July 19, 2018
FDA finalizes guidance for use of EHR data in clinical studies
Editor's Note
The Food and Drug Administration (FDA) on July 19 finalized its guidance for using electronic health record (EHR) data in FDA-regulated clinical studies.
The guidance is meant to encourage the use of EHR data in clinical studies and promote greater interoperability between EHR and electronic data capture systems.
The guidance provides recommendations to sponsors, clinical investigators, clinical research organizations, institutional review boards, and others interested in using EHR data in clinical investigations.
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