SOUTH KOREA Law and Practice Contributed by: Kyungsun Kyle Choi, Eui Seok Kim, Han Kyul Nam and Eun Sun Jang, Kim & Chang
Increased work efficiency Electronic Health Records (EHR) allow health- care professionals to quickly access and share patient information, reducing consultation times and increasing work efficiency. Digital survey tools collect real-time feedback from patients, which is used to improve medical service quality. Remote collaboration and education App-based remote collaboration systems strengthen co-operation among health profes- sionals, while digital platforms enable continu- ous education, helping medical staff keep up with the latest treatment methods and knowl - edge. Impact on Medical Costs Cost reduction Telemedicine and remote monitoring reduce unnecessary hospital visits, saving on medical expenses. Automated insurance claim systems cut administrative costs and enhance process- ing speed. Increased economic effectiveness Focusing on preventive medicine and efficient data management, digital healthcare lowers healthcare expenditures in the long run, contrib- uting to increased economic effectiveness within South Korea. 2. Legal Framework 2.1 Definition of Digital Healthcare Currently, there is no official definition of “digital health” in South Korean law. However, several digital health-related bills pro- posed in the National Assembly include defini- tions of the term. For instance, the proposed Bill on the Promotion of Digital Healthcare and the
Facilitation of Healthcare Data Utilization (“Digi- tal Healthcare Promotion Act”) defines “digital healthcare” as a series of activities and tools that contribute to improving public health by utilising intelligent information technology (as defined in Article 2, subparagraph 4 of the Framework Act on Intelligent Informatization) and healthcare information (subparagraph 5 of the same Article) for the prevention, diagnosis, treatment, health management, research and development, and post-treatment care of diseases. In practice, the term digital health or digital healthcare is generally understood to refer to an industry or technology that integrates informa- tion and communication technology (ICT) into the healthcare sector to provide personalised medical or healthcare services tailored to indi- vidual health conditions and diseases. 2.2 Laws and Regulations Currently, there is no comprehensive legisla- tion governing the digital healthcare sector, although several bills have been proposed in the National Assembly, including the Bill on the Digital Healthcare Promotion Act, the Bill on the Promotion and Support of the Digital Healthcare Industry, and the Bill on the Utilization of Digital Healthcare and Healthcare Data. Yet, among the existing relevant laws, the new- ly minted DMPA represents the government’s major push to legislate a framework to regulate digital medical products. The legislation pro- vides the following key provisions. • It provides a definition for “digital medical products” as encompassing (i) digital medi- cal devices, (ii) digital convergence drugs, and (iii) digital medical/health support devic- es. Among them, digital medical devices are defined as medical devices to which
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