mature contacts First contacts Lessons learnt in the health care sector The network of ProRec centres

Bulgariya , Paris 1998, Rotterdam 1999, Sevilla 2001, Aix-en-Provence 2002, Berlin 2003, Dublin 2004, Bruxelles/Brussel 2006, Genève 10 October 2006 European Conferences on Electronic Health Records (EUROREC conferences)

Current and future activities: The Q-REC project IST – SSA European Quality Labelling and Certification of Electronic Health Records (EHR) Systems

Bulgariya Overall objectives Foster Quality of EHR Systems (EHRS) –To the benefit of patients Support Interoperability of EHRS in Europe –To the benefit of citizens Facilitate the emergence and consolidation of a European market of medical software

Bulgariya Design an effective, credible and sustainable mechanism for the certification of EHR Systems in Europe Main objective: define a model including –good practices and guidelines –harmonised procedures –and a Manual of benchmarking services by formal testing Intermediate objectives

Bulgariya Detailed objectives State of the art and existing procedures for the certification of EHR Systems Terminology regarding quality labelling and functional profiles for the classification of EHR Systems to certified Good practices and models of certification procedures –including a list of quality criteria Manual of benchmarking processes for the quality labelling and certification of EHR Systems

Bulgariya Necessary resources to support the interoperability of EHRs i.e. Registers of –Quality conformance criteria –EHR archetypes –Available XML schemas –Health coding systems –Relevant standards for EHRs Business model of a certification process Detailed objectives

Bulgariya The scope of Q-REC does include –neither national projects –nor general issues regarding interoperability is restricted to interoperability between EHR Systems Emphasis on conformity testing and certification

Bulgariya Liaison In the U.S. with CCHIT (Certification Communication for Healthcare Information Technology) As well as with other initiatives in Europe and the U.S.

Bulgariya Partners in the consortium Participants: 1European Institute for Health Records (Co-ordinator)EuroRec 2 ProRec ‑ Ireland ProRec-IE 3 ProRec ‑ France ProRec-FR 4 ProRec ‑ Belgium ProRec-BE 5MEDIQ A/S (ProRec-Danmark)MEDIQ 6 ProRec ‑ Deutschland ProRec-DE 7Research In Advanced Medical Informatics and TelematicsRAMIT 8University College LondonUCL 9 ProRec ‑ Slovenija ProRec-SI 10 ProRec ‑ Bulgariya ProRec-BG 11 ProRec ‑ România ProRec-RO 12Dutch Organisation for Applied Scientific ResearchTNO Sub-contractors: 13European Centre for Ontological ResearchECOR 14Empirica

Bulgariya Work Packages WP1Consortium Management, Project Co-ordination and Quality Assurance WP2EHR systems Quality Labelling and Certification Development WP3Resources for EHR Interoperability WP4Benchmarking Services WP5Communication and Dissemination Activities

Bulgariya WP2 - EHR systems Quality Labelling and Certification Development T2.1State of the Art Report on existing EHR Certification Schemes T2.2Pan-European Requirements Assay T2.3Labelling Terminology and Functional Profiles for EHRs to be certified T2.4Comparison and Harmonisation of Certification Guidelines and Procedures T2.5Model Certification Guidelines and Procedures including Legal Issues T2.6Plan for Validation of Guidelines

Bulgariya WP3 - Resources for EHR Interoperability T3.1Register of Conformance Criteria and Guidance Documents T3.2Inventory and Register of EHR Archetypes and Guidelines for their Use T3.3Register of Health Coding Systems in Use in Europe T3.4Inventory of Relevant Standards for EHR systems T3.5Register of XML Schemas and Open Source Components for EHR systems

Bulgariya T3.1 Register of Conformance 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 –implementing the European standard EN 1068 "Health Informatics - Registration of coding systems" T3.4 Inventory of Relevant Standards for EHR systems T3.5 Register of XML Schemas and Open Source Components for EHR systems WP3 - Resources for EHR Interoperability

Bulgariya WP4 – Benchmarking services T4.1Benchmarking Services Manual for Quality Labelling and Certification of EHRs T4.2Business Plan (for new certification related services)

Bulgariya WP5 - Communication and Dissemination Activities T5.1EHR Tutorials T5.2Project Website Development and Maintenance T5.3Liaison T5.4Conferences

Bulgariya 'Liaison' with US entities For certification –CCHIT (Certification Communication for Healthcare Information Technology) +++ –NAHIT (National Alliance for Healthcare Information Technology) –AHIC (American Health Information Community) For formal standards and other specifications –ANSI-HISB (Healthcare Informatics Standards Board) –HL7 (CDA / Care Record Summaries) –ASTM (E31.28 – Continuity of Care Record – CCR) etc.

Bulgariya 'Liaison' as well With other current initiatives activities –IHE-Europe –In Canada (InfoWay) –In Australia (Health Connect / Doctor Connect) –In Japan

Bulgariya Other projects EuroRec is member of the RIDE project –"A Roadmap for Interoperability of eHealth Systems in Support of COM 356 with Special Emphasis on Semantic Interoperability" EuroRec is member of the EHR-Implement project –Meant to examine political, social and organisational factors influencing large scale EHR implementations, and to identify best practices

Bulgariya Conclusion EuroRec is playing the role assigned by the services of the European Commission To facilitate and support the extensive development, implementation and use of interoperable EHR systems throughout Europe By providing an increasing number of services to suppliers, users, and public authorities

Introduction to CEN / TC 251 Health Informatics

Bulgariya CEN CEN – Comité européen de normalisation (European Committee for Standardisation) Founded in 1961 by the National Standards Bodies in the European Economic Community and EFTA countries To contribute to the objectives of the European Union and European Economic Area with voluntary technical standards Over 350 Technical Committees (TCs)

Bulgariya CEN’s remit Promote –free trade Lift undesirable barriers hidden behind permanent reference to national standards –safety of workers and consumers –interoperability of networks –environmental protection –exploitation of R&D programmes –and public procurement

Bulgariya CEN’s Structure Members –National Standards Bodies (NSBs) –Currently 29 (since 2004) Associates –Chemical industry, Construction industry, Consumers, Environment, Machine tools, Medical technology, Small and medium-sized enterprises, Trade unions Affiliates –The NSBs of Central and Eastern European countries which can become members of the Union, and therefore become full National Members of CEN The most important criterion to be met is the adoption of European Standards as national standards

Bulgariya Legal Framework Directive 83/189/EEC, revised into Directive 98/34/EC, then amended into Directive 98/48/EC Differing from international (ISO) ones, once published by CEN, European standards (EN) ipso facto become National Standards –European standards and documents are not retailed by CEN but by NSBs Once a work item is addressed by CEN, no competing or overlapping work item can be addressed at national level Therefore the Commission and all NSBs shall be informed of any new subjects decided by a NSB and the drafts be circulated Following, national laws apply with regard to the use of standards in procurement

Bulgariya A sample of outstanding European Standards for Health Informatics EN « General Purpose Components » (GPICs – 3 parts + 1 TS) EN « Service request and report messages - Basic services including referral and discharge » EN « Electronic Health Record Communication » (EHRcom – 5 Parts) EN « System of concepts to support Continuity of Care – Part 1: Basic concepts» (CONTsys) etc.

Bulgariya as well as for your questions ! Thank you for your attention…