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 https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm613793.htm.