SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
• Medical Services Act (MSA) – it establishes a comprehensive regulatory framework for national healthcare. Regarding digital health- care, it governs areas such as electronic medical records and pilot projects for tel- emedicine. Additionally, it governs innova- tive medical technologies and new medical technologies, providing detailed guidelines through subordinate regulations concerning the evaluation, implementation, and manage- ment of new medical technologies, as well as the processes and methods for designating innovative medical devices. • Medical Devices Act (MDA) – it establishes a comprehensive regulatory framework neces- sary for the manufacture, import, and sale of medical devices. With the implementation of the DMPA, however, the regulation of digital medical products, such as SaMD, is now governed by the DMPA, while other con- ventional devices that fall outside the scope of the DMPA, including those that host the SaMD, are still regulated under the Medical Devices Act. See 2.5 Issue-Specific Legal Framework . • In Vitro Diagnostic Medical Devices Act – it establishes a basic regulatory framework for the manufacture, import, and sale of in vitro medical devices. Products with digital tech- nology applications, like in vitro diagnostic software, were previously regulated by this law but are governed by the DMPA. Meanwhile, the collection, use and provision of personal health information may be subject to the Personal Information and Protection Act (PIPA), the MSA, and the Bioethics and Safe- ty Act (BSA). While the PIPA is a general law governing the processing of personal informa- tion, the MSA takes precedence over the PIPA for patient records held by medical institutions, and the BSA takes precedence over the PIPA
for research on human subjects including clini- cal trials. See more details in 2.5 Issue-Specific Legal Framework . 2.3 Role of Policymakers The trends of technological advancements are identified and reflected in legislation through the following research and investigations. • National Assembly Research Service – the Health, Welfare, and Gender Equality Team of the National Assembly Research Service (NARS) consistently collects and researches information related to the health sector, including pharmaceuticals and medical devices. When necessary, they share their findings through research reports or internal reports. Additionally, to understand the latest technologies, market trends, and academic opinions, they may hold expert discussions or seminars, or commission research projects. Furthermore, when lawmakers request informa - tion on trends in new technologies or foreign leg- islation to aid in lawmaking, the team conducts research and provides written responses to the respective offices. If needed, they may collabo- rate with the Science, Media, and Telecommuni- cations Team within the NARS or consult a pool of pre-arranged external experts. • Office of Expert Advisor of the Health and Welfare Committee – when a member of the National Assembly proposes a bill related to digital health, a legislative researcher from the Office of Expert Advisor of the Health and Welfare Committee conducts targeted research on the bill. If the legislative research- er finds it difficult to understand new technol- ogies or requires supplementary information, they may seek advice from researchers at the NARS or external experts.
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