Legal Challenges of Medical Artificial Intelligence : Focusing on Explainability, Liability, Personal Data Protection, Medical Robots, and Legislative Prospects

The commercialization of medical artificial intelligence (AI) offers numerous advantages, including improved accuracy in diagnosis and treatment and enhanced efficiency in medical services. However, it also raises legal and ethical concerns such as medical errors, unclear allocation of liability, and violations of personal privacy. This study aims to systematically examine the legal issues that may arise at each stage of the development of medical AI—introduction, utilization, diffusion, maturity, integration, and transcendence—and to propose appropriate institutional responses. In particular, the study focuses on the explainability of medical AI as a means to safeguard patients’ constitutional rights, including the right to know, the right to self-determination, and the right to equality. It explores the expansion of the physician’s duty of explanation to include not only invasive procedures but also non-invasive ones supported by AI systems. The study also examines the legal compatibility of existing laws such as the Patient Safety Act, the Personal Information Protection Act, and the Digital Medical Products Act, and addresses issues related to the legal subjectivity and responsibility of AI medical robots. By comparing legislative examples from the United States, the European Union, and Japan, the study seeks to strike a balance between the utilization and regulation of medical AI, and ultimately proposes a direction for establishing a Korean model of medical AI legal framework that harmonizes patient protection with technological innovation.