FDA Issues Final Guidance on Use of EHR Data in Clinical Investigations


Posted August 2, 2018

As part of the Food and Drug Administration’s (FDA’s) ongoing effort to streamline and modernize clinical investigations, the agency has issued final guidance that specifies when and how researchers can use data from electronic health records (EHRs) to assess the safety and efficacy of medical devices, combination products, and other healthcare products. 

The final guidance, Use of Electronic Health Record Data in Clinical Investigations, provides recommendations for study sponsors, clinical investigators, contract research organizations, institutional review boards, and others on incorporating EHR data collected in routine care settings, such as a doctor’s office, in FDA-regulated clinical investigations. The guidance also encourages increased collaboration between study sponsors, healthcare organizations, EHR vendors, and electronic data capture (EDC) system vendors to improve the interoperability and integration of EHR and EDC systems by employing open data standards. 

“Harnessing the real-world data being captured in electronic health records enables clinical investigators to collect data from routine medical care and generate scientific evidence that’s appropriate for regulatory decision making and helps generate accurate, science-based information healthcare professionals and patients need to use medical products to maintain and improve public health,” said Jacqueline Corrigan-Curay, director of the Office of Medical Policy in the FDA’s Center for Drug Evaluation and Research, in a statement

One benefit of using EHR data, which can include clinical notes, diagnoses, physician orders, and lab results, is that it can be combined, aggregated, and analyzed, providing more accurate data and greater efficacy in clinical trials, according to the guidance document.

“EHRs may have the potential to provide clinical investigators and study personnel access to real-time data for review and can facilitate post-trial follow-up on patients to assess long-term safety and effectiveness of medical products,” the FDA wrote. “In addition, there are opportunities for long-term follow up of large numbers of patients, which may be of particular importance in studies where the outcome of interest occurs rarely, such as in prophylaxis studies.” 

The FDA does not regulate EHRs; however, according to the guidance, its “acceptance of data from clinical investigations for decision-making purposes depends on FDA’s ability to verify the quality and integrity of the data during FDA inspections.” To that end, the final guidance provides recommendations on: 

  • Deciding whether and how to use EHRs as a source of data in clinical investigations 

  • Using EHR systems that are interoperable with EDC systems in clinical investigations 

  • Ensuring the quality and integrity of EHR data collected and used in clinical investigations 

  • Ensuring that the use of EHR data collected and used in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirements 

The final guidance applies to prospective clinical investigations of drugs and biological products, medical devices, and combination products (including investigations conducted in clinical practice settings), as well as foreign clinical studies not conducted under an investigational new drug application or an investigational device exemption. 

According to the FDA, the guidance does not apply to: 

  • EHR data used in postmarket observational pharmacoepidemiologic studies designed to assess adverse events and risks associated with drug exposure 

  • The use of EHR data to evaluate the feasibility of a trial design or as a recruitment tool for clinical investigations 

  • Data collected for registries and natural history studies 

  • Data collected from mobile and telehealth technology, medical devices, remote monitoring devices, assistive technologies, or sensors