By Clinical Informatics News Staff

May 17, 2016 | The US Food and Drug Administration yesterday released a 12-page draft guidance on the “Use of Electronic Health Record Data in Clinical Investigations.” The guidance will be posted in the Federal Register, and comments will be accepted for the next 60 days.

The draft guidance is intended to modernize and streamline clinical investigations, the Agency stated, promoting the use of electronic health records in clinical investigations.

The guidance is meant to, “assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations,” the document introduction states. It provides recommendations for using EHRs as a data source in trials, using EHRs that are interoperable with clinical trial technologies, and ensuring the quality and integrity of EHR data.

Electronic health records are not generally subject to FDA oversight; those systems belong to healthcare institutions governed by HHS. FDA, on the other hand, oversees clinical trial sponsors and investigators. Trial sponsors are responsible for assessing the “validity, reliability, and integrity” of any data they use, but the new guidance clarifies FDA’s expectations when those data come from EHRs.

The draft guidance promotes the use of EHRs in clinical trials, pointing out advantages for longitudinal studies and data collection, but lays significant burden on study sponsors to prove their data’s provenance.

“FDA’s acceptance of data from clinical investigations for decision-making purposes depends on FDA’s ability to verify the quality and the integrity of data during FDA on-site inspections and audits,” the guidance states.

Study sponsors must ensure that their data are, “attributable, legible, contemporaneous, original, and accurate (ALCOA).” The draft guidance recommends that study sponsors address EHR data in the study protocol: how the study will use data, which data the study plans to access, and a diagram of how data will flow between the EHR and the study’s clinical trial systems.

“Sponsors should ensure that software updates to the sponsor’s electronic system or the EHR do not affect the reliability and the integrity of EHR data entering the sponsor’s electronic system,” the guidance reads. “They should also consider the clinical investigator’s ability to appropriately archive and backup any EHR data that may be used for the clinical investigation so that data are not lost before the record retention period.” This includes archiving data from the EHR as used in the trial, even if a healthcare provider later makes changes to the patient’s record.

FDA also used the document to challenge health care systems and study sponsors to strive for interoperability in their EHR and EDC systems.

“Interoperable technology may also allow full integration of the EDC system with the EHR so that the clinical investigator and the patient’s other health care providers would have access to all of the research and clinical care data as appropriate,” the guidance noted. “Full integration of both systems may reduce the use of stand-alone EDC systems by health care providers who are participating as investigators in clinical investigations.”

At the same time, the guidance highlights some challenges of informed consent that such interoperability presents.

The informed consent document should identify all entities who may access the patient’s medical record, which will depend heavily on a carefully-orchestrated data flow, and explain the risks associated with data breach.

For its part, FDA must have access to, “all relevant data within the EHR pertaining to the clinical investigation.”