Title: CDASH, electronic medical records and ODM
1CDASH, electronic medical records and ODM
status update
2The Standards
- ODM standard for clinical data
- CDASH standardized Forms - SDTM
- EHR standards
- HL7 Continuity of Care Document (CCD)
- OpenEHR
3The challenge
- Can we integrate EHR and EDC systems ?
- Physicians/Investigators only need to use 1
system - eCRFs are prepopulated with EHR data
4It 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
5IHE Integrating the Healthcare Enterprise
- Defines Integration Profiles
- Brings SDOs, vendors, developers and users
together - Organizes Connectathons
- 2009 Vienna, Chicago
6The IHE Process
7IHE Connectathon
8Retrieve 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
9The RFD and CRD Ingredients
- HL7 Continuity of Care Document
- HL7-v3 message in XML
- Generated from CDA
- CDISC ODM 1.3
- CDASH
- XForms
10The 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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12Continuation of Care Document(CCD)
13CDASH - ODM Metadata(a CDASH form in ODM)
14The missing link ...
- Must be vendor-neutral
- Must be EHR-neutral
- Not limited to CCD
- Must match with CDASH
15The solutionODM-CDASH ClinicalDataPrepopData
16The process
17The result
18The 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
19RFD 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
20The source OpenEHR extract
21The PrepopData(intermediate)
22The result prefilled eCRF
23CDISC 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
24Europeans raise your voice !