HHS Seeks Input on Adoption of AI in Clinical Care and Strengthening Supply Chain Resilience

Overview

Recent notices published in the Federal Register highlight a series of initiatives undertaken by the Department of Health and Human Services (HHS) and related federal agencies aimed at strengthening the public health supply chain and accelerating the adoption of artificial intelligence (AI) in clinical care.

These efforts reflect a coordinated federal strategy to enhance health system resilience, modernize regulatory and reimbursement frameworks, and foster innovation through stakeholder engagement.

Public Health Supply Chain Initiatives

HHS, in collaboration with the White House and other federal entities, is pursuing a multi-year plan to fortify the public health supply chain. Key actions include reducing reliance on foreign sources, enhancing domestic manufacturing, and improving emergency preparedness.

Notably, the establishment of the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) is designed to secure a domestic supply of essential drug components.

To support these objectives, HHS is seeking a three-year extension of its Paperwork Reduction Act clearance, which will enable continued data collection from a broad spectrum of stakeholders, including state, local, tribal, and territorial governments; private sector companies; healthcare providers; manufacturers; and community organizations.

Engagement mechanisms range from surveys and town halls to focus groups and instrumented data collection, with an estimated total burden of over 350,000 hours across a three-year period. The information gathered will inform coordinated stockpiling plans and other preparedness activities.

Accelerating AI Integration in Clinical Care

HHS has issued a Request for Information (RFI) seeking public comments on strategies to accelerate the adoption and use of AI in clinical care. This initiative aligns with the HHS Artificial Intelligence Strategy and recent White House directives, emphasizing a unified approach to embedding AI in agency operations while safeguarding patient privacy and civil rights.

The RFI seeks input on three primary policy levers:

1. 1. Regulation: HHS aims to establish a clear and predictable regulatory environment for AI in clinical care, striking a balance between rapid innovation and patient protection, while maintaining public trust. Stakeholders are invited to comment on how existing regulations impact AI adoption and what changes could facilitate effective use.
   2. Reimbursement: Recognizing the limitations of legacy payment systems, HHS is exploring payment policy reforms to incentivize access to high-value AI interventions, foster competition, and accelerate affordability. Feedback is sought on how reimbursement structures can better support AI innovation.
   3. Research and Development: HHS supports extensive health research and is interested in ways to invest in AI research and development, including public-private partnerships and cooperative agreements, to translate AI technologies from concept to clinical application.

Specific Areas for Stakeholder Feedback

The RFI poses targeted questions to stakeholders, including:

• • Barriers to private sector innovation and adoption of AI in healthcare;
  • Regulatory and payment policy changes that are needed to incentivize effective AI usage;
  • Legal and implementation challenges for non-medical device AI tools;
  • Promising evaluation methods and metrics for AI in clinical care;
  • Support for private sector accreditation and certification activities;
  • Performance and cost outcomes of deployed AI tools;
  • Influential roles and administrative hurdles within healthcare organizations;
  • Opportunities for enhanced interoperability and data standards;
  • Patient and caregiver challenges and concerns regarding AI adoption; and
  • Priority areas for AI research to accelerate clinical integration.

Comments are due by February 23, 2026, and will inform future HHS policy and program design.

Implications for Businesses and Stakeholders

• • These federal initiatives present significant opportunities for businesses involved in healthcare, technology, manufacturing, and supply chain management.
  • Stakeholder engagement is central to shaping policies that will impact regulatory compliance, reimbursement strategies, and innovation pathways.
  • Companies developing or deploying AI tools in clinical care, as well as those involved in public health supply chain activities, should consider participating in the comment process to ensure their perspectives are reflected in future federal actions.
  • The evolving landscape underscores the importance of proactive engagement with federal agencies to navigate regulatory changes, leverage new funding and partnership opportunities, and contribute to the modernization of the US healthcare system.