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HHS is soliciting stakeholder input on the adoption and integration of AI in clinical care, specifically addressing regulatory frameworks, reimbursement models, and research and development priorities. The Department seeks to understand how AI integration would further public trust in modern technology, while safeguarding patient privacy and improving affordability and access. HHS invites comments from clinicians, developers, and others using—or planning to use—AI in clinical care across a broad set of topics, including the three priority areas outlined below.
- Regulation: HHS seeks feedback on how current HHS regulations would impact AI's use in clinical care and how to craft future regulations and policies that are understandable, predictable, and reliable.
- Reimbursement: Recognizing that the traditional fee-for-service model can impede cost-effective innovation, HHS is exploring payment reforms that support reasonable AI adoption. Specifically, the Department wishes to modernize its payment systems and seeks feedback on payment policy changes to ensure its goal of promoting access and affordability of clinical AI use are not undercut by current legacy payment systems.
- Research and Development: HHS is seeking perspectives on applied AI research and development to create long-term market opportunities to improve health outcomes.
HHS also poses targeted questions on topics such as: (i) barriers in the use of AI in clinical care spaces; (ii) priority regulatory, payment policy, and design changes; (iii) novel legal and implementation issues that should be addressed; and (iv) high-impact areas for AI research investment.
This RFI signals the first major effort focused on incorporating AI in clinical care and reimbursement. Stakeholders that weigh in now can help shape a more workable, industry-friendly regulatory response. Comments are due by February 23, 2026.
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