FDA publishes guidance on use of EHR data in FDA-regulated studies

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The FDA has released a draft guidance covering the use of EHR data in FDA-regulated clinical studies.

The guidance was developed for “sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties” to help facilitate EHR use in clinical investigations and promote interoperability between EHRs and other electronic systems.

The guidance clarifies that EHRs are not under the control of entities regulated by the FDA, but the FDA will only accept data in clinical investigations if it can verify “the quality and integrity” of that data.

“Sponsors are responsible for assessing the validity, reliability, and integrity of any data used to support a marketing application for a medical product,” the guidance read. “Therefore, this guidance clarifies FDA’s expectations when EHRs are used as a source of data in clinical investigations.”

The guidance also reviews some of the various benefits of using EHRs in research, including its potential to provide researchers with real-time healthcare data, and the importance of interoperability between EHRs and electronic data capture (EDC) systems.

“The interoperability between EHRs and EDC systems may simplify data collection for a clinical investigation by enabling clinical investigators and study personnel to capture source data at the time of a subject’s point-of-care visit,” the guidance read. “These interoperable systems may reduce errors in data transcription and provide data that is more accurate and complete allowing for improvement in the quality of clinical investigations and the interpretation of data. Interoperability offers the opportunity for health care professionals who are not part of the clinical investigation to be aware of and treat emerging health care issues that arise as a part of the clinical investigation and document such issues in the EHR.”

Technology that is not interoperable, the FDA pointed out, may lead to more manual data transcription, “similar to the transcription performed with paper records.”

The full guidance, which also covers the use of EHRs sponsored by the Office of the National Coordinator for Health Information Technology (ONC) and EHRs not sponsored by the ONC, is available on the FDA’s website.