• 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.

• Journal of Digital Convergence
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• v.18 no.4
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• pp.325-340
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• 2020

Today's rapidly developing health technology is accumulating vast amounts of data through medical devices based on the Internet of Things in addition to data generated in hospitals. The collected data is a raw material that can create a variety of values, but our society lacks legal and institutional mechanisms to support medical Big Data. Therefore, in this study, we looked at four major factors that hinder the use of medical Big Data to find ways to enhance use of the Big Data based healthcare industry, and also derived implications for expanding domestic medical Big Data by identifying foreign policies and technological trends. As a result of the study, it was concluded that it is necessary to improve the regulatory system that satisfies the security and usability of healthcare Big Data as well as establish Big Data governance. For this, it is proposed to refer to the Big Data De-identification Guidelines adopted by the United States and the United Kingdom to reorganize the regulatory system. In the future, it is expected that it will be necessary to have a study that has measures of the conclusions and implications of this study and to supplement the institutional needs to play a positive role in the use of medical Big Data.

• Journal of the Korean Society of Radiology
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• v.16 no.3
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• pp.327-334
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• 2022

In this study, the purpose of this study was to conduct a basic study on the effectiveness and feasibility of the regulation of the Nuclear Safety Act for the department of radiology by examining the questionnaire on the satisfaction of on-campus practice while attending the department of radiology and the current status of radiation workers and radiation related workers. As for the satisfaction of the workers who were designated as frequent visitors while attending the department of radiology and did not handle and operate the radiation generator during on-campus training, 34.62% of the workers answered 'not satisfied'. On the other hand, 50% of workers who were designated as radiation workers while attending school or who were enrolled in school before the regulation of the nuclear safety act and handled and operated radiation generators were 'satisfied' at 50%. In addition, the annual exposure dose of radiation workers in educational institutions was found to be less than 0.05 mSv. If you look at the trends of radiation workers and radiation workers, it can be seen that students who graduate from the Department of Radiology find the most employment in the field dealing with diagnostic radiation generators registered as radiation workers among medical institutions. Therefore, by easing the regulations of the current Nuclear Safety Act or by amending the medical act and the rules on the safety management of diagnostic radiation generating devices, etc. It is presumed that something is necessary.

• The Korean Society of Law and Medicine
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• v.23 no.1
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• pp.3-33
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• 2022

In relation to telemedicine in Korea's medical law, there are Articles 17, 17-2, and 34 of the Medical Act. Since 'direct examination' in Articles 17 and 17-2 of the Medical Act can be interpreted as 'self-examination' rather than 'face-to-face examination', it is difficult to see the above regulation as a regulation prohibiting telemedicine. Prohibiting telemedicine only with the concept of medical examination or the 'principle of face-to-face treatment' is against the principle of "nulla poena sine lege"(the principle of legality). However, in order to qualify as 'examination', it must be faithful enough to replace face-to-face examination, so issuing a medical certificate or prescription after a poor examination over the phone is considered a violation of the Medical Act. In that respect, the above regulation can be said to be a regulation that indirectly limits telemedicine. On the other hand, most lawyers interpret that telemedicine between medical personnel and patients is completely prohibited based on Article 34, and the Supreme Court recently ruled that such telemedicine is not permitted even if there is a patient's request. However, this interpretation is not only far from the legislative intention at the time when telemedicine regulations were introduced into the Medical Act of 2002, but also does not match the needs of reality or the legislative trend of foreign countries. The reason is that telemedicine regulations are erroneously legislated. The premise of the legislation is wrong, and there are considerable problems in the form and content of the legislation. As a result, contrary to the original legislative intent, telemedicine was completely banned. In foreign countries, it is difficult to find cases where telemedicine is completely banned and criminal punishment is imposed for it. In order to fundamentally solve the problem of telemedicine, Article 34 of the Medical Act needs to be deleted.

• Proceedings of the Plant Resources Society of Korea Conference
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• 2022.09a
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• pp.124-124
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• 2022

대마(Cannabis sativa)는 카나비노이드(cannabinoids) 계열의 성분으로 인한 약리효능 뿐만 아니라 섬유, 식품 등의 분야에서도 식물소재로 활용도가 높은 것으로 알려져 있다. 최근 의료용 대마의 경우 규제완화가 예정됨에 따라 관련 산업분야에서도 안정적 원료 소재 생산에 대한 연구가 요구되고 있다. 대마는 실생번식이 가능한 종이나, 의료용 등 소재의 안정적 공급을 위해서는 균일한 cannabidiol(CBD) 성분의 확보가 가능한 영양증식 방법이 대안으로 사용될 수 있다. 따라서 본 연구에서는 영양증식 방법 중 조직배양 기술을 이용한 대마 품종별(Cherry Blossom, Queen Dream과 Hot Blonde) 증식법 구명을 위하여 식물생장조절제의 종류 및 농도에 따른 기내생육특성을 조사하였다. 세 품종 모두 1 mg l^-1 thidiazuron (TDZ) 단독처리 시 신초(> 2cm)가 가장 많이 유도되었다. 단 Queen Dream 품종은 0.5 mg l^-1 와 TDZ 0.2 mg l^-1 NAA 혼용처리구에서 많은 수의 신초가 유도되었으나 상대적으로 신초의 길이(< 2cm)는 짧은 것으로 확인할 수 있었다. 발생된 신초는 MS 기본배지에서 발근을 유도한 후 토양에 순화하여 정상적인 식물체로 발달되었다. 이와 같은 식물생장조절제 처리를 포함한 식물조직배양 방법은 유용 개체·품종의 증식 및 의료·산업용 원료 소재의 안정적 생산에 활용될 수 있다.

• The Journal of the Convergence on Culture Technology
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• v.6 no.4
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• pp.591-598
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• 2020

Since COVID-19's 1st pandemic came in February 2020, the demand for telemedicine grew greatly that in most countries the deregulation for telemedicine policy have been implemented in more countries. Also in Korea, with the name of 'Non-face-to-face Treatment' telemedicine began to be approved. Telemedicine having strength in chronic disease management has been effective in more and more specialties along with the recent development of ICT that it is expected to contribute to the improvement of the quality of healthcare service and creation of new treatment model. On the contrary it may also exacerbate the distortion in the hospital healthcare service industry in Korea, which is the excessive tipping toward large hospitals. So the dual promotion policy approach in which the settlement of family doctors system extensively utilizing telemedicine for chronic disease management and the support for tertiary hospitals and hospitals focusing on treating foreign patients to provide quality service using telemedicine technology are pursued simultaneously are recommended.

• Journal of Technologic Dentistry
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• v.17 no.1
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• pp.82-108
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• 1995

인력은 한 사회에 있어서 자본을 축적하며 자연자원을 개발하고 사회 경제 정치적 조직을 성장시키는 변화요인으로, 인간을 중심으로 하는 사회경제적 자원을 종합적으로 지칭하는 말이다. 이렇게 국가 사회가 필요로 하는 인력을 정부가 적절히 계획하여, 형성시키며, 배분 및 활용하는 문제를 논리적이고 일관성 있게 다루는 것을 인력정책이라 한다. 이러한 거시적이고 대 사회적인 정부의 인력정책은 국민의 건강과 생명을 보호하기 위한 보건의료 서비스를 제공해야 하는 의료인력을 대상으로 하는 경우 그 중요성이 더욱 특별하다 할 것이다. 국민에 대한 보건의료 서비스는 훈련된 보건 인력에 의해서 제공되며, 국가의 인력정책의 결과로 나타나는 보건의료인력 공급의 적합성은 인력의 불균형이라는 개념들을 통해서 검토될 수 있다. 의료인력의 불균형이라 함은 의료인력의 수, 종류, 기능, 분포, 질 등과 의료서비스에 대한 국민의 전체적 요구에 대응하여 정부가 생산하여 채용, 지원, 유시할 수 있는 정부 능력의 한계를 의미한다. 다시 말해서 국민에 대한 의료서비스의 적정화는 잘 훈련된(well qualified) 의료인력이 충분히 공급되어야(adequately supplied) 하고, 또한 적절히 분포되어야(well distributed) 한다는 양적, 질적, 그리고 분포의 세 가지 측면에서 살펴볼 수 있다. 질적, 양적, 그리고 분포의 불균형이라는 범주를 통하여 살펴본 치과기공사 분야의 인력정책에 대한 연구 결과와 개선방안은 다음과 같다. 첫째, 수적 불균형의 면에서 치과기공사의 인력은 1970년대 중반이래 계속 과잉 공급되어 왔으며, 이에 대해 정부는 그동안 소극적으로 대처하므로 과잉공급을 가속시켜왔다. 따라서 이러한 과잉공급을 최소하기 위해서는 치과이용에 대한 수요의 확장, 무면허자의 취업규제단속 및 대학의 치과기공학과 정원 축소 등을 생각해 볼 수 있다. 이러한 외형상의 과잉공급에도 불구하고 현업에 종사하는 실제인력은 수용에 비해 부족한 과소 공급현상을 빚고 있다는 점이 문제이다. 이러한 역설적인 현상을 타파하기 위하여 무면허자의 적발을 위시한 제도적 장치가 마련되어야 한다. 둘째, 질적 불균형은 수적 과잉공급에 의한 취업률 저하로 인한 실력 있는 전문인력 확보의 어려움과 전문 교육인력 및 교육시설의 열악한 조건이 원인으로 지적될 수 있으며, 이에 대한 해결방안으로 적절한 인력수요의 조절과 교육인력 및 시설 여건의 향상이 요망된다. 예컨대 3년제로 되어있는 학제를 4년제로 상향조정하는 방안을 고려할 수 있다. 세째, 치과기공사 분야의 인력분포 불균형은 그다지 심각하지는 않은 것으로 나타난다. 그러나 변화하는 소득수준과 사회환경은 의료인력과 균등한 지역적 분포에 대해 지속적인 관심을 가질것을 요청한다고 할 것이다. 이를 위하여 현재의 공중보건의 제도처럼 치기공 분야의 인력을 무의촌지역에 배치하여 공익요원으로 봉사케 하는 제도를 생각해 볼 수 있다.

• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.119-139
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• 2022

Brain stimulation technology that administers electrical and magnetic stimulation to a brain has shown a significant level of possibility for treating a wide range of various neurological and psychiatric disorders. Depending on its nature, the technology is defined either as invasive or non-invasive, and deep brain stimulation (DBS) is one of the most well-known invasive brain stimulation technologies. Currently categorized as grade 4 medical device in accordance with Guideline On Medical Devices And Their Grades, a Notification of Ministry of Food and Drug Safety (MFDS), the DBS has been used as a stable treatment for several diseases. At the same time, the DBS technology has recently achieved substantial advancement, encouraging active discussions for its use from various perspectives. On the contrary, debates over legal regulation related to the use of DBS has relatively been smaller in numbers. In this context, this article aims to 1) introduce the DBS technology and its safety in setting out the tone; 2) touch upon major legal issues that would potentially rise from its use for four different purposes of treatment, clinical study, areas of non-standard treatment where no other methods are available, and enhancement; and finally 3) highlight disputes concerning common emerging issues observed in the aforementioned four purposes from the viewpoint of legal responsibility and liability of using the DBS, which are benefit-risk assessment, physicians' duty of information, patients' capacity to consent, control for device, and insurance coverage.

• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.207-229
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• 2019

It is a general recognition that more serious criminal acts in a certain area of society should be given more serious condemation than the same general crimnal act. In particular, considering the purpose of the medical treatment and the trust relationship between the doctor and the patient, the sexual violence by doctor in medical field can not be placed on the same line as that of the general public. But the special legislation to solve this through criminal legal sanctions is not desirable. The basic principle of criminal law ist ultima ratio, so the principle of supplementality. It means to try to solve by all possible means and finally to enter with punishment. A flat and hasty Reaction without the considering of the speciality of medical treatment will cause serious cracking in that area. In addition, it will not be able to expect desirable results in legal practice by breaking down the legal system. Rather, administrative regulation is more efficient than punishment sanctions. But the best way is autonomous control by members of the medical area. Penalties in criminal law must make an enterance at the last, and administrative regulation should be timely intervene in specific situations through diversification. In conclusion, state interventions should be farthest in order to proceed to autonomous control of medical area.

• International Commerce and Information Review
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• v.16 no.2
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• pp.297-318
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• 2014

The study has try to analyze firm-level marketing strategy for making inroads into United Arab Emirate(UAE) in the Middle East Rrgion. Korea's pharmaceutical medicine industry can overcome that growth limit by strategically advancing into the world market even the its market share is slight as of 2013. The results of Marketing Mix strategies to enter the UAE pharmaceutical medicine market are as follows: STP strategy and Marketing Mix strategy based on the findings of this study, the practical implications of the following. First of all, domestic pharmaceutical industries in Korea due to the domestic market, growth in the various institutional devices have limits on the expansion. On the other hand, supports the Government's active policy of UAE health care industry is booming. UAE Government medical facilities and health care in the health care industry in 2010 to improve the level of 80 billion dollars of investment. The UAE's medical sector is equipped with independent regulatory regime by the Emirates. The UAE is a foreign worker influx has been showing a high population growth rate, over the last 30 years, UAE resident population has increased about 7 times. The UAE Government to improve the quality of medical services, the private sector and the public to encourage the signing of partnership (PPP) can also be found in the regulation of foreign direct investment. The results of this study would play a role in analyzing a marketing strategy to make inroads into UAE pharmaceutical medicine market.