• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.163-207
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• 2020

Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

• The Korean Society of Law and Medicine
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• v.23 no.3
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• pp.139-207
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• 2022

As various state restrictions on individual freedom were imposed during the COVID-19 pandemic, concerns have been raised that excessive infringements on fundamental rights were indiscriminately permitted based on the public interest of preventing infectious diseases. Therefore, the question of how to set acceptable limits of liberty restrictions on individuals has emerged. However, since the phenomenon of infections spreading to the population is only predicted statistically, how to deal with the risk of the infected individual as a subject of legal analysis has become a problem. In the absence of a theoretical framework of legal analysis of risk, the risk of infected individuals during the pandemic was not analyzed strictly, and proportionality review of infection prevention measures was often only an abstract comparison of the importance of public interest and individual rights. Therefore, this research aims to conduct a theoretical review on how risk can be conceptualized legally in a public health crisis, and to develop a theoretical framework for proportionality review of the risk of liberty-limiting measures during a pandemic. Chapter 2 analyzes the legal philosophical concepts of risk, which are the basis for liberty restrictions during a public health crisis, and applies and extends them to the pandemic. Chapter 3 reviews previous studies related to liberty restriction measures in the context of the COVID-19 pandemic, and points out they have a limitation that specific criteria for the proportionality review of public health measures in the pandemic have not been presented. Accordingly, Chapter 3 specifies the methodological framework for proportionality review, referring to the theoretical discussion on risks in Chapter 2. Chapter 4 reviews the legitimacy of gathering restriction orders, applying the theoretical discussion in Chapter 2 and the criteria for proportionality review established in Chapter 3. In particular, Section 4 examines logic of proportionality review in judicial precedents over the ban on gathering restrictions implemented in the COVID-19 pandemic. In analyzing the precedents, the logic of proportionality review in each case is critically reviewed and reconstructed based on the theoretical framework presented in this research.

• The Korean Society of Law and Medicine
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• v.23 no.3
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• pp.3-44
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• 2022

As a result of a close review focusing on the case of obstruction of epidemiological investigation by a religious group A in Daegu, which was a problem when the pandemic of Covid-19 infection began in Korea around February 2, 2020, when an epidemiological investigator requested a specific group to submit a list, While there have been cases where an act of not responding or submitting an edited omission list was sentenced to the effect that the act did not fall under an epidemiological investigation, in the case of non-submission of the visitor list for the B Center, even though a 'list of visitors' was requested. Regarding the fact of refusal without a justifiable reason, 'providing a list of persons entering the building is a key factual act that forms a link between epidemiological investigations accompanying an epidemiological investigation, and refusing to do so is also an act of refusal and obstruction of an epidemiological investigation. There are cases where it is possible to demand criminal punishment. Regardless of whether the request for submission of the membership list falls under the epidemiological investigation, there are cases in which the someones' actions correspond to the refusal or obstruction of the epidemiological investigation. A lower court ruling that if an epidemiological investigation is rejected or obstructed as a result of interfering with factual acts accompanying an epidemiological investigation, comprehensively considering whether or not the list has been diverted for purposes other than epidemiological investigation, the logic is persuasive. Epidemiological investigations such as surveys and human specimen collection and testing are conducted for each infectious disease patient or contact confirmed as a result of the epidemiological investigation, but epidemiological investigations conducted on individual individuals cannot exist independently of each other, and the This is because the process of identification and tracking is essential to an epidemiological investigation, and if someone intentionally interferes with or rejects the process of confirming this link, it will result in direct, realistic, and widespread interference with the epidemiological investigation. In this article, ① there are differences between an epidemiological investigation and a request for information provision under the Infectious Disease Control and Prevention Act, but there are areas that fall under the epidemiological investigation even in the case of a request for information, ② Considering the medical characteristics of COVID-19 and the continuity of the epidemiological investigation, the epidemiological investigator the fact that the act of requesting a list may fall under the epidemiological investigation, ③ that the offense of obstructing the epidemiological investigation in certain cases may constitute 'obstruction of Performance of Official Duties by Fraudulent Means', and ④ rejecting the request for information provision under the Infectious Disease Control and Prevention Act from September 29, 2020 In this case, it is intended to be helpful in the application of the Infectious Disease control and Prevention Act and the practical operation of epidemiological investigations in the future by pointing out the fact that a new punishment regulation of imprisonment or fine is being implemented.

• The Korean Society of Law and Medicine
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• v.23 no.1
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• pp.37-80
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• 2022

By analyzing informed consent and the refusal of emergency medical treatment (called patient dumping) under the current Emergency Medical Service Act, this study suggests that an emergency medical professional is only liable for patient dumping if their duty to protect the patient's life takes precedence over the patient's right to self-determination. In emergency medical situations, as in general medical situations, medical treatment should be performed after the emergency medical professional informs the patient about the medical treatment, including its necessity and methods, and obtains consent from the patient. Refusing or evading the performance of emergency medical services on the excuse of the informed consent not considering a waiver or alteration of informed consent requirements without reasonable reasons violates the Emergency Medical Service Act and thus makes an emergency medical professional liable to administrative disposition or criminal penalty. In other words, depending on the existence of a waiver of alteration of the informed consent, patient dumping may be established. If the patient is a minor or has no decision-making ability, and their legal representative makes a decision against the patient's medical interests, the opinion of the legal representative is not unconditionally respected. A minor also has the right to decide over their body, and the decisions of their legal representatives should be in the patient's best interests. If the patient refuses treatment, in principle, the obligation of life protection of emergency medical professionals is the top priority. However, making these decisions in the aforementioned situations in the emergency medical field is difficult because of the absence of explicit regulations regarding these exceptional problems. This study aims to organize the following precedents of the Supreme Court of Korea. The court states that, when balancing the conflicting interests between the duty to provide emergency medical service and the duty to inform is unavoidable for emergency medical professionals, they should put the duty to protect the patient's life ahead of the duty to inform if the patient's life matters. Exceptionally, when a patient has seriously considered whether they should receive treatment before the emergency medical situation, their right to self-determination can be considered equal to the obligation of emergency medical professionals to provide emergency medical treatment. This research also suggests that an amendment of the Emergency Medical Service Act should include the following. First, the criteria for determining the decision-making ability of emergency patients should consist of medical content. Second, additional consent from a medical professional is unnecessary for first-aid treatment. Finally, new provisions for emergency medical obligations for minors, new provisions for the decision standard when there are conflicting opinions about the treatment of a patient, and new penalty provisions for professionals who suspend emergency medical examinations and treatments need to be established.

• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.209-244
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• 2020

TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

• The Korean Society of Law and Medicine
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• v.24 no.2
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• pp.35-77
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• 2023

As the amendment to the Personal Information Protection Act, which newly established the basis for the right to request transmission of personal information, was promulgated through the plenary session of the National Assembly, MyData, which was previously applied only to the financial sector, could spread to all fields. The right to request transmission of personal information is the right of the information subject to be guaranteed for the realization of MyData. However, since the right to request transmission of personal information stipulated in the Personal Information Protection Act is designed to be applied to all fields, not a special field such as the medical field, it has many shortcomings to act as a core basis for implementing MyData in Medicine. Based on this awareness of the problem, this paper compares and analyzes major legal trends related to the right to portability of personal health information at home and abroad, and examines the limitations of Korea's Personal Information Protection Act and Medical Act in realizing Medical MyData. Under the Personal Information Protection Act, the right to request transmission of personal information is insufficient to apply to the medical field, such as the scope of information to be transmitted, the transmission method, and the scope of the person obligated to perform the transmission, etc.. Regulations on the right to access medical information and transmission of medical records under the Medical Act also have limitations in implementing the full function of Medical My Data in that the target information and the leading institution are very limited. In order to overcome these limitations, this paper prepared a separate and independent special law to regulate matters related to the use and protection of personal health information as a measure to improve the legal system that can effectively guarantee the right to portability of personal health information, taking into account the specificity of the medical field. It was proposed to specifically regulate the contents of the movement and transmission system of personal health information.

• The Korean Society of Law and Medicine
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• v.24 no.2
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• pp.147-196
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• 2023

Advances in brain science have made it possible to stimulate the brain to treat brain disorder or to connect directly between the neuron activity and an external devices. Non-invasive neurotechnologies already exist, but invasive neurotechnologies can provide more precise stimulation or measure brainwaves more precisely. Nowadays deep brain stimulation (DBS) is recognized as an accepted treatment for Parkinson's disease and essential tremor. In addition DBS has shown a certain positive effect in patients with Alzheimer's disease and depression. Brain-computer interfaces (BCI) are in the clinical stage but help patients in vegetative state can communicate or support rehabilitation for nerve-damaged people. The issue is that the people who need these invasive neurotechnologies are those whose capacity to consent is impaired or who are unable to communicate due to disease or nerve damage, while DBS and BCI operations are highly invasive and require informed consent of patients. Especially in areas where neurotechnology is still in clinical trials, the risks are greater and the benefits are uncertain, so more explanation should be provided to let patients make an informed decision. If the patient is under guardianship, the guardian is able to substitute for the patient's consent, if necessary with the authorization of court. If the patient is not under guardianship and the patient's capacity to consent is impaired or he is unable to express the consent, korean healthcare institution tend to rely on the patient's near relative guardian(de facto guardian) to give consent. But the concept of a de facto guardian is not provided by our civil law system. In the long run, it would be more appropriate to provide that a patient's spouse or next of kin may be authorized to give consent for the patient, if he or she is neither under guardianship nor appointed enduring power of attorney. If the patient was not properly informed of the risks involved in the neurosurgery, he or she may be entitled to compensation of intangible damages. If there is a causal relation between the malpractice and the side effects, the patient may also be able to recover damages for those side effects. In addition, both BCI and DBS involve the implantation of electrodes or microchips in the brain, which are controlled by an external devices. Since implantable medical devices are subject to product liability laws, the patient may be able to sue the manufacturer for damages if the defect caused the adverse effects. Recently, Korea's medical device regulation mandated liability insurance system for implantable medical devices to strengthen consumer protection.

• Korean Journal of Environmental Agriculture
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• v.42 no.1
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• pp.52-62
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• 2023

This study focused on determining the specific causes and prevention methods of mass fish deaths occurred in five reservoirs (Gagugi, Neupgokgi, Danggokgi, Sagokji, and Hangokji) in Andong-si. For this purpose, a survey of agricultural land and livestock in the upper part of the reservoirs and analysis of water quality in the reservoir irrespective of whether it rains or not were conducted. We attempted to examine the changes in dissolved oxygen (DO) in the surface and bottom layers of reservoirs and changes in DO depending on the amount of livestock compost and time. Based on the above investigations, treatment plans were established to efficiently control the inflow of contaminated water into reservoirs. The rainfall and farmland areas in the upper part of the reservoir were investigated using Google and aviation data provided by the Ministry of Land, Infrastructure, and Transport. The current status of livestock farms distributed around the reservoirs was also examined because compost from these farms can flow into the reservoir when it rains. Various water quality parameters, such as phosphate phosphorus (PO₄-P) and ammonium nitrogen (NH₃-N), were analyzed and compared for each reservoir during the rainy season. Changes in the DO concentration and electrical conductivity (EC) were also observed at the inlet of the reservoir during raining using an automated instrument. In addition, DO was measured until the concentration reached 0 ppm in 10 min by adding livestock compost at various concentrations (0.05%, 0.1%, 0.3%, and 0.5% by wt.), where the concentration of the livestock compost represents the relative weight of rainwater. The DO concentration in the surface layer of reservoirs was 3.7 to 5.3 ppm, which is sufficient for fish survival. However, the fish could not survive at the bottom layer with DO concentration of 0.0-2.1 ppm. When the livestock compost was 0.3%, DO required 10-19 h to reach 0 ppm. Considering these results, it was confirmed that the DO in the bottom layer of the reservoir could easily change to an anaerobic state within 24 h when the livestock compost in the rainwater exceeds 0.3%. The results show that the direct cause of fish mortality is the inflow of excessive livestock compost into reservoirs during the first rainfall in spring. All the surveyed reservoirs had relatively good topographical features for the inflow of compost generated from livestock farms. This keeps the bottom layer of the reservoir free of oxygen. Therefore, to prevent fish death due to insufficient DO in the reservoir, measures should be undertaken to limit the amount of livestock compost flowing into the reservoir within 0.3%, which has been experimentally determined. As a basic countermeasure, minerals such as limestone, dolomite, and magnesia containing calcium and magnesium should be added to the compost of livestock farms around the reservoir. These minerals have excellent pollutant removal capabilities when sprayed onto the compost. In addition, measures should be taken to prevent fish death according to the characteristics of each reservoir.

• Journal of Venture Innovation
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• v.4 no.3
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• pp.141-150
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• 2021

Although management decisions centered on the board of directors and directors must be made in order to effectively promote ESG management, the company's management is not obligated to make decisions considering ESG factors. A Korean corporation(company) is an established organization for commercial or other profit, and the purpose of treating a legal organization as a corporation is to easily handle the legal relationship of a group (corporate's property) and individual property of a group member, but legal person such as rights to "harm public rights" or "defend fraud". Criminal liability for illegal acts of a corporation, but the liability of a corporation (natural person) for illegal acts of a corporation is recognized within a limited range, but the criminal liability of a corporation (natural person) is limited. As the social responsibility of a corporation is great, limiting the responsibility of a corporation-related person (natural person) to civil responsibility will halve its effectiveness if considering the impact on the corporation's national economy. Objective requirements such as the completeness of control, hybridization of property, infringement of creditors' rights, and small-capitalization, and the subjective intention of abusing the company system to avoid legal application to controlling shareholders should be denied. Despite the increasing influence on corporate society, such as large-scale projects and astronomical business profits, corporate officials (natural persons) are forced to be held liable for negligence and intentional liability within a limited range. In such cases, it is necessary to introduce criminal responsibility separately from civil responsibility to legal persons (natural persons) in consideration of the maturity of capitalism in Korean society and the economic status of the world. In Korea, the requirements for recognition of corporate denial are strict, but the United States says that it is sufficient to have control or fraud. Therefore, it is not about civil responsibility, but about criminal responsibility of a legal person (natural person), so if fraud is recognized, it can strengthen the corporate social responsibility.