Docket Number:
FDA-2016-D-1224
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health

This guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record data in FDA-regulated clinical investigations.2 For the purposes of this guidance, electronic health record (EHR) systems3are electronic platforms that contain individual health records for patients. EHR systems are generally maintained by health care providers, health care organizations, and health care institutions and are used to deliver care. EHR systems can be used to integrate real-time electronic health care information from medical devices and multiple health care providers involved in the care of patients.

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All written comments should be identified with this document's docket number: FDA-2016-D-1224.