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CDASH, electronic medical records and ODM – status update

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Jozef Aerts - XML4Pharma. CDASH, electronic medical records and ODM – status update. The Standards. ODM: standard for clinical data CDASH: standardized Forms - SDTM EHR “standards”: HL7: Continuity of Care Document (CCD) OpenEHR. The challenge. Can we integrate EHR and EDC systems ?

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Presentation Transcript
the standards
The Standards
  • ODM: standard for clinical data
  • CDASH: standardized Forms - SDTM
  • EHR “standards”:
    • HL7: Continuity of Care Document (CCD)
    • OpenEHR
the challenge
The challenge
  • Can we integrate EHR and EDC systems ?
    • Physicians/Investigators only need to use 1 system
    • eCRFs are prepopulated with EHR data
it is not only a technical problem
It is not only a technical problem
  • EHR vendors are not interested in EDC
    • niche market
    • 21 CFR Part 11
  • EDC vendors are afraid of EHR
    • too big world
    • complex
ihe i ntegrating the h ealthcare e nterprise
IHE: Integrating the Healthcare Enterprise
  • Defines “Integration Profiles”
  • Brings SDOs, vendors, developers and users together
  • Organizes “Connectathons”
    • 2009: Vienna, Chicago
retrieve form for data capture profile rfd clinical research data capture profile crd
“Retrieve Form for Data Capture” profile (RFD)“Clinical Research Data Capture” profile (CRD)
  • Retrieve data from an EHR system
  • Populate eCRF with EHR data
    • within EHR system
    • or within EDC system
  • Submit completed form
    • to EDC system
    • or to EHR system
the rfd and crd ingredients
The RFD and CRD “Ingredients”
  • HL7 “Continuity of Care Document”
    • HL7-v3 message in XML
    • Generated from CDA
  • CDISC ODM 1.3
  • CDASH
  • XForms
the integration team the geeks
The “integration” team(the geeks)
  • Kevin Powel – Cerner
  • John Gedeon – Cerner
  • Daemon Whittenburg - Greenway Medical
  • Jason Colquitt – Greenway Medical
  • Andrew Fowler – XClinical
  • Gary Walker – Quintiles
  • Chris Connor – Phoenix Data Systems
  • Rhonda Facile – CDISC
  • Jozef Aerts – XML4Pharma
the missing link
The missing link ...
  • Must be vendor-neutral
  • Must be EHR-neutral
    • Not limited to CCD
  • Must match with CDASH
the european situation
The European situation
  • CEN 13606 for EHR extracts
  • HL7-v3-XML does not comply
  • OpenEHR extracts comply
  • CDISC, IHE and HL7 are US-centric
  • IHE-RFD should be extended to other EHR “standards” than HL7
rfd and crd profiles for openehr
RFD and CRD-profiles for OpenEHR
  • XSLT stylesheet for OpenEHR to PrepopData has been developed
  • Trying to interest OpenEHR vendors for demo application
  • CDISC seems to be open for integration with non-HL7 systems
cdisc and ehr jozef s strong opinions
CDISC and EHRJozef\'s strong opinions
  • CDISC thinks too US-centric
  • There is more in the world than HL7HL7 is not the only SDO in Healthcare
  • HL7-v3-XML is not the best basis for EHR(HL7-v3-XML datatypes rejected by CEN)
  • CEN, ISO, HL7 do talk to each otherfirst result: ISO-21090 datatypes
  • CDISC should have the same relationship with CEN-TC251 as it has with HL7
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