Copyright HEALTHone Global – October 2006. The Relevance of EHR Standards and of EHR Quality labelling for SMEs Alain Maskens

Copyright HEALTHone Global – October 2006



The Relevance of

EHR Standards and of EHR Quality labelling

for SME’s

Alain Maskens


HEALTHHEALTH one TM

Clinical Management, for life

The Relevance of

EHR Standards and of EHR Quality labelling

for SME’s

Alain Maskens


Contents

• Certification requirements: examples– Generic requirements– Specific requirements

• Certification << >> Standards• Advantages for SMEs• Issues for SMEs• What should SMEs do?


U.S.A.: certification criteria: excerpt


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


Belgium: certification criteria: excerpt


- « 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


CEN TC251prEN13606-1


CEN TC251EN13606


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”


“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


The GEHR (Good European Electronic Healthcare Record) Architecture


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. »


« 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


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.



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.


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”.



Quality labelling (certification) and standards



certification



certification

User requirements•generic•specific



certification


Standards



certification


Standards



certification


Standards

Research and development



certification


Standards

Research and development


Advantages: Certification and standards



• Offer a rigorous analysis of market requirements



• Offer a rigorous analysis of market requirements• Offer the results of extensive, multidisciplinary

R&D work (architectures, specifications)




R&D work (architectures, specifications)• Offer protection against the imposition of « de

facto standards » by big industrial players




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


Difficulties


Difficulties

• Discrepancy between market demand / maturity and standards sophistication


Difficulties


• Instability of the standards


Difficulties


• Instability of the standards• Multiplicity of the standards


Difficulties


• Instability of the standards• Multiplicity of the standards• Ongoing cohorts of customers..


Main issue:

• Ongoing cohorts of existing customers..


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


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:


South Africa

The AIDS team, AngloPlatinum healthcare services,

South Africa


USA

The Madrona Clinic, Whashington State, USA


Europe

Clinique Sainte-AnneSaint-Remy, Brussels


Shanghai



Documents

Copyright HEALTHone Global – October 2006. The Relevance of EHR Standards and of EHR Quality labelling for SMEs Alain Maskens