1. Electronic Health Record Systems Certification: the European Perspective presented by
Georges De Moor, MD, PhD
EuroRec President
22/10/2007

2. AGENDA 1. The EuroRec Institute
2. EHR-systems Certification: the QRec Project
3. Rationale for EHRs Certification
4. The EuroRec Repository:Methodology and Tools
5. The EuroRec Resources and Services for Interoperability
6. Forthcoming Events
7. Questions and Answers
22/10/2007

3. 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
22/10/2007

4. ProRec Centers Centres Applicants Belgium United Kingdom 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 ”
22/10/2007

5. LIAISON
DG INFSO
BT, TC251,
TC215
22/10/2007

6. EHRs: TRENDS EHRs start to become: transmural, virtual
multidisciplinary and interactive
longitudinal and intelligent
Administrative
Records
Medical
Records
Nursing
Records
Personal Patient
Records
! Integration with other eHealth applications ...!
22/10/2007

7. Coordinator: Prof. Georges De Moor
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
22/10/2007

8. 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)
22/10/2007

9. 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
22/10/2007

10. 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.
22/10/2007

11. Benefits for the Stakeholders
Industry
Market ( R.O.I.)
EHRs - Quality Labelling / Certification
Quality and Safety
Efficiency of HC Delivery Systems
Health Authorities
Clinicians, Patients,
Public Health
22/10/2007

12. 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.
22/10/2007

13. 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
22/10/2007

14. EuroRec Repository
Repository Workflow
22/10/2007

15. Some statistics
22/10/2007

16. 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
22/10/2007

17. 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 a given care setting
identify which modules are relevant
choose which requirements are of greatest local relevance
find certified suppliers that meet these
22/10/2007

18. Other Repository Requirements…
(Obtained from stakeholder interviews and events)
Focus primarily on pragmatic (de facto) requirements
Keep aspirational (best practice) ones separate
Do strip out very particular national phrases
Reference the statements to their original sources
Cross-index them against all likely usage scenarios
i.e. be inclusive when indexing
An English language only version will initially be fine
22/10/2007

19. Methodology for the Repository Design
Typology of EHR system statements
Generic information model for the repository
Design of indices (ontology)
Planning of the repository management workflow
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
22/10/2007

20. 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
22/10/2007

21. The system calculates a date for the delivery on the basis of the date of the last menstruation
Too specific, and complementary requirements were not found in the source materials
Need to meet the clinical requirements
The system must be able to calculate the expected date of delivery on the basis of the date of the last menstrual period
The system must be able to document the expected date of delivery on the basis of one or more sources of evidence
The system must be able to note which source of evidence for the expected date of delivery is considered to be the most trusted in a given patient for clinical management purposes
22/10/2007

22. The system offers the possibility to group medical data in SOAPT headings, in order to facilitate their display
Need to expand SOAPT to Subjective, Objective, ... for clarity
This requirement can only be enforced for display if the data are captured or mapped to these headings
The EHR system must offer the option for authors to enter data under standard clinical headings: "Subjective, Objective, Analysis, Plan, Treatment", or their equivalent
The EHR system must provide the ability to display data under the standard clinical headings: "Subjective, Objective, Analysis, Plan, Treatment", or their equivalent, if the EHR data is represented under, or can be mapped to, such headings
22/10/2007

23. The system should list of generic medication sorted by the cheapest product first
Change a national mandatory stipulation into a more generic feature option
The EHR system should enable a list of generic medication to be sorted by the cheapest product first
22/10/2007

24. Indexing the statements (1)
Multiple indexing of each statement
to maximise the likelihood of finding all relevant statements when searching via the indices
Business Function (50 in 8 subcategories)
Care Setting (18 in 3 subcategories)
Component Type (18 in 4 subcategories)
22/10/2007

25. Management-Tools (Excel Table)
22/10/2007

26. Indexing the statements (2)
Indexing the source artefact
so that users know the “strength” and jurisdictional acceptance of each original criterion
Specification weight (11)
Specification function (17)
22/10/2007

27. Typology of Indexes Business Functions Care Settings Component Types
Multiple indexing of each statement to maximise the likelihood of finding
all relevant statements when searching via the indices
Business Function (50 in 8 subcategories)
Care Setting (18 in 3 subcategories)
Component Type (18 in 4 subcategories)
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
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
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
Business
Functions
Care Settings
Component Types
22/10/2007

28. Repository Information Model Requirements
Version management
identifiers, time-stamping, ratification status, versioning
Attribution
authorship, review, comments
Traceability
backward references to source materials
cross-references between statement types
reference to publication organisations and country
Translation
ability to link translated versions of statements
22/10/2007

29. User Interface Requirements
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 (not yet implemented)
Browse statements through EuroRec Profiles
Export query results
Save personal profiles and searches
22/10/2007

30. 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
22/10/2007

31. 1. 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
22/10/2007

32. Indexing Editor Linking an existing FGS 22/10/2007
2. From Reference Statements to Fine Grained Statements: editor and linkage and indexing FGS
Editor
Linking an
existing FGS
Indexing
22/10/2007

33. 22/10/2007 3. Fine Grained Statement: list and overview of functions
List of Fine Grained Statements, with
number of linked Reference Statements
number of Good Practice Requirements including that Fine Grained Statement
view icon on indexes
display icon of links and indexes
icon enabling the user to give comments
view icon on the translations
maintenance icon
22/10/2007

34. 22/10/2007 4. Fine Grained Statement: maintenance interface
Linked to 4 reference statements
Included in 1 Good Practice Requirement
Version and translation management
Editing area
22/10/2007

35. 5. 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
22/10/2007

36. 22/10/2007 6. Fine Grained Statement
View of a Fine Grained Statement with link to the Source Statements and the
Good Practice Requirements.
22/10/2007

37. 22/10/2007 7. Creation of Good Practice Requirements
Redaction of a Good Practice Requirement: indexing and linking that GPR to its constituent FGSs.
Selection tool for linking existing FGSs to a new GPR.
22/10/2007

38. 22/10/2007 8. Good Practice Requirement linkages
Overview of GPRs selected per code or on the basis of one or more indices. The interface gives an indication of the
number of FGSs linked and of the number of EuroRec baskets in which the given requirement has been included.
22/10/2007

39. 22/10/2007 9. Good Practice Requirement
View on a GPR with assigned FGS as well as the indexes applicable for that requirement.
22/10/2007

40. 10. Interface for the Creation of Good Practice Requirements
Selection of linked / included FGS
Editing area
Redaction of a Good Practice Requirement: indexing and linking that GPR to its constituent FGSs.
Indexing area, indexing the collection
22/10/2007

41. 11. Selection of the Fine Grained Statements to be included in a Good Practice Requirement
List of statements that can be included
Indication that the FGS has yet been included in one or more GPR
Selection button
22/10/2007

42. 22/10/2007 12. 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
22/10/2007

43. 22/10/2007 13. Good Practice Requirement View The statement
Five Fine Grained Statements included
The indexes for that Good Practice Requirement
Area with comments from outside, if any
22/10/2007

44. Editor 22/10/2007 14. Translation interface
Statements in red are yet translated. The language depends on who logged in.
The statement to be translated
Editor
Linked Fine Grained Statement
22/10/2007

45. 15. Translations maintenance
Slovenian
Dutch
22/10/2007

46. Example of Good Practice Requirement in
16. Multilingual Good Practice Requirement
Example of Good Practice Requirement in
English, Bulgarian, German, Danish, French, Dutch, Romanian and Slovenian
22/10/2007

47. EuroRec stakeholders (users of the EuroRec tools)
National or Regional Healthcare Authorities
EHR System providers
Health IT purchasers
Health IT professional users
Health IT research and education
22/10/2007

48. 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
Export query results
Save personal profiles and searches
22/10/2007

49. EuroRec Languages (non-exhaustive list)
English (default language)
Bulgarian
Danish
Dutch
French
German
Romanian
Slovenian
22/10/2007

50. EuroRec
Baskets
Certification
Documentation
Procurement
Test Criteria
Sets
Test
Scenarios
Test
Procedures
22/10/2007

51. 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.
22/10/2007

52. Result of the search on “password”
22/10/2007

53. EuroRec Services
An Inventory of Certification Criteria for EHR systems
An Inventory of Standards relevant for EHR systems
EHR Archetypes
Open Source Components and XML Schemas
EHR Tutorials
Register of Health Coding Systems in use in Europe
Events
22/10/2007

54. 22/10/2007

55. Definition 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 specialisations of other archetypes.
22/10/2007

56. 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.
22/10/2007

57. Questions
Are the business cases for EuroRec, CCHIT, and others similar? What are their corporate goals ?
Are the EHRs markets in the different regions of the world comparable? (in Europe the EHRs market is highly regulated and fragmented: differences in languages, HC delivery systems, majority of companies are SMEs...)
Is the decision power in the different regions at the same side? (vendors/US) (purchasers/Europe); how to strike the balance?
What should be the procedure? Should certification be required or only recommended and thus organised on a voluntary basis?
How to ensure credibility/authority: how independent should be the bodies implementing the certification?
22/10/2007

58. Thank you for your attention!
22/10/2007