SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
medical devices. Additionally, the Act intro- duced cybersecurity guidelines to combat digital threats such as hacking and email attacks, thus reinforcing corporate accountability. The legislation also implemented mechanisms for continuous safety evaluation tailored to digi- tal medical devices and mandated the disclosure of training data used in AI-based products to enhance transparency. Despite these advance- ments, the DMPA does not address the utilisa- tion of health data generated by digital medical devices. This omission is widely recognised as a critical regulatory gap that must be filled to support the growth of the digital health industry. To address these issues, several legislative pro- posals have been introduced to facilitate the safe and effective use of medical data and to promote digital healthcare. For instance, the Bill for the Digital Healthcare Promotion Act, pro- posed in the National Assembly, includes the following key provisions. • Promotion of healthcare data utilisation – the bill promotes data utilisation by acknowledg- ing the right of individuals to request the transfer of their data to themselves or to third parties. • Support for the digital healthcare industry – it aims to activate digital-based healthcare ser- vices by tasking the government to establish a comprehensive national policy on digital healthcare and providing systematic support for the development of the digital- and bio- health industries. • Relation to existing healthcare legislation – the bill seeks to define the concepts of digital healthcare and healthcare information, as well as to establish its relationship with related laws in the healthcare sector, such as the
MSA, the Pharmaceutical Affairs Act (PAA), and the Bioethics and Safety Act.
3. Regulatory Oversight 3.1 Oversight of Digital Healthcare Ministry of Health and Welfare (MOHW) The MOHW is a key stakeholder as the ministry in charge of: • developing national healthcare policies; • managing the fiscal sustainability of the National Health Insurance (NHI) system; and • overseeing policy implementation. The MOHW has issued guidelines such as the Guidelines on Non-Medical Healthcare Services (which provide guidelines on which healthcare services constitute medical services) and the Guidelines for the Use of Anonymised/Pseu- donymised Medical Data, among others. Health Insurance Review and Assessment Service (HIRA) The HIRA reviews and assesses healthcare costs and healthcare service quality and sup- ports NHI policies in determining medical fee schedules and drug prices. HIRA is responsi- ble for developing guidelines that apply to the insurance reimbursement listing of digital medi- cal services and devices. National Health Insurance Service (NHIS) For drugs determined to be reimbursable, the NHIS and pharmaceutical companies negotiate drug prices after HIRA evaluation. A key factor to be considered by the NHIS is the budget impact of the addition of a new drug.
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