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Focus on Regulation

FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations

On May 17, 2016, FDA published a Draft Guidance for Industry regarding use of electronic health records (EHRs) in clinical trials, building on previously issued guidance on computerized systems and electronic source data used in clinical investigations. As summarized below, this Draft Guidance provides a number of important recommendations to study sponsors who rely on electronic data that are generated and maintained by healthcare facilities in the routine care of patients.

For purposes of the new Draft Guidance, EHRs are “electronic platforms that contain individual electronic health records for patients and are maintained by health care organizations and institutions.” Typical EHRs can include a patient’s medical history, radiology images, pharmacy records, and laboratory test results. The agency recognizes that EHRs may provide advantages, such as the ability to aggregate and/or analyze data from many sources or the ability to access near real-time clinical data, and that use of EHRs can, among other things, improve data accuracy and clinical trial efficacy when used properly.

Significantly, the Draft Guidance emphasizes that FDA does not intend to assess compliance of EHRs with FDA’s regulation governing electronic records (21 CFR Part 11). This is a useful clarification for drug and device companies that rely on EHRs maintained by their clinical sites. Nonetheless, FDA still intends to assess compliance with Part 11 at the point when EHR data enters the sponsor’s electronic system supporting the clinical study. For example, Part 11 obligations would be triggered once data from the EHR is entered (automatically or manually) into the electronic Case Report Form for the trial.

Under the Draft Guidance, FDA recommends that sponsors ensure that EHRs used in clinical investigations provide electronic source data that are attributable, legible, contemporaneous, original, and accurate (ALCOA), more information about which can be found in FDA’s previous guidance on computerized systems. FDA suggests that interoperability between EHRs and clinical study electronic data capture systems is valuable and could simplify data collection, reduce errors in data transcription, and generate more accurate and complete data by allowing data capture and use at the time of a subject’s visit.

In order to streamline EHR use, FDA encourages the use of EHR technology certified under the Office of the National Coordinator for Health Information Technology’s (ONC) Health IT Certification Program. The use of such certified technology would give FDA confidence during inspections that the EHR data is reliable and that privacy and security protection considerations have been met. For non-ONC-certified EHRs, sponsors should consider whether the systems in place ensure preservation of confidentiality, integrity, and reliability of data, including consideration of whether (i) system access is limited to authorized users, (ii) authors are identifiable, (iii) audit trails are available to track data changes, and (iv) records are maintained for FDA inspection as required by applicable regulations.

Best practices for sponsor use of EHRs set forth in the Draft Guidance include the following:

  • Describing in writing (such as in the protocol or data management plan) intended use of EHRs during a clinical investigation;
  • Including a statement in the informed consent forms that describes the extent to which confidentiality of subject-identifiable records will be maintained;
  • Identifying in the informed consent forms all entities with access to the subject’s EHRs relating to the investigation and describing the extent to which access is granted;
  • Retaining all paper and electronic source documents and records for the periods detailed in 21 CFR 312.62(c) (drugs and biologics) and 812.140(d) (medical devices) for FDA inspection;
  • Ensuring that software updates to the sponsor’s electronic system or EHR do not affect EHR data reliability or integrity as used in the investigation;
  • Confirming the investigator’s ability to archive, backup, and retain EHR data pursuant to FDA record retention requirements;
  • Considering whether safeguards in place ensure privacy and confidentiality of data from subjects who later decide to discontinue participation in the clinical investigation; and
  • Making all relevant data within the EHR pertaining to the clinical investigation available to FDA for review upon request.

According to the Federal Register notice announcing the availability of the Draft Guidance, comments are due by July 18, 2016. If you have any questions about the Draft Guidance, or are interested in working with Hogan Lovells to draft and submit a comment on the Draft Guidance, please do not hesitate to contact one of the authors of this client alert or other attorneys you work with at Hogan Lovells.