SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
3.4 Sufficiency of Oversight As explained in 2.6 Sufficiency of Legislative Framework , regulatory authorities are working to address the risks associated with the rapid advancement of digital healthcare technologies by issuing guidelines and revamping regulatory frameworks. Notably, South Korea has recently published the world’s first guidelines for the approval and review of generative AI medical devices, which is expected to influence the crea- tion of the standards and methods for evaluating the safety and efficacy of generative AI medical devices. However, as is the case globally, there are still concerns in South Korea about the growing gap between rapidly advancing digital health- care technologies and the regulations that gov- ern them. Particularly, as previously discussed, although several legislative proposals such as the Digital Healthcare Promotion Act have been introduced, there is no overarching law or regu- latory authority for the digital healthcare sector, resulting in some gaps in the regulatory frame- work (see 2.6 Sufficiency of Legislative Frame - work ). 4. Liability 4.1 Legal Risks of Digital Healthcare For important compliance and enforcement legal issues in digital healthcare, refer to 2.5 Issue- Specific Legal Framework and 3.3 Enforce- ment . A significant liability issue in digital healthcare involves harm or legal violations resulting from AI and machine learning technologies. To operate effectively, these technologies must be trained on large datasets that often contain sensitive information, such as patients’ medical records
out a licence is strictly prohibited. However, the current MSA does not define “medical services”, and court precedents have broadly interpreted its meaning (eg, tattooing is considered a medi- cal practice in South Korea). Therefore, providing some basic diagnostic services to customers (eg, using mobile phone applications) can be deemed as providing medi- cal services. This has been controversial for insurance companies that have been attempt- ing to use big data to provide consumers with a statistical analysis of their health (eg, life expec- tancy, or chances of being diagnosed with a par- ticular disease). For reference, in the Guidelines on Non-Medical Healthcare Services, the MOHW states that a service is medical if it meets any of the following three criteria: • requires medical expertise (basis for the act); • involves diagnosis, prescription, or treatment based on the condition of the subject (nature of the act); or • may cause harm to health and hygiene (effects and side effects). Prohibition of Provision of Economic Benefits to HCPs Both the PAA and the MDA, which apply to pharmaceutical companies and medical device companies, respectively, explicitly prohibit those companies from providing economic benefits to HCPs to promote sales. As the term “economic benefits” is interpreted broadly, providing meals or drinks (or paying for other forms of entertain- ment for HCPs) is considered prohibited per the above statutes. However, attendant regulations to the PAA and MDA provide for certain safe harbours regarding the provision of economic benefits to HCPs.
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