8th Global Gastroenterology and Artificial Intelligence Summit Separating AI Hype from Clinical Reality | September 2026-11

11 - Curtis_AI and the Federal Agenda

Pdf Summary

The document summarizes the rapidly changing federal policy landscape for healthcare AI and digital health. It notes that the Trump Administration prioritized getting healthcare AI to market, with major shifts at the FDA and CMS. Congress has shown strong interest in AI, but little substantial legislation has passed. There is bipartisan support for some regulation, though many issues remain politically divided. State AI actions are increasingly influencing federal policy, and public concern about AI safety has grown.<br /><br />At the FDA, the approach is generally deregulatory for lower-risk tools. Key actions include guidance for general wellness devices, clinical decision support, and a discussion paper on generative AI. The FDA is developing a risk-based framework that considers patient risk and system autonomy, using pre-market benchmarking and clinical confirmation, plus post-market monitoring. Open questions remain about foundational models and agentic AI.<br /><br />CMS is also pushing to expand digital health and AI adoption, but payment pathways remain limited. The agency is exploring reimbursement through the Physician Fee Schedule, including proposals for tech-enabled care and autonomous clinical AI. The ACCESS model would pay technology companies based on outcomes for chronic care programs, while the TEMPO pilot would let digital health products build evidence for FDA authorization within ACCESS.<br /><br />The document also highlights growing attention to autonomous clinical AI, including state pilots like Utah’s, model legislation, and possible national licensure approaches.<br /><br />Finally, the AMA’s priorities are outlined: oppose autonomous AI acting independently, address liability, support payment pathways for AI tools, and reject AI-driven claims denials without human review and appeal rights.

Keywords

healthcare AI

digital health

FDA regulation

CMS reimbursement

autonomous clinical AI

risk-based framework

generative AI

clinical decision support

physician fee schedule

AI policy