HHS Seeks Public Input on Expanding AI in Clinical Care

Federal health officials are seeking public input about AI in clinical care and how the technology is adopted and regulated in those settings, as Wilson Sonsini writes in a recent alert.

In a newly issued Request for Information (RFI), the U.S. Department of Health and Human Services (HHS) signaled interest in accelerating clinical AI deployment while addressing patient safety, trust, and systemic barriers that slow innovation.

The effort is designed to inform future regulatory, reimbursement, and research strategies affecting healthcare providers, developers, and payers.

The RFI was issued on December 19, 2025, with public comments due in February 2026. The agency framed the inquiry around aligning federal incentives to promote efficiency, reduce costs, and improve outcomes through AI-enabled tools.

The initiative reflects concerns that the existing legal and payment frameworks may discourage adoption of AI, despite its growing technical capability and market interest.

On regulation, the agency asked how a clear, risk-based framework could protect patients and health data while supporting innovation, including questions on governance, liability, testing, and interoperability. On reimbursement, HHS questioned whether fee-for-service models inhibit uptake of high-value AI tools. It invited proposals to encourage competition, affordability, and access.

As for research and development, the agency requested recommendations for targeted investments, including public-private partnerships, to integrate AI into care delivery and establish sustainable markets.

Attorneys should view the RFI as an opportunity to influence policy at an early stage. Responses may shape how clinical AI is regulated, paid for, and evaluated, with downstream implications for compliance, contracting, and liability.

Legal teams advising healthcare organizations, technology developers, and investors should consider engaging in the process. It poses an opportunity to address legal uncertainty, payment misalignment, and research priorities before agency positions become binding rules.

As reported, AI is increasingly central to healthcare cybersecurity, serving as both a tool for defense and a generator of attacks.