prof. dr. georges de moor, august 23, 2005 / boston health it trends & marketing conference 2005...

Prof. Dr. Georges De Moor, August 23, 2005 / Boston

Health IT Trends & Marketing Conference 2005

« QUALITY LABELLING and CERTIFICATION of ELECTRONIC HEALTH RECORD systems (EHRs) in

EUROPE »

Georges J.E. DE MOOR, M.D., Ph.D.

(EUROREC)



EuroRec

– The « European Institute for Health Records »

– A non-for-profit organization, established April 16, 2003

– Mission: the promotion of high quality Electronic Health Record systems (EHRs) in Europe in Primary and Acute Hospital - care settings

– Federation of national ProRec centres in Europe



ProRec CENTRESCentres

BelgiumBulgariaDenmarkFranceItalyGermanyIrelandRomaniaSloveniaSpain

Applicants

NorwayGreeceHungaryPortugalPolandSwedenThe NetherlandsUnited KingdomSlovakia

“ Differences in languages, cultures and HC-delivery systems ”



HISTORY of EU-PROJECTS (1)

WIDENET : Offering World-Wide Services through an International Network of Health Record

centres (CEU, FP5,IST-14203, 2000-2003)

PROREC : Promotion Strategy for the European HC Record

(CEU, FP4, HC 1110,1996-1998)

QREC : Quality Labelling and Certification of Electronic Health Record systems in Europe (CEU, FP6, IST-27360, 2005-2008)



Other EU-PROJECTS

– « Feasibility Study on Certification of EHRs in Europe » 2005-2006) (CEU, DG Enterprise)

– RIDE, « A Roadmap for Interoperability of eHealth Systems with emphasis on Semantic Interoperability » (2005-2008) (CEU, DG Information Society)



HISTORY of EU-PROJECTS (2)

PROREC First PROREC centres established and

cooperation between all stakeholders

{ Extension of the PROREC network

WIDENET (additional PROREC centres created) Establishment of EUROREC (June 14, 2003)

{ QREC Harmonisation of EHRs-Certification Delivery of EuroRec Services



European Conferences on Electronic Health Records

1997, Paris1998, Rotterdam1999, Sevilla2001, Aix-en-Provence2002, Berlin2003, Dublin2004, Brussels2005, Copenhagen

PROREC

WIDENET

QREC



EUROREC: GOALS

– Support to ProRec centres

– Inform users of current trends in EHRs and express their needs

– Help public authorities to define and implement strategies

– Defend the EHRs-industry (ROI)

– Promote research, education and development in EHRs

– Foster international co-operation



EUROREC’s wish to liaise: e.g. with the US

– Standards :

– ANSI-HISB (Healthcare Informatics Standards Board)– HL7 (CDA / Care Record Summaries)– ASTM E31.28 Electronic Health Record SC (Continuity of Care Record)

- Certification : - CCHIT (Certification Commission for Healthcare Information Technology) - NAHIT (National Alliance for Healthcare Information Technology) - AHIC (American Health Information Community)



EUROREC: ORGANIZATION (1)

EUROREC

PROREC - CENTRES … (Complementarity / Languages)

(Economy of scale / Synergy)

Healthcare

Authorities

…

Users

(Clinicians, Citizens)

EHRs -

Vendors

Purchasers,

Payers

“Think European (or Globally), but act locally”



EUROREC: ORGANIZATION (2)

President : Georges De Moor (Belgium)

Secretary General : François Mennerat (France)

Vice-President (1) : Rolf Engelbrecht (Germany)

Vice-President (2) : Kieran Hickey (Ireland)

Treasurer : Louis Schilders (Belgium)

Deputy-Treasurer : Knut Bernstein (Denmark)



EUROREC: FUNDING

– Membership fees

– Annual conferences

– Services (cf. business plan)

– E.C. projects funded: CERTFE, QREC, RIDE,...



EHRs: TRENDS (1)

EMR EPR: – transmural– virtual– multidisciplinary

AdministrativeRecords

Patient Health Diaries

MedicalRecords

NursingRecords

! Integration with other health care software applications ...!



EHR: TRENDS (2)

-Medical and Bio-Medical data -Security: Privacy Enhancing Techniques-Semantic interoperability: Ontologies-Added value of EHRs: Decision Support Systems-TeleHealth-GRID Technology: HealthGrid

“PHENOTYPE will meet GENOTYPE in future EHRs”



QREC: FP6-IST4

Results of the 4th Information Society Technology (IST4)

Call for proposals under the EU’s 6th Research

Framework Programme (FP6):

– 276 new research projects

– With EUR 1 billion in EU funding

QREC-project on « Quality Labelling and Certification of EHR systems in Europe » is a Specific Support Action (SSA) with EUR 1.3 million in EU funding.



QREC: ORIGIN

Several EU-member states (Belgium, Denmark, UK, Germany, …) have already proceeded with quality labelling and certification schemes, but they differ in scope, in legal framework under which they operate, in policies, in organization, in the choice of quality conformance criteria for benchmarking and testing…

These differences could represent a risk of further market fragmentation: harmonization efforts should counter this!



QREC: Main Objective

To develop formal methods and to create a mechanism for the certification of EHR systems in Europe

EuroRec Institute is coordinating partner QREC has 12 partners and 2 subcontractors



QREC PARTNERS

EuroRecProRec-IE, IrelandProRec-FR, FranceProRec-BE, BelgiumMEDIQ, DenmarkProRec-DE, GermanyRAMIT, BelgiumUCL, U.K.ProRec-SI, SloveniaProRec-BG, BulgariaProRec-RO, RomaniaTNO, The NetherlandsECOR, GermanyEmpirica, Germany



EHRs Certification: EXPECTED IMPACT

– to reduce EHRs investment risk for buyers

– to foster availability, accesibility, interoperability and portability of the patient records no matter where the patients are located or travelling

– to stimulate confidence and increased investment in EHRs

– to guarantee better return on investment (ROI) for vendors

– cost savings in healthcare

– improvement in quality of care and safety of patients

– to encourage patients to play a greater role in managing their own health information

– to provide valuable population health information



Stakeholders / Benefits

INDUSTRY

Standards / Certification

OPENS UP the MARKET & REDUCES RISKS

QUALITY & SAFETY EFFICIENCY & COST SAVINGS

CLINICIANS, PATIENTS, PUBLIC HEALTH

HEALTH AUTHORITIES



EHR- Interoperability and - Standards

- CEN EN 13606: EHRCOM:2004, Message based standard- GEHR/ OpenEHR: Archetype concept based- ISO/ TC215’s EHR- related standards- HL7 Version 3: RIM and CDA based message protocols- ACR-NEMA’s DICOM standard- IHE’s XDS Integration Profile , eb- XML based- JAPAN’s MML, Medical Mark-up Language

“All these standards vary in scope and content: complementarity ?”



EN 13606: Five Parts

- 1. Reference Model (stable since 2004)- 2. Archetype Interchange Specification (*)- 3. Reference Archetypes and Terms Lists- 4. Security Features - 5. Exchange Models

(*) EN 13606 has adopted the OpenEHR archetype methodology



EHRcom (EN 13606): Basic Building Blocks

- 1. EHR: the EHR for one person

- 2. Folders: high level organisation e.g. per episode, per clin.specialty

- 3. Compositions: a clinical care session,encounter or document

- 4. Sections: clinical heading reflecting workflow & consultation process - 5. Entries: clinical statement about observations,evaluations,instructions

- 6. Clusters: nested multi-part data structures

- 7. Elements: leaf nodes with single data values, e.g. body weight

- 8. Data values: instance values,e.g. coded terms, measurements with units



ISO/ TC 215’s EHR Related Standards

– ISO TR 18307:2001 Interoperability and compatibility in messaging and communication standards (a list of fundamental principles and objectives)

– ISO TS 18308:2004 Requirements for an Electronic Health Record Architecture (EHRA) (a list of requirements, not the architecture)

– ISO TR 20514 EHR, definition, scope and content (a pragmatic categorization of Electronic Health Records)



Definitions (1)

Electronic Health Record (EHR)

Repository of information regarding the health status of a subject of care, in computer processable form.

(ISO TR 20514:2004)

The EHR is the primary source of data and information in Health

Information Networks (HINs)

Goals:

- Supporting continuing, efficient and high quality integrated healthcare

- Ability to share patient health information between authorized users



Definitions (1’)

Electronic Health Record (EHR)

The structural organisation of the EHR needs to be appro-

priate to the needs of clinicians.

Flexibility of data entry and support of narratives are major reasons for the retention of paper records by many clinicians.

Answer:

- The EHR must not be prescriptive about this: it needs to accomodate both.



Definitions (2)

Archetype (in eHealth):

A uniquely identified, reusable and formal expression of a specific health concept.

Expressed by means of an Archetype Definition Language and composed of descriptive data, constraint rules and ontological definitions.

Archetypes can be specializations of other archetypes.



EHRs Certification: the case of Belgium

– Early 1998: PROREC Belgium develops a quality labelling system for EHRs in ambulatory setting (333 Quality Criteria defined)

– Belgian Ministry of Public Health and Social Affairs establishes a national Health Telematics Committee, and implements the EHRs certification process in Belgium (May 3,1999):

– the conformance criteria list is reduced in size (100)

– the certification is a voluntary one, but is incentivized by legislation and budgets: GPs are actually paid to use certified systems (about 1.5 K- EURO per physician per year)

– The conformance testing (initially organized on a yearly basis) is being conducted (since 2005) on a permanent basis



QREC: Coordination with Health Authorities

The coordination with healthcare authorities will be done through the collaboration with the eHealth ERA consortium and its European Health Care Authorities (HCA) Ministries Group that is co-ordinating with the national e-Health roadmap activities within the EU-Framework Programme.

Both platforms (EuroRec and eHealth ERA) will follow the necessary bottom-up and top-down approaches for the adequate assessment of needs and for the optimal choice of methods for EHRs certification in Europe.



QREC: Core Tasks (1)

1. Study of current EHRs « Quality Labelling andCertification » -systems (State-of-the-Art Report)

2. Assay of the requirements amongst all stakeholders across Europe, covering both current and planned EHRs certification activities (Survey)

3. In-depth analysis of the ways to classify and profile EHR systems (based on “functional profiles” and other aspects)

4. Comparison of various possible EHR certification systems



QREC: Core Tasks (2)

5. Definition of a model (a common European template) with harmonized guidelines and procedures for EHRs certification

6. Benchmarking process manual for EHRs certification

7. Business plan for EHRs certification (cf. sustainability of services)

(Extra: harmonization of terms and concepts ( an iterative process) to be used, resulting in a general glossary)



QREC: Main WorkPackages

WP 1: Consortium Management, Project Co-ordinationand Quality Assurance

WP 2 : EHR systems Quality Labelling and Certification Development

WP 3 : Resources for EHR Interoperability

WP 4 : Benchmarking Services

WP 5 : Communication and Dissemination Activities



QREC: WP 1

WP 1 : Consortium Management, Project Co-ordination and Quality Assurance

T1.1 Consortium ManagementT1.2 Project Co-ordinationT1.3 Quality Assurance



QREC: WP 2

WP 2 : EHR systems Quality Labelling and Certification Development

T2.1 State of the Art Report on existing EHRCertification Schemas

T2.2 Pan-European Requirements AssayT2.3 Labelling Terminology and Functional Profiles for

EHRs to be certifiedT2.4 Comparison and Harmonisation of Certification

Guidelines and ProceduresT2.5 Model Certification Guidelines and Procedures

including Legal IssuesT2.6 Plan for Validation of Guidelines



QREC: WP 3

WP 3 : Resources for EHR Interoperability

T3.1 Register of Conformance Criteria and GuidanceDocuments

T3.2 Inventory and Register of EHR Archetypes andGuidelines for their Use

T3.3 Register of Health Coding Systems in Use in EuropeT3.4 Inventory of Relevant Standards for EHR systemsT3.5 Register of XML Schemas and Open Source

Components for EHR systems



QREC: WP 3/ T3.3

T3.3 Registration of Health Coding Systems in Use in Europe

Implementation of the European Standard EN 1068

EuroRec has applied to act as a Registration Authorityand has been mandated by CEN/TC 251



QREC: WP 4

WP 4 : Benchmarking Services

T4.1 Benchmarking Services Manual for QualityLabelling and Certification of EHRs

T4.2 Business Plan (for new certification related services)



QREC: WP 5

WP 5 : Communication and Dissemination Activities

T5.1 EHR TutorialsT5.2 Project Website Development and MaintenanceT5.3 LiaisonT5.4 Conferences



EUROREC: Communication and Dissemination (1)

Fostering a harmonised implementation of high quality EHRs will require promotion, awareness and educational actions, hence :

– EuroRec Website and associated services based on trustworthy resources (to help purchasers, vendors and end-users)

– Tutorials on EHRs and Certification

– Workshops and Annual Conferences:

– Liaison (with US, Canada, Japan, Australia…)



EUROREC’s wish to liaise (example: with the US)

– Standards :

– ANSI-HISB (Healthcare Informatics Standards Board)– HL7 (CDA / Care Record Summaries)– ASTM E31.28 Electronic Health Record SC (Continuity of Care Record)

- Certification : - CCHIT (Certification Commission for Healthcare Information Technology) - NAHIT (National Alliance for Healthcare Information Technology) - AHIC (American Health Information Community)



Harmonization Efforts

CEN/ TC 251 EHRCOM

Convergence

OpenEHR Archetypes HL7 CDA, RMIM...



Global Health IT Standards Summit 2005

Global Health Information Technolgy Standards Summit (ISO/TC 215)

19-20 September 2005, Hamamatsu City, Japan

ISO, CEN, HL7...



EUROREC (QREC): Communication and Dissemination (2)

– Annual Conferences:

– Eurorec 2005 Conference (in Denmark)– EuroRec 2006 Conference (in Bulgaria)– EuroRec 2007 Conference and Global EHRs Certification Summit (in Slovenia)– Eurorec 2008 Conference (in Romania)



http://www.eurorec.org



Thanks for listening!

http://www.eurorec.org

[email protected]