디지털 의료기기의 등장에 따른 법적 문제와 법 개선에 관한 연구 - ‘디지털의료기기게임물’ 개념의 도입을 중심으로 -

초록

This study aims to review and improve the current legal issues related to the emergence of Digital Therapeutics. First, we reviewed the scope of the Game Industry Promotion Act (Game Industry Act) and what regulations are made under the Game Industry Act. In particular, the scope of application of the Game Industry Act is the same as whether or not a game falls under Article 2(1) of the Game Industry Act, and we found that the concept of a game is used in a broad sense both in literature and in practice. In other words, there have been precedents in which content in the field of education and video, which has not traditionally been considered a game, that uses VR technology or has a game nature, has been considered a game under the Game Industry Act. In addition, after reviewing the concept of Digital Therapeutics and examining related laws such as the Digital Medical Products Act, we found that some of the Digital Therapeutics use VR technology or take the form of a game, so there is room for them to fall under the Game Industry Act, but there is no discussion of game products in the legal discussions related to Digital Therapeutics. Therefore, in order to ensure that Digital Therapeutics with game characteristics are appropriately regulated in the Korean legal system, it is necessary to introduce a new concept of 'Digital Therapeutics game product' in the Digital Medical Products Act, establish a classification system that considers the characteristics of both Digital Therapeutics and game products, and provide special provisions. In addition, it suggests that improvements should be made to medical treatment benefits and telemedicine related to digital medical device games.

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