• 의료법학
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• 제15권1호
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• pp.123-164
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• 2014

Under the new system of 'Separation of pharmaceutical prescription and dispensing' in Korea, which was implemented in 2000, physician could not dispense a medicine, and outpatient should have a physician's prescription filled at a drugstore. After pharmacist makes up outpatient's prescription, National Health Insurance Service(NHIS) pay for outpatient's medicine to pharmacist, except an outpatient's own medicine charge. And NHIS only pay for outpatient's prescription fee to physician and, physician doesn't derive profit from dispensing medicine in itself. Nevertheless, if physician writes out a prescription with violation of 'Criteria for the Medical Care Benefits', NHIS clawed back the payment of outpatient's prescription and medicine from the physician or the medical institution which the physician belongs to. In the past, NHIS's confiscation was in accordance with 'the National Health Care Insurance Act, Article 52, Clause 1'. But, since 2006 when the Supreme Court declared that there was no legal basis on the NHIS's confiscation of outpatient's medicine payment, NHIS had put in a claim for illegal prescriptions on the basis 'the Korean Civil law, Article 750(tort)'. So, Many medical institutions filed civil actions against NHIS. The key point of this actions was whether the issuing outpatient prescriptions with violations of Criteria for the Medical Care Benefits constitute of the law of tort. On this point, the first trial and the second trial took different position. Finally the Supreme Court acknowledged the constitution of the law of tort in 2013. In this paper, the author will review critically the decision of the Supreme Court, and consider the relativeness between the legal effect of Criteria for the Medical Care Benefits and the constitution of the issuing outpatient prescriptions with violations of Criteria for the Medical Care Benefits as the law of tort.

• 대한예방의학회:학술대회논문집
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• 대한예방의학회 2000년도 제52차 추계학술대회 연제집
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• pp.201-202
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• 2000

• 의료법학
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• 제15권1호
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• pp.263-302
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• 2014

The court handed down meaningful rulings related to medical sectors in 2013. This paper presents the ruling that the care workers could be the performance assistants of the care-giving service although the duties of care worker are not included in the liability stipulated in the medical contract signed with the hospital for reason of clear distinction of duties between care workers and nurses within the hospital in connection with the contract which was entered into between the hospital and patients. In relation to negligence and causal relationship, the court recognized medical negligence associated with the failure to detect the brain tumor due to the negligent interpretation of MRI findings while rejecting the causal relationship with consequential cerebral hemorrhage. The court also recognized negligence based on the observation on the grounds of inadequate medical records in a case involving the hypoxic brain damage caused during the cosmetic surgery. In terms of the scope of compensation for damages, this paper presents the ruling that the compensation should be estimated based on causal relationship only in case the breach of the 'obligation of explanation' is recognized, however rejecting the reparation for de factor property damages in the form of compensation, and the ruling that the lawsuit could be instituted in case that the damages exceeded the agreed scope despite the agreement that the hospital would not be held responsible for any aftereffects of surgery from the standpoint of lawsuit, along with the ruling that recognized the daily net income by reflecting the unique circumstances faced by individual students of Korean National Police University and artists of Western painting. Many rulings were handed down with respect to medical certificate, prescription, etc., in 2013. This paper introduced the ruling which mentioned the scope of medical certificate, the ruling that related to whether the diagnosis over the phone at the issuance of prescription could constitute the direct diagnosis of patient, along with the ruling that required the medical certificate to be generated in the name of doctor who diagnosed the patients, and the ruling which proclaimed that it would constitute the breach of Medical Act if the prescription was issued to the patients who were not diagnosed. Moreover, this paper also introduced the ruling that related to whether the National Health Insurance Service could make claim to the hospitals for the reimbursement of the health insurance money paid to pharmacies based on the prescription in the event that the hospitals provided prescription of drugs to outpatients in violation of the laws and regulations.

• 의료법학
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• 제21권3호
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• pp.3-33
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• 2020

'원격의료(telemedicine)'란 '의료인이 정보통신기술을 이용하여 원격으로 실시하는 의료행위'라고 정의할 수 있다. 지금까지 우리나라의 통설은 의료법 제34조를 근거로 의료인 간의 원격자문만 허용되고, 의료인과 환자 간의 원격의료는 금지되는 것으로 이해하였다. 그러나, 의료법 제34조는 의료업 수행에 대한 장소적 제한 규정일 뿐, 원격의료 자체를 금지하는 규정은 아니다. 그 외 현행 의료법에는 원격의료를 금지하는 규정이 존재하지 않는다. 건강보험 요양급여기준과 별개로 현행 의료법 해석상 원격의료가 일반적으로 금지된다고 보기는 어렵다. 다만, 의료법 제17조와 제17조의2에서의 '직접 진찰'의 의미와 관련해서 해석상 논란이 있다. 헌법재판소는 이를 '대면 진찰'로 해석한 반면, 대법원은 '스스로 진찰'로 해석하였다. '직접'의 사전적 의미와 관련 의료법 규정에 대한 해석 등에 비추어 볼 때, 대법원의 해석이 타당하다고 생각한다. '직접 진찰'이 '대면 진찰'을 의미하지는 않더라도, '진찰'의 개념 안에 '대면진찰의 원칙'이 내포되어 있고 '비대면 진찰'은 대면진찰을 보완하는 수준에서만 허용되기 때문에 비대면진찰로 인한 문제점은 충분히 극복할 수 있다고 본다. 결국은 진찰이 얼마나 충실하였느냐, 즉 '진찰의 충실성' 여부가 원격진료 허용의 한계라고 할 수 있다.

• 의료법학
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• 제10권1호
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• pp.213-260
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• 2009

While the medical supplies have positive functions such as extending lifespan, recovering health, and preventing diseases, they also cause unexpected tragic consequences due to their side effects, and the magnitude of such damage inevitably increases due to the mechanism of mass production, mass distribution, and mass consumption of those medical supplies. Therefore, needless to say, the optimal way to prevent or reduce such damage is rather through medical supply manufacturers' producing non-defective products, or through the government's controlling production and sales of medical supplies with more aggressive exercise of regulatory authority on medical supply manufacturers, than through a remedy by a legal relief after using medical supplies. In this case, although the victim died due to the defect of the cold medicine, 'CONTAC 600', the drug company's responsibility to cover damages was not recognized because a defect could not be found in the then-manufacturing process. Thus, while pharmaceutical companies are gaining economic profits by producing and selling a medical supplies, if they do not take any remedy measures for the victims of their products' side effects, the victims have to use medical supplies under their own responsibility of taking a risk, and they have to accept the full damage of the potential consequence. Therefore, to remove such absurdity and contradiction, and to practically remedy the victim of medical supplies' side effects, the pharmaceutical side effects remedy project pending in the the Drugs, Cosmetics and Medical Instruments Lawneeds to be actively implemented.

• 의료법학
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• 제15권1호
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• pp.165-181
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• 2014

Advertisements and labels provided by businesses are highly likely to contain false or exaggerated content because of the business's purposes. In these cases, it is difficult to deliver proper information to consumers, and regulation is necessary to some extent. In particular, information delivery is more important in the health medical and biotechnology areas than any other because of their specialized characteristics. The Fair Labeling and Advertising Act regulates ordinary content for labels and advertisements, while individual laws stipulate regulations for false or exaggerated advertisements and labels. Criminal law might apply in fraud cases depending on their characteristics. Therefore, consistency is needed among criminal fraud laws and regulations, the Act on Fair Labeling and Advertising, and legal punishment. However, a review of all these laws found that there is no such consistency. Accordingly, this paper asserts the need for improvement in this area.

• 의료법학
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• 제9권1호
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• pp.505-534
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• 2008

Aesthetic plastic surgery rarely has the lifesaving, the medical necessity, and the emergency, because it was executed in order to acquire personal satisfaction in the external features. In addition, aesthetic plastic surgery has the strong commerciality in that it is based on the attraction of a client through medical advertisement and the range of uninsurance. These characteristics cause whether aesthetic plastic surgery is included in medical procedure and the legal contract between physician and client is controversial issue. Also, attention and explanation in aesthetic plastic surgery are more emphasized than those in general medical procedure. According, this document presents the various characteristics of aesthetic plastic surgery, which differs from that of general medical procedure.

• 의료법학
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• 제21권2호
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• pp.75-103
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• 2020

의료기술의 발전과 환자 진료 향상 등을 목적으로 빅데이터나 인공지능에 의료정보를 분석·활용하면 유전적 질병이나 암 등 특이 질병 등에 대비할 수 있어 의료정보가 공유되어야 한다는 목소리가 높아지고 있다. 환자의 개인정보에 관한 활용과 보호는 동전의 양면과 같다. 의료기관 또는 의료인은 일반 정보처리자와 다른 환경적 특수성과 민감도가 높은 개인정보를 처리함에 있어 신중하여야 한다. 대체적으로 환자의 개인정보는 의료인이나 의료기관에서 수집·생성부터 파기까지 개인정보를 처리하고 있으나 의료법의 개인정보에 관한 용어 사용의 혼재되어 있거나 적용 범위가 명확하지 않아 판례의 해석에 의존하고 있다. 의료법 제23조의 전자의무기록에 저장·보관된 개인정보는 고유식별정보만을 의미하는 것이 아니라 진료기록부 등 의무기록의 개인정보와 동일하며, 그 내용은 인적 정보, 고유식별정보, 진료정보, 재산정보 등을 포함한다. 의료인이나 의료기관 개설자는 의료법 제24조의4 진료정보가 침해된 경우 제23조의 개인정보와 동일하게 취급하여야 하는지에 대해 전자의무기록에 환자의 민감정보가 기록·저장·보관되어 있으므로 특별히 개인정보 중 진료정보만을 의미한다고 볼 수 없다. 의료법 제19조의 정보 누설 금지는 업무상 알게 된 '비밀'에서 '정보'로 개정되었으나 명칭만 바뀌었을 뿐 보호법익은 형법상의 비밀과 동일하여 환자의 개인정보자기결정권을 보호하고 있지 못하다. 개인정보보호법과 지역보건법은 '업무상 알게 된 정보'에서의 보호법익을 개인정보자기결정권으로 보아 누출, 위조, 변조, 훼손 등 개인정보 침해 행위에 대하여 동일하게 벌칙을 규정하고 있다. 의료법의 개인정보 보호 규정은 용어의 정의가 불명확하여 정보주체 및 정보처리자, 국민에게 적용 범위 등 혼란을 일으킬 수 있어 용어가 통일적으로 정비되어야 할 필요가 있으며, 개인정보 보호에 관한 특별법인 의료법과 일반법인 개인정보보호법의 규정 내용이나 범위가 일치하지 않아 해석상 혼란이 생길 수 있어 개인정보 보호에 대하여 일정한 한계를 보인다. 환자의 개인정보는 민감정보로서 그 활용과 처리에 있어 안전하게 보호되어야 한다. 개인정보 보호 원칙에 따라 개인정보를 처리하여야 하며, 정보주체인 환자나 보호자의 권리인 사생활의 비밀과 자유, 인격권, 개인정보자기결정권을 보장하여야 할 것이다.

• 의료법학
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• 제15권2호
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• pp.399-434
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• 2014

A criminal liability of the divisional medical-institution is faced a new aspect in the connection with development of the medical techonology. Especially, a division of labor in the medical-institution in Korea will be greatly increased in the foreseeable future. A general hospital will be frequently confronted with sofisticated techniques such as MRI, CT-screen. Accordings to the nature of its functions, a general hospital may make accommodation or services or both available for patients who give undertakings (or for whom undertakings are given) to pay, in respect of the accommodation or services (or both) such charges as the government may determine. It shall be the duty of the government to develop, promote and regulate a criminal liability of the divisional medical-institution. Above all, the government shall have to determine the standard of a criminal liability of the medical-institution in the horizontal specialization and the vertical specialization. But, the court may give finally by directions the standard of the criminal liability of the divisional medical-institution.

• 의료법학
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• 제15권2호
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• pp.317-343
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• 2014

In order to account for whether a doctor should indemnify damages resulted from violation of duty of care, the fact that a doctor violated duty of care, that damages were incurred, and the link between violation of duty of care and damages incurred, respectively, should be verified. So even though a doctor violated duty of care to patients, he or she will not bear the responsibility to indemnify damages unless it is not verified. If a doctor's negligence in medical practices is assessed that obviously unfaithful medical practice far exceeds the limit of admission of a patient, it will not go against people's general perception of justice or law and order to constitute a medical malpractice itself as an illegal action that will require liabiliy for damage. However, when the limit of admission is set too low, a patient's benefit and expectation of proper medical treatment can be violated. In contrast, if the limit of admission is set high, it can leave too little room for doctors' discretion for treatments due to a bigger risk of indemnification for damages. Thus, a reasonable balance that can satisfy both benefit and expectation of patients and doctors' right to treatment is needed.