CDISC has commenced a project to facilitate the use of electronic health record (EHR) data in clinical research to achieve efficiencies that speed up global regulatory reviews.
This will also help in the analysis of new treatments for patients and boost next-generation discovery.
The FHIR to CDISC project will make use of Fast Healthcare Interoperability Resources (FHIR), HL7’s standard for the electronic exchange of information related to healthcare, and CDISC’s standards for data collection (CDASH) and data tabulation (SDTM). This will aid in streamlining the data flow from EHRs to CDISC submission-ready datasets.
Gevity Consulting is being engaged by CDISC to conduct project scoping and development.
Gevity’s senior consultant, one of the initial developers of the FHIR standard Lloyd McKenzie, will lead the effort.
CDISC and Gevity will work to develop a dynamic mapping of FHIR resources and an Implementation Guide.
This guide will be made available only to CDISC member organisations.
Eventually, the mapping and Implementation Guide will available via the CDISC Library API, an authoritative source of CDISC standards metadata.
CDISC President and CEO David R Bobbitt said: “Facilitating the development of quality tools to help unlock the benefits of standardisation is an essential component of CDISC’s Strategic Plan. We look forward to providing our community with the knowledge and tools they need to support good science.”
CDISC vice-president for development opportunities Rhonda Facile said: “As EHRs and other real-world data sources play an increasingly important role in clinical research and healthcare decision making, our FHIR to CDISC project is timelier than ever. The project will foster greater efficiencies across systems and resources, and encourage end users to support higher quality data exchange integrations within, and outside of, research.”
CDISC will make use of existing work from the EHR to CDASH project, which developed mappings to allow the transfer of healthcare data into a kind for data collection in clinical research. It anticipates to release the mapping and Implementation Guide next year.