SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
they complied with all standards prescribed by relevant laws and regulations at the time of sup- plying the product. Therefore, companies can defend themselves with these facts. Meanwhile, whether a company sufficiently noti- fied about related risks at the time of product supply and obtained sufficient consent from users regarding the purchase and use of the product can also be considered when determin- ing the company’s liability. Thus, it is necessary to provide users with adequate notice and expla- nations about the risks related to product use and obtain their consent in advance. 5. Emerging Legal Issues and Reform 5.1 Emerging Legal Issues in Digital Healthcare South Korea’s digital healthcare sector faces ongoing legal challenges as it seeks to balance technological innovation with the protection of sensitive personal health information. A key emerging issue is the regulatory treat- ment of AI in healthcare, particularly generative AI. In this regard, the MFDS’s introduction of the Guidelines for Approval and Review of Genera- tive Artificial Intelligence Medical Devices marks a pioneering approach, setting early global prec- edents for the registration and evaluation of such technologies. See 2.5 Issue-Specific Legal Framework for more details. Another significant issue involves the cyber- security and privacy risks associated with the increased use of health data, especially in light of the growing reliance on digital medical devices. As a response, the government has published the Digital Medical Device Electronic Intrusion
Security Guidelines, which mandate robust tech- nical safeguards such as encryption, access controls, and real-time risk assessments. See 2.5 Issue-Specific Legal Framework for more details. Simultaneously, data governance continues to be a focal concern, particularly in respect of the right to request third-party transmission of medical data, which is widely considered as a bottleneck that hinders the industry’s develop- ment. Several bills are currently pending in the National Assembly, the most notable being the Digital Healthcare Promotion Act. This proposed legislation explicitly introduces both the right for individuals to access and transfer their own medical data, as well as the right to request its transmission to designated third parties. The goal is to create a more dynamic digital health- care ecosystem where individuals can actively share and utilise their health information for pur- poses such as research and co-ordinated care. However, there are ongoing debates regarding the scope of data covered, the responsibilities and obligations of medical institutions, and the need for clear government guidelines to ensure privacy and security. The proposed legislation also includes provisions for pseudonymised data processing, regulatory sandboxes, and the establishment of oversight committees, but as of April 2025, these bills remain under considera- South Korea has recently enacted significant regulatory reforms in digital healthcare. The policy basis for these changes is to accelerate innovation, ensure patient safety, and support the integration of digital health technologies into the healthcare system, key updates include the following. tion and have not yet been enacted. 5.2 Recent or Imminent Reform
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