한빛사논문
Changwon Wang 1,4, Chungkeun Lee 2,4 and Hangsik Shin 3*
1Biomedical Engineering Research Center, Asan Medical Center, Seoul 05505, Republic of Korea.
2Digital Health Devices Division, Medical Device Evaluation Department, National Institute of Food and Drug Evaluation, Ministry of Food and Drug Safety, Osong 28159, Republic of Korea.
3Department of Digital Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.
4These authors contributed equally: Changwon Wang, Chungkeun Lee.
*Corresponding author : Correspondence to Hangsik Shin.
Abstract
As a new therapeutic technique based on digital technology, the commercialization and clinical application of digital therapeutics (DTx) are increasing, and the demand for expansion to new clinical fields is remarkably high. However, the use of DTx as a general medical component is still ambiguous, and this ambiguity may be owing to a lack of consensus on a definition, in addition to insufficiencies in research and development, clinical trials, standardization of regulatory frameworks, and technological maturity. In this study, we conduct an in-depth investigation and analysis of definitions, clinical trials, commercial products, and the regulatory status related to DTx using published literature, ClinicalTrials.gov, and web pages of regulatory and private organizations in several countries. Subsequently, we suggest the necessity and considerations for international agreements on the definition and characteristics of DTx, focusing on the commercialization characteristics. In addition, we discuss the status and considerations of clinical research, key technology factors, and the direction of regulatory developments. In conclusion, for the successful settlement of DTx, real-world evidence-based validation should be strengthened by establishing a cooperative system between researchers, manufacturers, and governments, and there should be effective technologies and regulatory systems for overcoming engagement barriers of DTx.
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