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

CDASH, electronic medical records
and ODM – status update
Jozef Aerts - XML4Pharma
The Standards
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ODM: standard for clinical data
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CDASH: standardized Forms - SDTM
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EHR “standards”:
 HL7:
Continuity of Care Document (CCD)
 OpenEHR
The challenge
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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
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EHR vendors are not interested in EDC
 niche market
 21 CFR Part 11
EDC vendors are afraid of EHR
 too big world
 complex
IHE: Integrating the Healthcare
Enterprise
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Defines “Integration Profiles”
Brings SDOs, vendors, developers and users
together
Organizes “Connectathons”
 2009:
Vienna, Chicago
The IHE Process
IHE Connectathon
“Retrieve Form for Data Capture” profile (RFD)
“Clinical Research Data Capture” profile (CRD)
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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”
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HL7 “Continuity of Care Document”
 HL7-v3 message in XML
 Generated from CDA

CDISC ODM 1.3
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CDASH

XForms
The “integration” team
(the geeks)
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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)
CDASH - ODM Metadata
(a CDASH form in ODM)
The missing link ...
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Must be vendor-neutral
Must be EHR-neutral
 Not limited to CCD
Must match with CDASH
The solution:
ODM-CDASH ClinicalData
“PrepopData”
The process
The result
The European situation
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CEN 13606 for EHR extracts
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HL7-v3-XML does not comply
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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
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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 “PrepopData”
(intermediate)
The result: prefilled eCRF
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)
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CEN, ISO, HL7 do talk to each other
first result: ISO-21090 datatypes
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CDISC should have the same relationship
with CEN-TC251 as it has with HL7
Europeans: raise your voice !