FDA issues draft guidance on use of EHRs in clinical investigations

The U.S. Food and Drug Administration has released draft guidance regarding the collection and use of electronic health record data in clinical trials.

The draft guidance is an effort to modernize and streamline clinical investigations, and its goals are to "facilitate use of EHR data in clinical investigations and promote the interoperability of EHRs and electronic systems supporting the clinical investigation."

The FDA notes that EHRs may enable researchers to more easily combine, aggregate and analyze data, both in real-time and longitudinally, as well as facilitate post trial follow ups. The FDA's acceptance of such data depends on the FDA's ability to verify its quality and integrity.

The guidance, which is non-binding, would apply to the use of EHR data in prospective clinical investigations of human drugs and biological products, medical devices and combination products. It would not apply to the use of EHR data in postmarket observational pharmacoepidemiologic studies designed to assess the risk associated with a drug exposure or designed to test a prespecified hypothesis for such studies, or when used as a recruitment tool for clinical investigation.

Some of the recommendations and/or suggested best practices the FDA makes include:

  • Use interoperable EHRs and electronic data capture systems to allow for auto population and full integration.
  • The EHRs and the policies and processes for their use provide electronic source data that are attributable, legible, contemporaneous, original and accurate. To meet such ends, sponsors are encouraged to use certified EHR technology, include information regarding the intended use of EHR in their protocols, use audit trails, consider whether risks, such as data breaches, should be part of informed consent and consider whether privacy and security safeguards are in place.  

Comments on the draft guidance are due July 18.

To learn more:
- read the notice
- here's the guidance