• Journal of Legislation Research
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• no.44
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• pp.387-433
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• 2013

Understanding the concepts of health and medical practice are significant because they are the basis of health and medical policy and law. How legislators, policy makers, and the public perceive those concepts defines the direction of legislation and policy making. This study aims to show the changes of the concepts by reviewing the history of major Statutes relating to health and medicine. Alongside medicalization of human conditions and daily activities, the concepts of health and medical practice also expanded. On the other hand, as technologies of health and medicine have specialized and segmented, the large portion of public services of the past is now provided by the private sector. We argue that the actual laws and decisions by the judiciary should be responsive to social and scientific changes, which may cause the changes of the perceptions of health and medical practice. By doing so, they not only can have actual legal force but also even initiate a movement for establishing new medical policy or law.

• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.141-169
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• 2022

Article 34 of 'Medical Service Act' of Korea provides telemedicine service between medical personnel. Telemedicine between medical personnel and patients, therefor, in principle, is not recongnized. Increasing demand for telemedicine fueled by COVID-19 pandemic and accumulation of telemedicine experience lead a change in stubborn opposition of the medical community, tenuous though it may be. This article focuses on the telemedicine legislation in France, which can be used as a reference for the telemedicine legislation premised on telemedicine between medical personnel and patients. The legislation stipulates the concept, types, and conditions of telemedicine performance through 'Code de la santé publique'. The principle that telemedicine shall be performed alternately with direct medical treatment to a patient and details relating to such telemedicine performance as telemedicine costs, medical fees, and telemedicine equipment support are stipulated through an agreement between the medical community and health insurance organizations. From this point, the implications for our legal system were presented.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.315-346
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• 2016

With the development of big data processing technology, the potential value of healthcare big data has attracted much attention. In order to realize these potential values, various research using the healthcare big data are essential. However, the big data regulatory system centered on the Personal Information Protection Act does not take into account the aspect of big data as an economic material and causes many obstacles to utilize it as a research purpose. The regulatory system of healthcare information, centered on the primary purpose of patient treatment, should be improved in a way that is compatible with the development of technology and easy to use for public interest. To this end, it is necessary to examine the trends of overseas legal system reflecting the concerns about the balance of protection and utilization of personal information. Based on the implications of the overseas legal system, we can derive improvement points in the following directions from our legal system. First, a legal system that specializes in healthcare information and encompasses protection and utilization is needed. De-identification, which is an exception to the Privacy Act, should also clearly define its level. It is necessary to establish a legal basis for linking healthcare big data to create synergy effects in research. It is also necessary to examine the introduction of the opt-out system on the basis of the discussion on the foreign debate and social consensus. But most importantly, it is the people's trust in these systems.

• 대한예방의학회:학술대회논문집
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• 2000.10a
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• pp.183-184
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• 2000

• Review of KIISC
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• v.19 no.1
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• pp.115-124
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• 2009

오늘날 의료는 정보통신 기술의 발달과 소비자의 건강에 대한 관심 고조 등을 동인으로 하여 기존의 환자가 치료 목적으로 병원을 찾아가던 환경에서 개인의 질병 예방과 건강 증진을 위해 언제 어디서나 의료서비스가 찾아가는 소위 u-Health 환경으로 패러다임이 전환되고 있다. 본 논문은 이러한 환경에 대처하는 보건의료 관련 법제에 대한 연구로 현행법률과 현재 계류 중인 법안을 고찰하여 가장 민감한 개인정보인 건강정보의 보호와 활용의 균형을 위한 입법 방향을 제시하였다.

• The Journal of the Korea Contents Association
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• v.13 no.4
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• pp.170-186
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• 2013

As the population is getting older, medical expenses amount of the whole is keep increasing. So, the pressure of the finances, Health Insurance, Medical Care Assistance Act and etc, is getting higher. The share of healthcare-expense is increasing due to elderly illness. And it became a social problem; we analysed present state of senior healthcare in South Korea-looked into current laws and policies, and found problems. We tried to suggest improvements that drew from the current state of foreign country senior healthcare of those problems. For the result, we found the problem in relevant-law system of senior healthcare guarantee. In this study, we proposed the ways to qualitatively upgrade of medical standard that considered on elderly' features: the strengthened guarantee for healthcare, financial secure for long-term convalescence benefit, linking and functional reinforcement for elderly welfare and long-term convalescence insurance, the solution for overlapped laws about convalescence in long-term convalescence insurance and elderly welfare, a betterment of grading, and a home service consolidation. We need to secure right amount of emergency medical service budget, and effective management system for the improved level of senior severely emergency medical service. Furthermore, we suggested that South Korea needs to legislate [The Law for Senior Medical Secure] to respond to rapidly increasing senior healthcare fee.

• The Korean Society of Law and Medicine
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• v.23 no.1
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• pp.149-176
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• 2022

South Korean law strictly prohibits engagement in medical activities by non-medical practitioners. In the country, tattooing is classified as a medical practice, and non-medical practitioners who engage in it are penalized because they are unauthorized to carry out this procedure. In reality, however, people rarely seek tattooing services from medical personnel. Arguing that their freedom of job selection is violated, non-medical personnel who make a living as tattoo artists reject the characterization of the procedure as a form of medical treatment and demand the decriminalization of tattooing by non-medical practitioners. Nevertheless, tattooing can cause health- and hygiene-related dangers when it is not performed by medical professionals because it involves penetration into the skin using needles. Hence, stringent management is necessary for infection prevention. The gap between reality and the law gives rise to the need for proactive thinking about the institutionalization of tattoo practice by non-medical personnel. Policymakers should reflect on the fact that only minimal tattooing services are currently performed by medical staff while also accounting for health and safety. On this basis, this study examined tattoo-related legislation in South Korea to determine whether the procedure corresponds to medical practice and identify ways to solve problems that occur from the perspective of health care. As a response that promotes safety and reflects reality, this research proposed a three-phase approach.

• The Journal of the Korea Contents Association
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• v.13 no.7
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• pp.203-213
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• 2013

In the current legal system, establishing aging friendly smart home based on healthcare for the senior people over 65 seems hard to be achieved. For these reasons, this study is intended to explore the improvements in the legal system using the comparative analysis in the domestic and foreign legal systems. The related legal system is divided into three sections - 'healthcare,' 'aging friendly,' and 'smart home' - providing that telemedicine would be implemented. According to the analysis of the legal system for healthcare, telemedicine is executed by the medical law. Thus, we need to investigate the concept and all the matters of telemedicine on the basis of foreign cases. As the result of the analysis of the legal system for 'Aging Friendly,' the definition of the elderly is ambiguous and we find the improvement of health and medical system. In addition to these, the definite bounds of the healthcare equipment have to be set. From these results, we are aware of the necessity of the improvements of the legal system, and suggest plans for these problems. That is to organize the legal system and make a new law through revising the current specific identification. This study focuses on suggesting the improvements of the legal system with the comparative analysis of the domestic and foreign legal systems.

• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.117-157
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• 2021

This research reviewed the HIPAA/HITECH, 21st Century Cures Act, Common Law, and private Guidances from the perspectives in protecting and utilitizing the medical data, while implications were followed. First, the standards for protection and utilization are relatively clearly regulated through single law on personal medical information in the United States. The HIPAA has been introduced in 1996 as fundamental act on protection of medical data. Medical data was divided into personally identifiable information, non-identifying information, and limited dataset under HIPAA. Regulations on de-identification measures for medical information, objects for deletion of limited data sets, and agreement on prohibition of data re-identification were stipulated. Moreover, in the 21st Century Cures Act regulated mutual compatibility for data sharing, prohibition of data blocking, and strengthening of accessibility of data subjects. Common Law introduced comprehensive consent system and clearly stipulates procedures. Second, the regulatory system is relatively simplified and clearly stipulated in the United States. To be specific, the expert consensus and the safe harbor system were introduced as an anonymity measure for identifiable medical information, which clearly defines the process while increasing trust. Third, the protection of the rights of the data subject is specified, the duty of explanation is specified in detail, while the information right of the consumer (opt-out procedure) for identification information is specified. For instance, the HHS rule and FDA regulations recognize the comprehensive consent system for human research, but the consent procedure, method, and requirements are stipulated through the common rule. Fourth, in the case of the United States, a trust-based system is being used throughout the health and medical data legislation. To be specific, Limited Data Sets are allowed to use in condition to the researcher's agreement to prohibit re-identification, and de-identification or consent process is simplified under the system.

• Broadcasting and Media Magazine
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• v.24 no.3
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• pp.100-113
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• 2019

VR 기술 및 활용에 대한 다양한 연구와 장밋빛 전망에도 불구하고, 현재 우리 법 제도는 VR 산업 활성화의 걸림돌이 되는 규제들을 완전히 제거하지 못한 상태이다. 특히, 의료 및 게임 분야에서 VR 콘텐츠의 특수성을 고려한 맞춤형 규제설계가 필요하다. 먼저, 현행 규제상 의료용 VR 콘텐츠 및 소프트웨어는 의료기기 수입 제조허가와 신의료기술평가를 모두 거쳐야 하는데, 특히 신의료기술평가의 경우에는 의료용 VR 콘텐츠 및 소프트웨어에 대한 대비가 충분하지 않아 이의 활용에 상당한 장애가 될 수 있다. 그러므로 정부가 가이드라인 등 적절한 해석기준을 통해 의료기기의 범위를 불필요하게 확대하지 않도록 하고, 아울러 신의료기술평가에 있어 '선 진입, 후 평가' 제도를 활용할 수 있도록 개선이 요구된다. 다음으로, 게임의 경우에는 현행 게임산업법상 게임물의 정의가 너무 광범위하여 양방향성이 있는 VR 콘텐츠들이 게임물로 분류되어 불필요한 규제를 받을 가능성이 있으며, 여기에 더하여 최근 세계보건기구에서 '게임 이용 장애'를 국제질병분류에 포함시킴으로써 추가 규제에 대한 우려까지 더해지고 있다. 이러한 문제점을 해결하기 위해서는 법제처가 최근 발표한 "적극행정 법제 가이드라인"의 취지에 맞게 정부가 게임물 규제의 범위를 적극적으로 축소 해석하거나, 이러한 규제의 예외를 정하는 고시 또는 가이드라인을 제정할 필요가 있다. 또한, 현재 시행 중인 'ICT 규제 샌드박스' 제도를 잘 활용하고, 이와 별도로 국제질병분류의 국내 수용에 대해서도 보다 신중하게 접근할 필요가 있을 것이다.