The emergence of artificial intelligence (AI) in healthcare holds great promise for transforming patient care by supporting clinician work, reducing administrative burden, and enhancing the patient experience. However, advancements in AI technologies may be outpacing the necessary guardrails to ensure their safe, ethical, and effective use. It is critical that there are updates to existing regulations to keep pace with technological advancements and address evolving challenges. Currently, many nations, including the United States are in various stages of developing their own regulatory frameworks and guardrails on the use of AI. This chapter will summarize current regulations not just in the United States but in other parts of the world and discuss the critical importance of establishing comprehensive regulations for AI in healthcare, examining current regulations, impending legislation, and future directions so that the clinician is prepared when implementing and using these new technologies.