국내 디지털치료기기 시장 활성화를 위한 정책 제언: 해외 주요국 제도 분석을 중심으로

Abstract

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.