SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
oversight. RPM devices collect objective health metrics and usually require regulatory clearance
under the DMPA when they provide clinical deci- sion support, which require regulatory approv- al from the Ministry of Food and Drug Safety (MFDS). 1.2 Use/Application of Digital Healthcare In light of South Korea’s rapidly aging soci- ety and rising healthcare costs, digital tech- nologies are increasingly viewed as essential tools for improving chronic disease manage- ment, expanding access to care, and control- ling national health expenditures. Bolstered by strong government initiatives, advanced IT infra- structure, and a tech-savvy population, a diverse range of digital health solutions is being actively implemented in both clinical settings and every- day healthcare practices. Telemedicine South Korea’s policy on telemedicine has been conservative. The Medical Service Act histori- cally banned most doctor-to-patient teleconsul- tations, only allowing teleconsultation between medical professionals (for second opinions). However, temporary measures during the COV- ID-19 pandemic (2020–22) and an emergency doctors’ strike (from 2023 to first five months of 2025) prompted the government to ease regula- tions. See 2.5 Issue-Specific Legal Framework . Mobile Health mHealth adoption is very high in South Korea, with a smartphone penetration rate exceeding 90%. Consumers routinely use apps for exer- cise, diet tracking, sleep, and chronic disease management. The government and insurers are also promoting mHealth. For instance, South Korea’s National Health Information Portal and the “My HealthWay” system allow patients to download health records to a mobile app.
if intended for diagnosis. Digital Therapeutics (DTx)
Digital therapeutics are evidence-based thera- peutic interventions delivered via software (usu- ally mobile or web apps) to prevent, manage or treat medical conditions. They often require clinical trials and regulatory approval similar to medical devices or drugs. DTx are a subset of mHealth that function as treatment modalities. Unlike EHRs or telemedi- cine which support care delivery, DTx are the treatment (eg, a cognitive behavioural app for insomnia). and therefore prove efficacy through trials and are integrated with the healthcare system (prescription or physician oversight). In South Korea, DTx are regulated as software medical devices (SaMDs), which is regulated as digital medical devices under the newly legis- lated Digital Medical Products Act (DMPA). AI-Based Healthcare AI-based healthcare uses algorithms (machine learning, deep learning, etc) to analyse medi- cal data and support healthcare tasks – from image interpretation and diagnosis to risk pre- diction and personalised treatment. Unlike the other types of digital healthcare technologies mentioned above, which are defined by the use case or platform, AI-based healthcare refers to the technology layer embedded in many appli- cations. AI solutions perform data-driven analysis or decision support; they may be integrated into telemedicine platforms, mobile apps, or moni- toring devices, but what makes them “AI-based” is the use of advanced analytics. AI models are typically classified as “digital medical devices”
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