News Feature | June 6, 2016

FDA Issues Guidelines Covering EHR Data In Clinical Trials

Christine Kern

By Christine Kern, contributing writer


Agency offers recommendations on proper use of personal data in FDA-regulated trials.

The FDA does not technically control EHRs under its purview, but it has issued new guidelines recommending proper use of protected data in FDA-regulated clinical trials. This is not the first foray the FDA has made into the medical technology arena as they earlier released draft guidance for medical device cybersecurity thereby addressing post-market management of cybersecurity vulnerabilities as Health IT Outcomes reported.

The new guidance document is designed to give clarity to clinical investigators, research organizations, IRBs, and others on the use of EHR data in FDA-regulated clinical investigations. It addresses issues such as how to use EHRs as data sources in clinical studies, quality of EHR data, and ensuring EHRs meet the agency's requirements for record keeping and retention. 

The document states, “In general, EHRs are not under the control of FDA-regulated entities (e.g., sponsors, clinical investigators), because in most instances, these systems belong to healthcare organizations and institutions. However, FDA’s acceptance of data from clinical investigations for decision-making purposes depends on FDA’s ability to verify the quality and the integrity of data during FDA on-site inspections and audits. Sponsors are responsible for assessing the validity, reliability, and integrity of any data used to support a marketing application for a medical product.”

The goals of the guidance are to facilitate the use of EHRs in clinical investigations as well as to promote the interoperability of EHRs and electronic systems supporting those investigations. Because EHRs have gained such widespread acceptance and use, the FDA says it provides new opportunities to improve patient safety, increase clinical trial efficiency, and combine data from a range of sources.

In fact, EHRs “may have the potential to provide clinical investigators and study personnel access to real-time and longitudinal health care data for review and can facilitate post-trial follow-up on patients to assess long-term safety and efficacy of medical products,” according to the draft guidance.