6 Things Healthcare Leaders Need to Know About HHS’s New AI RFI

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 uptake and is looking for concrete payment pathways that reward proven value, widen access, and spur competition. Bring real‑world proposals inclusive of incentives and pathways for payers to promote access and affordability of AI clinical interventions.
3. R&D and partnerships will matter. The RFI invites ideas for targeted investments, public‑private partnerships, and cooperative research and development agreements (CRADAs) to move AI from pilot to practice and create durable markets.
4. The questions signal HHS’s roadmap. HHS asks you to identify practical barriers, cite specific rules to fix (include CFR cites), and propose robust pre‑ and post‑deployment evaluation for non‑device AI that is human‑centered and workflow‑aware. It also probes accreditation and credentialing needs, decision‑makers inside health systems, interoperability opportunities, and what patients most want from AI, as well as what they may fear.
5. This aligns with the federal AI playbook. The RFI connects to the HHS AI Strategy and recent OMB guidance, and coordinates with FDA, NIH, and CMS efforts—so expect cross‑agency coherence.
6. Your voice can shape the market. Thoughtful comments can influence regulatory clarity, coverage pathways, evaluation expectations for non‑device AI, and market infrastructure that supports workflow‑integrated adoption.

How to comment: Submit via Regulations.gov or by mail. HHS will post timely submissions publicly (so do not include PII, PHI, or confidential business information you do not want disclosed).

What to do next:

• Prioritize your asks. Focus on 2–3 barriers and specific policy fixes HHS can adopt.
• Map evidence to payment. Align your validation plans and use‑case outcomes to reimbursement levers.
• Explain lifecycle oversight. Describe pre‑deployment testing, ongoing monitoring, and mitigation for non‑device AI.
• Leverage interoperability. Identify standards and data flows that unlock scale and benchmarking.

If you are preparing comments or want to align governance, contracting, and compliance with the RFI’s direction, we can assist. We advise health systems, technology companies, physicians/providers, and investors on strategy, drafting persuasive submissions, and building practical guardrails for safe, scalable adoption.