• The Korean Society of Law and Medicine
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• v.20 no.1
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• pp.109-132
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• 2019

Recently, medical accidents related to surgical procedures have increased. In addition, the media reported that some of these accidents were involved in health crimes. Patient-advocate groups have called for mandatory establishment and management of CCTV in operating rooms. There is a lot of discussion among the interested parties, so it is necessary to review the relevant laws and regulations. The purpose of this study is to identify the characteristics of CCTV in operating rooms and to review legislations related to establishment and management of the CCTV in operating rooms. Medical institutions use CCTV for management of facilities and patient safety and install it in operating rooms optionally. The Constitution guarantees the privacy and the privacy of correspondence of every citizen, but it can be limited by the law for public welfare. Currently, however, there is no existing law about establishment and management of the CCTV in operating rooms and it can be defect of legal system. Under the current legislations, it is likely that the Self-determination can be violated due to the characteristic of healthcare provider when CCTV is mandatorily installed in operating room. In addition, the regulations on access and leakage of confidential information known by operator are insufficient. So that, the safety of the visual data might be threatened. Furthermore, unless the period and the place of storage of the visual data are clearly defined, it is highly unlikely to meet the original purpose of patient safety and prevention of medical accidents. This study is meaningful as there is few previous study on this topic although the need for legal review about this is growing and several bills are being proposed. It is expected that the results of this study can be utilized as basic data for enactment or amendment of the laws and regulations about establishment and management of CCTV in operating rooms.

• 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.