Project ScopeIncreasing interest in eSource keeps the issue of data integration between Research Systems (EDC, CTMS, CDMS, etc) and healthcare systems (EHR, etc) as a consistent want for Sponsors of Clinical Investigators and Regulators. Previous efforts to make this a repeatable, scalable solution have not met with widescalewide-scale adoption, for a variety of reasons. Some common historical points of view have included:
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.government programs have pushed the adoption and accessibility of electronic health records. In addition, there are a number of stakeholders in the Research Industry that are making the use of healthcare resources a priority for the future; examples include Transcelerate eSource initiative and HL7 Vulcan Accelerator. Solution Work with stakeholders to adopt the HL7 Fast Healthcare Interoperability Resources (FHIR) Potential Solution Review the HL7 FHIRstandard 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). |