• Journal of Society of Preventive Korean Medicine
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• v.26 no.2
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• pp.69-74
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• 2022

Objective : This study was aimed to review the Act on the Promotion of Korean Medicine and Pharmaceuticals. Method : We searched document about the Act on the Promotion of Korean Medicine and Pharmaceuticals. We used Korean Law Information Center(https://www.law.gov.kr) to find the revision of the act. Results : We looked at the current status of the revision of the Act on the Promotion of Korean Medicine and Pharmaceuticals, and the law was revised four times in total. Through the revision of the law, the definition of Korean medical practice was not only expanded, but also the establishment and role of National Institute of Korean Medicine Development were extended. Specific descriptions of Korean medicine technology will be needed in the future, and laws that are less effective should be revised and the role of National Institute of Korean Medicine Development should be further strengthened. Conclusion : For the future of Korean medicine, in-depth consideration is needed on how to foster oriental medicine.

• The Journal of Korean Medical History
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• v.26 no.2
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• pp.175-185
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• 2013

Purpose : The current Medical Law and the Pharmaceutical Affairs Act, which are incapable of utilizing the research results and the advanced academic, clinical, and pharmaceutical system of the present-day Korean (Oriental) medicine, have limitations and create a paradox by provoking social conflict among the professionals in the field. The aim of this study was to find out the legal and systematic problems that contributed to a complicated conflict amongst Korean (Oriental) medicine doctors, doctors, pharmacists, and Korean (Oriental) pharmacists regarding the classification of their functions. Methods : We reviewed the history and characteristics of the legislation regarding the duties of Korean (Oriental) medicine doctors and Korean (Oriental) pharmacists as well as the relevant and important public health policies since the enactment of the National Medical Services Law in 1951. We focused on the laws and regulations that are made in the process of the separating functions of physicians and pharmacists and the dispute between the Korean (Oriental) medicine doctors and the Korean (Oriental) pharmacists in the 1990s and 2000s. Results : The legislations and amendments of the medical and pharmaceutical laws and regulations that reflect the modern academic, clinical, and pharmaceutical system of the Korean (Oriental) medicine and the research results could be summarized as follows: 1) A partial amendment of the Medical Law in 1987, which added the provision of "Oriental health guidance" as one of the duties of Korean (Oriental) medicine doctors, assured a place for Korean (Oriental) medicine doctors in the field of public health. 2) A partial revision of Pharmaceutical Affairs Act in 1994 established a new system for Korean (Oriental) pharmacists, bringing about the creation of dualistic pharmaceutical system that complements the dualistic medical system. 3) The Promotion of the Research and Development of Wonder Drugs by Using Natural Substances Act was legislated in 2000 in order to stimulate research and development of Korean (Oriental) medicine and its industrialization. 4) Oriental Medicine Promotion Act in 2003 was enacted to lay foundation to specify and promote technology and industry that are related to Korean (Oriental) medicine. Discussions and conclusions : Although the dualistic medical and pharmaceutical system is set up by the Medical Law and Pharmaceutical Affairs Act, it is shown that the relevant regulations have been developed from a perspective of the western medicine.

• The Korean Society of Law and Medicine
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• v.11 no.1
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• pp.117-143
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• 2010

Along with the development of digital technologies, the information obtained during the medical procedures was working as a source of valuable assets. Especially, the secondary use of personal health information gives the ordeal to privacy protection problems. In korea, the usage of personal medical information is basically regulated by the several laws in view of general and administrative Act like Medicine Act, Public institutions' personal information protection Act, Information-Network Act etc. There is no specific health information protection Act. Health information exchange program for the blood donor referral related with teratogenic drugs and contagious disease and medical treatment reporting system for income tax convenience are the two examples of recently occurred secondary use of health information in Korea. Basically the secondary use of protected health information is depend on the risk-benefit analysis. But to accomplish the minimal invasion to privacy, we need to consider collection limitation principle first. If the expected results were attained with alternative method which is less privacy invasive, we could consider the present method is unconstitutional due to the violation of proportionality rule.

• The Korean Society of Law and Medicine
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• v.11 no.2
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• pp.75-112
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• 2010

This article analyses the concept of medicine in the legal context. It is not easy to define the concept of medicine because medical practice has various dimensions and the situation in which the practice is performed has a broad variety. The duty of medical law is to build the boundary of protection in that the nature of medicine would not be distorted by the factors of social systems like industry or governmental authorities. Without understanding the various dimensions - especially the dimension of Humanities and Sociology - of the medicine it is not possible to draw the limit on the performance of medicine appropriately. Concerning the medical practice (especially in the context of the regulation of medical licence), the enacted law (Medical Act) defines the concept just for form's sake and it finally depends on the interpretation of the legal enforcement authorities. Moreover, between the judgments of the courts there exists no coherent principles for the regulation and the interpretation of the Medical Act depends often on the riskiness, the abstract concept, which finally leads the interpretation to depend on the subject of the practice. On the contrary, the development and scientific movement of the technology tends to tighten the range of the medical professionals of medical practice and the perspectives of the medicine. Medical act is actually oriented at the patient's understanding of him- or herself. The above-mentioned tendency of the interpretation and the legal policy could lead the medicine away from its nature.

• 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.

• The Korean Society of Law and Medicine
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• v.23 no.3
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• pp.89-115
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• 2022

In this article, the Medical Act, the Emergency Medical Act, Act on remedies for injuries from medical malpractice and mediation of medical disputes were reviewed and interpreted based on the Civil Act. In the health and medical field, there are various laws that reflect changes in the medical field due to the development of health and medical technology, and their revision is very frequent. And the legislation has become very complicated. They contradict each other or require interpretation. In this situation, a person must take considerable care not to violate the law. In many cases, specific guidelines or authoritative interpretation are required to apply the law. Even guidelines and authoritative interpretations often conflict with civil law. In this article, errors in the legal text related to health care were found. In addition, it found a case that contradicts the civil law perspective in interpretation. Thus, it was confirmed that civil legal thinking was necessary to legislate, interpret, and apply health care-related laws.

• The Korean Society of Law and Medicine
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• v.13 no.1
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• pp.125-153
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• 2012

The adult guardianship system has been introduced through amendments of Korean Civil Code for the first time in the March 2011(Act No. 10429, 7. 1. 2013. enforcement). The adult guardianship system has the main purposes to provide a lot of help vulnerable adults and elderly, and protect them on the welfare related with property act, treatment, care, etc. There could be a controversy about whether the protection Legal Guardian's consent(formerly known as the Mental Health Act) or permission of the Family Court(revised Civil Code) are required to, or the Mental Health Act should be revised, when mental patient will be hospitalized forcibly. The author proposes that mental patient with Adult guardians should be determined by Legal Guardian's consent and approval of the Family Court, but mental patient without Adult guardians could be determined by Legal Guardian's consent. The issue of Withdrawing of life-sustaining treatment could be occurred due to the aging society and the development of modern medicine, and this has provided difficult, various problems to mankind in Legal, ethical, and social welfare aspects. The need of Death with dignity law or Natural death law has been reduced for a revision of the Civil Code. Therefore, on the issue of Withdrawing of life-sustaining treatment, in the future, intervention of the court is necessary in accordance with the revised Civil Code Section, and Organ Transplantation Act and the brain death criteria may serve as an important criterion.

• The Korean Society of Law and Medicine
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• v.11 no.2
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• pp.11-74
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• 2010

This article analyzes legal meaning and definition of medical practice examining Korean Supreme Court cases. Until now, there is no right answer about the meaning of medical practice and it is also hard to define of it. Moreover, not only Acts and regulations containing medical practice but also many cases ruling a person who practice medicine, the concept of medical practice involves various meanings. So, it has caused confusion. In order to solve this problem, this article divides the medical practice's meaning into range and nature within prohibition article of the Medical Act about unlicensed personnel who practice medicine. After providing a explanation of the meaning of medical practice according to amendment of the Act, this article disputes the meanings of the several cases following the amendment. And then analyzing non-medical person's unlicensed medical practice and medical person's unlicensed medical practice. In order to provide more accurate legal concept of medical practice when Korean government amends the Medical Act or making policies in this field, this classifying analysis approach should be needed. Looking at the result, in general, Korean Supreme Court has interpreted unlicensed prohibition clause of the Medical Act widely; not only non-medical person's unlicensed medical practice but also medical person's unlicensed medical practice. Therefore, this article suggests that the prohibition clause needs to be careful applying to non-medical practice. Because, in fact, even though there are some necessity of non-medical practice, there are no qualificatory or license system of non-medical practitioner in the Medical Acts or regulations forbidding whole non-medical practices. Furthermore, the Supreme Court has decided medical person's unlicensed medical practice too narrowly, thus it does not keep up with rapid change of medical development and people's demands these days. Regarding this subject, in order to take advantage of medical practitioners effectively and cope with increasing people's medical demands, this article proposes that medical person's unlicensed medical practice only to be prohibited in case of endangering our public health.

• The Journal of Korean Medical History
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• v.28 no.1
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• pp.121-133
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• 2015

Objectives : The purpose of this study is to suggest how to interpret the 'practice of Korean Medicine', differentiating it from 'medical practice'. Methods : I analyze the legislations and precedents regarding the practice of Korean Medicine. Results : The Korean Medicine and Pharmaceutics Promotion Act defines 'practice of Korean Medicine' and it clearly differentiates it from the definition of 'medical practice'. However, the scope of this definition is somewhat restricting and it can violate doctors of Korean Medicine's right to equality and their academic freedom. Thus, the application of this definition of the 'practice of Korean Medicine' should be limited to the field of research and development. Meanwhile, criteria of distinguishing 'practice of Korean Medicine' from 'medical practice', which used to make a sharp distinction between Medicine and Korean Medicine by rigorously applying their academic standards, are now focusing more on protecting and improving health of the people. Discussions & Conclusions : I suppose that the distinction between the 'practice of Korean Medicine' and 'medical practice' will be more focused on public health rather than the academic stance of those two medical fields. Meanwhile, in accordance with dualistic medical system, the mutual usage of medical equipment in the area of 'treatment' should be limited while it should be allowed in the area of 'diagnosis' if it satisfies requirements suggested by the Constitutional Court.

• The Korean Society of Law and Medicine
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• v.14 no.1
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• pp.117-144
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• 2013

After several bills for the reasonable medical dispute resolution had been proposed for over twenty years, "Act on Remedy for Damage from Medical Accident and Medical Dispute Mediation" was eventually enacted on April 7, 2011 and came into effect from April 8, 2012. This study evaluates the achievements and results of the past year, suggesting the future improvements or tasks. The main issue of Act on Medical Dispute Mediation is Korea Medical Dispute Mediation and Arbitration Agency. Therefore, the success of the Act depends on the outcomes of Korea Medical Dispute Mediation and Arbitration Agency. Although the Act has been enforced for only one year, this paper examines the outcomes of the Agency with limited materials for its development. Korea Medical Dispute Mediation and Arbitration Agency was established for rapid, fair, and effective medical dispute resolution. Thus, the evaluation of the performances of the Agency is based on the 1) rapidness, 2) fairness, and 3) effectiveness of the dispute resolution. To sum up, the system earned positive evaluations as for the rapidness and fairness, but some problems were indicated with regard to the effectiveness. As the system of medical dispute mediation and arbitration in Korea has no parallel in the world, other countries show many interests in it. The rapid and fair medical dispute resolution is of benefit in both patients and medical institutes and decreases social costs. As the Act had a difficult passage through Parliament, it should be maintained and improved continuously.