This chapter provides a comprehensive exploration of the rise of artificial intelligence (AI) systems, focusing on their applications, benefits, and risks in clinical decision-making. It begins by examining the global integration of AI algorithms into medical practice, addressing their role in assisting healthcare professionals with diagnoses, prognoses, and treatment recommendations. The discussion also identifies the key challenges and risks associated with the implementation of AI in medicine, including issues of safety, reliability, and accountability. The chapter then delves into the European regulatory landscape, analysing the AI Act and the European framework for civil liability related to damages involving AI systems in healthcare. Ethical principles guiding the use of AI in medicine are also explored, with an emphasis on their influence upon the physician’s duties of conduct. Finally, the chapter turns to the Brazilian context, providing an analysis of Bill No. 2338/23, which proposes a regulatory framework for AI in Brazil. This section highlights how current European discussions on AI ethics and regulation are influencing Brazilian legal developments. By integrating global, European, and Brazilian perspectives, the chapter offers an in-depth examination of the interplay between technology, ethics, and regulation in the rapidly evolving field of AI in healthcare.