Summary
South Korea’s comprehensive national AI law, enacted in 2025 and enforced beginning January 22, 2026. The Act defines high-impact AI to include AI used in systems for providing and using healthcare services and AI used in the development and use of medical devices or digital medical devices. It establishes national AI governance structures, transparency duties for high-impact and generative AI, safety and risk-management expectations, confirmation procedures for high-impact AI classification, user protection measures, human management and supervision, documentation duties, and impact-assessment encouragement.
Healthcare Implications
Healthcare and medical-device AI are expressly included within the Act’s high-impact AI framework, making the law relevant to Korean health systems, medical AI developers, and digital medical device companies. Operators of healthcare AI may need to assess whether systems qualify as high-impact AI, notify users that products or services are AI-based, maintain risk-management and user-protection measures, support explainability where technically feasible, retain safety/reliability documentation, and preserve human management and supervision. Certified digital medical products may also interact with the Act’s deemed-compliance/safe-harbor structure.