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A Study on the Improvement of Domestic Medical Device Classification System through the Analysis of Major Foreign Countries (주요국의 의료기기 품목 분류체계 조사분석을 통한 국내 의료기기 품목 신설 및 세분화 연구)

  • Ji Min, Son;Kang Hyeon, You;You Rim, Kim; Gyeong Min, Kwon;Hui Sung, Lee;Won Seuk, Jang
    • 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.

A Study on the Characteristics of the Delivery System in Welfare to Work : the Case of the Employment Partnerships in United Kingdom (근로연계복지정책의 전달체계 성격에 관한 연구 - 영국 뉴딜정책(New Deal)의 파트너십전략을 중심으로 -)

  • Lim, Su Kyoung;Kwon, Hyeok Chang
    • Korean Journal of Social Welfare Studies
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    • v.42 no.2
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    • pp.71-96
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    • 2011
  • This study explores the characteristics of the delivery system of the New Deal, with a particular attention to the partnerships and welfare governance. The study analyzes the partnerships of the New Deal policy in Britain, which consist of two dimensions of partnerships. The results are: First, the method of the transformation of delivery in central government dimension is the unity of the governmental organizations, Another outcome of reform in the central government dimension is the establishment of the Jobcentre Plus. Second, the characteristic of delivery system in public-private dimension is the contract through competition, which means the introduction of market paradigm. Especially, the reform of the delivery system in the local dimension is to deliver integrated services through the introduction of labour market paradigm in demand-side. The central government also supports the reform in the local level. This study also explores the forms of welfare governance in these dimensions, This study suggests the importance of united services in the Korean welfare to work.

Design and Development of an EHR Platform Based on Medical Informatics Standards (의료정보 표준에 기반한 EHR 플랫폼의 설계 및 개발)

  • Kim, Hwa-Sun;Cho, Hune;Lee, In-Keun
    • Journal of the Korean Institute of Intelligent Systems
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    • v.21 no.4
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    • pp.456-462
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    • 2011
  • As the ARRA enacted recently in the United States, the interest in EHR systems have been increased in the field of medical industry. The passage of the ARRA presents a program that provides incentives to office-based physicians and hospitals adapting the EHR systems to guarantee interoperability with various medical standards. Thanks to the incentive program, a great number of EHR systems have been developed and lots of office-based physicians and hospitals have adapted the EHR systems certified by CCHIT. Keeping pace with the rapid changes in the market of healthcare, some enterprises try to push in to the United States healthcare market based on the experience acquired by developing EHR systems for hospitals in Korea. However, the developed system must be customized because of the different medical environment between Korea and the United States. In this paper, therefore, we design and develop an integrated EHR platform to guarantee the interoperability between different medical information systems based on medical standard technologies. In the developed platform, an integrated system has been composed by integrating various basic techniques such as data transmission standards and its methods, medical standard terminologies and its usage, and knowledge management for medical decision-making support. Moreover, medical data can be processed electronically by adapting an HL7 interface engine and the terminologies for exchanging medical information and the standardization of medical information. We develop SeniCare, an EHR system for supporting ambulatory care of the office-based physicians, based on the platform, and we verify the usability of the platform by confirming whether SeniCare satisfies the criteria of "meaningful use" issued by CMS or not.

A Review on End-of-life Care System between South Korea and the United States (한국과 미국의 생애말기케어 시스템 비교 연구)

  • Choi, Ji-Won;Rhee, YongJoo
    • Journal of Digital Convergence
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    • v.17 no.9
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    • pp.301-310
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    • 2019
  • This study aims to examine eligibilities, services and delivery of services for the current end-of-life care and analyze the quality control of services for end-of-life care. We analyzed the literature and laws on end-of-life systems in Korean and the United States. Current end-of-life care, hospice and palliative care in Korea is being provided mainly in hospital setting. Quality control for the services focuses on setting the criteria for structures in hospitals (i.e. staffing, facilities and equipment). Whereas American end-of-life care system has much broader eligibility for service beneficiaries and provides care mostly at home. Also quality control for services includes process (delivering service) and outcomes, such as monitoring performance indicators and consumer's satisfaction. This is linked to annual payment. The comparative analysis findings contributed to give the next direction of current Korean end-of-life care system. It is nessary to establish the better and extensive end-of-life care system in Korea in considering other countries' end-of-life care systems based on more future research.

A Study on the Modeling and Control of High-Speed/High-Accuracy Position Control System (고속/정밀 위치제어시스템의 모델링 및 제어에 관한 연구)

  • 신호준;박민규;윤석찬;한창수
    • Proceedings of the Korean Society of Machine Tool Engineers Conference
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    • 2000.10a
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    • pp.83-89
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    • 2000
  • This paper presents a dynamic modeling and a sliding mode controller for the high-speed / high-accuracy position control system. Selected target system is the wire bonder head assembly which is used in semiconductor assembly process. This system is a reciprocating one around the pivot point that consists of VCM(voice coil motor) as a actuator and transducer horn as a bonding tool. For the modeling elements, the system is divided into electrical circuit, magnetic circuit and mechanical system. Each system is modeled by using the bond graph method and united into the full system. Two major aims are considered in the design of the controller. The first one is that the horn must track the given reference trajectory. The second one is that the controller must be realizable by using the DSP board. Computer simulation and experimental results show that the designed sliding mode controller provides better performance than the PID controller.

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Consideration on the Convention of Space Station as Law-Making Process among Nations (다수국간법정립행위로서의우주기지협정에관한고찰(多数国間法定立行為としての宇宙基地協定に関する一考察))

  • Horish, Saito
    • The Korean Journal of Air & Space Law and Policy
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    • v.14
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    • pp.87-110
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    • 2001
  • This Article examines a structure of two Conventions of Space Station, compares 1988 Convention and 1998 Convention, and tries to apply "model" to it. The structure of 1988 Convention shows us three phases: the Convention as a framework, the bilateral memorandum of understanding and the legislation by domestic process of United States. There were many advantageous provisions for United States. In 1998 Convention, however, those provisions are dampened and provisions become impartial, for example, the criminal jurisdiction, the right of intellectual property and the codes of conducts in Space Station. On the other hand, we sets the "model" up, that is "input of national benefits and ideas ${\Rightarrow}$ process of law-making ${\Rightarrow}$ output of common benefits, universal ideas and wastes." In the case of applying this "model" to 1988 and 1998 Conventions, we are convinced of enough possibility to understand and explain the legal system of Space Station by this "model." This result awakes us that study of legal system of Space Station according to the "model" influences the fundamental theory of International Law Study: the relation between international law and domestic law. This "model" has possibility to change the theory of relation between from "international law and domestic law" to "domestic law and domestic law through international legal system." In the end, we should reconsider on "policy-oriented jurisprudence" by professor McDougal to use his key words for explanation of concepts in the "model," because his theory contains important suggestions to the study of law-making process and legal system for outer space activities in the near future.

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A Comparative Study on International Convention and National Legislation Relating to the Liability of the Air Carrier

  • Lee, Kang-Bin
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.40
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    • pp.97-144
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    • 2008
  • The purpose of this paper is to review the text of national legislation relating to the carrier's liability in respect of the carriage of passengers, baggage and cargo by air in major states such as United Kingdom, Germany, France, Canada, Russia and China, and to compare the air carrier's liability under the national legislations of above states with them under the Warsaw System relating to the international carriage by air. Also this paper reviews the text of the draft legislation relating to the carrier's liability in respect of the carriage by air in Korea. The Warsaw Convention for the Unification of Certain Rules Relating to International Carriage was adopted in 1929. In 1999, the ICAO adopted the Montreal Convention for the Unification of Certain Rules for International Carriage by Air vastly modernizing the unification of private air law. The Montreal Convention replaced the instruments of the “Warsaw System”, and came into force on 4 November 2003. The Montreal Convention is not only an international convention. It has also exercised a considerable influence on national legislation. A the Convention, or certain of its principles, with the object of regulating their national air transport. The main feature of the liability regime of the air carrier under the Montreal Convention is the two-tier liability system for death or injury of the passenger with strict liability up to 100,000 SDR and presumptive liability with a reversed burden of proof without any limit above that threshold. The principles of the liability of the air carrier under the Montreal Convention have been adopted into national legislations by the United Kingdom, Germany, France, Canada, Russia and China. Now the Ministry of Justice of Korea is proceeding to make a new national legislation relating to the liability of the air carrier in respect of the carriage by air. The draft legislation of the Part VI the Carriage by Air of the Commercial Code of Korea has adopted the main principles of the liability of the air carrier under the Montreal Convention. In conclusion, the national legislation relating to the liability of the air carrier in Korea will contribute to settle efficiently the dispute on the carrier's liability in respect of the carriage of passengers, baggage and cargo by air.

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Development of Regulation System for Off-Label Drug Use (의약품 허가외사용 관리 체계 발전 방안)

  • Lee, Iyn-Hyang;Seo, Mikyeong;Lee, Young Sook;Kye, Seunghee;Kim, Hyunah;Lee, Sukhyang
    • YAKHAK HOEJI
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    • v.58 no.2
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    • pp.112-124
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    • 2014
  • This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers' self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official 'Off-Label Drug Use Report' to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.

Comparative Study on the National Health Screening Programs according to the Health Insurance System (국가별 건강보험체계에 따른 국가건강검진제도 비교 연구)

  • Lee, Yeji;Kim, Eunyoung;Lee, Donghyun
    • Health Policy and Management
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    • v.31 no.3
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    • pp.272-279
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    • 2021
  • Background: Korea's health screening program has been faced the need for changes as the population and diseases structure are changing. In addition to Korea, many countries operate state-led health check-up programs to improve the health level of the people, and the operating methods of the program appear in various forms according to each country's health insurance system. This study examines other state-led health screening programs and proposes a direction for the development of Korea's health screening program. Methods: The study was conducted using the literature review method, and the "country" was set as a unit for the case analysis. The operating method of the health screening programs and the financial resources were compared according to the health insurance system. Five countries were selected as Korea, the United States, the United Kingdom, Japan, and Taiwan. Results: The analyzed countries mainly operate the health screening program as a management method for chronic diseases, but there were differences in the operating method, financing, and targeted subjects and examination items. In most countries, a risk assessment was performed prior to the examination (screening), and the subjects who needed the examination were first selected, and a follow-up management service was provided in accordance with the risk each individual exposed. Conclusion: Rather than applying the same screening method to populations with different risk levels, a health screening program will be constructed in consideration of the individual's health level and exposure risk, and the healthcare delivery system will be reorganized so that screening and treatment services can be linked.

A Study on the Role and Improvement Direction of Empty Homes Policy in Korea (빈집제도의 역할과 개선 방향에 관한 연구)

  • Hong, Ji-Wan
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.12
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    • pp.387-394
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    • 2020
  • The aim of this study is to improve the "empty house problem" in Korea. The direction of improvement of systems in Korea was considered and compared with empty house systems in the United Kingdom, France, Germany, the United States, and Japan. Korea's system is based on comprehensive regulations centered on the demolition of empty houses. To actively solve the problem of unoccupied houses, detailed guidelines are needed, which must consider the current status and surrounding environment of empty houses. There should be institutional grounds for local governments to actively intervene in the issue of empty houses, and there should be a system that enables tax and cost support for the reuse of such houses. An information sharing system is also needed for sharing empty house information among local governments. To utilize empty houses as resources for the housing market, it is necessary to establish a consultative system consisting of residents, urban and architectural experts, and private businesses.