Shaping FDA, NLM, and NIH Strategies

August 27, 2025
Category:
Regulation

The LTPAC HIT Collaborative recently responded to three Requests For Information (RFIs) from the following federal agencies - (FDA), (NLM), (NIH)

Author:
LTPAC HIT Collaborative

The LTPAC HIT Collaborative recently  responded to three Requests For Information (RFIs) from the following federal agencies - the Food and Drug Administration (FDA), the National Library of Medicine (NLM), and the National Institute of Health (NIH). Scroll down for links to view the files.

  • The FDA RFI focused on challenges and approaches to structuring and standardizing clinical study data, sharing such data via HL7 FHIR and alignment with broader HHS interoperability policies.
  • The NLM RFI asked for insights on research gaps and opportunities regarding underexplored for future biomedical informatics and data science priorities.
  • The NIH RFI sought input designed to shape its AI Strategic Plan and one-year action plan. Common themes addressed strategic pillars and biomedical and public health AI use cases. 

Each response from the Collaborative emphasized the need for and importance of age‑stratified and representative datasets for geriatric and LTPAC populations. We advocated for the adoption of HL7 FHIR and PACIO data exchange standards. These standards support transitions of care, functional status, and cognitive status. We further stressed the importance of relying on clinical guidelines applicable to the geriatric and LTPAC populations (like those developed by PALTMed) in training AI tools. Finally, the Collaborative called for more appropriate guardrails for AI/ML tools serving under-resourced settings to ensure safety, equity, and real‑world impact for the populations they serve.

Link to FDA file:

Click here to view the FDA Comments from the LTPAC HIT Collaborative

Link to NLM file:

Click here to view the NLM Comments from the LTPAC HIT Collaborative

Link to NIH file: 

Click Here to view the NIH Comments from the LTPAC HIT Collaborative

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