• Title/Summary/Keyword: 미국 연구윤리제도

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Legal Issues on the Collection and Utilization of Infectious Disease Data in the Infectious Disease Crisis (감염병 위기 상황에서 감염병 데이터의 수집 및 활용에 관한 법적 쟁점 -미국 감염병 데이터 수집 및 활용 절차를 참조 사례로 하여-)

  • Kim, Jae Sun
    • The Korean Society of Law and Medicine
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    • v.23 no.4
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    • pp.29-74
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    • 2022
  • As social disasters occur under the Disaster Management Act, which can damage the people's "life, body, and property" due to the rapid spread and spread of unexpected COVID-19 infectious diseases in 2020, information collected through inspection and reporting of infectious disease pathogens (Article 11), epidemiological investigation (Article 18), epidemiological investigation for vaccination (Article 29), artificial technology, and prevention policy Decision), (3) It was used as an important basis for decision-making in the context of an infectious disease crisis, such as promoting vaccination and understanding the current status of damage. In addition, medical policy decisions using infectious disease data contribute to quarantine policy decisions, information provision, drug development, and research technology development, and interest in the legal scope and limitations of using infectious disease data has increased worldwide. The use of infectious disease data can be classified for the purpose of spreading and blocking infectious diseases, prevention, management, and treatment of infectious diseases, and the use of information will be more widely made in the context of an infectious disease crisis. In particular, as the serious stage of the Disaster Management Act continues, the processing of personal identification information and sensitive information becomes an important issue. Information on "medical records, vaccination drugs, vaccination, underlying diseases, health rankings, long-term care recognition grades, pregnancy, etc." needs to be interpreted. In the case of "prevention, management, and treatment of infectious diseases", it is difficult to clearly define the concept of medical practicesThe types of actions are judged based on "legislative purposes, academic principles, expertise, and social norms," but the balance of legal interests should be based on the need for data use in quarantine policies and urgent judgment in public health crises. Specifically, the speed and degree of transmission of infectious diseases in a crisis, whether the purpose can be achieved without processing sensitive information, whether it unfairly violates the interests of third parties or information subjects, and the effectiveness of introducing quarantine policies through processing sensitive information can be used as major evaluation factors. On the other hand, the collection, provision, and use of infectious disease data for research purposes will be used through pseudonym processing under the Personal Information Protection Act, consent under the Bioethics Act and deliberation by the Institutional Bioethics Committee, and data provision deliberation committee. Therefore, the use of research purposes is recognized as long as procedural validity is secured as it is reviewed by the pseudonym processing and data review committee, the consent of the information subject, and the institutional bioethics review committee. However, the burden on research managers should be reduced by clarifying the pseudonymization or anonymization procedures, the introduction or consent procedures of the comprehensive consent system and the opt-out system should be clearly prepared, and the procedure for re-identifying or securing security that may arise from technological development should be clearly defined.

Health Economic Approach to End-of-Life Care in the US: Based on Medicare (말기의료의 경제적 요소에 관한 논의: 미국 메디케어 상황을 중심으로)

  • Suk, Ryan
    • The Korean Society of Law and Medicine
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    • v.15 no.1
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    • pp.335-373
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    • 2014
  • According to one Medicare report, in the US, total federal spending on health care expends almost 18 percent of the nation's GDP, about double what most industrialized nations spend on health care. And in 2011, Medicare spending reached close to $554 billion, which amounted to 21 percent of the total spent on U.S. health care in that year. Of that $554 billion, Medicare spent 28 percent, or about $170 billion, on patients' last six months of life. So what are the reasons of this high cost in EOL care and its possible solutions? Much spendings of Medicare on End-of-Life care for the terminally ill/chronically ill in the US has led health economics experts to assess the characteristics of the care. Decades of study shows that EOL care is usually supply-sensitive and poor in cost-effectiveness. The volume of care is sensitively depending on the supply of resources, rather than the severity of illness or preferences of patients. This means at the End-of-Life care, the medical resources are being overused. On the other hand, opposed to the common assumption, "The more care the better utility", the study shows that the outcome is very poor. Actually the patient preference and concerns are quite the opposite from what intense EOL care would bring about. This study analyzes the reasons for the supply-sensitiveness of EOL care. It can be resulted from the common misconception about the intense care and the outcome, physicians' mission for patients, lack of End-of-Life Care Decision which helps the patients choose their own preferred treatment intensity. It also could be resulted from physicians' fear of legal liabilities, and the management strategy since the hospitals are also seeking for financial benefits. This study suggests the possible solutions for over-treatment at the End-of-Life resulting from supply-sensitiveness. Solutions can be sought in two aspects, legal implementation and management strategy. In order to implement advance directive properly, active ethics education for physicians to change their attitude toward EOL care and more conversations about end-of-life care between physicians and patients is crucial, and incentive system for the physicians who actively have the conversations with patients will also help. Also, the general education towards the public is also important in the long run, and easy and official advance directive registry system-such as online registry-has to be built and utilized more widely. Alternative strategies in management are also needed. For example, the new strategic cost management and management education, such as cutting unnecessary costs and resetting values as medical providers have to be considered. In order to effectively resolve the problem in EOL care for the terminally ill/chronically ill and provide better experience to the patients, first of all, the misconception and the wrong conventional wisdom among doctors, patients, and the government have to be overcome. And then there should be improvements in systems and cultures of the EOL care.

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