• Title/Summary/Keyword: medical law

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The Clinical Trial of Terminal Cancer Patients and The Nature of Self-Determination of The Subject (말기 암 환자에 대한 임상시험과 피험자의 자기결정권의 본질)

  • Song, Young-Min
    • The Korean Society of Law and Medicine
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    • v.15 no.1
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    • pp.211-237
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    • 2014
  • Because of unpredictability and high possibility of abnormal results by clinical trials compared to general medical behaviors, a procedure for ensuring with sufficient explanations by investigators must be secured. Therefore, in a sequence of clinical trials, what kinds of scope, stage, and method of explanations provided by investigators, including doctors or researchers, to trial subjects are closely related to the compensation for damages by violation of liability for explanation. In case of application of clinical trials to patients who have critical illness such as cancer, issues of "Quality of Life" regarding trial subjects, cancer patients, should be discussed. Especially, in case of clinical trials for terminal cancer patients, the right of subjects' self-determination, which is a fundamental principle in medical behaviors, should be discussed. The right of self-determination includes participation in clinical trials for the possibility of life-sustaining even a little bit, or no participation in clinical trials in order to have a time for completing the rest of his life. Like this, if the extent and scope of explanations related to the issues of "Quality of Life" are raised as main issues, the evaluation of "Quality of Life", should be a prerequisite. In many occasions, realistically, despite bad results such as deaths or serious adverse drug reactions after clinical trials, it may not be easy for compensating to trial subjects or their survivors, who requested civil compensation for damage. Futhermore, in abnormal results after concealment of clinical trials or performance of clinical trials without permission, and in the case of trial subjects' failures of proving proximate cause between the clinical trials and abnormal results, problematic results such as no protection to the trial subjects could be occurred. In performing clinical trials, investigators should provide sufficient explanations for trial subjects and secure voluntary informed consents from the trial subjects. Therefore, clinical trials without trial subjects' permissions and the informed consent process violate trial subjects' rights of self-determination, and the investigators shall be liable for compensation for damages. Then, issues might be addressed are what are essential contents of patients' "rights of self-determination" infringed by clinical trials without subjects' permissions. Two perspectives about patients' rights of self-determination might be considered. One perspective regards physical distress of patients (subjects) from therapies without sufficient explanations as the crux of the matter. The other perspective regards infringement of human dignity caused by being subjects without permission as the crux of the matter irrespective of risks' big and small influences. This research follows perspective of the latter. Forming constant fiduciary relation between investigators (doctors) and subjects (patients) pursuant medical contracts, and in accordance with this fiduciary relation, subjects, who are patients, have expectations of explanations and treatments by the best ways. If doctors and patients set this forth as a premise, doctors should assume civil liability when doctors infringe patients' expectations.

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Surrogate and Shared Medical Decision Making for Unrepresented Patients (의료행위에 대한 동의에서 환자 보호자의 법적 지위와 역할 - 대행결정권과 공동의사결정을 중심으로 -)

  • Kim, SooJeong
    • The Korean Society of Law and Medicine
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    • v.20 no.2
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    • pp.43-82
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    • 2019
  • In Korea surrogate medical decision makings happen without legal grounds. The purpose of this article is to research the issues in preparing policies for decision-making on behalf of unrepresented patients. As aspects of comparative law, there are two approaches. One of them is to regulate default surrogate list. If no agent or guardian has been appointed, some legislatures provide that members of patient's family who is reasonably available, in descending order of priority of not, may act as surrogate: (1) the spouse, unless legally separated; (2) an adult child; (3) a parent; or (4) an adult brother or sister. If none of them is eligible to act as surrogate, some legislatures allow close friends to make health-care decisions for adult individuals who lack capacity. On the other hand there are other legislatures which provide no surrogate decision maker list but oblige the responsible authority to determine with advice of family members or friends of the patient. In the end the first approach can not guarantee that the surrogate decision maker like family members or friends will determine in the best interest of the patient.

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.

A Study on the Legal Aspect of Concept for the Acupuncture and Moxibustion in Traditional Korean Medical Practice: based on Judicial Precedent (침구의료행위의 의미에 관한 법학적 고찰: 판례분석 중심의 접근)

  • Lee, Mee-Sun;Kim, Kun-Hyung;Kim, Jae-Kyu;Lee, Byung-Ryul;Yang, Gi-Young
    • Journal of Acupuncture Research
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    • v.28 no.5
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    • pp.19-27
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    • 2011
  • Objectives : The purpose of this study is to describe the concept of the acupuncture and moxibustion in traditional Korean medical practice and to identify the meaning and potential rearrangement of the acupuncture and moxibustion. Methods : The study was performed by analyzing 136 cases of lawsuit in the year between 1968 and 2010 which were selected among the acupuncture and moxibustion in traditional Korean medical practice. Results : According to court rulings, the acupuncture and moxibustion in traditional Korean medical practice is an act to diagnose a person's illness, prescribe and treat to cure based on traditional Korean medicine, to be understood as a medical care in traditional Korean medicine, to have some factor to create or increase danger to preservation of health or hygiene, and to be practiced by medical specialists based on their professional knowledge. But, such definition is not proper and exceedingly vague. Besides medical circumstances in traditional Korean medicine are changing, the enlargement of definition of the acupuncture and moxibustion is required. Conclusions : The meaning and scope of the acupuncture and moxibustion in traditional Korean medical practice should be modified and amended, reflecting these conditions.

Latest Supreme Court Decision on Proof of Causation in Medical Malpractice Cases - Focusing on Supreme Court decision 2022da219427 on August 31, 2023 and the Supreme Court decision 2021Do1833 on August 31, 2023 - (의료과오 사건에서 인과관계 증명에 관한 최신 대법원 판결 - 대법원 2023. 8. 31. 선고 2022다219427 판결 및 대법원 2023. 8. 31. 선고 2021도1833 판결을 중심으로 -)

  • HYEONHO MOON
    • The Korean Society of Law and Medicine
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    • v.24 no.4
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    • pp.3-36
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    • 2023
  • The main issue in medical malpractice civil litigation is medical negligence and the causal relationship between medical negligence and damages. Regarding the presumption of causality in cases where medical negligence is proven, there is a previous Supreme Court decision 93da52402 on February 10, 1995, but it is difficult to find a case that satisfies the textual requirements of the above decision, and yet, in practice, the above decision is cited. In many cases, causal relationships were assumed, and criticism was consistently raised that it was inconsistent with the text of the above judgment. In its ruling, the Supreme Court reorganized and presented a new legal principle regarding the presumption of causality when medical negligence is proven in a civil lawsuit. According to this, If the patient proves ① the existence of an act that is assessed as a medical negligence, that is, a violation of the duty of care required of an ordinary medical professional at the level of medical care practiced in the field of clinical medicine at the time of medical practice, and ② that the negligence is likely to cause damages to the patient, the burden of proving the causal relationship is alleviated by presuming a causal relationship between medical negligence and damage. Here, the probability of occurrence of damage does not need to be proven beyond doubt from a natural scientific or medical perspective, but if recognizing the causal relationship between the negligence and the damage does not comply with medical principles or if there is a vague possibility that the negligence will cause damage, causality cannot be considered proven. Meanwhile, even if a causal relationship between medical negligence and damage is presumed, the party that performed the medical treatment can overturn the presumption by proving that the patient's damage was not caused by medical negligence. Meanwhile, unlike civil cases, the standard is 'proof beyond reasonable doubt' in criminal cases, and the legal principle of presuming causality does not apply. Accordingly, in a criminal case of professional negligence manslaughter that was decided on the same day regarding the same medical accident, the case was overturned and remanded for not guilty due to lack of proof of a causal relationship between medical negligence and death. The above criminal ruling is a ruling that states that even if 'professional negligence' is recognized in a criminal case related to medical malpractice, the person should not be judged guilty if there is a lack of clear proof of 'causal relationship'.

A Study of Improvement of School Health in Korea (학교보건(學校保健)의 개선방안(改善方案) 연구(硏究))

  • Lee, Soo Hee
    • Journal of the Korean Society of School Health
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    • v.1 no.2
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    • pp.118-135
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    • 1988
  • This study is designed to analyze the problems of health education in schools and explore the ways of enhancing health education from a historical perspective. It also shed light on the managerial aspect of health education (including medical-check-up for students disease management. school feeding and the health education law and its organization) as well as its educational aspect (including curriculum, teaching & learning, and wishes of teachers). At the same time it attempted to present the ways of resolving the problems in health education as identified her. Its major findings are as follows; I. Colculsion and Summary 1. Despite the importance of health education, the area remains relatively undeveloped. Students spend a greater part of their time in schools. Hence the government should develop a keener awareness of the importance of health education and invest more in it to ensure a healthy, comfortable life for students. 2. At the moment the outcomes of medical-check-up for students, which constitutes the mainstay of health education, are used only as statistical data to report to the relevant authorities. Needless to say they should be used to help improve the wellbeing of students. Specifically, nurse-teachers and home-room teachers should share the outcomes of medical-check-up to help the students wit shortcomings in growth or development or other physical handicaps more clearly recognize their problems and correct them if possible. 3. In the area of disease management, 62.6, 30.3 and 23.0 percent of primary, middle, and highschool students, respectively, were found to suffer from dental ailments. By contrast 2.2, 7.8, and 11.5 percent of primary, middle and highschool students suffered from visual disorders. The incidence of dental ailments decreases while that of visual impairments increases as students grow up. This signifies that students are under tremendous physical strain in their efforts to be admitted by schools of higher grade. Accordingly the relevant authorities should revise the current admission system as well as improve lighting system in classrooms. 4. Budget restraints have often been cited as a major bottleneck to the expansion of school feeding. Nevertheless it should be extended at least, to all primary schools even at the expense of parents to ensure the sound growth of children by improving their diet. 5. The existing health education law should be revised in such a way as to better meet the needs of schools. Also the manpower for health education should be strengthened. 6. Proper curriculum is essential to the effective implementation of health education. Hence it is necessary to remove those parts in the current health education curriculum that overlaps with other subjects. It is also necessary to make health education a compulsory course in teachers' college at the same time the teachers in charge of health education should be given an in-service training. 7. Currently health education is being taught as part of physical education, science, home economics or other courses. However these subjects tend to be overshadowed by English, mathematics, and other subjects which carry heavier weight in admission test. It is necessary among other things, to develop an educational plan specifying the course hours and teaching materials. 8. Health education is carried out by nurse-teachers or home-room teachers. In connection with health education, they expressed the hope that health education will be normalized with newly-developed teaching material, expanded opportunity for in-service training and increased budget, facilities and supply of manpower. These are the mainpoints that the decision-makers should take into account in the formation of future policy for health education. II. Recommendations for the Improvement of Health Education 1. Regular medical check-up for students, which now is the mainstay of health education, should be used as educational data in an appropriate manner. For instance the records of medical check-up could be transferred between schools. 2. School feeding should be expanded at least in primary schools at the expense of the government or even parents. It will help improve the physical wellbeing of youths and the diet for the people. 3. At the moment the health education law is only nominal. Hence the law should be revised in such a way as to ensure the physical wellbeing of students and faculty. 4. Health education should be made a compulsory course in teachers' college. Also the teachers in service should be offered training in health education. 5. The curriculum of health education should be revised. Also the course hours should be extended or readjusted to better meet the needs of students. 6. In the meantime the course hours should be strictly observed, while educational materials should be revised in no time. 7. The government should expand its investment in facilities, budget and personnel for health education in schools at all levels.

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A Study on the Position and Role of Korean Medicine Doctors Working at Long-Term Care Hospitals (요양병원 근무 한의사의 지위와 역할에 관한 연구)

  • Kang, Tae-Ri;Lee, Sang-Ryong
    • Journal of Society of Preventive Korean Medicine
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    • v.19 no.3
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    • pp.77-90
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    • 2015
  • Objective : The purpose of this study is to discuss the role and ways to improve the position and rights of Korean Medicine Doctors (KMDs) working at long-term care hospitals (LTCHs) through survey analysis. Method : (1) The legal and institutional position of KMDs is studied using current law and related papers. (2) The online survey was conducted through KMD community websites, targeted at KMDs working at LTCHs. Results : (1) Whereas there is perceived added benefit for the eight specializations for a specialist of Western medicine at LTCHs, in the case of a specialist of Korean Medicine, their value is not institutionally recognized at all. (2) A Western inpatient's medical fee is more than a Korean inpatient's medical fee, and the individual fee for the same medical treatment is also higher in Western hospitalization. So, Korean medical hospitalization actually cannot be made. Because of that, Korean Medicine Doctors find it difficult to be primary care physicians. (3) Musculoskeletal diseases and the aftereffects of cerebrovascular diseases were the most common chief complaints addressed in Korean medical consultations. Conclusion : This study shows that KMDs working at LTCHs have suffered many kinds of inequality. That is because of the limited medical scope of the current medical system and real constraints from the gap in Korean-Western medical fees by the National Health Insurance Corporation. Therefore, it is necessary to eliminate these variations along with revising the statute with continuous research.

A Survey on the Medical Conditions of Public Health Oriental Medical Doctors (공중보건한의사의 진료여건에 관한 조사연구)

  • Chong, Myong-Soo;Oh, Chung-Sun;Lee, Ki-Nam
    • Journal of Society of Preventive Korean Medicine
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    • v.10 no.2
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    • pp.63-80
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    • 2006
  • Public health oriental medical doctor has played a great role in providing oriental medical treatment and oriental medical health program with public health medical services, the basic infrastructure, however, is not sufficient. In this study, the researcher surveyed the treatment working or service condition of public health oriental medical doctor. 1. The payment, allowance of doctors are fixed upon the law and guideline according to the financial status of local government. The branch of public health center has more support like an official residence with expenses. 2. The public health center mainly has assitants and ratio of full-timer is more than the branch public health center without any assistants if any, they are temporary employee 3. The public health center has 5.22 beds while the branch has 3.14 beds. The daily average number of patient for public health center is 15.01 while the branch has 8.7 More than half of outpatients are over sixties with musculoskeletal disease. 4. Regarding the traveling clinic, the public health center put into more operation than the branch. The 3rd year serving public doctor gives negative about the traveling clinic much more than 1st and 2nd year serving public doctor. The treatment service condition of public doctor of the public health center is better than the branch doctor, but we are on the point of role-changing as health promotion and preventive treatment to bring up motivation, education and competence strengthening for execution the local-bound health program.

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Long-term Policy Development for the Aged on Medical and Health Care Security (노인의료보장 및 건강관리를 위한 장$cdot$단기 대책)

  • Rhee Seonja;Lee Yoon Sook
    • Journal of Korean Public Health Nursing
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    • v.5 no.1
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    • pp.70-95
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    • 1991
  • The ageing problem of the population has been emerging in Korea since 1970's so that it is expecting the elderly 65 years and over among the total population from $4.5\%$ in 1988 to be $6.3\%$ in year 2000. This study was conducted to provide secure policy development in coming years for the aged on medical and health care aspects based on the examining current status of the aged problems and health care policies and systems. The study divided into four parts; The first part examined the medical insurance program and public assistance program of the health services in relation to the aged. The second part emphasized on reduction of medical care cost for the aged. The third part studied the regular health check-up program and health education for the aged. The fourth part examined the chronic disease management programs for the aged and strategies of the health care service quality improvement and specialized programs. The following recommendations made as the results of the study. 1. At present, the medical insurance program and public assistance program for the medically indigent is not appropriate to the elderly because it is a part of general medical insurance program so that Health Security Law for the Aged is proposed. 2. Medical cost will be increased due to the high occupancy rate of hospital beds and long stay of the elderly so that it is recommended to develop an early discharge program, home health care program, Health hospice and an althernative programs. 3. At present, a regular health check-ups for the elderly is not included in medical insurance program so that it is recommended to be included in the insurance program and at the same time health education program thoroughly developed for the aged. 4. To make proper medical and nursing services on chronic diseases for the elderly, it is recommended manpower development, specialized clinics or hospitals, nursing homes and an equivalent long term care facilitices should be established on the community based and a research institutions also to be related to supper the care programs.

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Hospice and Palliative Care Education for Medical Students in Korea (우리나라 의과대학의 호스피스 완화의료 교육)

  • Kim, Do Yeun;Lee, Soon Nam
    • Korean Medical Education Review
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    • v.22 no.3
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    • pp.146-152
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    • 2020
  • Hospice and palliative care (HPC) education is an essential component of undergraduate medical education. Since February 4th, 2018, withholding and withdrawing life-sustaining treatment at the end of life (EOL) has been permitted in Korea as put forth by law, the "Act on Hospice and Palliative Care and Decisions on Life-Sustaining Treatment for Patients at the End of Life." Therefore, Korean medical schools have faced a challenge in providing comprehensive HPC education in order to better prepare medical students to be competent physicians in fulfilling their role in caring for patients at the EOL. There have been considerable variations in the evolution and organization of HPC education across Korean medical schools for the past 20 years. In 2016, all medical schools taught HPC curriculum as a separate course or integrated courses, with the most frequently taught topics including: delivering bad news, pain management, and the concept of palliative medicine. However, the content, time allocation, learning format, and clinical skills practice training of HPC education have been insufficient, inconsistent, and diverse. For this reason, we propose a HPC curriculum containing seven domains with 60 learning objectives in a course duration of over 20 hours based on the Palliative Education Assessment Tool (PEAT) as standard HPC curriculum. Furthermore, we recommend development of a national curriculum for HPC/EOL care education to be organized by the HPC board and managed under the accreditation criteria of the Korea Institute of Medical Education and Evaluation.