• Journal of Internet Computing and Services
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• v.24 no.4
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• pp.15-24
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• 2023

Digital therapeutics (DTx) are utilized to replace or supplement drug therapy to treat patients. DTx are developed as a mobile application for portability and convenience. The government requires security verification to be performed on digital medical devices that manage sensitive information during the transmission and storage of patient data. Although safety verification is included in the approval process for DTx, the cybersecurity checklist used as a reference does not reflect the characteristics of mobile applications. This poses the risk of potentially overlooking vulnerabilities during security verification. This study aims to address this issue by comparing and analyzing existing items based on the mobile tactics, techniques, and procedures of MITRE ATT&CK, which manages globally known and occurring vulnerabilities through regular updates. We identify 16 items that require improvement and expand the checklist to 29 items to propose improvement measures. The findings of this study may contribute to the safe development and advancement of DTx for managing sensitive patient information.

• The Korean Journal of Pain
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• v.34 no.3
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• pp.247-249
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• 2021

• Journal of Biomedical Engineering Research
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• v.44 no.4
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• pp.264-274
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• 2023

Purpose: The objective is to extract insights that can contribute to the formulation of harmonized international policies and support measures for innovative medical devices and management systems. This study aims to propose effective strategies for future medical device innovation and healthcare delivery. Results: It investigates technological advancements, regulatory approval systems, insurance policies, and successful commercialization cases in South Korea, the United States, and the European Union. In 2018, the FDA implemented insurance coverage for Software as a Medical Device (SaMD) and recognized insurance coverage for Digital Therapeutics (DTx). Germany is a country that ensures permanent reimbursement for healthcare applications since 2020, making it the first country to provide legal health insurance coverage for fostering a digital ecosystem. Conclusion: The findings of this research highlight the importance of cultivating a supportive regulatory and environmental framework to facilitate the adoption of innovative medical devices. Continuous support for research and development (R&D) efforts by companies, along with the validation of clinical effectiveness, is crucial.

• International Journal of Advanced Culture Technology
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• v.11 no.1
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• pp.332-336
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• 2023

In this paper, we design and implement an ADHD diagnostic rating scale algorithm and virtual reality- based digital treatment by combining virtual reality technology that enables multiple access based on specialized medical data. The VR ADHD digital treatment to be implemented is intended to be applied directly to diagnosis and treatment of child/adolescent ADHD by applying various psychiatric treatment technologies. In order to evaluate the usability of the digital therapeutic agent developed in this paper, an expert group consisting of 2 males and 12 females "targeted counseling psychology majors at the Asian Dementia Center once a day for 3 weeks, ADHD VR-based digital therapeutics for children Experienced and usability evaluation conducted. As a final result of this thesis, it was possible to develop attentional concentration ability, working memory improvement ability, and impulsive control ability in four games of digital therapy, and it was possible to confirm significant results that can be expected to have ADHD therapeutic effects.

• International Journal of Advanced Culture Technology
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• v.12 no.1
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• pp.305-310
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• 2024

The purpose of this study is to implement game content within the generative artificial intelligence module Chat-GPTs, grounded in the humanistic discourse of self-reflection. This content aims to empower the dignity of the silver generation, which has been marginalized by digital technology. Simultaneously, we intend to prototype a digital psychotherapeutic tool. The development of a flexible device that adapts to the silver generation's living environment and temporal constraints is also part of our plan. However, there are still few commercially available products, and digital therapeutics developed in the form of content are virtually nonexistent. The goal is to implement game content that allows the elderly, who have been marginalized by digital technology, to find their true dignity. Simultaneously, we plan to commercialize a prototype of digital psychotherapy that can flexibly adapt to the range of living environments and time constraints of the elderly. This study has been extended based on the game content 'Daily Run' created by Hyein Kwon, an undergraduate student at Kyungil University.

• Trans-
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• v.12
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• pp.21-49
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• 2022

This study examines the possibility of chronic brain disease rehabilitation treatment using VR/AR technology and raises the research need for the development of digital therapeutics. In addition, by proposing a digital therapeutic research and development process this study intends to contribute to the development of VR/AR rehabilitation treatment. To this end, this study identified research trends of VR/AR technology, neurophysiology, and chronic brain disease and proposed a method for applying VR/AR technology to treat chronic brain disease patients in three stages. The first stage is to prepare a neurophysiological basis for rehabilitation treatment of brain disease patients using VR technology. The second stage is to provide a treatment method using VR/AR technology and systematize the contents characteristics. The third stage is to conduct clinical trails and validate that the treatment method and contents utilization is effective for the patient. It is hope that this study serves as a guide for developing media production base technology for treating patient with a chronic brain disease.

• The Journal of the Convergence on Culture Technology
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• v.9 no.1
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• pp.581-586
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• 2023

Recently a drama that features a lawyer with autism spectrum disorder has attracted a lot of attention, raising interest in the difficulties faced by people with autism spectrum disorders. If the Autism spectrum gets detected early and proper education and treatment, the prognosis can be improved, so the development of the treatment is urgently needed. Drugs currently used to treat autism spectrum often have side effects, so Digital Therapeutics that have no side effects and can be supplied in large quantities are drawing attention. In this paper, we introduce 'AEmotion', an application and a Digital Therapeutic that provides emotion and facial expression learning for toddlers with an autism spectrum disorder. This system is developed as an application for smartphones to increase interest in training autistic children and to test easily. Using machine learning, this system consists of three main stages: an 'emotion learning' step to learn emotions with facial expression cards, an 'emotion identification' step to check if the user understood emotions and facial expressions properly, and an 'expression training' step to make appropriate facial expressions. Through this system, it is expected that it will help autistic toddlers who have difficulties with social interactions by having problems recognizing facial expressions and emotions.

• Asian Journal of Innovation and Policy
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• v.12 no.1
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• pp.054-074
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• 2023

With the advent of the '4th Industrial Revolution', digitalization using AI (Artificial Intelligence), big data, IoT (Internet of Things), cloud computing and mobile is accelerating across all industries and global companies have fundamentally reorganized customer experiences, business models, and operations centering on digital transformation. Business innovation drives productivity improvement, process simplification, price, competitiveness and sustainable expansion. Whether digital transformation will be necessary for the current industrial environment is no longer important, and how quickly companies achieve digitalization has emerged as the utmost crucial element in industrial continuity. As non-face-to-face and remote technologies have begun in earnest, and accelerated in the pharmaceutical industry. They are looking for ways to provide value, generate profits, improve efficiency, and sustain the future. Compared to other industries, the pharmaceutical-related sectors have shown high interest in digital transformation especially to reduce costs and meet the challenge of delivering products during the pandemic environment.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Journal of Korea Multimedia Society
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• v.25 no.4
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• pp.640-648
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• 2022

Menopausal women have to care for their health. Menopause is a symptom that needs to be managed in the long term, which requires safe and economical treatment even after long term use. This study proposes digital-based exercise therapy. This study also suggests resistance exercise and walking exercise methods according to the proof of previous studies. It provides motivational contents for those who cannot perform regularly. As motivational methods, self-efficacy and narrative-based history methods are accepted. Self-efficacy is improved through voice agents feedback during exercise. Feedback is a type of messages such as encouragement and motivation. The narrative-based history consists of characters of visualization that improves through values, which leveraged by the exercise.