HHS Seeks Input on Systemic Approach to Healthcare AI Regulation

In the wake of the President’s recently promulgated Executive Order, “Ensuring a National Policy Framework for Artificial Intelligence,” on December 19, 2025, the Department of Health and Human Services (HHS) issued a broad Request for Information (RFI) that could reshape how artificial intelligence is developed, deployed, and reimbursed in healthcare settings. For healthcare organizations, AI developers, and the patients they serve, this RFI represents an unprecedented opportunity to influence federal policy at a formative stage, and HHS should be lauded for soliciting feedback from those working in the healthcare AI trenches.

HHS has published an RFI seeking "broad public comment on what HHS can do to accelerate the adoption and use of AI as part of clinical care." The RFI follows the HHS AI Strategy released earlier this month and aligns with the Administration's broader AI Action Plan and recent Executive Orders on artificial intelligence.

The RFI’s scope is notable. HHS is not merely asking about regulatory tweaks—it is soliciting input across three interconnected policy domains: regulation, reimbursement, and research and development. HHS's stated goals are ambitious: "support the rapid adoption and use of AI in clinical care, to foster public trust and confidence in modern technology solutions, to reduce uncertainty that impedes AI innovation, and to align federal incentives so that AI is deployed in ways that enhance productivity, reduce burden, lower health care costs, and improve health outcomes for patients, caregivers, and communities."

This is not HHS's first foray into AI policy. The RFI acknowledges that over the past year, various arms of HHS have sought public feedback on AI-related matters. This RFI represents a coordinated, department-wide effort to hear from "those building, buying, evaluating, using, and receiving care from AI tools that are part of clinical care as well as from those who wish to do so but face barriers."

Key Questions Put to Stakeholders

The RFI poses ten specific questions that merit attention from anyone building or deploying healthcare AI.

Several questions focus on barriers and enablers: What are the biggest barriers to private sector AI innovation? Which decision-makers within healthcare organizations most influence AI adoption? Where would enhanced interoperability widen market opportunities and accelerate AI development?

Others address evaluation and accountability: What are the most promising AI evaluation methods for clinical care, both pre- and post-deployment? Where have AI tools met or exceeded expectations, and where have they fallen short?

Perhaps most consequential for the long-term development of healthcare AI policy is Question 3, which asks about "novel legal and implementation issues that challenge existing governance and accountability structures (e.g., relating to liability, indemnification, privacy, and security)" for non-medical device AI tools.

What Comes Next

The RFI comment period runs 60 days from publication in the Federal Register. For healthcare AI stakeholders, this is an opportunity to shape policy at a formative moment. The questions HHS is asking—about barriers to innovation, liability frameworks, evaluation methods, and reimbursement structures—will influence how AI is developed and deployed in clinical settings for years to come. The most constructive responses will likely be those grounded in practical experience: where AI tools have delivered measurable value, where they have fallen short, and what policy changes would enable responsible innovation. HHS has explicitly sought "concrete, experience-based feedback" rather than abstract position statements. As healthcare AI continues to evolve, the frameworks we establish now will determine whether these technologies enhance the capabilities of skilled clinicians or create new risks that outpace our ability to manage them. The RFI suggests HHS understands the stakes. The questions are whether stakeholders will engage with the specificity and candor the moment requires and whether HHS use that input to strike the delicate balance between innovation, on the one hand, and safety, security, and trustworthiness, on the other.

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