past, current and future initiatives of eurorec

Amstelveen, 8 oktober, 2009 Georges De Moor, MD, PhD

Current and Future Initiatives of EuroRec

Past, Current and Future Initiativesof EuroRec

Prof. Dr. Georges DE MOOREuroRec President

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD


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EuroRec is an independent not-for-profit organisation established in 2003.

Its main mission is to promote - as a federation of national ProRec centres (15 member countries and 7 new applicants) - the use of high quality Electronic Health Record systems (EHRs) in Europe.

It therefore also supports certification by defining quality criteria.

http://www.mie2009.org/



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- Adapt EuroRec’s Articles of Association (General Assembly Meeting,Nov.2009, Dublin)- Redefine EuroRec’s Global Business Plan

Organisational Issues:



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International Liaison:

BT and TC 251 TC 215

DG INFSO

IHTSDO

http://www.aamse.org/AAMSE/uploadedImages/cchit_logo_4PC.jpg



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Trends in Health Systems

The Old WorldProvider-focused

Illness

Site-of-care

Episode Management

Supply Management

Solitary Decision Making

Efficiency

General care

The New WorldPatient and family-focused

Wellness

Continuum of care

Disease Management

Demand Management

Collaborative EBM

Effectiveness

Specialized care

(from UHN, Toronto)



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The care settings as starting points…

In eHealth the technical landscape is so fast moving that the boundaries between tertiary, secondary and primary care settings, homecare settings and even body settings are fading away…

… leading to a continuum of care (cf. health and wellness).



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Electronic Health Record (EHR)

All stakeholders across the world 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 .



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Trends in Electronic Health Record systems (EHR s)

• Patient-centered (gatekeeper?) and longitudinal (life-long) records• Multi-disciplinary / multi-professional• Transmural and virtual • Structured and coded (cf. semantic interoperability) • Intelligent (cf. decision support)• Personalised• Predictive• More sensitive content (e.g. genetic data)• Integrative

Integrated Health Records

EnvironmentalData

Biosensors

Phenomic data

Genomic data

Biochips

Seeing the full picture of an individual’s health status (I. Iakovidis)



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- MediRec (FP3) (94-95) (C.A.) Lisbon Declaration (Recom. 9)

- ProRec (FP4) (96-98) (S.A.) Creation of first ProRec centres

- Widenet (FP5) (00-03) (A.M) Creation of EuroRec

- QRec (FP6) (05-08) (S.S.A.) Creation of Repository & Tools

- EHR-Implement (FP6) (07-10) Strategic Recommendations

- EHR-Q-TN (FP7) (09-12) (T.N.) Dissemination/Implementation

- HITCH (FP7) (09-10) Interoperability

- (Argos (FP7) (10-11) EU-US Collaboration)

History of EU funded EuroRec Projects



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Q-REC Rationale (Why Certification is Essential)

- To assure the quality of EHR systems: operability and patient safety!

- Sharing of information requires a quality assessment of EHR products with a view to ensuring interoperability with other systems (users)

- Certification of EHRs is essential for both the buyers and the 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 otherwise difficult to judge!)



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QREC: Origin

Several EU-member states (Belgium, Denmark, UK, Ireland,France …) have already proceeded since many 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: therefore harmonisation efforts should help to avoid further market fragmentation in Europe



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A few business cases for the quality criteria...

• An e-Health programme wishing to implement quality labelling or certification as to ensure consistent EHR system functionality regionally or 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

• Administrative simplification• Electronic billing• Care pathways and disease management projects• Electronic prescription• Interaction with validated databases• Secure medical data exchange (summary records!)• Interoperability, operability and portability• ...

A growing number of strategic eHealth projectsalready are, or become certification-dependent, e.g.:



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EuroRec Repository Flow

Typology of IndexesMultiple 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

EuroRec Statements

EuroRec Languages (non-exhaustive list)

• English (default language)• Bulgarian• Danish• Dutch• French• German• Italian• Romanian• Slovakian• Slovenian• Serbian

Multilingual: statement 2265



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Q-REC Approach

EuroRec has installed a central repository of 1500 « validated » quality criteria and other relevant materials and has developed tools that can be used to harmonise certification, product documentation and procurement specification of EHR systems.

EuroRec does not impose particular certification approaches or specific criteria on any interested party but wishes to foster, via appropriate channels, the progressive adoption of consistent and comparable approaches to EHR system quality labelling. EuroRec could therefor be considered as a service provider.

How to Manage Certification? EuroRec has Multiple Options:

1. Authority: Government (or mandated subcontr.) vs. Non Gov.

2. Self-certification by Industry (also an option!)

3. National based vs. Pan European (or joint, cf. specific/generic)

4. Mandatory vs. voluntary (with or without incentives)

5. Formal audit/testing vs. self-assessment (or pre-test assessment)

6. Scoring/rating scheme: pass/fail or more graded approach

7. Scheme review rate (1,2,…n year cycles)

8. Quality Assurance vs. Quality Improvement focus

Authority

Pressure

New functions

New instruments

€1

2

3

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Certification: a powerful weapon…



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- In the US: increased momentum via Obama’s stimulus plan: Meaningful Use standards that HHS is developing under the American Recovery and Reinvestment Act (ARRA);

- Meaningful Use: incentive payment from Medicare and Medicaid for physicians and hospitals using EHRs;

- Terms for Meaningful Use under development;

- Certification ! CCHIT is already starting 2 new certification programs with an eye toward helping providers earn federal subsidies starting in 2011! (criteria and test scripts published…) (incremental inspection program…).

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.



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- MediRec (FP3) (94-95) (C.A.) Lisbon Declaration (Recom. 9)

- ProRec (FP4) (96-98) (S.A.) Creation of first ProRec centres

- Widenet (FP5) (00-03) (A.M) Creation of EuroRec

- QRec (FP6) (05-08) (S.S.A.) Creation of Repository & Tools

- EHR-Implement (FP6) (07-10) Strategic Recommendations

- EHR-Q-TN (FP7) (09-12) (T.N.) Dissemination/Implementation

- HITCH (FP7) (09-10) Interoperability

- Argos (FP7) (10-11) EU US Collaboration

History of EU funded Projects



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EHR-Implement is collecting, analyzing and comparing broad scale Electronic Health Record implementations in European countries in order to provide best practice and strategic recommendations.In the past political, social and organizational aspects that can ruin implementation have been overlooked.



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EHR-QTN is a Thematic Network project that prepares the health community across Europe (including also most Eastern European countries) for systematic and comparable quality assurance and certification of Electronic Health Record systems and other e-Health products.

The project fits with objective 1.6 of the 2nd Call for Proposals for the CIP-ICT PSP program: “Improving certification of e-Health products”

EuroRec is offering its repository of quality criteria and its tools to facilitate the deployment of such certifications throughout Europe.

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD


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EHR-QTN

28 Partners24 Countries

Austria

Ireland

United Kingdom

Belgium

Czech Republic

Hungary

Greece

Germany

France

Estonia

Denmark

Bulgaria

Croatia

Cyprus

Italy

Luxembourg

Netherlands

Norway

Poland

Portugal

Romania

Serbia

Slovakia

Slovenia

Spain

http://www.mie2009.org/



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EHR Q TN Activities

1. Validate and customise the EuroRec criteria (with a focus on on e- prescription and patient summaries) in 25 countries

2. Database of stakeholders (esp. EHRs vendors,incl.SMEs)3. Inventory of legal issues regarding certification4. Annual EHR-QTN International Conferences5. In each of the 25 countries one workshop per year on:

• Validation of EuroRec Repository and Criteria (Y1)• Tools for certification, product documentation & procurement (Y2)• Procedures for EHR Quality Labelling and Certification (Y3)



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Healthcare Interoperability Testing and Conformance Harmonization

Establish a deployable process for the Interoperability Conformance Testing of information systems in the field of Healthcare.

…where two different worlds interact with each other in a common project:

- Technical Conformance Testing of Interoperability , ,and

- Quality Labelling and Certification

! CEN/CENELEC/ETSIM403 – eHealth Interoperabillity / Phaze 2

HITCH



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- Semantic Interoperability: the EHR-content, ontologies, archetypes, templates, terminologies

- Personal Health Records: and their interaction with Professional Health Records

- Re-use of Electronic Health Record data: for research, clinical trials (and vice-versa! )

- EHRs and Pre-emptive care: genetic data to manage individual risk for potential diseases

- Certification of other (EHR-related) systems: widening EuroRec’s scope

- Collaboration at global level: e.g. between the EU and the US

Other New Areas of Interest of EuroRec



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Value of Clinical Archetypes (D. Kalra)

• Empowerment of healthcare professionals– enable clinical data sets and structures to be shared

• Provide target knowledge representations for use by guidelines and care pathway systems

• Decision support of physicians and intelligent coaching of patients

• EHR entries identify the Archetypes used when the data were created, and/or to which they map– aids future interpretation, analysis, computation– contributes towards semantic interoperability



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- to identify high quality archetypes which will have been developed elsewhere and to make them available to a broader community

- to organize the involvement of clinicians via their official and authoritative associations (part of the 500 million Euro ELSA; to start a major experimental and clinically driven project for clinical content quality assurance embracing archetypes and terminology)

- to develop formal methods of validating the design and content of archetypes

- to develop a formal process of verification and certification for archetypes

Archetypes / Detailed Clinical Models



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Clinician

Clinical Trials& Research

Safety and Adverse

Event Registers

EHR (EMR, EPR…)

Decision SupportSystems

MarketingBilling

KnowledgeMgmt

Platforms

Privacy Enhancing Techniques

Patient

PHR

TRUST

HealthcareManagement

Re-use of (medical) data



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Pilot Projects: “Transatlantic Methods for Handling Global Challenges in the European Union and United States”

RELEX/C1/2009/PP

The general objective of the pilot projects is to promote mutual understanding and learning among EU and US policy researchers and policymakers on a number of challenges with a global dimension.

EuroRec’s main interest:

Comparative assessment of the EU and US approaches in the target area:“e-Health: interoperability and certification of Electronic Health Records”

EuroRec is 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. Validation of clinical archetypes (clinical models)

8. Continous & total Q.A. of processes and procedures

• Certification is a powerful weapon: use it!• Continuity of certification should be guaranteed (this is for the matter

credibility) • Efficiency: do not (re-)invent the wheel• Take advantage of the growing EuroRec repository and of the broadening

certification scope (e.g. Certification of “EHRs in other settings” and of other eHealth applications)

• Align choices & strategies with European and International ones (cf. standards, clinical models and 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



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http://[email protected]

Thanks for listening!

past, current and future initiatives of eurorec

Documents

phd current

creation of eurorec

individuals health status

primary care settings

homecare settings

effective care

body settings

continuum of care