1. Copyright HEALTHone Global – October 2006

3. The Relevance of EHR Standards and of EHR Quality labelling for SMEs Alain Maskens

4. Copyright HEALTHone Global – October 2006 HEALTH HEALTH one TM Clinical Management, for life The Relevance of EHR Standards and of EHR Quality labelling for SMEs Alain Maskens

5. Copyright HEALTHone Global – October 2006 Contents Certification requirements: examples –Generic requirements –Specific requirements Certification > Standards Advantages for SMEs Issues for SMEs What should SMEs do?

6. Copyright HEALTHone Global – October 2006 U.S.A.: certification criteria: excerpt

7. Copyright HEALTHone Global – October 2006 5. The system shall record the identity of the user finalizing each note and the date and time of finalization. … 7. The system shall provide the ability to addend and/or correct notes that have been finalized. 8. The system shall record and display the identity of the user who addended or corrected a note, as well as other attributes of the addenda or correction, such as the date and time of the change. U.S.A.: certification criteria: excerpt

8. Copyright HEALTHone Global – October 2006 Belgium: certification criteria: excerpt

9. Copyright HEALTHone Global – October 2006 - « Le système doit pouvoir reconstituer l'historique des versions successives d'une donnée, gérées selon les règles suivantes : - Chaque version de donnée est associée à un auteur et un moment (date, heure) d'enregistrement. - Chaque modification d'une donnée (à l'exception des notes personnelles du médecin) en génère une nouvelle version. Dans ce cas, la suppression d'une donnée doit être considérée comme une modification et ne peut entraîner la perte physique de cette donnée. Belgium: certification criteria: excerpt

10. Copyright HEALTHone Global – October 2006 CEN TC251 prEN13606-1

11. Copyright HEALTHone Global – October 2006 CEN TC251 EN13606

12. Copyright HEALTHone Global – October 2006 pr EN 13606 – 1: Requirements basis for this EHR communication standard Many investigations of user and enterprise requirements for the EHR have taken place over this period, which have sought to span the information needs of diverse specialties across primary, secondary and tertiary care, between professions and across countries. These requirements have been distilled and analysed by expert groups, mainly within Europe, in order to identify the basic information that must be accommodated within an EHR information architecture

13. Copyright HEALTHone Global – October 2006 This work includes the GEHR, EHCR-SupA, Synapses, I4C and Nora projects and work by SPRI. These key requirements publications are listed in the bibliography in Annex F. These requirements have recently been consolidated on the international stage within an ISO Technical Specification, ISO TS 18308. pr EN 13606 – 1: Requirements basis for this EHR communication standard

14. Copyright HEALTHone Global – October 2006 The GEHR (Good European Electronic Healthcare Record) Architecture

15. Copyright HEALTHone Global – October 2006 GEHR: requirements for clinical comprehensiveness « Author Responsibility It is widely recognised that every entry in the record must be attributed to an author. What is displayed in the record should be a true account of events as recorded by the author. If changes need to be made, it must be possible to step through and account for those changes individually within a rigorous audit trail. »

16. Copyright HEALTHone Global – October 2006 « Recording a Transaction A new Transaction will incorporate the identifier of the responsible clinician, the date/time of the Transaction, and the type of the Transaction. If an amendment has occurred, then the amendment version, the identifier of the amending clinician and the date/time of the amendment will also be documented. » GEHR: functional specifications

17. Copyright HEALTHone Global – October 2006 Specific requirements

18. Copyright HEALTHone Global – October 2006 Specific requirements CCHIT : The system shall associate standard codes with discrete data elements in a note. Examples include but are not limited to SNOMED-CT, ICD-9CM, DSM-IV, CPT-4, MEDCIN, and LOINC. This would allow symptoms to be associated with SNOMED terms, labs with LOINC codes, etc.

19. Copyright HEALTHone Global – October 2006 Specific requirements CCHIT : The system shall associate standard codes with discrete data elements in a note. Examples include but are not limited to SNOMED-CT, ICD-9CM, DSM-IV, CPT-4, MEDCIN, and LOINC. This would allow symptoms to be associated with SNOMED terms, labs with LOINC codes, etc. Belgium: Les codes associés au contenu sont issus soit de la classification CISP-2 et/ou ICD-10 (voir les critères 54 et 55), soit d'un système de codification de référence ou propriétaire. En cas de codage propriétaire, le logiciel offre en plus une correspondance vers la classification CISP-2 et/ou ICD-10.

20. Copyright HEALTHone Global – October 2006 GEHR: requirements for clinical comprehensiveness There are many classification systems used in medicine, and a shared healthcare record must allow use of any one or all of these systems. They are usually designed for a specific purpose and may be used in specific or general settings.

21. Copyright HEALTHone Global – October 2006

22. Quality labelling (certification) and standards

23. Copyright HEALTHone Global – October 2006 Quality labelling (certification) and standards certification

24. Copyright HEALTHone Global – October 2006 Quality labelling (certification) and standards certification User requirements generic specific

25. Copyright HEALTHone Global – October 2006 Quality labelling (certification) and standards certification User requirements generic specific Standards

26. Copyright HEALTHone Global – October 2006 Quality labelling (certification) and standards certification User requirements generic specific Standards

27. Copyright HEALTHone Global – October 2006 Quality labelling (certification) and standards certification User requirements generic specific Standards Research and development

28. Copyright HEALTHone Global – October 2006 Quality labelling (certification) and standards certification User requirements generic specific Standards Research and development

29. Copyright HEALTHone Global – October 2006 Advantages: Certification and standards

30. Copyright HEALTHone Global – October 2006 Advantages: Certification and standards Offer a rigorous analysis of market requirements

31. Copyright HEALTHone Global – October 2006 Advantages: Certification and standards Offer a rigorous analysis of market requirements Offer the results of extensive, multidisciplinary R&D work (architectures, specifications)

32. Copyright HEALTHone Global – October 2006 Advantages: Certification and standards Offer a rigorous analysis of market requirements Offer the results of extensive, multidisciplinary R&D work (architectures, specifications) Offer protection against the imposition of « de facto standards » by big industrial players

33. Copyright HEALTHone Global – October 2006 Advantages: Certification and standards Offer a rigorous analysis of market requirements Offer the results of extensive, multidisciplinary R&D work (architectures, specifications) Offer protection against the imposition of « de facto standards » by big industrial players Offer the same level of visibility for small and large players

34. Copyright HEALTHone Global – October 2006 Difficulties

35. Copyright HEALTHone Global – October 2006 Difficulties Discrepancy between market demand / maturity and standards sophistication

36. Copyright HEALTHone Global – October 2006 Difficulties Discrepancy between market demand / maturity and standards sophistication Instability of the standards

37. Copyright HEALTHone Global – October 2006 Difficulties Discrepancy between market demand / maturity and standards sophistication Instability of the standards Multiplicity of the standards

38. Copyright HEALTHone Global – October 2006 Difficulties Discrepancy between market demand / maturity and standards sophistication Instability of the standards Multiplicity of the standards Ongoing cohorts of customers..

39. Copyright HEALTHone Global – October 2006 Main issue: Ongoing cohorts of existing customers..

40. Copyright HEALTHone Global – October 2006 SME strategy Take advantage of requirements analysis provided by GEHR and complementary projects –Comprehensiveness –Communication capacity –Portability and independence Take advantage of GEHR generic architecture concepts

41. Copyright HEALTHone Global – October 2006 SME strategy –Comprehensiveness and expandability of the data architecture – the constraints must be at a higher level –Terminology independence –Standards compatibility / standards independence –Internal inter-operability HEALTH one Global:

42. Copyright HEALTHone Global – October 2006 South Africa The AIDS team, AngloPlatinum healthcare services, South Africa

43. Copyright HEALTHone Global – October 2006 USA The Madrona Clinic, Whashington State, USA

44. Copyright HEALTHone Global – October 2006 Europe Clinique Sainte-Anne Saint-Remy, Brussels

45. Copyright HEALTHone Global – October 2006 Shanghai

46. Copyright HEALTHone Global – October 2006