This press releases announces a “Guidance for Industry” document that the U.S. Food and Drug Administration provides from time to time on technical issues. This document discusses the use of the Electronic Health Record as an additional source of information for prospective clinical trials.

U.S. FDA. FDA issues policy to facilitate the use of electronic health record data in clinical investigations. July 18, 2018. Available at

This Recommendation was added to the website on 2018-07-23 and was last modified on 2020-02-29. You can find similar pages at Data management.

An earlier version of this page appears here.