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KMID : 1142220210160020181
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 2 p.181 ~ p.192
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A Study on Digital Therapeutics and Their Possibilities on Disease Control
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Kwon Seo-Young
Kim Min-Seo
Lee Chae-Bin
Ryu Jong-Hoon
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Abstract
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The increase in patients with mental illness due to COVID-19 is a global phenomenon, and the interest in digital therapeutics is increasing as the number of patients who are not receiving effectually hospital treatment due to the difficulty of face-to-face treatment. In this era, digital healthcare is attracting attention, and, especially, digital therapeutics are in the spotlight. In this study, we clarified the conception of digital therapeutics, and analyzed the digital therapeutics-related industries in the United States, Europe, Japan, Germany, digital therapeutics development trends, market forecasts by field and disease, and regulatory trends. By analyzing the problems of the regulation of digital therapeutics in Korea, which have not yet been activated and commercialized, we proposed a plan to activate digital therapeutics in Korea by adoption of the advantages of overseas regulatory trends and guidelines. As a result of this study, it would be expected that the digital therapeutics market in Korea is also expanded and activated.
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KEYWORD
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Digital therapeutics, Software as a Medical Device, Developmental trends of digital therapeutics, Regulatory trend
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