This study was conducted with the aim of deriving the basis for legislative and institutional improvement measures appropriate for the current Digital Therapeutics Technology. Based on this research purpose, through literature research and expert advisory, we focused on how Korea’s regulations regarding Digital Therapeutics can be appropriately changed.

  At first, Chapter II examines the concept and type of Digital Therapeutics and current status of clinical research conducted in Korea. Subsequently, Chapter III analyzed Digital Therapeutics related Policies and Laws in the United States, the EU, and Japan. In Chapter IV and V, we reviewed Korea’s law and systems related to Digital Therapeutics and presented basic policy directions for drawing up a plan.

  In conclusion, the suggested policy directions are as follows. First of all, Korea law specifies software as a‘medical device’under the Medical Device Act(｢의료기기 법｣), but there is no legal provision for what medical device software is. Therefore, in terms of clarity and consistency of regulations, it seems reasonable to establish a substantial definition of‘medical device software’in the Medical Device Industry Promotion and Innovative Medical Device Support Act(｢의료기기 산업법｣). Next, it is proposed to establish a standard for determining the safety and clinical effectiveness of medical device software in the Medical Device Industry Promotion and Innovative Medical Device Support Act or the Enforcement Decree. Finally, to promote the rapid development and sale of the products, it would be more desirable to find a way to systematically realize the special permission review cases already stipulated in the law rather than to finish the examination of innovative medical devices as soon as possible.