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KMID : 1812620230030020130
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HIRA Research
2023 Volume.3 No. 2 p.130 ~ p.141
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Policy Proposals to Revitalize Korea Digital Therapeutics Market: Focused on the Institutional Analysis in Other Countries
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Chung Ji-Min
Shin Jae-Yong
Ryu Gyu-Ha
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Abstract
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The digital therapeutics market is predicted to grow rapidly due to several factors such as changes in the medical paradigm and coronavirus disease 2019 (COVID-19). The Ministry of Food and Drug Safety has approved two digital therapeutics in 2023. The Korean government is announcing many deregulation policies to revitalize the healthcare industry. However, specific governance, such as medical device industry policy and health insurance, is still needed. In addition, the government’s continuous support for the healthcare industry in Korea is necessary. Accordingly, we investigated regulatory trends pertaining to digital therapeutics in other countries. Through this study, implications for insurance design suitable for the attributes of digital therapeutics and raising awareness of such therapeutics were derived.
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KEYWORD
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Digital therapeutics, Software as medical device, Medical device, Regulation, Digital health
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