• Proceedings of the Korea Information Processing Society Conference
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• 2023.11a
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• pp.1240-1243
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• 2023

의료기관에서 접근이 용이한 마약류 약물로 오남용하는 사례가 지속적으로 증가하고 있다. 이를 해결하고자 본 논문은 블록체인 프레임워크인 하이퍼레저 패브릭을 기반으로 구축된 약물 오남용 관리 시스템을 제안한다. 하이퍼레저 패브릭의 분산 원장 기능을 사용하면 의약품 거래를 투명하게 기록하고 처방 기록을 안전하게 보존하여 모든 거래 세부 정보를 변조할 수 없게 된다. 또한 약물 사용 기록을 추적하고 남용을 방지하기 위해 과다 복용 사용자를 규제하는 기능을 제안한다. 본 논문이 약물 오용을 크게 완화하고 과다 복용 사용자 보호가 가능할 것이라 기대한다.

• Proceedings of the Korean Society of Computer Information Conference
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• 2024.01a
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• pp.157-160
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• 2024

비만은 단순히 개인의 게으름의 문제가 아니라 하나의 위험한 질병으로서 치료를 위해 전문가의 도움이 전적으로 필요로 한다. 개인만의 극복해야 하는 문제가 아니라 사회적 문제로 거론되어 국가 차원에서의 규제와 같은 적극적인 도움이 필요하다. 비만으로 생기는 경제적 손실 또한 무시할 수 없다. 의료비용, 생산성 감소, 사회 보건 문제, 질병 예방 비용 등이 있다. 이 연구는 전 연령층을 대상으로 하되, 아시아, 북아메리카, 남아메리카와 같이 대륙별로 근처 나라들의 2009년에서 2019년까지 10년의 비만 지수와 경제지표를 R을 활용한 회귀분석, 상관관계 분석, Pearson 회귀분석으로 비교하여 가치 있는 결과를 찾는 데 있다. 비만의 해결은 개인의 행복뿐만 아니라 국가의 경제 성장 그리고 회복에 큰 핵심적 요소가 된다는 걸 검증하는 연구이다.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.19 no.6
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• pp.382-390
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• 2018

This study developed a model to evaluate the quality management system of a medical device manufacturing company, and applied it to medical device manufacturers to understand the impact on business performance in response to international regulations and industry's change. This study prepared preliminary items, defined four (4) major factors (Plan-Do-Check-Act) that consist of the evaluation layers and items per category according to prior research review and expert interview, and calculated the weight and importance using AHP. The study results showed that responsibility & authority and quality objective in Planning Category, product-related requirement and R&D in Doing Category, Measuring and monitoring in Check Category, and review of meeting Regulatory and regulation in Action Category are relatively more important factors. The evaluation model developed based on the calculated weight and importance to business performance was applied to medical device manufacturers to investigate and analyze the implementation level of QMS and its impact on business performance according to each category. Most medical device manufacturers to be studied showed a reasonable level of QMS and effective business performance. Almost all the evaluation layers and items in the four (4) factors had a significant influence on business performance. Although the medical device quality management system is aimed mainly at license acquisition, it is important that management environment factors not related directly to licensing and authorization are important to business performance, and it is effective when these factors are integrated and operated within and outside the manufacturer.

• The Korean Society of Law and Medicine
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• v.18 no.1
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• pp.237-264
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• 2017

With the onset of the Human Genome Project, social concerns about 'genetic information discrimination' have been raised, but the problem has not yet been highlighted in Korea. However, non-medical institutions' genetic testing which is related to disease prevention could be partially allowed under the revised "Bioethics and Safety Act" from June 30, 2016. In the case of one domestic insurance company, DTC genetic testing was provided for the new customer of cancer insurance as a complimentary service, which made the social changes related to the recognition of the genetic testing. At a time when precision medicine is becoming a new standard for medical care, discipline on genetic information discrimination has become a problem that can not be delayed anymore. Article 46 and 67 of the Bioethics Act stipulate the prohibition of discrimination on grounds of genetic information and penalties for its violation. However, these broad principles alone can not solve the problems in specific genetic information utilization areas such as insurance and employment. The United States, Canada, the United Kingdom, and Germany have different regulations that prohibit genetic information based discrimination. In the United States, Genetic Information Non-Discrimination Act takes a form that adds to the existing law about the prohibition of genetic information discrimination. In addition, the range of genetic information includes the results of genetic tests of individuals and their families, including "family history". Canada has recently enacted legislation in 2017, expanding coverage to general transactions of goods or services in addition to insurance and employment. The United Kingdom deals only with 'predictive genetic testing results of individuals'. In the case of insurance, the UK government and Association of British Insurers (ABI) agree to abide by a policy framework ('Concordat') for cooperation that provides that insurers' use of genetic information is transparent, fair and subject to regular reviews; and remain committed to the voluntary Moratorium on insurers' use of predictive genetic test results until 1 November 2019, and a review of the Concordat in 2016. In the case of employment, The ICO's 'Employment Practices Code (2011)' is used as a guideline. In Germany, Human Genetic Examination Act(Gesetz ${\ddot{u}}ber$ genetische Untersuchungen bei Menschen) stipulates a principle ban on the demand for genetic testing and the submission of results in employment and insurance. The evaluation of the effectiveness of regulatory framework, as well as the form and scope of the discipline is different from country to country. In light of this, it would be desirable for the issue of genetic information discrimination in Korea to be addressed based on the review of related regulations, the participation of experts, and the cooperation of stakeholders.

• Korean Journal of Medical Ethics
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• v.21 no.4
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• pp.316-329
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• 2018

Although the use of social media by doctors raises important issues concerning medical professionalism, the relevant professional bodies in South Korea have failed to issue clear guidelines on social media usage. The Korean Medical Association's newly revised ethics guidelines do require members to maintain dignity while using social media, but the idea of "maintaining dignity" is far from clear, and its premodern connotation prevents it from being reliably used in professional codes of conduct. The authors of this article examine the concept of maintaining dignity and conclude that once it is clarified and redefined it can and should be used as a viable ethical standard in a variety of contexts, including the use of social media. Social media's unpredictability and uncontrollability, and the blurred distinction between professional/public and personal/private can be a threat to medical professionalism. In order to deal with this threat, the concept of dignity is important. We present three examples in which the dignity of medical professionals is undermined and explain why these jeopardize public trust. We conclude that in order to maintain public trust the Korean Medical Association should provide more detailed guidelines on the use of social media by its members.

• Journal of the Korean Society of Radiology
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• v.17 no.6
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• pp.881-887
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• 2023

This study aims to analyze the development and current trends of AI-based medical imaging devices commercialized in South Korea. As of September 30, 2023, there were a total of 186 AI-based medical devices licensed, certified, and reported to the Korean Ministry of Food and Drug Safety, of which 138 were related to imaging. The study comprehensively examined the yearly approval trends, equipment types, application areas, and key functions from 2018 to 2023. The study found that the number of AI medical devices started from four products in 2018 and grew steadily until 2023, with a sharp increase after 2020. This can be attributed to the interaction between the advancement of AI technology and the increasing demand in the medical field. By equipment, AI medical devices were developed in the order of CT, X-ray, and MR, which reflects the characteristics and clinical importance of the images of each equipment. This study found that the development of AI medical devices for specific areas such as the thorax, cranial nerves, and musculoskeletal system is active, and the main functions are medical image analysis, detection and diagnosis assistance, and image transmission. These results suggest that AI's pattern recognition and data analysis capabilities are playing an important role in the medical imaging field. In addition, this study examined the number of Korean products that have received international certifications, particularly the US FDA and European CE. The results show that many products have been certified by both organizations, indicating that Korean AI medical devices are in line with international standards and are competitive in the global market. By analyzing the impact of AI technology on medical imaging and its potential for development, this study provides important implications for future research and development directions. However, challenges such as regulatory aspects, data quality and accessibility, and clinical validity are also pointed out, requiring continued research and improvement on these issues.

• Journal of radiological science and technology
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• v.40 no.4
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• pp.633-638
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• 2017

The amount of radioactive waste has been rapidly increased with development of radiation treatment in medical field. Recently, it has been a common practice to use I-131 for thyroid cancer, F-18 for PET/CT and Tc-99m for diagnosis of nuclear medicine. All the wastes concerned have been disposed of by means of the self-disposal method, for example incineration, after storage enough to decay less than clearance level. IAEA proposed criteria for clearance level of waste which depends on the individual ($10{\mu}Sv/y$) and collective dose (1 man-Sv/y), and concentration of each nuclide (IAEA Safety Series No 111-P-1.1, 1992 and IAEA RS-G-1.7, 2004). In this study, specific radioactivity of radioactive waste contaminated with Re-186 was measured to confirm whether it meets the clearance level. Re-186 has long half life of 3.8 days relatively and emits beta and gamma radiation, therefore it can be applied in treatment and imaging purposes. The specific radioactivity of contaminated gloves weared by radiation workers was measured by MCA(Multi-channel Analyzer) which was calibrated by reference materials in accordance with the measuring procedure. As a result, comparison evaluation of decay storage period between the half-life which was calculated by attenuation curve based on real measurement and physical half-life was considered, and it is showed that the physical half-life is longer than induced half-life. Therefore, the storage period of radioactive waste for self-disposal may be curtailed in case of application of induced half-life. The result of this study will be proposed as ISO standard.

• Journal of radiological science and technology
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• v.33 no.3
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• pp.231-237
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• 2010

Computed tomography (CT) has been established as an important diagnostic tool in clinical medicine and has become a major source of medical exposure. A nationwide survey regarding CT examinations was carried out in 2007. Thanks to the appeasement policy regulating the import of CT scanners, there are 1,825 CT scanners across the country as of the end of March 2010, which means that we have 36.8 CT scanners per one million people. The annual number of examinations was 3.29 million, the number of examinations per 1000 population was 68. The most part of examinations was abdomen and pelvis. and the collective effective dose was in these parts. The effective dose per one population was evaluated as 0.952 mSv.

• The Journal of the Convergence on Culture Technology
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• v.9 no.2
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• pp.525-531
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• 2023

In Korea, which is entering a super-aged society, the number of elderly patients who have difficulty walking independently is expected to increase rapidly, and it is necessary to develop wheelchair products with various functions to improve the quality of life of people with walking disabilities. Recently, wheelchair power assist devices that provide propulsion power by being attached to a manual wheelchair has been developed and is entering the domestic and global markets. In this study, we compared and analyzed the process of obtaining medical device certification for wheelchair power assist devices in Korea, the United States, and Europe. In Korea, a Class 2 medical device certification process was developed in 2021, and in the US FDA, it corresponds to Class 2 like the existing electric wheelchair and must pass the 510k certification process. In the case of Europe, it is uniquely regulated as Class I, and the CE mark can be attached through a relatively easy self-declaration of conformity. The Korean medical device industry, which is struggling with MDR certification, a new European medical device regulation, should pay attention to the relatively easy entry into the global market for wheelchair power assist products.

• The Korean Society of Law and Medicine
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• v.16 no.2
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• pp.131-157
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• 2015

NHIS claimed for damages to doctors that by doing the treatment breaching medical insurance criteria caused by doctors, NHIS paid for medicine cost to pharmacy; as a result, the doctors caused the tort to NHIS. Following consecutive rulings afterwards, NHIS also argued that the medicine cost violating medical law or medical treatment expense paid to medical organizations are both the tort in civil law. NHIS claimed for all the damages, and the Supreme Court confirmed this judgment. However, within our national health insurance system, the subject of insurance payment is NHIS and the subject of medical treatment expense are also NHIS since the treatment expense is also insurance payment by asking the treatment to medical organizations. Further, national health insurance law is not made to control the violation of medical treatment cases; therefore, the breach of medical law cannot be covered by illegality of tort in civil law regarding NHIS. If that is the case, in the case that if the patients are treated according to treatment criteria via the doctors delegated the doctors' permission by Health and Welfare minister, NHIS acquired the benefits to remove the duty to give treatment payment to doctors in civil law; thus, even though the doctors have breached the medical law, NHIS does not have any damages. The fact that supreme court confirmed the ruling that the treatment is the tort in civil law towards NHIS is the judgment not counting the benefits of insurance payment as the subject but only considering the fact that NHIS paid to the doctors and this ruling have gone against the principle under civil code section 750. If the doctors have breached the medical law, the case should be sanctioned by medical law not national health insurance law, and the ruling of supreme court is assumed that they have confused both with the principle of national health insurance law and civil law.