As a novel tool, AI raises significant regulatory challenges related to safety, efficacy, privacy, and ethics. As the global investment leader in digital health, the U.S. is experiencing a significant influx and adoption of AI technologies in various healthcare applications, from diagnostics and personalized medicine to administrative tasks and operations. While attracting substantial investment and fostering innovative developments boasts exciting potential, the rapid pace of AI development often outstrips existing regulatory frameworks, creating potential risks for patients and providers.The integration of artificial intelligence (AI) within the United States healthcare system has the potential to revolutionize patient care, improve operational and administrative efficiency, and refine decision-making processes. As a novel tool, AI raises significant regulatory concerns related to safety, efficacy, privacy, and ethical use. This poster presents findings from a policy review conducted by a HITLAB Delphi Intern to outline the current U.S. regulatory framework of AI in healthcare, identifies key challenges for integration, and recommends a cohesive regulatory framework to ensure the safe, effective, and equitable use of AI technologies in the U.S. healthcare system.