Regulating artificial intelligence in medical care in South Korea

Abstract

In South Korea, healthcare artificial intelligence (AI) is overseen by three key bodies: the Personal Information Protection Commission enforces data protection; the Ministry of Food and Drug Safety (MFDS) regulates AI classified as medical devices; and the Ministry of Health and Welfare impacts market access through national health insurance coverage. Medical device classification considers software based on intended use and patient risks. Software medical devices, including machine learning-based ones, undergo a pre-market approval process. Clinical Decision Support Software (CDSS) classification varies based on healthcare provider reliance. Health AI devices can be distributed post-MFDS approval, but health insurance coverage significantly influences adoption. To charge more with AI assistance, a ʼnew procedure’ must be established via a New Health Technology Assessment. In South Korea, health data is not owned but controlled under the Personal Information Protection Act (PIPA). Pseudonymised data can be used for research under specific conditions. Data review committees are required, and legal obligations for transfers must be documented. AI algorithms created with health data are protected by copyright law and can be treated as trade secrets.