Use of Electronic Health Record Data in Clinical Investigations. Guidance for Industry

*Recommendation
2018
Electronic health records
Author

Steve Simon

Published

September 13, 2018

The U.S. Food and Drug Administration (FDA) is encouraging great use of electronic health record data to supplement the traditional randomized clinical trials. But you need to use care. Here is some guidance on what the FDA is recommending to industry.

U.S. Food and Drug Administration. Use of Electronic Health Record Data in Clinical Investigations. Guidance for Industry. July 2018. Available in PDF format

Earlier versions are here and here.