Reminder: Comments to the HHS Request for Information on Accelerating AI Adoption in Clinical Care
As outlined in previous communications, the Department of Health and Human Services (HHS) has issued a significant Request for Information (RFI) seeking broad public comment on how the agency can accelerate the adoption and use of artificial intelligence as part of clinical care. Published in the Federal Register on December 23, 2025, this RFI represents a critical opportunity for stakeholders across the healthcare and technology sectors to shape federal policy on AI in medicine.
The deadline to submit comments is February 23, 2026. Given the potential impact of this initiative on healthcare delivery, innovation, and patient outcomes, interested parties should take advantage of this valuable opportunity to help shape formative federal policy.
Background and Purpose
This RFI emerges from HHS’s December 2025 AI Strategy, developed in response to Office of Management and Budget Memorandum 25-21 and recent Executive Orders on artificial intelligence. The initiative reflects a OneHHS approach, bringing together expertise from across the Department, including the Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Medicare & Medicaid Services (CMS), and the Office of the National Coordinator for Health Information Technology (ONC).
HHS is seeking concrete, experience-based feedback from a wide range of stakeholders, including those who are building, buying, evaluating, using, or receiving care from AI tools. Importantly, the agency also wants to hear from those who wish to leverage AI in clinical care but currently face barriers to doing so.
Why Your Input Matters
This RFI presents a valuable opportunity for commenters to directly influence the federal government’s approach to AI in clinical care at a formative stage. By participating, stakeholders can:
- Identify specific regulatory barriers that hinder AI development and deployment.
- Advocate for reimbursement policies that support innovation and patient access.
- Highlight successful AI implementations that deserve broader support.
- Flag legal and governance challenges that require federal attention.
- Help direct HHS research priorities and funding mechanisms.
Comments that include concrete examples, specific regulatory citations, and evidence-based recommendations are likely to carry particular weight as HHS develops its policies.
This RFI represents a meaningful opportunity to influence how the federal government approaches AI in healthcare. With AI technologies advancing rapidly and their applications in clinical settings expanding, the policies that emerge from this process could have lasting implications for innovation, patient care, and the healthcare industry as a whole.
Three Key Focus Areas
The RFI is organized around three primary approaches through which HHS can influence AI adoption in healthcare:
Regulation
As the nation’s principal health regulator, HHS shapes the environment in which AI for clinical care is developed, evaluated, and deployed. The agency seeks to establish a regulatory posture that is well understood, predictable, and proportionate to any risks presented. HHS is asking how current regulations impact AI adoption and use for clinical care, with the goal of enabling rapid innovation while protecting patients and maintaining public trust.
Reimbursement
Recognizing that payment policies have massive effects on healthcare delivery, HHS is seeking feedback on how to modernize legacy payment systems to support AI innovation. The agency acknowledges that fee-for-service regimes can be slow to cover new innovations and wants to ensure that the potential of AI is not diminished through inertia. Commenters are encouraged to address payment policy changes that would promote access to high-value AI clinical interventions, foster competition among AI tool builders, and accelerate affordability.
Research and Development
HHS supports one of the world’s largest health research ecosystems and seeks input on how to better translate AI technologies from concept to clinical use. The agency is interested in public-private partnerships, cooperative research and development agreements (CRADAs), and other mechanisms to integrate AI into care delivery and create long-term market opportunities.
Specific Questions for Comment
In addition to feedback on the three focus areas above, HHS has posed ten specific questions for public comment:
- What are the biggest barriers to private sector innovation in AI for healthcare and its adoption in clinical care?
- What regulatory, payment policy, or programmatic changes should HHS prioritize to incentivize effective AI use? Commenters are encouraged to provide specific Code of Federal Regulations citations.
- For non-medical devices, what novel legal and implementation issues exist regarding liability, indemnification, privacy, and security, and what role should HHS play in addressing them?
- What are the most promising AI evaluation methods (pre- and post-deployment) for clinical care, and should HHS support these processes through contracts, grants, cooperative agreements, or prize competitions?
- How can HHS best support private sector activities such as accreditation, certification, industry-driven testing, and credentialing?
- Where have AI tools met or exceeded expectations, and where have they fallen short? What novel AI tools would have the greatest potential impact?
- Which roles, decision makers, or governing bodies within healthcare organizations have the most influence on AI adoption, and what are the primary administrative hurdles?
- Where would enhanced interoperability widen market opportunities and accelerate AI development? Consider specific data types, standards, and benchmarking tools.
- What challenges do patients and caregivers wish to see addressed by AI, and what concerns do they have?
- Are there specific areas of AI research HHS should prioritize, and what does the existing literature say about the costs, benefits, and impacts of AI in clinical care?
Commenters may consider responding to some or all of the specific questions.
Important Considerations for Commenters
Comments must be submitted through the Federal eRulemaking Portal, mail, or hand delivery.
All comments received before the deadline will be made available for public inspection at www.regulations.gov. Commenters should not include any information they do not wish to share publicly, including Social Security numbers, dates of birth, financial account numbers, personal health information, or proprietary business information.
