디지털 치료기기(DTx)의 사용 맥락 기반 위해요인 분석 및 통제 방안 연구

초록

Digital Therapeutics (DTx), as software-based medical devices, are increasingly playing a significant role in disease management and treatment. This study aims to analyze the major user-related hazard that may arise for each digital therapeutics based on its context of use and propose measures to address these risks. The characteristics of the context of use and potential hazards were systematically identified for four representative digital therapeutics evaluated by Korea University Guro Hospital Usability Test Center. The study found that users' physical and cognitive characteristics, the use environment, and the type of interfaces (e.g., HMDs, controllers) significantly influenced the occurrence of major hazard. The risk control alternatives proposed in this study are expected to contribute to improving usability, enhancing patient safety, and increasing therapeutic efficacy during the design and development of digital therapeutics by manufacturers. This study deepens the understanding of hazard related to the use of digital therapeutics and emphasizes the need for further research involving diverse environments and user groups in the future.

키워드