• The Journal of the Convergence on Culture Technology
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• v.8 no.5
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• pp.29-37
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• 2022

MDR, a new European medical device regulation newly enacted in 2017, requires that medical device products that have received CE conformity certification through MDD be re-certified by May 2024 in line with the new CE MDR regulation. The new MDR requires more stringent medical device clinical evaluation and clinical investigation than the previous MDD required, and also require the submission of documented post-marketing surveillance data. Korean medical device makers also need to meet the new MDR requirements and obtain conformity certification, but the industry is still confused because they do not understand the new regulations thoroughly. In this study, medical device regulations in Korea, the United States, and Europe are compared, and the European MDR is further compared with the previous European Medical Device Directive MDD to help understand the requirements of the new European Medical Device Act.

• Journal of the Korean Medical Association
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• v.61 no.12
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• pp.702-705
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• 2018

Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers, and patients all face the challenge of balancing patient safety and health effectiveness with a reasonable profit. In Korea, the New Health Technology Assessment system aims to introduce safe and effective health technology, but this is only effective for the entry of devices onto the healthcare market. This system is not enough for creating a healthy ecosystem in which high-quality technologies and devices survive in the market and naturally exit from the market if not successful. The nation must not lag in the rapid development of medical devices, but the concomitant requirement for patient safety is like two rabbits moving in different directions. There is not enough time to resolve each source of uncertainty for both developers and users. The early adoption of health technologies, including medical devices, offers new opportunities for treatment and diagnosis, but also poses unexpected health risks. Thus, we need to design a plan to generate scientific evidence related to medical devices after they introduced into practice. Additionally, regarding the use of individual medical devices, we believe that the creation of a healthy ecosystem for medical devices by implementing medical device surveillance culture is a way to manage the opportunities and risks of the early introduction of innovative medical devices.

• Journal of Electrical Engineering and Technology
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• v.10 no.6
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• pp.2384-2392
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• 2015

The technical development and practical applications of big-data for health is one hot topic under the banner of big-data. Big-data medical image fusion is one of key problems. A new fusion approach with coding based on Spherical Coordinate Domain (SCD) in Wireless Sensor Network (WSN) for big-data medical image is proposed in this paper. In this approach, the three high-frequency coefficients in wavelet domain of medical image are pre-processed. This pre-processing strategy can reduce the redundant ratio of big-data medical image. Firstly, the high-frequency coefficients are transformed to the spherical coordinate domain to reduce the correlation in the same scale. Then, a multi-scale model product (MSMP) is used to control the shrinkage function so as to make the small wavelet coefficients and some noise removed. The high-frequency parts in spherical coordinate domain are coded by improved SPIHT algorithm. Finally, based on the multi-scale edge of medical image, it can be fused and reconstructed. Experimental results indicate the novel approach is effective and very useful for transmission of big-data medical image(especially, in the wireless environment).

• The Journal of the Korea Contents Association
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• v.22 no.7
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• pp.652-662
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• 2022

Currently, in the field of spinal surgery around the world, various new technologies have been rapidly developed and applied to patients. The author believes that it is necessary to discuss whether these new technologies are being fully reviewed for efficacy and safety before being applied to patients. To consider this issue, the author analyzed the basic research data and clinical application process of the intradiscal electrothermal therapy, which was developed as a new technology for discogenic pain disease in the 2000s and has been widely used worldwide. As a result, it was found that this procedure has been performed on patients in a state where there is insufficient base research on efficacy and safety. The author judges that this case reveals an essential problem related to the clinical operation of new medical technologies in the field of spine surgery. Therefore, the author believes that in order to minimize the side effects that new medical technology in the field of spinal surgery may have on patients, more full-fledged basic research and higher clinical acceptance standards should be established.

• International journal of advanced smart convergence
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• v.10 no.2
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• pp.37-44
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• 2021

At the time of entering the super-aged society, the health problem of the elderly is becoming more prominent due to the rapid digital era caused by COVID-19, but the gap between welfare budgets and welfare benefits according to regional characteristics is still not narrowed and there is a significant difference in emergency medical access. In response, this study proposes an ICT-based New Normal Smart Care System (NNSCS) to bridge the gap I n health and medical problems. This is an integrated system model that links the elderly themselves to health care, self-diagnosis, disease prediction and prevention, and emergency medical services. The purpose is to apply location-based technology and motion recognition technology under smartphones and smartwatches (wearable) environments to detect health care and risks, predict and diagnose diseases using health and medical big data, and minimize treatment latency. Through the New Normal Smart Care System (NNSCS), which links health care, prevention, and rapid emergency treatment with easy and simple access to health care for the elderly, it aims to minimize health gaps and solve health problems for the elderly.

• Journal of radiological science and technology
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• v.6 no.1
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• pp.35-41
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• 1983

Boot-Strap method is used to measure the sensitivity of X-ray film, but it is too complicated to design the plot and this method is generally a falling-off in the accuracy and the reproducibility. Authors made an attempt a new method to obtain the stable H-D curve, that is to say; Boot-Strap method used in combination with distance-change method, and the accuracy and the reproducibility.

• Korean Medical Education Review
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• v.16 no.1
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• pp.50-54
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• 2014

It is becoming increasingly important for medical doctors to have a thorough understanding of human genetics and the ethical, legal, and social implications of genetic testing, counseling, and treatment. As genetic engineering and technology evolves, medical doctors will find themselves called in to counsel patients about a rapidly increasing number of diseases for which genetic testing and treatments are available. Medical doctors will need to master a new set of principles and clinical skills. A lack of knowledge about these issues and problems may lead to serious, lifelong or even fatal negative effects on patients. Medical genetics has moved from the study of rare conditions to the illumination of disorders that impact the entire spectrum of medical practice. This study demonstrates several areas in which medical genetics is clearly an important tool in medical practice and the necessity of establishing new curriculum for clinical genetic education in Korea. Medical students nearing graduation may lack genetic knowledge that is essential for daily practice because genetics has little or no place in clinical teaching. Medical schools should make extensive curriculum changes to increase students' awareness of clinical genetics and its ethical implications. The medical school curriculum will need creative new approaches to keeping up with the rapid pace of evolution of clinical genetics.

• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.4
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• pp.571-579
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• 2010

The advancement of medical technology has made it possible to treat various incurable diseases. Especially organ transplantation can give another life to the patients who have organ failure and could not find any other ways to treat their diseases. According to the development of medical technology and immunosuppressive drugs, the rate and extent of organ transplantation is increasing these days. New medical technologies like organ transplantation brought on critical issues and these have changed the way of thinking and morals that has been the fundamental rules in our society. Bioethics is already an important field of medicine and oriental medicine should investigate the problem caused by the development of medical technology and life science and should form a view of life in oriental medicine. Oriental medicine is East Asian traditional medicine based on "Huangdi-Neijing", constructed by the system of Jangfu and meridian. The traditional therapies of oriental medicine have completed a scientific system on the point of view that looks on human and nature equally. This process continued to form a new medical theory as the environment was changed and the new diseases were appeared since "Huangdi-Neijing" and "Shoganron" showed a new scope to investigate human and diseases. Therefore, it is important to develop the point of view of oriental medicine as the medical situation was changed. Oriental medicine has a holistic view that considers human as a little cosmos resonated by a big cosmos and regards the possibility to recover and to regulate the energy in our body. This theory is a basic idea of oriental philosophy. Oriental medicine focuses on the balance of yin and yang of the body and tries to harmonize the imbalance of yin and yang caused by the life style and environment. This can solve many problems that cannot be settled by modern medicine and this can accomplish the new paradigm of oriental medicine that is needed these days.

• Health Policy and Management
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• v.31 no.2
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• pp.148-157
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• 2021

Background: Based on that the key function of health technology is improving the quality of healthcare services, our study purports to explore the process of medical device development in detail and to discuss its policy implications. Methods: A total of 12 in-depth interviews were conducted with four groups of industry, hospital, academia, and civil society. All of the interviewees except those from civil society were involved in the new medical device development between 2009 and 2018. We performed a text network analysis and content analysis of the interview data. Results: The frequency and the degree centrality rankings suggested a close association between the utilization issue and the technology development. Similarly, the results of the content analysis showed that the appropriate intervention in the utilization of technology has a direct impact on the progress of development. Under the continuous industrial effort to boost profits by developing new technology, service providers and citizens should be knowledgeable of and make good use of the new technology for the provision of better services. Conclusion: As the development itself would not guarantee the improvement of service quality and better health outcomes, health technology policies should take a more comprehensive view to serve the unmet needs and even to facilitate the technology development.

• Proceedings of the KOSOMBE Conference
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• v.1991 no.05
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• pp.9-12
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• 1991

The correlation search method yields velocity information by tracking scatter patterns between medical image frames. The displacement vector between a target region and the best correlated search region indicates the magnitude and direction of the inter-frame motion of that particular region. However, if the noise sources in the target region and the search region are correlated Gaussian, then the cross-correlation technique fails to work well because it estimates the cross-correlation of both signals and noises. In this paper we develop a new correlation search method which seeks the best correlated third-order statistics between a target and the search region to suppress the effect of correlated Gaussian noise sources. Our new method yields better estimations of velocity than the conventional cross-correlation method.