The regulation of artificial intelligence (AI) in healthcare must strike a balance between technological innovation and legal as well as ethical requirements. While the European Union (EU) employs a preventive and standardized approach through the AI Act, the Medical Device Regulation (MDR), and the General Data Protection Regulation (GDPR), the United States (US) adopts industry-specific and more flexible regulations. Key challenges include governing adaptive AI systems, ensuring the use of large health data sets while maintaining data protection, and clarifying liability issues. The integration of clinical research and medical practice necessitates clear guidelines to protect patients’ rights while maximizing the potential of AI. At the same time, AI is fundamentally changing healthcare delivery, placing new demands on specialists and existing infrastructures. Future regulations must therefore provide legal certainty and promote innovation while consistently ensuring transparency, fairness, and patient protection.