FDA Expands on Recommendations Regarding Use of EHR Data in Clinical Trials, Part Two: Best Practices & Other Considerations


FDA Draft Guidance on Use of Electronic Health Record Data in Clinical Trials

Additional information on FDA’s draft guidance is available in our preceding FDA News article, entitled “FDA Expands on Recommendations Regarding Use of EHR Data in Clinical Trials, Part One: Overview of Recent Draft Guidance

Earlier this week, FDA announced the availability of a draft guidance regarding the use of electronic health record (EHR) data in clinical trials.  The guidance, which was published on May 12, 2016, provides sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties with recommendations for using EHRs in FDA-regulated clinical trials.

Although the draft guidance includes recommendations on a number of topics, there is an abundance of information concerning best practices for the use of EHR data in clinical investigations.  As such, when using EHRs as a source of clinical trial data, FDA states that “sponsors should ensure that the EHRs they use and the processes and policies for their use provide electronic source data that are attributable, legible, contemporaneous, original, and accurate (ALCOA).”

ONC-Certified Health Information Technology

As required by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), the Office of the National Coordinator for Health Information Technology (ONC) has established a voluntary health IT certification program.  The ONC program “supports the availability of certified health IT for its encouraged and required user under other federal, state and private programs.”

EHR technology that is certified under the ONC Health IT Certification Program must be in compliance with the provisions of 45 CFR part 170.  EHR technology with certified capabilities provides numerous advantages to users because the certification’s requirements are aimed at keeping electronic data confidential and reliable.  Accordingly, FDA states that the “use of such certified EHR technology is encouraged and, if used, 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.”

EHRs Not Certified by ONC

As long as adequate controls are in place to guarantee the confidentiality, integrity, and reliability of data, non-certified EHRs can still provide FDA with the data needed to make informed regulatory decisions. To ensure the confidentiality, integrity, and reliability of data, FDA advises sponsors to implement the following security safeguards:

  • “Access to electronic systems is limited to authorized user
  • Authors of records are identifiable
  • Audit trails are available to track changes to data (see section VI.C of this guidance)
  • Records are available and retained for FDA inspection for as long as the records are required by applicable regulations (see section VII of this guidance)”

FDA notes that “Sponsors should consider these factors when determining the suitability of EHRs not certified by ONC for use in clinical investigations. If the clinical investigation site is using a system that does not contain the adequate controls previously described in the bulleted items, sponsors should consider the risks of employing such systems.”

Other General Considerations

In its draft guidance, FDA provides a number of additional considerations that should be taken when using data from EHRs in clinical investigations.

Use of EHRs in Clinical Investigations

  • “Sponsors should include (e.g., in the protocol or the data management plan) information about the intended use of the EHR during a clinical investigation and a description or diagram of the electronic data flow between the EHR and the sponsor’s electronic system supporting the clinical investigation. This should include a description of how the relevant EHR data are extracted and subsequently imported into the sponsor’s electronic system.”
  • “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.”
  • “Sponsors should also ensure that study monitors have suitable access to all relevant subject information pertaining to a clinical investigation as appropriate.”
  • “Sponsors should discuss with the relevant FDA review division any unique issues or challenges encountered that are related to the data collection from the EHRs.”

Data Modifications

  • “The sponsor’s electronic system should capture any updated information as well as any accompanying audit trail information.”

Audit Trails

  • “For EHR data gathered during the course of a clinical investigation, sponsors and clinical investigators should ensure that there are adequate methods to monitor, track, and document all changes made to information in the EHR pertaining to the conduct of the clinical investigation.”

Informed Consent

  • “The informed consent for clinical investigations in which EHRs will be used must include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and must also identify all entities who may gain access to the patient’s electronic health record relating to the clinical investigation.”

Privacy & Security of Data

  • “Clinical investigators should comply with any privacy and security requirements applicable to their institution or organization.”

For additional information on best practices regarding the use of EHRs in clinical trials, view the full draft guidance.

Are you developing an FDA-regulated product?  Do you need to submit an application to FDA that involves clinical data?  We can help you achieve a successful interaction with FDA or audit that data and your processes.  To learn more about our services and how we can help you, contact us today.