FDA seeks input on using HL7 FHIR standard for collecting RWD

The US Food and Drug Administration (FDA) announced Tuesday it is seeking feedback from industry and other stakeholders on using Health Level Seven’s (HL7) Fast Healthcare Interoperable Resources (FHIR) standard for leveraging real-world data into regulatory submissions.

This initiative arises as the FDA seeks to standardize clinical study data collected from real-world data sources for regulatory submissions.

The notice requesting feedback states, “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.”

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

The FDA has announced several current initiatives already use the HL7 FHIR standards. These include the Structured Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (PQ/CMC) project, which aims to standardize the data elements in module 3 of the electronic Common Technical Document (CTD).

Another initiative is the Structured Product Labeling (SPL) on FHIR, which explores potential methods for transitioning SPL submissions from HL7 version 3 to HL7 FHIR.

Additionally, the Center for Biologics Evaluation and Research (CBER) is using FHIR in its Biologics Effectiveness and Safety (BEST) initiative to enhance postmarket surveillance capabilities through using electronic health records.

FDA is requesting public comment on several questions, including:

What challenges does the pharmaceutical industry face with the current submission of clinical study data from RWD sources to the FDA?
What opportunities and challenges do you see for the pharmaceutical industry in achieving a future state of clinical study data submissions collected from real-world data (RWD) sources using HL7 FHIR? Consider aspects such as business processes and technical considerations.
What suggestions do you have for how the FDA can achieve a future state of clinical study data submissions collected from real-world data sources?

Stakeholders have 60 days to comment.

Notice

FDA seeks input on using HL7 FHIR standard for collecting RWD

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