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The Relevance of
EHR Standards and of EHR Quality labelling
for SME’s
Alain Maskens
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HEALTHHEALTH one TM
Clinical Management, for life
The Relevance of
EHR Standards and of EHR Quality labelling
for SME’s
Alain Maskens
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Contents
• Certification requirements: examples– Generic requirements– Specific requirements
• Certification << >> Standards• Advantages for SMEs• Issues for SMEs• What should SMEs do?
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U.S.A.: certification criteria: excerpt
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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
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Belgium: certification criteria: excerpt
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- « 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
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CEN TC251prEN13606-1
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CEN TC251EN13606
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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”
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“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
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The GEHR (Good European Electronic Healthcare Record) Architecture
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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. »
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« 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
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Specific requirements
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Specific requirements
CCHIT : The system shall associate standard codes withdiscrete 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.
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Specific requirements
CCHIT : The system shall associate standard codes withdiscrete 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.
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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”.
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Quality labelling (certification) and standards
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Quality labelling (certification) and standards
certification
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Quality labelling (certification) and standards
certification
User requirements•generic•specific
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Copyright HEALTHone Global – October 2006
Quality labelling (certification) and standards
certification
User requirements•generic•specific
Standards
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Copyright HEALTHone Global – October 2006
Quality labelling (certification) and standards
certification
User requirements•generic•specific
Standards
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Quality labelling (certification) and standards
certification
User requirements•generic•specific
Standards
Research and development
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Quality labelling (certification) and standards
certification
User requirements•generic•specific
Standards
Research and development
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Advantages: Certification and standards
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Advantages: Certification and standards
• Offer a rigorous analysis of market requirements
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Advantages: Certification and standards
• Offer a rigorous analysis of market requirements• Offer the results of extensive, multidisciplinary
R&D work (architectures, specifications)
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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
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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
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Difficulties
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Difficulties
• Discrepancy between market demand / maturity and standards sophistication
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Difficulties
• Discrepancy between market demand / maturity and standards sophistication
• Instability of the standards
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Difficulties
• Discrepancy between market demand / maturity and standards sophistication
• Instability of the standards• Multiplicity of the standards
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Difficulties
• Discrepancy between market demand / maturity and standards sophistication
• Instability of the standards• Multiplicity of the standards• Ongoing cohorts of customers..
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Main issue:
• Ongoing cohorts of existing customers..
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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
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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:
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South Africa
The AIDS team, AngloPlatinum healthcare services,
South Africa
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USA
The Madrona Clinic, Whashington State, USA
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Europe
Clinique Sainte-AnneSaint-Remy, Brussels
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Shanghai
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