The integration of artificial intelligence (AI) into healthcare is rapidly transforming clinical practice. While AI offers significant potential for improving diagnosis, treatment, and patient outcomes, it also raises complex ethical and legal challenges. This paper explores the ethical considerations surrounding AI in healthcare, including bias in algorithms, data privacy, and allocation of responsibility for AI-related errors. The authors also examine the legal frameworks governing AI in the European Union and Poland, focusing on the recently adopted AI Act. The study highlights the need for a comprehensive regulatory framework that balances the benefits of AI with the protection of patient rights and public safety. Key issues discussed include the risk of algorithmic bias, the importance of transparency as well as accountability, and the challenges of assigning liability for AI-related harms.