CDASH, electronic medical records and ODM

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CDASH, electronic medical records and ODM
status update

• Jozef Aerts - XML4Pharma

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The Standards

• ODM standard for clinical data
• CDASH standardized Forms - SDTM
• EHR standards
• HL7 Continuity of Care Document (CCD)
• OpenEHR

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The challenge

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

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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

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IHE Integrating the Healthcare Enterprise

• Defines Integration Profiles
• Brings SDOs, vendors, developers and users
  together
• Organizes Connectathons
• 2009 Vienna, Chicago

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The IHE Process
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IHE Connectathon
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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

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The RFD and CRD Ingredients

• HL7 Continuity of Care Document
• HL7-v3 message in XML
• Generated from CDA
• CDISC ODM 1.3
• CDASH
• XForms

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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

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(No Transcript)
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Continuation of Care Document(CCD)
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CDASH - ODM Metadata(a CDASH form in ODM)
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The missing link ...

• Must be vendor-neutral
• Must be EHR-neutral
• Not limited to CCD
• Must match with CDASH

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The solutionODM-CDASH ClinicalDataPrepopData
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The process
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The result
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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

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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

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The source OpenEHR extract
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The PrepopData(intermediate)
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The result prefilled eCRF
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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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Europeans raise your voice !