On May 17, 2016, FDA issued draft guidance encouraging clinical investigators to make their electronic data capture (“EDC”) systems interoperable with health care organizations’ electronic health records (“EHRs”). Although EHRs are generally under the control of health care organizations and institutions (not FDA-regulated entities such as sponsors), when records are used in clinical investigations, FDA has certain expectations about the source of data. In its draft guidance, FDA addresses the use of EHRs and integrating the data to the EDC for agency decision-making purposes.
The new draft guidance, titled Use of Electronic Health Record Data in Clinical Investigations, builds on and relates to several other previously-released guidances still applicable to the use of EHRs in clinical investigations, most notably: Electronic Source Data in Clinical Investigations (2013), Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data (2013), Computerized Systems Used in Clinical Investigations (2007), and Part 11, Electronic Records; Electronic Signatures — Scope and Application (2003).
FDA acknowledges interoperability of EHR and EDC systems as serving several useful purposes. Interoperability reduces errors in data transcription, provides more complete patient data to clinical investigators and makes health care professionals aware of patients’ health issues as they arise during clinical investigations. To these ends, FDA identifies the following key issues for sponsors to address when using EHRs in clinical trials:
- FDA Access to EHR Data. FDA expects that it will have access to EHRs and “all relevant data within” the EHRs when EHR data are used in clinical investigations. FDA also expects that EHR metadata (such as who changed what information and when) will be retained and made available to FDA in inspections. For medical devices, investigators must retain EHR data for two years after the date on which the investigation is terminated, completed, or the records are no longer needed for a premarket approval application or notice of completion.
- Informed Consent. Patients must be informed of “all entities who may gain access” to their EHRs and the extent of that access, pursuant to established FDA regulations on informed consent. “Reasonably foreseeable risks,” such as “an increased risk of data breaches,” should also be disclosed. FDA expects that sponsors and clinical investigators will understand EHR “data flow and data visibility” in detail, in order to give patients a sufficiently clear description of which parties have access to what information within an interoperable system.
- Description in Protocol. FDA expects sponsors to include information about the intended use of EHRs in their protocols or data management plans, including “a description or diagram of the electronic data flow” between EHRs and the sponsor’s system used in the clinical trial.
- ONC-Certified Health Information Technology. FDA encourages the use of the voluntary ONC Health IT Certification Program, established by the Office of the National Coordinator for Health Information Technology. The use of certified EHR technology gives FDA “confidence during inspections” that the data are reliable and security requirements have been met. Whether certified or not, FDA expects that EHR used by sponsors provide source data that are attributable, legible, contemporaneous, original, and accurate (“ALCOA”). In particular, sponsors should ensure that (1) access to EHR is limited to authorized users, (2) authors of records are identifiable, (3) audit trails keep track of changes to data, and (4) records are available and retained for FDA inspection. FDA warns sponsors to “consider the risks of employing systems” that do not satisfy these four criteria, which could result in risks such as harm to research subjects, loss of patient privacy, and the “regulatory implications” of compromised clinical trial data.
Comments and suggestions on FDA’s draft guidance should be submitted by July 18, 2016 to ensure FDA consideration before the agency begins work on the final version.
