Lexology December 23, 2025
Katten Muchin Rosenman LLP

The Department of Health and Human Services (HHS) just issued a major Request for Information (RFI) on artificial intelligence in clinical care. Comments are due February 21, 2026. It is led by the Assistant Secretary for Technology Policy and the Office of the National Coordinator for Health IT, aiming to promote responsible innovation and patient trust.

Here are six things healthcare AI leaders need to know—and do—now:

  1. HHS is pulling three big levers. Regulation, reimbursement, and research and development are front and center to reduce uncertainty and accelerate clinically valuable AI. Expect a “predictable, proportionate-to-risk” posture, especially for non‑device AI where liability, privacy, and security issues loom.
  2. Payment policy is in play. HHS flags that legacy fee‑for‑service can slow...

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Topics: AI (Artificial Intelligence), Govt Agencies, HHS, Technology
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