10 Indest-2008-7By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On May 17, 2016, the United States Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigations” (Draft Guidance) which emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. The newly published Draft Guidance is intended to assist sponsors, clinical investigators, contract research organizations (CROs), institutional review boards, and other interested parties on the use of EHR data in FDA-regulated clinical investigations.

Click here to read the Draft Guidance in full.

Overview of New Draft Guidance.

According to the FDA, the Draft Guidance is the next step towards modernizing and streamlining clinical investigations. Specifically, FDA’s goals are to facilitate the use of EHR data in clinical investigations and promote the interoperability of EHRs and electronic systems supporting clinical investigations.

Additionally, the recommendations outlined in the Draft Guidance apply to prospective clinical investigations of human drugs and biological products, medical devices, and combination products. The recommendations apply to foreign clinical studies not conducted under an investigational new drug (IND) application or an investigational device exemption (IDE) that are submitted to FDA in support of an application for the marketing approval of a medical product.

When the Draft Guidance Does Not Apply.

The Draft Guidance does not apply to the use of EHR data in postmarketing observational pharmacoepidemiologic studies designed to assess the risk associated with a drug exposure or designed to test pre-specified hypotheses for such studies; and when used as a recruitment tool for clinical investigations.

Advantages of EHRs.

The use of EHRs in the health care industry can be very beneficial when appropriate guidelines are implemented and followed. As stated in the FDA’s Draft Guidance, “With the widespread use of EHRs, there are opportunities to improve patient safety, data accuracy, and clinical trial efficiency when data from these systems are used in clinical investigations.  EHRs may enable clinical investigators and study personnel to more easily combine, aggregate, and analyze data from many different sources (e.g., clinical notes; physician orders; and radiology, laboratory and pharmacy records).  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.  There are also opportunities for long-term follow-up of large numbers of patients in studies where primary endpoints are rare, such as in prophylaxis studies.”

The FDA has recommended several best practices to help ensure the accuracy and integrity of data collected in clinical studies when employing a system that integrates data from EHRs and electronic data capture systems. Click here to read the recommendations. (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf)

To learn more about the importance of EHRs, click here to read one of my prior blogs.

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“New FDA Draft Guidance on Use of Electronic Health Record Data in Clinical Investigations.” The National Law Review. (May 27, 2016). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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