On December 19, 2025, the Office of the Deputy Secretary and Assistant Secretary for Technology Policy (ASTP) and Office of the National Coordinator for Health Information Technology (ONC) (ASTP/ONC) announced the release of a Request for Information (RFI) seeking broad public input on questions for how the U.S. Department of Health and Human Services (HHS) can accelerate the adoption and use of artificial intelligence (AI) as part of clinical care.

Comments are due February 21, 2026, within 60 days from publication in the Federal Register (expected December 23, 2025).

According to the RFI, responses are intended to inform HHS’s approach to updating regulations, reimbursement, and research and development related to using AI in clinical care. The stated intent is to support the rapid adoption and use of AI in clinical care, foster public trust, and reduce uncertainty that impedes AI innovation, and align federal incentives so that AI improves efficiency, lowers costs, and improves health outcomes.

Regulation

HHS seeks to establish a regulatory clear, risk-based position on AI and clinical care and noted the importance of protecting patients and confidentiality of identifiable health information. The RFI asks questions related to HHS’s regulatory approach, including specifically:

• What regulatory, payment policy, or programmatic design changes should HHS prioritize to incentivize the effective use of AI in clinical care, and why?
• What HHS regulations, policies, or programs could be revisited to augment your ability to develop or use AI in clinical care? Please provide specific changes and applicable Code of Federal Regulations citations.

There are a number of other related questions raised in the RFI related to governance, liability, evaluation and testing, and interoperability.

Reimbursement

HHS noted inherent flaws in legacy payment systems. The RFI calls out fee-for-service regimes, stating that coverage and reimbursement decisions are slow and covering new innovations rarely reduces spending. HHS is seeking feedback on payment policy changes that ensure payers have the incentive and ability to promote access to high-value AI clinical interventions, foster competition among clinical care AI tool builders, and accelerate access to an affordability of AI tools for clinical care.

Research and Development

In the RFI, HHS seeks input on ways in which HHS may invest in research and development (including public-private partnerships and cooperative research and development agreements) to integrate AI in care delivery and create new, long-term market opportunities that improve the health and wellbeing of Americans.

Takeaways

This RFI provides an opportunity for stakeholders focused on developing and implementing AI for clinical use to identify legal, reimbursement, and practical barriers resulting from existing frameworks and to offer input and recommendations, including for priority research areas, payment updates, promising workflow and evaluation methods, and how HHS can help support and promote clinical use of AI.

For more information, please contact Jodi Daniel, Lidia Niecko-Najjum, or any member of Wilson Sonsini’s Digital Health practice.