• Health Policy and Management
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• v.6 no.2
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• pp.14-42
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• 1996

On rationale for government intervention is the failure of competition in the market. Health care markets are characterized by such unique aspects as information asymmetry, prevalence of insurance, and cost-increasing competition based on the adoption of costly medical technology. Therefore, government policy to guarantee a sufficient number of providers in markets may not lead to socially beneficisal outcomes such as higher quantity and lower price. This paper examines the unique nature of health services and its implications for competition, the evidence that competition may not reduce health care ex[enditures, and policy tools that government can use to encourage competition which contributes to supporting a sustainable health care 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.

• Journal of Digital Convergence
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• v.18 no.12
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• pp.445-457
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• 2020

The purpose of this study is to analyze various issues that may arise from the recent deregulation of telemedicine implemented by the government, propose initiative preparations for the implementation of telemedicine policies, and suggest implications for the basic conditions and direction of the deregulation of telemedicine. Recently, deregulation policy cases in telemedicine include that designation of a special zone for regulatory freedom in Gangwon Province, allowing physician-patient telemedicine and telephone counseling and prescription cases in the COVID-19 crisis. There are four main issues that could arise with the deregulation of telemedicine: safety, effectiveness, differences in access to health care and the economic industry, and legal responsibility. As a initiative preparation, this study proposed a pilot project for telemedicine and enhanced support for face-to-face care complementary tools, vitalizing remote co-operation, policy model that do not disrupt the medical delivery system, and legal maintenance. In conclusion, as a suggestion of basic premise and direction in the implementation of telemedicine deregulation, the implementation of initiative measures to address issues concerning telemedicine, the review and regulation of conditions to be considered in the implementation of telemedicine, and the establishment of a close communication and cooperative sturcture with medical providers.

• Korean System Dynamics Review
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• v.6 no.2
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• pp.53-71
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• 2005

In the short view, the medical fee regulation has contributed for patients by reducing their hospital expenses and helping them to visit hospital more easily. But, some medical parts have gone into red ink because the medical fee has been different with each item. So, that medical parts have been experienced the medical specialist shortage. And some hospitals have been interested in high-priced medical services to cover their deficit. Moreover, most medical doctors don't need to use low-priced medicine undergo these circumstance, domestic small and medium pharmaceutical company has been going into bankruptcy and the dependence on foreign drug company has been rising. If these abnormal medical service keep to patience, people will get more burden of medical fee cause 9 casual loop work very complicated. In other words, present medical fee regulation were made by some politicians who had plain thinking. Those who govern the people, therefore, stand for not present medical service user but the welfare and health promotion of people and give attention to desirable medical fee with systems thinking.

• The Korean Society of Law and Medicine
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• v.16 no.1
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• pp.191-219
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• 2015

The Japanese government has announced that it would invest 30 billion yen in iPS cell research for the next 10 year, and the Japan National Assembly has made an act that supports the iPS cell research. This study analyzes 1) the current trend and application field of stem cell research under Japan; 2) recent policy and regulation change in stem cell research and its application under Japan. This treatise reviews about "Act for Promoting Regenerative Medicine", "Act for Assuring Safety of Regenerative Medicine", and "the Revision of Pharmaceutical Act under Japan. This study may serve as the fundamental reference for the improvements of legal and institutional systems with regard to regulations on the stem cell research under Korea.

• The Journal of the Convergence on Culture Technology
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• v.1 no.2
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• pp.85-89
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• 2015

It has been reported that cerebral disease is the most leading to death as a single disease even though next to cancer in the most important cause of death in the country. Even if patients maintain a life without death, it will have to suffer from side effects such as hemiplegia and language disorders. In this paper, the symptoms and treatment of cerebral infarction cases are described through the medical dramas (The Third Hospital, The Brain) and movie (Amur). Even if there is the same stroke each drama or movie, depending on the previous history or current physical condition of the patient knew which treatment the law is different.

• Journal of Service Research and Studies
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• v.4 no.1
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• pp.83-93
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• 2014

Telemedicine is performed at a place far away from medical practice with physicians and patients by the means of communication appropriately. It will be identified in general the remote medical service to deliver the medical information and also defined as any action by interactive information communication technology. Medical services can be said to be fused as television, communication, computer, engineering of various technologies of information and communication applications. If doctors can not be reached due to distances away from the patient, Information technologies could be used to get medical information and to give expert advice provided by the system remotely. And it could be used patient care as well as medical administration, medical education, professional advice and consulting. In this paper, we take a look at the legal requirements of telemedicine for improving regulatory in the current law to investigate the matter.

• Journal of Service Research and Studies
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• v.4 no.2
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• pp.1-10
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• 2014

According to recent trends in technological advances and globalization, medical device industry may improve the constitution to meet worldwide medical equipment management system. Also it is holding a strand of mitigation to reach the level of international regulation. In addition, recent legislation tends are to stay limited ranges of industry regulations at least and take as open attitude for integration of new technologies combined medical devices. A greater environmental risk is not likely to work in medical technology, Combinded medical device is used as close to zero risk in most of the human body, which is classified as Class 1. Even medical device such as little or no risk in handling, it is possible to minimize the unnecessary administrative power and a waste of time to occur. For the medical device may be improving people's choices and access, medical equipment operator is expanding to include dealers, because this will be exalted to particular area of the business of the company. In this paper, we investigate the legal prerequisites for the establishment of a medical device. And propose improved regulations in topics in order to facilitate the repair and distribution markets for fair trade.

• Journal of Technology Innovation
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• v.28 no.4
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• pp.1-26
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• 2020

Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.177-219
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• 2016

A commercial advertisement is not only a way of competition but also a medium of communication. Thus, it is under the constitutional protection of the freedom of business (article 15 of the Constitution) as well as the freedom of press [article 21 (1) of the Constitution]. In terms of the freedom of business or competition, it should be noted that an unfair advertising (false or misleading advertisement) can be regulated as an unfair competition, while any restraint on advertising other than unfair one might be doubted as an unjustifiable restraint of trade. In terms of the freedom of press or communication, it is important that article 21 (2) of the Constitution forbids any kind of (prior) censorship, and the Constitutional Court applies this restriction even to commercial advertising. In this article, the applicability of these schemes to advertising of the so-called learned professions, especially physician, are to be examined, and some proposals for the reformation of the current regulatory regime are to be made. Main arguments of this article can be summarized as follows: First, the current regime which requires advance review of physician advertising as prescribed in article 56 (2) no. 9 of Medical Act should be reformed. It does not mean that the current interpretation of article 21 of the Constitution is agreeable. Though a commercial advertising is a way of communication and can be protected by article 21 (1) of the Constitution, it should not be under the prohibition of censorship prescribed by article 21 (2) of the Constitution. The Constitutional Court adopts the opposite view, however. It is doubtful that physician advertising needs some prior restraint, also. Of course, there exists severe informational asymmetry between physicians and patients and medical treatment might harm the life and health of patients irrevocably, so that medical treatment can be discerned from other services. It is civil and criminal liability for medical malpractice and duty to inform and not regulation on physician advertising, to address these differences or problems. Advance review should be abandoned and repelled, or substituted by more unproblematic way of regulation such as an accreditation of reviewed advertising or a self-regulation preformed by physician association independently from the Ministry of Health and Welfare or any other governmental agencies. Second, the substantive criteria for unfair physician advertising also should correspond that of unfair advertising in general. Some might argue that a learned profession, especially medical practice, is totally different from other businesses. It is performed under the professional ethics and should not persue commercial interest; medical practice in Korea is governed by the National Health Insurance system, the stability of which might be endangered when commercial competition in medical practice be allowed. Medical Act as well as the condition of medical practice market do not exclude competition between physicians. The fact is quite the opposite. Physicians are competing even though under the professional ethics and obligations and all the restrictions provided by the National Health Insurance system. In this situation, regulation on physician advertising might constitute unjustifiable restraint of competition, especially a kind of entry barrier for 'new physicians.'