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EuroRec: current standing on EHR certification in Europe Georges De Moor, MD, PhD Electronic Health Record Systems Certification: the European Perspective Georges De Moor, MD, PhD EuroRec President Portoroz, 5 May 2008
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EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

Electronic Health Record Systems Certification: the European Perspective

Georges De Moor, MD, PhDEuroRec President

Portoroz, 5 May 2008

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

EuroRec (http://www.eurorec.org )

• 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 Vienna, 23/10/2007

ProRec Centers

Belgium

Bulgaria

Denmark

France

Italy

Germany

Ireland

Romania

Slovenia

Spain

Slovakia

Serbia

UK

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

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD Vienna, 23/10/2007

Contacts and Liaison

BT and TC 251 TC 215

DG INFSO

EuroRec: current standing on

EHR certification in Europe

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… »

EuroRec: current standing on

EHR certification in Europe

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 structured and coded

• Intelligent (cf. decision support)

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 end a critical factor for clinical research.

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD Vienna, 23/10/2007

EHRs: Secondary Uses (examples)

User / Clinician

re-use

ClinicalTrial Safety and

Adverse event

Register

EHR

Decision Support

UtilisationReview

MarketingBillingt2 t4

t5

t6

t3

KnowledgeMgmt

Platform

t1 (de-identification)

Patient

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

The QREC project: Objective

To develop formal methods and to create a mechanism for the quality labelling and certification of EHR systemsin Europe, in primary- and in acute hospital-care settings

EuroRec Institute is coordinating partner QREC has 12 partners and 2 subcontractorsProject duration is 30 months (1/1/2006-30/6/2008)

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

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

Central Repository

EuroRec has installed a central repository of validated quality criteria and other relevant materials that can be used to harmonise European quality labelling, product documentation and procurement specification of EHR systems.

It will not impose particular certification models or specific criteria on any member country but will foster, via authorized 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

Benefits for the Stakeholders

Industry

EHRs - Quality Labelling / Certification

Market ( R.O.I.)

Quality and Safety Efficiency of HC Delivery Systems

Clinicians, Patients,

Public Health

Health Authorities

EuroRec: current standing on

EHR certification in Europe

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 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 buyers 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.

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

EHRs Criteria: Business Cases

• A purchaser wishing to procure an EHR system module

• An e-Health programme wishing to implement certification as to ensure consistent EHR system functionality nationally

• A vendor/developer wishing to (re-)develop an EHR system module or wishing to interface a given EHR system module across multi-vendor systems

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

Example Use Cases for the Repository

• For a given EHR system module, to– browse the functional criteria– query for specific requirements or criteria– extract (download) the full set of criteria for the module

• to put into a procurement specification• to use in order to develop a local test plan for certification• for product documentation

• For a given care setting– identify which modules are relevant– choose which requirements are of greatest local relevance– find certified suppliers that meet these

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

Methodology for the Repository Design

1. Typology of EHR system statements2. Generic information model for the repository3. Design of indices (ontology)4. Planning of the repository management workflow5. Design of the 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

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

Repository Workflow

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

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

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: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

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

16. 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

EuroRec Languages (non-exhaustive list)

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

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

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 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.

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

For Q-REC repository managers– Manage users and authorisations– Enter or importing statements– Maintain indices– Manage cross-references

For Q-REC classifiers– Search for statements using multiple index terms– Index statements– Cross-reference similar statements– Compose new FGS or GPR based on existing statements

For end users– Browse statements through EuroRec Profiles– Search for statements using multiple index terms– Export query results– Save personal profiles and searches

EuroRec: current standing on

EHR certification in Europe

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

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

TestProcedures

EuroRecBaskets

Certification Documentation Procurement

TestScenarios

Test CriteriaSets

EuroRecRepository ofStatements

Composer

ProcurerDocumenter

Certifier

Scripter

EuroRec Use Tools

EuroRec Repository Use Flow

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

Other 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

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

A European Seal

• To have a “base” level set of functions (minimum baseline requirements) that can be accredited across Europe, which 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;

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

Content of the Seal (1)

• Not all EHR functions can - at present - be harmonised across the European Community:

– Specific reimbursement systems;– Language specific issues;– Differences in available drug- and other databases;– Even sometimes different options regarding evidence based

issues !

• First set of criteria will therefor mainly focus on what is really essential and thus be related to “generic” aspects of “the trustworthiness of the content of an EHR”.

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

Content of the Seal (2)

• The first set of selected criteria will:– not be too specific, e.g related to very particular functions;– correspond what is considered essential.

• Fair chance that a large number of existing EHR products will conform to the chosen criteria.

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

The GPR with most selected FGS

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

Important but not selected

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

EuroRec: current standing on

EHR certification in Europe

Georges De Moor, MD, PhD

www.eurorec.org [email protected]

I thank you for your attention!


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