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CDASH, electronic medical records and ODM – status update

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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CDASH, electronic medical records and ODM – status update

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  1. Jozef Aerts - XML4Pharma CDASH, electronic medical records and ODM – status update

  2. The Standards • ODM: standard for clinical data • CDASH: standardized Forms - SDTM • EHR “standards”: • HL7: Continuity of Care Document (CCD) • OpenEHR

  3. The challenge • Can we integrate EHR and EDC systems ? • Physicians/Investigators only need to use 1 system • eCRFs are prepopulated with EHR data

  4. 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

  5. IHE: Integrating the Healthcare Enterprise • Defines “Integration Profiles” • Brings SDOs, vendors, developers and users together • Organizes “Connectathons” • 2009: Vienna, Chicago

  6. The IHE Process

  7. IHE Connectathon

  8. “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

  9. The RFD and CRD “Ingredients” • HL7 “Continuity of Care Document” • HL7-v3 message in XML • Generated from CDA • CDISC ODM 1.3 • CDASH • XForms

  10. 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

  11. Continuation of Care Document(CCD)

  12. CDASH - ODM Metadata(a CDASH form in ODM)

  13. The missing link ... • Must be vendor-neutral • Must be EHR-neutral • Not limited to CCD • Must match with CDASH

  14. The solution:ODM-CDASH ClinicalData“PrepopData”

  15. The process

  16. The result

  17. 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

  18. 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

  19. The source: OpenEHR extract

  20. The “PrepopData”(intermediate)

  21. The result: prefilled eCRF

  22. 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

  23. Europeans: raise your voice !

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