The use of electronic health record data in clinical investigations

On 19 July 2018, the U.S. Food and Drug Administration (‘FDA’) announced their latest guidance, Use of
Electronic Health Record Data in Clinical Investigations (‘EHR Guidance’). Providing recommendations
for clinical trial sponsors on the permissible use of electronic health records (‘EHRs’) in FDA-regulated
clinical investigations, a major challenge remains with the change from paper to digital – that adoption
is voluntary and consequently, record-keeping varies in the industry. Jefrey K. Shapiro, Director at
Hyman, Phelps & McNamara, P.C., provides insight into the recommendations and the best practices
in using the EHR Guidance – and its significance for those wanting to investigate further.