The Department of Health and Human Services (HHS) has issued a significant Request for Information (RFI) aimed at advancing the use of artificial intelligence (AI) in clinical care. Comments on the RFI are due by February 21, 2026, and the initiative is spearheaded by the Assistant Secretary for Technology Policy alongside the Office of the National Coordinator for Health IT. The primary goal is to foster responsible innovation while enhancing patient trust in AI technologies.
As HHS undertakes this effort, it is utilizing three critical levers: regulation, reimbursement, and research and development. The department aims to mitigate uncertainty surrounding AI applications in healthcare and to expedite the integration of clinically valuable AI solutions. Industry experts can anticipate a regulatory framework characterized by a “predictable, proportionate-to-risk” approach, particularly regarding non-device AI, where issues related to liability, privacy, and security are prevalent.
Payment policies are also under scrutiny. HHS has identified that legacy fee-for-service models could hinder the adoption of AI technologies. The agency is therefore seeking clear payment pathways that not only reward demonstrated value but also expand access and stimulate competition among healthcare providers. Stakeholders are encouraged to present real-world proposals that include incentives for payers, aimed at promoting access and affordability for AI-driven clinical interventions.
Additionally, the RFI opens the door for targeted investments and collaborations in research and development. HHS is inviting ideas for public-private partnerships and cooperative research and development agreements (CRADAs) to transition AI applications from pilot phases into regular practice and to establish sustainable markets for these technologies.
The questions posed in the RFI highlight HHS’s strategic roadmap. The agency is seeking input on practical barriers that hinder AI implementation, specific regulatory rules that require revision, and robust evaluation frameworks for the deployment of non-device AI. This includes a focus on human-centered design and awareness of healthcare workflows. HHS is also probing accreditation and credentialing requirements, decision-making processes within health systems, interoperability opportunities, and understanding patient preferences and concerns regarding AI technologies.
This RFI aligns with broader federal AI strategies, connecting with the HHS AI Strategy and recent guidance from the Office of Management and Budget (OMB). It also aims to ensure coherence across various federal agencies, including the FDA, NIH, and CMS, signaling a comprehensive approach to the integration of AI in healthcare.
Industry stakeholders are encouraged to actively participate, as their feedback can significantly influence regulatory clarity, coverage options, evaluation standards for non-device AI, and the overall infrastructure that supports seamless adoption in clinical workflows. To contribute comments, stakeholders can submit their feedback through Regulations.gov or by mail, with HHS committing to publicly post submissions, thus urging contributors to refrain from including personally identifiable information or proprietary business details.
As organizations prepare their responses, it is advisable to prioritize critical requests, focusing on two to three barriers and specific policy adjustments that HHS could undertake. Mapping evidence to payment structures is essential, aligning validation plans with reimbursement mechanisms. Stakeholders should also detail lifecycle oversight, encompassing pre-deployment testing and ongoing monitoring for non-device AI technologies. Additionally, identifying interoperability standards and data flows will be key to unlocking scalability and benchmarking in AI applications.
The announcement marks a pivotal moment in the intersection of technology and healthcare, with the potential to reshape how AI is utilized to enhance patient care. As the conversation around AI in clinical settings evolves, the collective input from healthcare leaders and innovators will be crucial in shaping a landscape that prioritizes both innovation and patient safety, paving the way for a future where AI-driven solutions are integrated into everyday clinical practice.
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