> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# EHR Data Use Guidance
- URL: https://www.fdaweb.com/ehr-data-use-guidance/
- Published: 2018-07-18T12:00:00.000Z
- Updated: 2026-09-15T00:20:04.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5141898

FDA has published a guidance, *Use of Electronic Health Record Data in Clinical Investigations*, to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties in using electronic health record (EHR) data in FDA-regulated clinical investigations. The [document](http://www.fda.gov/Downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf?ref=fdaweb.com) defines electronic health systems for its purposes as “electronic platforms that contain individual health records for patients. EHR systems are generally maintained by healthcare providers, healthcare organizations, and healthcare institutions and are used to deliver care. EHR systems can be used to integrate real-time electronic healthcare information from medical devices and multiple healthcare providers involved in the care of patients.”

For purposes of the guidance, an EHR is an individual patient record contained within the EHR system. The document has recommendations on: 

- deciding whether and how to use EHRs as a source of data in clinical investigations;
- using EHR systems that are interoperable with electronic data capture systems in clinical investigations;
- ensuring the quality and integrity of EHR data collected and used as electronic source data in clinical investigations; and
- ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirements.

FDA says the goals of the guidance are to **(1)** facilitate use of EHR data in clinical investigations, and **(2)** promote the interoperability of EHR and electronic data capture systems.