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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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CDASH, electronic medical records and ODM – status update

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Jozef aerts xml4pharma

Jozef Aerts - XML4Pharma

CDASH, electronic medical records and ODM – status update


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


The ihe process

The IHE Process


Ihe connectathon

IHE Connectathon


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


Continuation of care document ccd

Continuation of Care Document(CCD)


Cdash odm metadata a cdash form in odm

CDASH - ODM Metadata(a CDASH form in ODM)


The missing link

The missing link ...

  • Must be vendor-neutral

  • Must be EHR-neutral

    • Not limited to CCD

  • Must match with CDASH


The solution odm cdash clinicaldata prepopdata

The solution:ODM-CDASH ClinicalData“PrepopData”


The process

The process


The result

The result


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


The source openehr extract

The source: OpenEHR extract


The prepopdata intermediate

The “PrepopData”(intermediate)


The result prefilled ecrf

The result: prefilled eCRF


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


Europeans raise your voice

Europeans: raise your voice !


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