7th Global Gastroenterology and Artificial Intelligence Summit (Live)

4 - Roehrenbeck

Pdf Summary

The current U.S. legislative landscape on artificial intelligence (AI) in healthcare is in an early, exploratory phase, with congressional caucuses and debates focusing on the innovation and regulation of AI technologies. Much of the legislation tends to defer to executive branch leadership, indicating ongoing development of federal AI policies.<br /><br />Key proposed bills include:<br /><br />1. The Health Tech Investment Act (S.1399) aims to establish a new payment classification for Algorithm-Based Healthcare Services (ABHS), which involve AI or machine learning software approved by the FDA to assist clinicians in screening, diagnosing, or treating patients. This classification would ensure reimbursement for at least five years to encourage innovation in AI healthcare tools.<br /><br />2. The SANDBOX Act proposes creating a federal "regulatory sandbox" to allow controlled experimentation and development of AI technologies. This framework aligns with the White House AI Action Plan and has significant implications for the FDA and other agencies overseeing AI medical devices and Software as a Medical Device (SaMD).<br /><br />3. The Health Technology Act of 2025 (H.R. 238) seeks to clarify that AI and machine learning technologies can qualify as authorized practitioners capable of prescribing medications if state laws and FDA clearance permit. The bill also highlights congressional attention to both the risks posed by AI chatbots and the benefits of AI in combating fraud and abuse in federal healthcare programs. <br /><br />Overall, U.S. healthcare AI legislation is emerging but still evolving, with policymakers balancing innovation, regulation, and oversight to integrate AI effectively and safely into healthcare delivery. Further legislative and regulatory efforts are expected in this rapidly developing area.

Keywords

U.S. healthcare AI legislation

Health Tech Investment Act

Algorithm-Based Healthcare Services

FDA AI approval

SANDBOX Act

regulatory sandbox for AI

Software as a Medical Device

Health Technology Act of 2025

AI prescribing authority

AI regulation in healthcare