• Journal of Service Research and Studies
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• v.4 no.1
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• pp.109-121
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• 2014

Used medical equipment utilized in medical technology, most are not human or environmental risks likely to in normal medical technology. Therefore, the risk is close to zero so that medical devices are classified into Class 1 medical device, such as little or no risk by treating. It can be minimized without arising unnecessary and waste of time. As handlers in the medical device vendors are expanding the area of the business, we can uplift operators' commitment to the business and for the people's choice. In this paper, our research are presented to improve the legal and regulatory directions for the distribution of used medical devicesin in order to establish and promote a fair deal of diversity.

• Journal of Service Research and Studies
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• v.4 no.2
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• pp.57-67
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• 2014

Because telemedicine is also the medical care, it is limited by law to allow medical personnel only physician because there would cause a risk to health and hygiene. Since the work dealing with the life and honor the human body involving a small mistake, it may be difficult to recover the damages can be recovered even if the telemedicine. Therefore, systematically it is to allow remote medical care only proven national healthcare only clinical practice starting with basic medical medicine, and received training as a systematic study of the body and life of humans. The patient information could get far away in the distance to provide medical information and professional advice to the remote system, even if you can not be reached due to several issues such as the number of differences that occur in time. We Mentioned various opinions on regulatory issues and information gathered for the development of the medical industry in this respect.

• Proceedings of the Korea Society of Design Studies Conference
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• 1999.05a
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• pp.50-51
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• 1999

병원은 생명을 다루는 서비스를 취급하고 이것은 국민의 건강 및 생명과 직결된 서비스인 만큼 상업적 목적으로 다루어질 수 없는 분야이다. 따라서 영리만을 목적으로 의료광고가 시행되는 것을 우려하여 의료광고를 법적으로 금지하고 있다. 이러한 상황은 내ㆍ외적으로 병원을 알릴 수 있는 매체와 방법을 극히 제한적 규제하였다. (중략)

• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.33-67
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• 2020

The hospitals that are owned by non-medical personnel result when non-medical personnel with resources conspire with newly graduated medical doctors who cannot afford the enormous amount of capital required at the beginning of the establishment of a medical institution. Such hospitals, though they may have met the external requirements as medical institutions, disrupt the medical market as it should be centered by medical personnels, In addition, such hospitals are causing a huge social problem as it is illegally receiving and reducing various benefits such as medical care benefits and subsidies from the government, resulting in a significant financial leak in the national health insurance. The illegality of the opening of a non-medical personnel hospital is so high that it nullifies the contractual arrangement for the establishment, imposes criminal penalties on all persons involved in the establishment under the Korean Medical Law, and imposes administrative sanctions on medical personnel. In case the hospital was aware of the illegality of its opening, but had applied to receive medical care benefits from the National Health Insurance Act and the Medical Care Act, such actions will result in the return of the benefits under the National Health Insurance Act and the Medical Care Assistance Act, subject to the penalty for the crime of fraud, and aggravated punishment for specific economic crimes based on the amount of gain, as well as civil liability for torts. In this study, we will examine the current status of the regulations on the non-medical personnel hospital and present the basis for future legislative directions by looking at the legal regulations and the attitude of the precedents.

• Journal of Radiation Protection and Research
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• v.37 no.4
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• pp.219-225
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• 2012

This study makes differentiated regulations which can maximize the efficiency and convenience of radiation safety regulations by deriving evidence required to establish reasonable safety regulatory structure based on the determination of the levels of actual radiation safety regulations for radiation safety managers to perform radiation safety. We surveyed approximately 10% of radiation safety managers from domestic radiation-using organizations which was based on the Nuclear Safety Act and NUREG Vol. 1~21 of RS-G-1.9 (2005), NRC of IAEA, etc. The radiation safety managers showed the highest level of awareness on the requirements for exposure management ($3.32{\pm}0.910$), and the lowest level on the requirements for record keeping and storage of documents ($2.84{\pm}0.826$). Industrial organizations showed higher levels of awareness than medical organizations whose regulations should be more stringent on requirements of the status and management of radioactive sources, facilities, measurements, pollution control, measuring equipment, monitoring, education and training, and exposure management. This suggests that the actual regulations need to be re-evaluated because it is attributed to the regulations which are statistically significant difference of the levels of radiation safety regulations between industrial organizations and medical organizations. The process of developing regulatory requirements for each characteristic of domestic organizations needs to be done in future studies, as well as safety regulations to maximize convenience should be achieved if radiation safety regulations are conducted in consideration with the characteristics of each organization.

• The Korean Society of Law and Medicine
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• v.18 no.1
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• pp.103-141
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• 2017

The (Korean) Medical Services Act revised in 2009 introduces the accreditation of specialty hospital. When a hospital meets prescribed standards, passes a board review, and is accredited as a specialty hospital by the Minister of Health and Welfare, then it may use 'specialty hospital' in its name and certification mark of specialty hospital. The problem is that the (Korean) Fair Trade Commission and the (Korean) Ministry of Health and Welfare, both of which have authorities to regulate advertising in general and in health care service in turn, announced the guidelines to prohibit internet (portal) service providers to provide keyword search ads service using key-words such as 'specialty' or 'specialized in' for those who are not accredited by the Minister of Health and Welfare. In this article, whether these guidelines can be justified by the current regime and whether the current specialty hospital policy is agreeable would be examined. To do this, the legal nature of accreditation of specialty hospital, the limit of advertisement regulation, the law of keyword search ads, and the liability of internet service providers also would be analyzed.

• Convergence Security Journal
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• v.21 no.1
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• pp.63-72
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• 2021

The hospital biomedical engineering team is responsible for establishing and regulating the Medical Device Management Program (MEMP) to ensure that medical devices are safe and reliable. As technology advances, medical devices such as artificial intelligence and precision medicine are developing into a form that allows connection between objects anytime, anywhere, and as various technologies converge, internal and external security threats continue to increase. In this paper, we present a study of the Medical Device Management Program (Secure-MEMP) method, considering that the security threat of medical devices continues to increase due to advances in technology.

• Proceedings of the Korea Information Processing Society Conference
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• 2004.10a
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• pp.465-468
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• 2004

의료기기 산업은 시장규모와 생산규모에서 미국이 전 세계의 $40\%$ 이상을 차지하고 있어 국내외 모든 의료기기 제조업체에서는 미국시장진출을 목표로 꾸준히 노력하고 있는 실정이다. 그러나 의료기기는 인체에 직접 적용된다는 특성으로 인해 각 국가의 정부는 저마다 다른 엄격한 기준으로 자국내 시장진출을 규제하고 있으며 엄격한 관리제도를 유지하고 있다. 국내 최신의 전자 의료기기는 필수적으로 의료기기를 제어하기 위한 의료용 소프트웨어를 필요로 하므로 의료기기 산업의 발전은 의료용 소프트웨어 산업의 발전에 직결된다고 할 수 있다. 그러나 의료기기의 경우에는 인$\cdot$허가를 위한 제도 및 절차가 갖추어져 활용되고 있는 반면, 의료용 소프트웨어의 경우에는 적합한 평가기준이 마련되어 있지 못하여 제도 및 체계구축의 필요성이 대두되고 있다. 본 논문에서는 국제표준(ISO/IEC 12119, ISO/IEC 9126을 바탕으로 평가메트릭을 구축하여 의료용 소프트웨어의 정량적인 품질을 측정, 평가하여 품질측정의 결과를 토대로 품질을 인증하는 의료응용 소프트웨어 시험인증 지원도구를 설계 및 구현하였다.

• 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.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.