New FDA Guidance Targets Electronic Health Records in Clinical Trials

On May 12, 2016 the U.S. Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigation,” which is intended to guide clinical trial sponsors, investigators, contract research organizations (CRO), and institutional review boards (IRB) on the use of electronic health record (EHR) data in FDA-regulated clinical investigations of human drugs and biological products, medical devices, and combination products.

Through this draft guidance the FDA seeks to modernize and streamline clinical investigations, with the goal of providing recommendations for: (1) facilitating the use of EHR data in clinical investigations; and (2) promoting interoperability between EHRs and electronic systems widely used in clinical investigations.   This guidance expands upon recommendations found in earlier guidance for the use of electronic source data from EHRs in clinical investigations, namely: “Computerized Systems Used in Clinical Investigations” (May 2007) and “Electronic Source Data in Clinical Investigations” (September 2013).

The draft guidance provides FDA’s current thinking on the evaluation and use of EHRs as a source of clinical investigation data, using EHRs that are interoperable with systems that produce electronic records supporting clinical investigations, ensuring the quality and integrity of data collected and used, and ensuring that use of EHR data meets inspection, recordkeeping, and record retention requirements.

Generally speaking, FDA neither regulates EHRs nor the health care professionals and institutions that use them.  Rather, HHS’s Office of the National Coordinator for Health Information Technology (ONC) is primarily responsible for establishing the standards and certification criteria for EHRs.  However, in order to accept data from clinical investigations for decision-making purposes, FDA must be able to verify the quality and the integrity of such data during FDA on-site inspections and audits; and sponsors must be able to assess the validity, reliability, and integrity of the data used when submitting  a marketing application to the FDA. Therefore, this guidance clarifies FDA’s expectations when EHRs are used as a source of data in clinical investigations.  Since the FDA cannot force clinical investigations to use only EHRs that have been certified by the ONC, it has provided some criteria for reviewing a system’s internal security safeguards and for ensuring adherence to best practices in data collection and use.  Notwithstanding, the FDA continues to encourage the use of certified EHR technology, stating that when used, this “would give FDA confidence during inspections that the EHR data is reliable and that the technical and software components of privacy and security protection requirements have been met.”

FDA is requesting comments on the draft guidance by July 18, 2016.

For assistance is understanding how this guidance affects your investigations, or additional legal assistance relating to clinic investigations, contact Ann Marie Gaitan, Esq. at 786.440.8115 or via e-mail at