SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
automated decisions by default, subject to spe- cific exceptions, signalling a more innovation- permissive stance. Environmental, Social and Governance (ESG) Matters Interest in ESG is growing in South Korea, and digital healthcare technologies hold significant potential to support ESG goals – for example, by improving healthcare access for seniors and people in remote areas. However, there are cur- rently no regulations specifically addressing the ESG aspects of digital healthcare. Telehealth Telemedicine is generally prohibited under the MSA in South Korea. However, temporary exceptions were introduced during the COV- ID-19 pandemic to permit telemedicine for consultations and prescriptions, with coverage under the National Health Insurance (NHI). Ini- tially, the government relied on existing laws – including the Framework Act on Public Health, the MSA, and the Infectious Diseases Prevention Act – to authorise these measures. In December 2020, Article 49 (3) was added to the Infectious Diseases Prevention Act, establishing a more permanent legal basis for telemedicine during public health crises by allowing its use when the healthcare crisis level is designated as “severe”. Following the pandemic, as the healthcare crisis level was downgraded to “alert”, these tempo- rary permissions ended. However, growing pub- lic demand prompted the government to launch a limited telemedicine pilot on 1 June 2023. Under this pilot, clinic-level medical institutions were allowed to provide telemedicine services to returning patients who had previously received in-person care.
In February 2024, a national strike by hospital doctors – triggered by the government’s plan to increase medical school admissions by over 50% – led to the healthcare crisis level being ele- vated back to “severe”. This reinstated broader permissions for telemedicine, allowing all medi- cal institutions, including hospital-level facilities, to offer non-face-to-face care to both returning and first-time patients, provided the attending doctor deemed it safe. As a result, telemedicine platforms that had been at risk of shutting down after the pandemic were able to resume full operations and marketing efforts. In response to this renewed momentum, legislative efforts have begun to institutionalise telemedicine. In March and April 2025, the ruling People Power Party proposed an amendment to the MSA to formally legalise telemedicine, which is currently under discussion. Addition- ally, in April 2025, the Democratic Party of Korea identified the legalisation of “non-face-to-face remote medical services” as one of its top sev- en policy initiatives for small and medium-sized enterprises, raising further expectations for per- manent regulatory reform. 2.6 Sufficiency of Legislative Framework Before the enactment of the DMPA, existing legal frameworks like the MDA failed to address the unique characteristics of digital healthcare, lead- ing to significant regulatory gaps. In response to this challenge, the DMPA was enacted in Janu- ary 2024, marking a substantial advancement in the regulation of digital healthcare. The DMPA establishes a legal foundation for software-driven digital medical devices, allowing for comprehensive safety management through- out the entire product life cycle. This approach reflects the rapid technological changes that differentiate digital products from traditional
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