Dive Brief:
- Although EHRs are not controlled by FDA-regulated entities like clinical investigators, the agency has issued recommendations on EHR data used in FDA-regulated clinical trials.
- The agency's guidance document covers topics such as how to use EHRs as data sources in clinical studies, quality of EHR data, and ensuring EHRs meet the agency's requirements for record keeping and retention.
- The guidance goals are to facilitate the use of EHRs in clinical investigations as well as to promote the interoperability of EHRs and electronic systems supporting those investigations.
Dive Insight:
The recommendations apply to EHR data in prospective clinical studies of human drugs, biological products, medical devices, and combination products.
EHRs could potentially improve clinical trial efficiency by allowing investigators to pool data from various sources such as physician orders, lab results, and pharmacy records, the guidance document stated.
The FDA wrote that their review of source data "is important to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity of the clinical investigation data."
The agency als stated it does not need permission to inspect records containing health information.