• Title/Summary/Keyword: medical affairs law

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Legal Grounds for Withholding or Withdrawal of Life-Sustaining Treatment (연명의료의 중단 - 대법원 2009.5.21. 선고 2009다17417 판결과 관련하여 -)

  • Suk, Hee-Tae
    • The Korean Society of Law and Medicine
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    • v.10 no.1
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    • pp.263-305
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    • 2009
  • Is it lawful to withhold or withdraw life-sustaining treatment applied to a patient in a terminal condition or permanent unconscious condition? In Korea, there are no such laws or regulations which control affairs related to the withholding or withdrawal life-support treatment and active euthanasia as the Natural Death Act or the Death with Dignity Act in the U. S. A. And in addition there has had no precedent of Supreme Court. Recently Supreme Court has pronounced a historical judgment on a terminal care case. The court allowed the withdrawal of life-sustaining treatment from a patient in a permanent unconscious state. Fundamentally the court judged that the continuation of that medical treatment would infringe dignity and value of a patient as a human being. And the court required some legal grounds to consider such withdrawal or withholding of medical care lawful. The legal grounds are as follow. First, the patient is in a incurable and irreversible condition and already entered a stage of death. Second, the patient executed a directive, in advance, directing the withholding or withdrawal of life-support treatment in a incurable and irreversible condition or in a terminal condition. Otherwise, at least, the patient's will would be presumed through his/her character, view of value, philosophy, religious faith and career etc. I regard if a patient is in a incurable and irreversible condition or in a terminal condition, the medical contract between a patient and a doctor would be terminated because of the actual impossibility of achievement of it's purpose. So I think the discontinuation of life-sustaining care would be legally allowed without depending on the patient's own will.

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Study on Significance and limitations of the Enactment of the Advanced Regenerative Bio Act (첨단재생바이오법의 제정 의의와 제한점)

  • Sohn, Seong Goo;Kwon, Kyeng Hee
    • The Korean Society of Law and Medicine
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    • v.22 no.4
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    • pp.159-184
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    • 2021
  • The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.

Review and Interpretation of Health Care Laws Based on Civil Law (보건의료관련 법령의 동의에 관한 민법적 검토)

  • Yi, Jae Kyeong
    • The Korean Society of Law and Medicine
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    • v.23 no.4
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    • pp.75-102
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    • 2022
  • In this article, 「Act on the hospice and palliative care and decisions on life-sustaining treatment for patients at the end of life」, 「Act On The Improvement Of Mental Health And The Support For Welfare Services For Mental Patients」, 「Organs Transplant Act」, 「Safety And Management Of Human Tissue Act」, 「Pharmaceutical Affairs Act」, 「Prevention Of Acquired Immunodeficiency Syndrome Act」, 「Tuberculosis Prevention Act」, 「Infectious Disease Control And Prevention Act」 were reviewed. Patients' right to self-determination and consent in these laws are related to civil law. even though they are closely related to the civil law in relation to patients' right to self-determination and consent. In order to consistently operate medical administration, it is necessary to understand the principles of civil law decision-making.

Review of 2016 Major Medical Decisions (2016년 주요 의료판결 분석)

  • Park, Tae Shin;Yoo, Hyun Jung;Jeong, Hye Seung;Lee, Dong Pil;Lee, Jung Sun
    • The Korean Society of Law and Medicine
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    • v.18 no.1
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    • pp.297-341
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    • 2017
  • We searched out court rulings on medical affairs through court library search sites and specialized articles on medically relevant judgments sentenced in 2016. And we selected and analyzed the judgements of the court we considered important as follows. In relation to the medical civil judgements, (1) In the case of applying surgery for female infertility during cesarean section operation but it has not been done, we expressed the regret for the lack of judgment in the process of entering the medical contract, introducing the rights infringed and the scope of compensation, (2) We pointed out that the ruling on the medical malpractice estimation goes out of limit of negligence estimation doctrine, and that the court asked very high degree duty of the traditional Korean medicine doctors to cooperate with Western medicine doctors. (3) In the case of admitting hospital's 100% responsibility, we pointed out the court overlooked the uncertainty and good intention of the medical practice. (4) Additionally, We introduced the cases admitted the hospital's responsibility in the accident related to the psychiatric patients in closed ward. Relating to a medical criminal ruling, we analyzed the supreme court decision about whether the dentist's Botox injection on the patient's face is a medical practice within the scope of the license from the viewpoint whether it is within the possible range of the word. And, concerning decisions on healthcare administration, (1) we analyzed the case about when medical personnel operate multiple medical institutions, whether it is possible to get back medical care costs under the National Health Insurance Law, (2) We commented on the ruling regarding explanation obligation in terms of object, degree, subject of explanation as a prerequisite for permissible arbitrary uninsured benefits. Finally, we reviewed the decision of the Constitutional Court about the Article 24 of the Mental Health Law, which it had allowed for a mental patient to be hospitalized forcibly by the consent of two guardians and a diagnosis of a psychiatrist. Also we indicated the problems of the revised Mental Health Law.

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Study on Using Medical Devices by Korean Medical Doctors through Judicial Precedents (판례 분석을 통한 한의사 의료기기 사용범위에 관한 한의학적 고찰)

  • Chung, Hyun-joo;Hong, Jin-woo
    • The Journal of Internal Korean Medicine
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    • v.40 no.4
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    • pp.597-611
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    • 2019
  • Objective: The goals of this study were to analyze each of the reasons adopted by the Constitutional Court or the Courts for Decisions determined to permit the use of medical devices by Korean medicine doctors and to look at the medical devices from a Korean medical perspective. Materials and Methods: For this study, several judicial precedent databases were used for searching judicial precedents that handle the usage of medical devices by Korean medicine doctors. Prior studies on similar issues were considered. The Korean medicine textbooks and related research studies were also used in this study. Results: From 2000 to 2018, a large number of lawsuits were filed regarding the legality of Korean medicine doctors using medical devices; approximately 20 final judgments or decisions were made. Among them, only two cases determined that Korean medicine doctors could legally use medical devices. Conclusion: The decisions in both cases could be interpreted as the judgments that Korean medicine doctors were allowed to use a medical device whose use or operating principles were commonly incorporated with Korean medical principles. That was provided that training was sufficient in the use of the medical device, to the extent that it could be used and that such use of the medical device was not feared to pose a health hazard.

Studies on the Standard Protocols of Bioequivalence Test

  • Yoon, Kyung-Eun;Chung, Soo-Youn;Park, Ki-Sook;Choi, Hong-Suk;Baek, Min-Sun;Jung, Sung-Hee;Choi, Sun-Ok
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.315.1-315.1
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    • 2003
  • After beginning the new medical system separating the prescription from the drug dispensary, the demand of bioequivalence test significantly increases to show the equivalence between the test and reference drugs as a result of amendment of the pharmaceutical affairs law which allows a generic substitution. Accordingly the standard protocols provided by the government are required for reducing the period andthe cost to perform the bioequivalence study. (omitted)

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Female College Students' Perception of Work Scope of Dental Hygienist and Boundaries of Medical Personnel according to the Major

  • Hong, Yang-Hee;Lee, Jung-Mi;Woo, Hee-Sun
    • Journal of the Korea Society of Computer and Information
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    • v.25 no.3
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    • pp.177-183
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    • 2020
  • The purpose of the study is to investigate the women's college students' perceptions on work scope of dental hygienists and the inclusion of dental hygienists in the category of medical personnel. A self-reported questionnaire was completed by 180 Suwon women's college students from August 26, to September 11, 2019. The questionnaire consisted of oral health condition of the subjects, perception of both legal and illegal work scope of dental hygienist, the degree of recognition of medical personnel occupations by subject, and the reason why they thought dental hygienists are medical personnel. The collected data were analyzed based on frequency, percentage, and descriptive statistics using IBM SPSS VER 22.0. It showed significantly different perception of work scope of dental hygienists according to the major. Percent of 70 of the subjects perceived dental hygienist as a medical personnel, the opinions on the necessity were as follows: The Ministry of Health and Welfare issues a license through the national examination role and dental hygienists assist the care of dentist. Therefore, clinical dental hygienists should be promoted to medical personnel through the amendment of the medical law so that the duties practiced by the dental hygienist can be matched with the legal practice.

A Study of Nurse Legal Obligation and Responsibility Related to their work (간호업무와 관련한 법적 의무 및 책임에 대한 조사 연구)

  • Yang, Kyung-Hee;Hwang, Jong-Hoon;Kim, Young-Hee
    • Research in Community and Public Health Nursing
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    • v.9 no.2
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    • pp.303-312
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    • 1998
  • The purpose of this study was to survey the knowledge level, attitude and practice of nurses toward their work. The subjects of the study were composed of 98 nurses from 3 general hospitals, 1 oriental medical hospital, 2 health centers and several community health posts and schools. Data were collected from May to October, 1998. In data analysis, an SPSS PC program was utilized for descriptions. 1) 16 nurses (16.3%) experienced medical accidents on the 7 nurses(7.1%) 1 time, 6 nurses (6.1%) 2 times, and 3 nurses(3.1%) 3 times. 2) Concerning knowledge of their legal obligations ; the prohibition of telling secrets was .89, the prohibition of reading medical records was .58, the keeping of medical records was 1.0 and the teaching of recuperation was. 79. The total mean score was. 86. Concerning attitude and practice; the prohibition of telling secrets was 81.6%, 63.3%. The prohibition of reading medical records was 61.2%, 60.2%. The keeping of medical records was 98%, 98%. The explanation for treatment, care and test was 91.8%, 66.3%. The teaching for recuperation was 63.3%, 63.3%. 3) Knowledge of their legal responsibilities; 29. 6% of the subjects thought that they should report a medical accident to their headnurse, but 75.5% of the subjects actually reported to the headnurse. 39.8% of the subjects thought that nurses were liable for the faults of nursing aides. The total mean score was .45. 46% of the subjects asked a senior staff's advide on difficult affairs. Nurses obeyed legal obligations when concern ing the protection of a client, but were passive when concerning self protection. Also, headnurses were required as adviser, guide and advocate.

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A Study on the Precedents Changing Related to Using Medical Devices of Korean Medicine Doctors (한의사 의료기기 사용과 관련된 판례 및 기존 연구 분석과 경향 변화)

  • Park, Jeongsu;Oh, Kichang;Kwon, Sanghyuk;Chu, Hongmin;Kim, Jungsang
    • The Journal of Internal Korean Medicine
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    • v.42 no.6
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    • pp.1303-1318
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    • 2021
  • Objectives: The aim of this study was to examine the debate on the use of medical devices between Western Medicine and Korean Medicine, as this is one of the greatest conflicts in Korea's medical profession. Judicial precedents and interpretations of authority serve as regulations because medical affairs law states that Korean Medicine practices are ambiguous. Method: We conducted a search in the Korean RISS, OASIS, and DBPIA databases using several keywords associated with medical devices, Korean Medicine, and Korean Medicine Doctors. The search period was until November 5 2021. The retrieved papers were classified according to the selection and exclusion criteria by checking the title, abstract, and text. For precedents, searches were done regarding comprehensive legal information, etc., and in the case of non-disclosure precedents, we requested access to the precedents by web-court requests. Results: A total of 80 documents were found as a result of the search, and 13 publications were included in the study. The selected publications were classified and analyzed by this research team into Korean medicine, Western medicine, and legal or state agency research. In the existing literature and judgments, the arguments that played a major role changed depending on the time the judgment was made. "Social conventions", "curriculum", "academic principles", and "health and hygiene dangers" were the key arguments. Conclusions: Further studies will be needed that can comprehensively arrange the existing literature and clinical results, and continuous study will be needed to verify that the use of medical devices by Korean medicine doctors is helpful for prognosis and accurate treatment of their patients.

Problems and Solutions for Korean Medical Fee Contract System (건강보험 요양급여비용 계약의 문제점과 개선방안 연구)

  • Shin, Sung-Chul
    • Health Policy and Management
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    • v.19 no.1
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    • pp.1-30
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    • 2009
  • Korean medical fee contract system between the insurer and healthproviders was introduced in 2000. However, a continuous discord among contracting parties concerned and an irrational operation of an arbitration committee of Ministry for Health, Welfare and Family Affairs (MIHWAF) have made it difficult for them to reach to an agreement over last 8 years. The purpose of this study is to observe the current problems of contract system from the view of health insurance law and actual examples. Furthermore, I examined the of breakdown of negotiation by analyzing the eligibility of contracting parties, rationality of Resource Based Relative Value System (RBRVS) and contracting method and fairness of arbitration method in case of negotiation rupture. The results were as follows: First, since the introduction of medical fee contract system, there has been a problem in that both the president of National Health Insurance Corporation (NHIC) and health care provider association have not held strong negotiation power. Second, the frequent changes and notifications of Relative Value Units (RVUs) without any mutual consent between the insurer and provider association negatively have influenced the conversion factors and finally hindered the agreement of contract. Third, a current process that the conversion factors are mediated and determined at the arbitration committee of MIHWAF in the case of contract breakdown between contracting parties has some flaw in that the irrational composition of committee provoked the lack of fairness and objectivity of mediation. Fourth, we can not prospect a satisfactory outcome of arbitration committee because the mediation always has failed to proceed smoothly due to boycott of both committee members from insurer and providers over last 8 years. As a result, we have to make an every effort to resolve problems mentioned above and then dream of an advanced national health insurance system.