Using EHRs in clinical research and trials

The Federal Drug Administration (FDA) issued guidance in May 2016 on the use of electronic health records (EHRs) in clinical trials and research. In its “Guidance for Industry,” Use of Electronic Health Record Data in Clinical Investigations, the FDA recognizes the widespread use of EHRs as well as the benefits of optimizing the technology tool in clinical research.

The introduction to the guidance documentation states that “in an effort to modernize and streamline clinical investigations, the goals of this guidance are as follows:

  • Facilitate the use of EHR data in clinical investigations
  • Promote the interoperability of EHRs and electronic systems supporting the clinical investigation”

The FDA recognizes that “there are opportunities to improve patient safety, data accuracy, and clinical trial efficiency when data from these systems are used in clinical investigations” while also providing guidance and recommendations on the use of EHRs in research and trials.

Interoperability between systems is seen as being a helpful tool in transmitting vital information and “may simplify data collection for a clinical investigation by enabling clinical investigators and study personnel to capture source data at the time of a subject’s point-of-care visit.” The FDA guidance adds that the “interoperability and automated electronic exchange of information between the EHR and the sponsor’s electronic system supporting the clinical investigation, such as an electronic data capture (EDC) system, may benefit the clinical investigation and patients and other health care providers.”

The security of patient data is a concern when EHRs are used in clinical investigation. Researchers and trial sponsors must adhere to HIPAA requirements for patient privacy and safety when accessing and transferring data. They must also conform to any regulations and requirements for data integrity that may be put in place by their own institutions.

The FDA guidelines advise that, when used properly, “EHRs may enable clinical investigators and study personnel to more easily combine, aggregate, and analyze data from many different sources.”