• 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.13 no.1
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• pp.359-395
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• 2012

In a broad term, health and medical data means all patient information that has been generated or circulated in government health and medical policies, such as medical research and public health, and all sorts of health and medical fields as well as patients' personal data, referred as medical data (filled out as medical record forms) by medical institutions. The kinds of health and medical data in medical records are prescribed by Articles on required medical data and the terms of recordkeeping in the Enforcement Decree of the Medical Service Act. As EMR, OCS, LIS, telemedicine and u-health emerges, sharing and protecting digital health and medical data is at issue in these days. At medical institutions, health and medical data, such as medical records, is classified as "sensitive information" and thus is protected strictly. However, due to the circulative property of information, health and medical data can be public as well as being private. The legal grounds of health and medical data as such are based on the right to informational self-determination, which is one of the fundamental rights derived from the Constitution. In there, patients' rights to refuse the collection of information, to control recordkeeping (to demand access, correction or deletion) and to control using and sharing of information are rooted. In any processing of health and medical data, such as generating, recording, storing, using or disposing, privacy can be violated in many ways, including the leakage, forgery, falsification or abuse of information. That is why laws, such as the Medical Service Act and the Personal Data Protection Law, and the Guideline for Protection of Personal Data at Medical Institutions (by the Ministry of Health and Welfare) provide for technical, physical, administrative and legal safeguards on those who handle personal data (health and medical information-processing personnel and medical institutions). The Personal Data Protection Law provides for the collection, use and sharing of personal data, and the regulation thereon, the disposal of information, the means of receiving consent, and the regulation of processing of personal data. On the contrary, health and medical data can be inspected or delivered of the copies, based on the principle of restriction on fundamental rights prescribed by the Constitution. For instance, Article 21(Access to Record) of the Medical Service Act, and the Personal Data Protection Law prescribe self-disclosure, the release of information by family members or by laws, the exchange of medical data due to patient transfer, the secondary use of medical data, such as medical research, and the release of information and the release of information required by the Personal Data Protection Law.

• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.111-140
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• 2019

The Bioethics and Safety Act provides a set of rules to regulate biobanks and research activities using human biological material, but the law seems to be defective in several folds. The law requires that, prior to collection or use of human biological materials, researchers should obtain the informed consent of the donors, but the law does not obligate biobanks to do so. Even in cases where the law requires informed consent, the ordinance of the Ministry of Health and Welfare allows open (or blanket) consent. In addition, a new article in the Act, Article 42-2 which will take effect from October 24, 2019, allows medical institutions to provide biobanks with remaining biospecimens collected in the course of diagnosis and treatment, unless the donors express their intent to opt-out, without obtaining specific consent from them. Given the need to protect the autonomy of donors and the unique characteristics of biobanks and research activities that use human biological materials, this paper concludes that such open consent-based law may not be suitable to protect the autonomy of the donors and that the broad consent requirement may be a desirable policy option. The paper acknowledges that the international community has long questioned whether broad consent (as well as open consent) is an effective choice to regulate the use of human biological materials. The paper stresses that the baseline requirement in designing the law is that the secondary use of human biological materials should be based on informed consent of the donors; the core value of the law should be a governance structure that promotes transparency and protects donor participation.

• The Korean Society of Law and Medicine
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• v.16 no.2
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• pp.263-291
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• 2015

In May, 2015, a 68 years old man, who has been Middle East Saudi Arabia and the United Arab Emirates, had high fever, muscle aches, cough and shortness of breath. he went two local hospital near his house and the S Medical Center emergency center. He was diagnosed MERS(Middle East respiratory syndrome) and the diseases had put South Korea the fear of epidemics for three months. Especially, this disease has firstly reported in Middle East Asia in September 2012 and spreaded to twenty-six countries. In 21, July, 2015, European Center for disease prevention and control reported 533 people were died and in South Korea, 186 people were infected, 36 people were died and 16,693 people were isolated from MERS. South Korea government were faced into epidemic control and blamed from public. Especially, hospital acquired infection, disease control chain, opening of information, ventilation, lack of isolation bed, the problem of function of local health center, the issue of reparation for hospital and insurance cover rate, the classification of disease, the role of Korea Centers for disease control and prevention, the culture of visiting hospital to see sick people, the issue of hospital multiple room and other related social support policy. it is time to study and discuss to solve these problems. South Korea citizens felt fear and fright from MERS. What is wore, they thought the dieses were out of their government control. It was unusual case for word except Middle East Asia. numerous tourists canceled visiting korea. South korea economic were severly damaged especially, tourism industry. South korea government should admit that they had failed initial action against MERS and take full reasonability from any damages. The government have to open information to public in terms of epidemic diseases and try to prevent any other epidemic diseases and try to work with local governments.