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USFDA Public Consultation: HL7 FHIR for Study Data from Real-World Data

The U.S. Food and Drug Administration (FDA) has announced a major initiative by opening a public docket seeking comments on the "Exploration of Health Level Seven Fast Healthcare Interoperability Resources for Use in Study Data Created from Real-World Data Sources for Submission". Published on 23 April 2025 under Docket No. FDA-2025-N-0287, this marks a critical step in modernizing regulatory submissions and aligning with the broader Department of Health and Human Services (HHS) Health IT goals.


This initiative reflects the FDA’s efforts to advance digital health technologies, promote interoperability, and harmonize clinical research practices with healthcare data standards.


Real-World Data (RWD) is defined as:

“Data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources” (FDA 2024).

HL7 FHIR

A standard for exchanging healthcare information electronically, designed for interoperability.


The FDA aims to streamline the submission of clinical study data collected from RWD sources (e.g., electronic health records, claims databases, registries) by leveraging HL7 FHIR. This effort seeks to:

  • Enhance interoperability between healthcare and clinical research systems.

  • Reduce burdens on sponsors by aligning with existing HHS health IT standards.

  • Improve data quality for regulatory decision-making.

The Agency is soliciting feedback on technical, operational, and strategic challenges in adopting FHIR for RWD submissions.


Why HL7 FHIR?

HL7 FHIR is already widely adopted in U.S. healthcare systems due to:

  • API-driven architecture: Enables seamless data exchange between systems.

  • Alignment with USCDI: Over 80 standardized data elements (e.g., patient demographics, lab tests) are accessible via FHIR.

  • Federal mandates: The 2020 Cures Act and 2024 HTI-1 Final Rule require FHIR for health IT certification.


FDA’s Ongoing FHIR Initiatives

The FDA highlights several projects using FHIR to modernize regulatory processes:

  1. BEST Innovative Methods (IM) Platform:

    • FHIR-based system for detecting adverse events from EHRs.

    • Piloted in studies to validate semi-automated adverse event reporting.

  2. Common Data Model Harmonization (CDMH):

    • Maps FHIR US Core elements to clinical research standards (e.g., CDISC SDTM).

  3. Structured Product Labeling (SPL) on FHIR:

    • Explores transitioning from HL7 v3 to FHIR for product labeling submissions.

  4. Pharmaceutical Quality/CMC Data Standardization:

    • Uses FHIR to automate analysis of manufacturing data.


Challenges & Opportunities for Stakeholders

The FDA seeks feedback on five critical areas:

1. Industry Challenges with Current RWD Submissions

  • Fragmented data formats (e.g., varying EHR systems).

  • High costs for data transformation and validation.

2. FHIR Adoption Opportunities

  • Potential benefits: Reduced data cleaning efforts, improved traceability.

  • Technical hurdles: Integration with legacy clinical trial systems (e.g., EDC platforms).

3. Alignment with ASTP/ONC Goals

  • Can USCDI v3 support RWD collection for research?

  • Should “Research” be added as a TEFCA exchange purpose?

4. Regulatory Implications

  • How will FHIR-based submissions impact existing standards (e.g., CDISC)?

  • Need for FHIR implementation guides tailored to FDA requirements.

5. Data Privacy & Security

  • Balancing interoperability with HIPAA compliance.


Impact on the Pharmaceutical Industry

  • Sponsors: May need to invest in FHIR-compatible data pipelines.

  • CROs/Technology Vendors: Opportunity to develop FHIR-based tools for RWD aggregation.

  • Regulatory Teams: Prepare for potential updates to FDA’s Data Standards Catalog.


Comments are to be submitted electronically via regulations.gov, and the docket will remain open for 60 days after publication. By adopting FHIR, the Agency aims to reduce redundancies and improve the reliability of real-world evidence (RWE) used in regulatory decisions. Stakeholders are encouraged to participate in this critical dialogue to shape the future of RWD submissions.


For the full Federal Register notice, visit: FDA Docket FDA-2025-N-0287

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