• Journal of Biomedical Engineering Research
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• v.42 no.6
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• pp.277-286
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• 2021

The global market size of AI based SaMD for medical image in 2023 will be anticipated to reach around 620 billion won (518 million dollars). In order for Korean manufacturers to efficiently obtain CE marking for marketing in the EU countries, the paper is to introduce the recommendation and suggestion of how to reclassify SaMD based on classification rules of MDR because, after introducing the Regulation EU 2017/745, classification rules are quite modified and newly added compared to the Directive 93/42/EEC. In addition, the paper is to provide several rules of MDR that may be applicable to decide the classification of SaMD. Lastly, the paper is to examine and demonstrate various secondary data supported by qualitative data because the paper focuses on the suggestion and recommendation with a public trust on the basis of various secondary data conducted by the analysis of field data. In conclusion, the paper found that the previous classification of SaMD followed by the rule of MDD should be reclassified based on the Regulation EU 2017/745. Therefore, the suggestion and recommendation are useful for Korean manufacturers to comprehend the classification of SaMD for marketing in the EU countries.

• Journal of Information Technology Services
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• v.22 no.1
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• pp.95-114
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• 2023

Smart healthcare, combining ICT (Information and Communications Technologies) and medical technologies, has been rapidly emerging. Accordingly, its market has also increased as interest in disease prevention, management, and diagnosis grows due to the COVID-19 pandemic. In particular, using mobile devices to support medical activities, mobile healthcare has been attracting attention as a leading service in the smart healthcare market. However, the intention to use mobile healthcare apps may vary depending on individual beliefs and attitudes. Many studies on the intention to use mobile healthcare apps have used the TAM (Technology Acceptance Model), but there is a lack of studies that have been verified from the perspective of users' health beliefs. This study aims to identify the factors that affect the intention to use mobile healthcare apps based on the HBM (Health Belief Model). Furthermore, it investigates how this influencing mechanism fluctuates based on the user's mHealth literacy, the ability to find and understand health information through mobile. This study contributes to the empirical examination of the intention to use mobile healthcare apps through the HBM. It also offers insights for app providers and public health officials to increase the use of mobile healthcare apps.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.41-52
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• 2023

With the international change in the medical device market owing to the development of innovative medical engineering and the use of various raw materials, a systematic and rational medical device classification system is needed to safely manage newly developed medical devices. This study aims to improve the domestic medical device classification system by proposing product establishment and segmentation. It is based on medical device products from the United States and Europe that are only available in foreign systems and are more subdivided than domestic products. This study analyzes and compares the domestic and foreign medical device classification systems by examining laws, guidelines, and analysis reports in Korea, the United States, and Europe. In accordance with product establishment and segmentation criteria, products subject to improvement are presented. This study contributes to safely managing medical devices that do not fit with the current classification system and to solving the confusion caused by the lack of international harmony in product classification systems.

• Journal of Convergence for Information Technology
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• v.10 no.8
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• pp.187-193
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• 2020

This study analyzed how risk factors in management affect the management of working capital in general hospitals in Korea. The data used accounting information for three years (2016~2017 and 2018) of 271 general hospitals using the medical institution accounting information disclosure system. The independent variables were the working capital level and the cash conversion cycle, The dependent variables were operational risk and market risk, Control variables were selected as components of working capital(cash, accounts receivable, inventory assets, accounts payable). According to the study, the lower the operational risk, the higher the level of working capital hospitals in Korea. Working capital decisions were confirmed to be attributable to operating risks, cash, inventory assets and accounts payable. And the lower the market risk (Operating Margin), the higher the cash conversion cycle. Therefore, it is necessary to review appropriate management measures of operational risks, cash, inventory assets and accounts payable identified as operating capital determinants so that medical institutions can also have economic response capabilities in consideration of the specificity of their operations.

• Journal of Digital Convergence
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• v.17 no.7
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• pp.35-41
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• 2019

This study aims to analyze the cosmedical cosmetics market and the nature of customer through the social big data analysis. More than 80,000 posts were analyzed using R program. After data cleansing, keyword frequency analysis and association analysis were performed to understand customer needs and competitor positioning, formulated several implications for marketing strategy sophistication and implementation. Analysis results show that "prevention" is a new and essential attribute for appealing target customers. The expansion of the product line for the gift market is also suggested. It has been shown that there is a high correlation with products that can be complementary to each other. In addition to the traditional marketing technique, the social big data analysis based on evidence was useful in deriving the characteristics of the customers and the market that had not been identified before. Word2vec algorithm will be beneficial to find additional.

• Journal of radiological science and technology
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• v.39 no.4
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• pp.651-660
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• 2016

Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.

• Management & Information Systems Review
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• v.35 no.2
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• pp.221-254
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• 2016

With increasing interest of health due to population aging, medical device industry is highlighted as a promising industry. However, Korea medical device industry is not enough market competitiveness compared to global company due to a narrow domestic market and a small company structure. In order to retain the national competitiveness, it is necessary that we have to derive a central technology and its trend. This study has predicted a central technology for medical device industrial using patent network analysis. The central technology is defined as a key technology that is connected to most other technologies and that significantly affects them. For the empirical study, we conducted social network analysis using covariance and correlation coefficient between IPC codes extracted from medical device patents, introduced by Jun(2012). A social network is a social structure of diverse items as well as of human beings. In this study, we set each medical device as a node in an SNA and analyze the Degree values between them. Also, Korea health industrial statistics system are utilized for verification of selected central technology. As a result, we found that the central technology is located on the medical device items, which are listed higher the amount of production. The central technology selected through the proposed methodology will provide a inspiration for establishment of R&D policy.

• The Journal of Korean Medical History
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• v.24 no.2
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• pp.135-143
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• 2011

The market of conferences and expos of traditional/ complementary and alternative medicine has not been mature enough while interests in those medicines are growing fast. Meanwhile, some related events in Europe, North America, and Asia, held on regular basis, have reached to the international level in size, such as CAMExpo The Complementary, Natural & Healthcare Show in Europe, Integrative Healthcare Symposium in North America, Ayurveda Congress & Arogya Expo in India, International Conference and Exhibition of the Modernization of Chinese Medicine & Health Products in Hong Kong. Those events have been held for 10 years or so, initiated their own features, and secured their own regular booth exhibitors and visitors. They open the homepage on the internet one or two years before their events are held and vigorously advertise their events on yearly basis. To succeed in, and bear fruits from, the 2013 World Traditional Medicine Expo in Sancheong, it is needed to analyze strong points of the events above and benchmark a practical timeline and technical road map to the 2013 Expo from them.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2013.05a
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• pp.677-680
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• 2013

The risk of leakage of personal information is growing with new services such as social networking and cloud services by the rapid development of information. In particular, the field of medical IT technology is required to solve problems arising from the aging society and sustainable economic development, and in accordance with the requirements to improve the quality of life, a new market for medical devices and healthcare services can be expected. However, most of the medical information system was computerized with the introduction of IT technology, and when they exchange and transfer of medical information between institutions, medical information leakage occurs and security risk is growing. In this paper we review and analyse the security of personal health information related to the major legal systems and technical and administrative protection.

• Korean Journal of Clinical Laboratory Science
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• v.44 no.4
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• pp.178-183
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• 2012

We investigated the latest trend of u-Health and relations with clinical technologist. Since 2000, Korea has become an aging society. Korea will become an aged society by 2018, and it is expected to enter the ultra-high aged society by 2026. Increase in over 65 years population means that the desire of medical service and care demand for the elderly is greatly required. In addition, many predicted Korean national health insurance would falter financially. Medical suppression policies and regulations are also amended continuously. U-Health based on the IT industry and development of related technologies and industries contains the variety concepts of telemedicine, telehealth, e-health, u-healthcare and POCT. Especially, the use of POCT supplied quick clinical examination is extending steadily in medical center and hospital, which will generate the field friction between nurses and medical technologists. In the transition situation from provider-centric service to consumer-driven health care system, this study recommended the principal role and correspondence of clinical laboratory workers and offered information about changes in healthcare market and the basic concept of expert system, measurement and the diagnosis principle to clinical technicians throughout the investigation of the recent research and government policy trends.