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

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

12. Continuation of Care Document (CCD)

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

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

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

16. The process

17. The result

18. 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

19. 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

20. The source: OpenEHR extract

21. The “PrepopData” (intermediate)

22. The result: prefilled eCRF

23. CDISC and EHR Jozef's strong opinions CDISC thinks too US-centric There is more in the world than HL7 HL7 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 other first result: ISO-21090 datatypes CDISC should have the same relationship with CEN-TC251 as it has with HL7

24. Europeans: raise your voice !