In a 2026 JAMA article, researchers proposed a federal licensure framework for autonomous clinical artificial intelligence (AI) systems.
The framework would require AI systems to pass standardized medical exams, complete a supervised clinical deployment period, operate within a defined scope of practice, undergo ongoing performance monitoring, and comply with clear accountability requirements for developers and health care organizations. The authors also propose creating an Office of Clinical AI Oversight within the Department of Health and Human Services to administer the program and establish national standards. Under the framework, congressional action would create a federal regulatory system that preempts conflicting state AI laws while allowing states to retain authority over scope-of-practice, supervision, and enforcement issues.
The proposal follows FDA’s recent discussion paper, Considerations for the Regulation of Generative AI-Enabled Medical Devices, which was released to solicit stakeholder feedback on regulatory approaches for generative AI-enabled medical devices. The paper examines topics including risk assessment, premarket evaluation, postmarket monitoring, and other considerations relevant to the regulation of AI-enabled medical technologies.
Learn more about the Licensure Framework for Autonomous Clinical AI.
Last Updated on August 25, 2026 by Aimed Alliance
