FDA Draft Guidance Addresses Use of EHR Data in Clinical Investigations

May 25, 2016 | Strategic Insights for Health System


​The U.S. Food and Drug Administration (FDA) has issued draft guidance for the healthcare industry intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties in the use of electronic health record (EHR) data in FDA-regulated clinical investigations, according to a notice published in the May 17, 2016, Federal Register. The draft guidance has been issued "in an effort to modernize and streamline clinical investigations," with the hopes of promoting the interoperability of EHRs and electronic systems supporting clinical investigations.

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