This chapter addresses the ethical and regulatory challenges for artificial intelligence in medical diagnostics. Key ethical considerations include explainability, balancing transparency with accuracy, and ensuring human autonomy amid increasing automation. This chapter highlights issues like bias, fairness, and the risks posed by generative artificial intelligence tools. Regulatory frameworks, such as the Health Insurance Portability and Accountability Act in the United States and the General Data Protection Regulation in the European Union, are analyzed for their roles in safeguarding data privacy, security, and transparency. Their limitations in keeping pace with artificial intelligence advancements are acknowledged. The chapter emphasizes the need for global, adaptive standards to ensure ethical and effective artificial intelligence implementation in health care.