FDA seeks public input on using HL7 FHIR to support real-world data submissions

The US Food and Drug Administration (FDA) is inviting public comment on the potential use of Health Level Seven’s Fast Healthcare Interoperability Resources (HL7 FHIR) standard to support clinical study data submissions derived from real-world data (RWD) sources.

The FDA has established a public docket titled, ‘Exploration of Health Level Seven Fast Healthcare Interoperability Resources for Use in Study Data Created From Real-World Data Sources for Submission to the Food and Drug Administration; Establishment of a Public Docket; Request for Comments’. This initiative seeks input from stakeholders on how HL7 FHIR could be used to standardize and structure clinical study data collected from RWD sources for regulatory purposes.

HL7 FHIR, developed in 2014, was designed to facilitate the exchange of healthcare data across systems. In 2020, the Office of the National Coordinator for Health IT (ONC) published a final rule under the 21st Century Cures Act that officially established HL7 FHIR as a nationwide standard for health data exchange among healthcare delivery organizations.

The FDA stated,

“Given the ubiquity of FHIR-based data elements generated, exchanged, and used in healthcare organizations, and considering the overlap between healthcare data and the information required for clinical research from RWD sources, FDA seeks input from interested parties regarding the range of challenges to be addressed when considering the use of FHIR for submission of clinical study data collected from RWD sources.”

FDA is already applying HL7 FHIR across several ongoing initiatives. These include the Structured Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (PQ/CMC) project, which standardizes data elements in module 3 of the electronic Common Technical Document (eCTD); the Structured Product Labeling (SPL) on FHIR initiative, which explores migrating from HL7 version 3 to FHIR; and the Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) initiative, which uses FHIR to enhance postmarket surveillance through the use of electronic health record data.

To inform future efforts, the FDA is seeking stakeholder perspectives on current challenges with submitting RWD-based clinical study data, potential technical and operational opportunities for adopting HL7 FHIR, and how FHIR might align with federal health IT goals. The FDA is also interested in views on the sufficiency of current data standards and frameworks, such as the US Core Data for Interoperability (USCDI) and the Trusted Exchange Framework and Common Agreement (TEFCA), in supporting clinical research.

Comments may be submitted by interested stakeholders, including regulated industry, academic centers, health IT vendors, and others. This effort aligns with broader Department of Health and Human Services (HHS) priorities to improve interoperability across healthcare and research environments.