• Title/Summary/Keyword: 질환예측

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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.

A Comparison of Tiotropium 18㎍, Once Daily and Ipratropium 40㎍, 4 Times Daily in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (만성폐쇄성폐질환 환자에서 Tiotropium 1일 1회, 1회 18㎍ 요법과 Ipratropium 1일 4회, 1회 40㎍ 요법의 치료효과 및 안전성 비교)

  • Kim, Seung Joon;Kim, Myung Sook;Lee, Sang Haak;Kim, Young Kyoon;Moon, Hwa Sik;Park, Sung Hak;Lee, Sang Yeub;In, Kwang Ho;Lee, Chang Youl;Kim, Young Sam;Kim, Hyung Jung;Ahn, Chul Min;Kim, Sung Kyu;Kim, Kyung Rok;Cha, Seung Ick;Jung, Tae Hoon;Kim, Mi Ok;Park, Sung Soo;Choi, Cheon Woong;Yoo, Jee Hong;Kang, Hong Mo;Koh, Won Jung;Ham, Hyoung Suk;Kang, Eun Hae;Kwon, O Jung;Lee, Yang Deok;Lee, Heung Bum;Lee, Yong Chul;Rhee, Yang Keun;Shin, Won Hyuk;Kwon, Sung Yeon;Kim, Woo Jin;Yoo, Chul Gyu;Kim, Young Whan;Shim, Young Soo;Han, Sung Koo;Park, Hye Kyung;Kim, Yun Seong;Lee, Min Ki;Park, Soon Kew;Kim, Mi Hye;Lee, Won Yeon;Yong, Suk Joong;Shin, Kye Chul;Choi, Byoung Whui;Oh, Yeon Mok;Lim, Chae Man;Lee, Sang Do;Kim, Woo Sung;Kim, Dong Soon;Jung, Sung Soo;Kim, Ju Ock;Ko, Young Chun
    • Tuberculosis and Respiratory Diseases
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    • v.58 no.5
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    • pp.498-506
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    • 2005
  • Background : This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules ($18{\mu}g$ once daily) with a ipratropium metered dose inhaler (2 puffs of $20{\mu}g$ q.i.d.) in patients with chronic obstructive pulmonary disease (COPD). Method : After the initial screening assessment and a two-week run-in period, patients received either tiotropium $18{\mu}g$ once daily or ipratropium $40{\mu}g$ four times daily over a period of 4 weeks in a double blind, double dummy, parallel group study. The outcome measures were the lung function, the daily records of the peak expiratory flow rate (PEFR), the patients' questionnaire, and the use of concomitant salbutamol. The forced expiratory volume in one second ($FEV_1$) and the forced vital capacity (FVC) were measured 5 minutes before inhalation, and 0.5, 1, 2 and 3 hours after inhaling the study drug on days 0, 14 and 28. Result : In 16 centers, 134 patients with a mean (SD) age of 66 (7) years and a predicted $FEV_1$ of 42 (12)% were analyzed. The trough $FEV_1$ response was significantly higher in the tiotropium group than in the ipratropium group after a four-week treatment period. The weekly mean morning PEFR of the tiotropium group was consistently higher than that of the ipratropium group during the 4-week treatment period with differences ranging from 12.52 to 13.88 l/min, which were statistically significant. Tiotropium was well tolerated by the COPD patients during the 4-week treatment period and had a similar safety profile to ipratropium. Conclusion : This study shows that tiotropium administrated once daily has a superior bronchodilator effect with a similar safety profile in treating COPD patients compared with ipratropium, inhaled four times daily.