FDA: Use of Electronic Health Record Data in Clinical Investigations

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 (EHR) data in FDA-regulated clinical investigations. For the purposes of this guidance, EHRs are electronic platforms that contain individual electronic health records for patients and are maintained by health care organizations and institutions. For example, a typical EHR may include a patient’s medical history, diagnoses, treatment plans, immunization dates, allergies, radiology images, pharmacy records, and laboratory and test results. EHRs can be used by health care institutions to integrate real-time electronic health care information from medical devices and different health care providers involved in the care of patients. This guidance uses a broad definition for EHRs in an attempt to be inclusive of many different types of EHRs.