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New FDA Draft Guidance on Use of Electronic Health Record Data in Clinical Investigations
Wednesday, May 25, 2016

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies.

Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the potential benefits of such use, on May 17, the US Food and Drug Administration (FDA or Agency) published a draft guidance titled Use of Electronic Health Record Data in Clinical Investigations (Draft Guidance).[1] The Draft Guidance is intended to assist sponsors, clinical investigators, contract research organizations (CROs), institutional review boards, and other interested parties on the use of EHR data in FDA-regulated clinical investigations.

The Draft Guidance seeks to clarify FDA’s expectations where EHRs are used as a data source to support a marketing application for a medical product. While EHRs usually belong to and are under the control of a healthcare organization or institution rather than a clinical study sponsor, sponsors should still be mindful of FDA’s expectations with regard to EHR data, given that FDA’s acceptance of clinical study data sourced from EHRs depends on the Agency’s ability to verify the quality and integrity of such data.[2]


The Draft Guidance is FDA’s third guidance document on the use of computerized systems and electronic source data in clinical investigations. In May 2007, FDA issued guidance on the use of computerized systems in clinical investigations.[3] In September 2013, FDA issued guidance on electronic source data in clinical investigations (eSource Guidance).[4] The eSource Guidance provides recommendations to sponsors, CROs, clinical investigators, and others on the attributes of electronic source data[5] used to fill electronic case report forms (eCRFs) that would meet FDA’s inspection, record retention, and recordkeeping requirements.[6]

The recently published Draft Guidance is FDA’s next step towards modernizing and streamlining clinical investigations. Specifically, FDA’s goals are to (1) facilitate the use of EHR data in clinical investigations and (2) promote the interoperability[7] of EHRs and electronic systems supporting clinical investigations.

The recommendations outlined in the Draft Guidance apply to prospective clinical investigations of human drugs and biological products, medical devices, and combination products. Additionally, the recommendations apply to foreign clinical studies not conducted under an investigational new drug (IND) application or an investigational device exemption (IDE) that are submitted to FDA in support of an application for the marketing approval of a medical product.[8] 

The Draft Guidance does not apply to the use of EHR data

  • in postmarketing observational pharmacoepidemiologic studies designed to assess the risk associated with a drug exposure or designed to test pre-specified hypotheses for such studies; and

  • when used as a recruitment tool for clinical investigations.

Potential Benefits of Using EHR Data and Best Practices

As a result of the enactment in 2009 of the Health Information Technology for Economic and Clinical Health Act (HITECH Act), which incentivized the use of EHRs, the use of EHR data has grown substantially. With this increase in use, there are greater opportunities to improve clinical trial efficiency. For example, EHRs may enable clinical investigators and study personnel to have access to real-time and longitudinal healthcare data for review. Additionally, they may facilitate post-trial follow-up on patients to assess long-term safety and efficacy of drugs and medical devices.

Recognizing the potential value of EHRs to clinical investigators and sponsors, FDA has recommended several best practices to help ensure the accuracy and integrity of data collected in clinical studies when employing a system that integrates data from EHRs and electronic data capture systems. These recommendations include the following:

  • Work with entities that control the EHRs to encourage the use of EHRs and electronic data capture systems that are interoperable.

  • Ensure that the EHRs being used, and the processes and policies for their use, provide source data that is attributable, legible, contemporaneous, original, and accurate.

  • If possible, use EHR technology that has been certified under the Office of the National Coordinator (ONC) Health IT Certification Program. If it is not, consider whether the non-certified systems have adequate controls in place to ensure that the confidentiality, integrity, and reliability of data are preserved.

  • Review the protocol or data management plan to determine if information concerning the use of EHRs during a clinical investigation and a diagram of the electronic data flow between the EHRs and the electronic system is present. Ensure that the data obtained from the EHRs are consistent with the data collection specified in the protocol.

  • Confirm that EHR software updates do not affect the reliability and integrity of the data.

  • Review the informed consent policy to ensure that

  • (1) a statement is present describing the extent to which the confidentiality of records identifying the subject will be maintained;

  • (2) a statement is provided that identifies all entities that may gain access to a patient’s EHR relating to the clinical investigation; and 

  • (3) any foreseeable risks with the use of EHRs (e.g., data breaches) is communicated.

  • Ensure that there are adequate methods to monitor, track, and document all changes made to information in the EHR relating to the conduct of the clinical investigation.

Comment Period

Comments on the Draft Guidance should be submitted to Docket No. FDA–2016–D–1224 by the due date of July 18, 2016, in order to be considered before the final guidance is prepared.

[1]  Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf.

[2] See 21 C.F.R. Parts 312 and 812.

[3] FDA Guidance for Industry, Computerized Systems Used in Clinical Investigations (May 2007), http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.pdf.

[4] FDA Guidance for Industry, Electronic Source Data in Clinical Investigations (September 2013), http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf.

[5] Refers to data initially recorded in electronic format.

[6] For inspection and principal recordkeeping requirements for sponsors and clinical investigators who develop human drugs and biological products, see 21 C.F.R. §§ 312.50, 312.57, 312.58, 312.62, and 312.68. For medical devices, see 21 C.F.R. §§ 812.140 and 812.145.

[7] Refers to the ability of two or more systems or components to exchange information and to use the information that has been exchanged.

[8] See 21 C.F.R. §§ 312.120, 314.106, and 814.15.

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