CDASH, electronic medical records – status update and ODM Jozef Aerts - XML4Pharma
Download
Report
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
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 ?
Physicians/Investigators
only need
to use 1 system
eCRFs
are prepopulated with EHR data
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: Integrating the Healthcare
Enterprise
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)
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”
HL7 “Continuity of Care Document”
HL7-v3 message in XML
Generated from CDA
CDISC ODM 1.3
CDASH
XForms
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)
CDASH - ODM Metadata
(a CDASH form in ODM)
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 process
The result
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
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)
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
Europeans: raise your voice !