AI시대에 디지털 의료기기의 법적 문제 ― 디지털의료제품법을 중심으로 ― = Legal Issues of Digital Medical Devices in the AI ​​Era - Focusing on the Digital Medical Products Act -

다국어 초록 (Multilingual Abstract)

The COVID-19 pandemic has brought about tremendous changes to our medical environment. As face-to-face treatment centered on doctors and patients became difficult, non-face-to-face treatment became necessary. Telephone treatment was temporarily allowed starting in February 2020, and even after the end of COVID-19, voices demanding permission for non-face-to-face treatment continued.
Recently, interest in digital healthcare has expanded due to various changes in the situation, and a certain level of consensus has been formed on the need to establish a new medical system. Interest in digital healthcare has greatly increased along with the development of information and communication technologies such as AI, big data, cloud, and wearables. However, in the current medical law system that is hardware-centered and optimized for traditional medicine, there are limitations in accepting innovations in digital technology centered on software, medical data, and networks and efficiently evaluating the safety and efficacy of continuously developing digital medical devices. In addition, as the development of medical devices, pharmaceuticals, and various new products related to them has expanded in the large category of healthcare, laws have become necessary to enhance the reliability of these products and support safety regulations. In January 2024, the ‘Digital Medical Products Act’ was enacted. The Digital Medical Products Act, which will be implemented from January 2025, introduces a full-cycle regulatory system in Korea, including clinical trials, approvals, and distribution management, tailored to the characteristics of medical products that use AI and network connection technology. I believe that the enactment of this law was possible because of the government’s will to lead the regulation of AI and digital medical products, and on the other hand, there was a demand for the introduction of a new system for the development of digital healthcare in a changing medical environment. However, various problems may arise during the implementation process of the law, and I believe that trial and error can be reduced through legal discussions on these issues.