HHS seeks info to guide AI regulation, reimbursement

HHS has released a Request for Information, or RFI, seeking public input on how the agency can use its regulatory, reimbursement and research and development capabilities to support AI adoption in healthcare.

HHS is asking stakeholders to offer feedback on how digital health and software regulations should evolve to spur adoption of AI tools while maintaining patient safety, how reimbursement structures can be simplified and aligned to support health AI technology use and how research and development investment can strengthen AI implementation, especially in complex clinical cases.

The goal is to accelerate AI adoption in ways that enhance patient experiences and outcomes, alleviate provider burden and lower healthcare costs.

"Artificial intelligence will be a transformative force for good across America," said HHS Deputy Secretary Jim O'Neill, in the news release. "We want to hear from you. Our efforts to accelerate AI adoption must be guided by the real needs and experiences of those developing these tools and delivering care."

In a blog post, Steven Posnack, principal deputy assistant secretary for technology policy, noted that HHS is "especially interested in comments from those building AI tools for clinical settings, those buying or implementing AI tools for clinical settings, and those who want to use AI in clinical care but face barriers."

The agency is also seeking input on longer-term challenges facing health systems, including addressing emerging or increasing conditions, such as dementia.

The RFI document is scheduled to be published in the Federal Register on Dec. 23, 2025. Comments will be due 60 days after publication.

The RFI comes on the heels of changes in the federal stance on AI regulation. After President Donald Trump rescinded a Biden-era executive order mandating trustworthy AI development and deployment, U.S. states took it upon themselves to regulate health AI. According to legal and consulting firm Manatt, 47 states have introduced over 250 AI bills impacting healthcare in 2025.

Of these, 33 were passed and enacted into law in 21 states. The bills focused on AI chatbots, especially those related to mental healthcare, the use of AI in clinical care, payer use of AI and the emergence of 'AI Sandboxes' for testing tools.

However, earlier this month, President Trump signed an executive order aimed at establishing a "minimally burdensome national policy framework for AI." According to the executive order, state-by-state regulations are creating a confusing patchwork of laws that stifles innovation, and some states require AI models to include ideological biases.

The executive order mandates that the attorney general establish an AI Litigation Task Force to challenge state laws inconsistent with the "minimally burdensome" national policy framework and requires federal regulators to withhold Broadband Equity Access and Deployment Program funds from states with "onerous AI laws."

Anuja Vaidya has covered the healthcare industry since 2012. She currently covers the virtual healthcare landscape, including telehealth, remote patient monitoring and digital therapeutics.