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Scope
Increasing interest in eSource keeps the issue of data integration
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between Research Systems (EDC, CTMS, CDMS, etc) and healthcare systems (EHR, etc) as a consistent want
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Project Lead:
Geoff Low:
glow@mdsol.com
for Sponsors of Clinical Investigators and Regulators. Previous efforts to make this a repeatable, scalable solution have not met with widescale adoption, for a variety of reasons.
Some common historical points of view have included:
- That the quality of the data that can be retrieved from the Healthcare sites is insufficient to meet research needs.
- That uptake of electronic systems at investigative sites has been slow, expensive, and not delivering real value to healthcare practises.
- Types of data captured in healthcare have been more operational rather than clinical.
- Enabling the Necessary interfaces is an expensive and process-heavy undertaking.
- There is not a suitable, generally supported electronic exchange format, with a number of standard representations being supported in recent memory.
Many of these issues are on the path to being resolved; both the HITECH ACT and Meaningful Use Programs have accelerated adoption of EHR systems across the US and is now continuing to incentivise sites to store more clinically relevant data in their EHR Systems. As an example the ONC Common Clinical Dataset is mandating the availability of many of the core domains of interest to the clinical trials industry. However, the solution to the lack of availability of a common exchange format has not been completely resolved; the HL7 Continuity of Care Document (CCD) is a mature standard, but is not used consistently across implementations or geographies.
Potential Solution
Review the HL7 FHIR standard as a basis for future data integrations between Research Systems and Healthcare systems. It will include looking at the existing FHIR based Research standards (including DAF and SDC)