SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
Ministry of Food and Drug Safety (MFDS) The MFDS reviews and approves pharmaceu- ticals and medical devices for safety, efficacy and quality, through technological review and inspection for their manufacturing and distribu- tion. In February 2022, the MFDS established a Digital Healthcare Regulatory Support Division, which aims to manage the review and approval of digital medical devices. National Evidence-Based Healthcare Collaboration Agency (NECA) According to the MSA, NECA evaluates new medical technologies and innovative medical technologies, including software-based diag- nostic and therapeutic devices, focusing on clinical safety and efficacy. It also supports the early market entry of innovative technologies through temporary permission of the use innova- tive medical technologies. NECA also facilitates early clinical implementation of digital medical devices by providing assistance for real-world validation projects and establishing the ground- work for health insurance registration. 3.2 Non-Healthcare Regulatory Bodies Several other regulatory agencies are involved in digital healthcare including the following. Ministry of Trade, Industry and Energy (MOTIE) As the agency responsible for formulating and implementing industrial policy, MOTIE aims to nurture and develop new industries, including digital healthcare, through initiatives focused on technology development, fostering industrial ecosystems, and providing support to busi- nesses. Ministry of Science and ICT (MSIT) The MSIT fosters scientific and technological advancement and innovation, supporting the
digital healthcare industry through the applica- tion and development of advanced technologies like AI, biotechnology, and information and com- munication technology (ICT). Additionally, MSIT oversees national AI policy and enforces the AI Act, which took effect in January 2025. Korea Communications Commission (KCC) KCC enforces regulations on information and telecommunications services. KCC primarily supports digital healthcare industry through pol- icy establishment and regulatory improvements, by ensuring that new healthcare service models, such as telemedicine and digital therapeutics, operate safely. Personal Information Protection Commission (PIPC) PIPC is primarily tasked with enforcing the PIPA. In the context of digital healthcare, the commis- sion addresses issues related to data leakage or misuse of personal healthcare information, which is classified as “sensitive” under PIPA. Through its enforcement actions, PIPC plays a crucial role in balancing privacy protection with promotion of digital health industry through the utilisation of personal information. 3.3 Enforcement The digital healthcare sector is governed by sev- eral laws, including the MSA, MDA, PIPA, and DMPA, with various regulatory bodies responsi- ble for ensuring compliance, as detailed in 3.1 Oversight of Digital Healthcare and 3.2 Non- Healthcare Regulatory Bodies . Some notable issues in enforcement actions include the fol- lowing. Regulating the Practice of Medicine The MSA stipulates that only HCPs are permit- ted to conduct medical services for which they have licences. Providing medical services with-
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