The Supreme Court made a decision that the doctor cannot be punished for not taking a blood transfusion to the patient, depending on the patient's will to refuse the blood transfusion on June 24, 2014. The reason is that, in a special situation of conflict between the right of patients to self-determination and the duty of care, and when it was impossible to compare whether which has the superior value, if the doctor made a medical practice to respect either of those two values according to the professional sense, he cannot be punished. In principle, the doctor should make medical practices according to the patient's will. However, if the patient's life was at stake, I think, the doctor is obliged to try his best to save the life of patient. Yet to entrust the patient's life to the doctors professional sense, is to give up the obligation of the country to protect lives. In this regard, I think that the Supreme Court Decision should be reviewed, and that an ongoing research is needed.

In this paper the good Samaritan civil liability is argued. In many cases some damage could be caused by an emergency medical service. In such situations the degree of duty of care taken by the service provider would be alleviated depending upon the degree of emergency. Then the service provided by anyone not carrying any duty to do so could be generally ruled by the 'Korean Civil Act' Article 735. This article is related to the management of affairs in urgency. The application of this article means the mitigation of civil liability of the service provider. If the service provider not carrying any duty to provide it "has managed the affairs" of the service "in order to protect the" victim "against an imminent danger to the latter's life", the provider "shall not be liable for any damages caused thereby, unless he acted intentionally or with gross negligence". Korea has another rule applied in such a situation, that is the Korean 'Emergency Medical Service Act' Article 5-2. This article is established for the exemption from responsibility for well-intentioned emergency medical service. It could be referred to as the Good Samaritan law. It provides: "In cases where no intention or gross negligence is committed on the property damage and death or injury caused by giving any emergency medical service or first-aid treatment falling under any of the following subparagraphs to an emergency patient whose life is in jeopardy, the relevant actor shall not take the civil liability ${\cdots}$" In this paper the two articles is compared in the viewpoints of the requirements for and effects of the application of them respectively. The 'Korean Civil Act' Article 735 is relatively general rule against the the Korean 'Emergency Medical Service Act' Article 5-2 in the same circumstance. Therefore the former could be resorted to only if any situation could not satisfy the requisites for the application of the latter. In this paper it has suggested that the former article be more specific for the accuracy of making decision to apply it; and that the latter be revise in some requirements including the victim, the service provider, and the service.

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

For a variety of reasons, the number of medical disputes is continuously rising. Due to the intrinsic qualities of medical treatments, one would find it more apt to subject medical disputes to general conflict resolution procedures rather than to once-for-all decisions under legal suits. To address the increasing medical disputes with greater professionalism and efficiency, the Medical Disputes Mediation Act was enacted and a medical dispute mediation system put in place, while drawbacks have been blamed to both. The current mediation procedures require the respondent's agreement as a disclosure requirement. A reasonable improvement to this would be to amend the regulation of agreement supposition, or to enforce procedural participation only to public health facilities managed by the national or regional government. Furthermore, small claims cases of 20 million KRW or less in claim may be considered for conciliation-prepositive principle. The concentration on small claim medical disputes is a phenomenon that can be addressed by carrying out maximum authentication commissions or similar measures, one of the solutions by enhancing the public trust in the Korea Medical Dispute Mediation and Arbitration Agency. The proper management of medical authentication teams is one way to address the existing problems in the authentication system. For this, the number of team members shall be increased under more flexible authentication procedures. All indemnity resources for medical accidents of force majeure must be borne by the Government, for it is the body principally responsible for social compensation. Placing this cost on the establisher of the subject medical facility holds the possibility of violating fundamental rights. While the costs for subrogation payment system for damages may be borne by the healthcare facility establisher, a deposit-based system must be created for cases in which the facility shuts down, without holding the responsibility for accident cause. Such change to a deposit-based system will evade the controversies of unconstitutionality, etc.

As results of analyzing judicial precedents about infection in hospitals in connection with mistakes and causality in medical litigations shows that the Mitigation of Law Principles To Prove responsibility in medical litigation has not been able to play its role compared to its intended purposes. And Major sentiment from those judgments is that a mistake can't be proved only by the fact that certain infection in hospital occurred in connection with hospital infection. Therefore, the number of indirect facts to deny estimation is overwhelmingly high. Like this, especially for hospital infection which is difficult to prove indirect facts themselves to estimate mistake, major sentiment from those judgments have a problem that impute sharing of losses caused by hospital infection to patient. In accordance with the Principles of equitable and proper sharing of losses, it's required to prepare legal interpretation and theoretical methods to largely mitigate patient's responsibility to prove medical mistakes compared to other medical litigations in connection with existing Mitigation of Law Principles To Prove responsibility and conventional theory of estimation. In connection with this, the results of review that duty of safety management in hospital infection cases can be the base of conversion of proving responsibility, the duty that prevent hospital infection, corresponding the duty of safety management in hospital infection is not conventional duty of safety management based on duty of good faith but secondary obligation of medical contract. The breach of duty preventing hospital infection is the violation of medical contract, but there is no logical necessity that convert proving responsibility from the obligation of contract itself. Therefore, the duty of preventing hospital infection from the obligation of medical contract, corresponding the duty of safety management in hospital infection cases cannot be the base of conversion of proving responsibility alone. But, it's still required to conversion of proving responsibility in hospital infection, we need further studies on cases of Germany which applies legal estimation of proving responsibilities in hospital infection.

Der Vertrag zwischen dem Arzt und seinem Patienten wird als Auftrag im Sinne des ${\S}680$ KBGB qualifiziert. Dem Arzt erwachsen innerhalb dieses Behandlungsvertrages zahlreiche Pflichten, von denen ein gro${\ss}$er Teil durch Richterrecht geschaffen wurde. Den Arzt treffen z.B. Behandlungspflicht, Informationspflicht ${\ddot{u}}$ber die Behandlung, Aufkl${\ddot{a}}$rungspflicht ${\ddot{u}}$ber einwilligungspflichtige Umst$\ddot{a}$nde, Dokumentationspflicht, Schweigepflicht. Der Arzt ist nach Rechtsprechung und Literatur verpflichtet, den Patienten ${\ddot{u}}$ber s${\ddot{a}}$mtliche f${\ddot{u}}$r die Einwilligung wesentlichen Umst${\ddot{a}}$nde aufzukl${\ddot{a}}$ren, insbesondere ${\ddot{u}}$ber Art, Umfang, Durchf${\ddot{u}}$hrung, zu erwartende Folgen und spezifische Risiken der Ma${\ss}$nahme, die Notwendigkeit, Dringlichkeit und Eignung der Ma${\ss}$nahme zur Diagnose oder zur Therapie und uber die Erfolgsaussichten der Ma${\ss}$nahme im Hinblick auf die Diagnose oder Therapie. Mu${\ss}$ der Arzt den Patienten auf einen eigenen Behandlungsfehler hinweisen, wenn f$\ddot{u}$r ihnen Umst${\ddot{a}}$nde erkennbar sind, die die Annahme eines Behandlungsfehlers begr${\ddot{u}}$nden. Allgemeine Offenbarungspflichr bei ${\ddot{a}}$rztlichen Behandlungsfehlern wird bisher nicht diskutiert. Nach derzietigem Recht besteht keine allgemeine Offenbarungspflicht des Arztes, den Patienten unaufgefordert ${\ddot{u}}$ber einen eigenen Behandlungsfehler hinzuweisen. Aber wie im ${\S}630c$ BGB, sind f${\ddot{u}}$r den Behandelnden Umst${\ddot{a}}$nde erkennbar, die die Annahme eines Behandlungsfehlers begr${\ddot{u}}$nden, hat er den Patienten ${\ddot{u}}$ber diese auf Nachfrage oder zur Abwendung gesundheitlicher Gefahren zu informieren.

Nurses are medical care providers most closely associated with the national health. Their works are subdivided and specialized, and it is such a factor making nurse's role more important, and with the appearance of specialized nurses, they have secured a position as an independent medical care provider. As the domain of nurse's service becomes broader, there are more accidents and disputes related to nurses. However, there are not many studies conducted on such problems, and even when medical disputes take place related to nurses, the court does not make consistent judgments as a matter of fact. Besides, as the ambiguity of nurse's range of service and the lack of nursing workforce work as a factor causing nurse's medical malpractice, more legal discussions and studies are required to seek proper solutions to such problems. Thus, as a plan to clarify legal issues likely to occur due to nurse's medical practice, this study classified nurse's work into medical assistance practice and other jobs based on their own independent judgments, and proposed establishing concrete regulations on the range of their work, while reviewing common problems extracted from precedents related nurse's medical malpractice. Moreover, while examining Japanese precedents related to the Act of Medical Service Personnel, Nurses and Midwives, which is the sole act of nurses in Japan, this study reviewed the necessity of revising the present nurse-related regulations in Medical Service Act, or enacting a sole act of nurses.

In current law, the premium medical treatment system gives patients the right of choice between normal medical treatment service and premium medical treatment service. Only the doctors having a career more than a certain period of time fixed in the law are eligible for providing the premium medical treatment service. So, the premium medical treatment system is highly related to the patients' right to know and the right of self-determination. The system is also relevant to the so-called 'economic explanation' notion because patients should pay additional fee when they want to use this system. Meanwhile, the situation as follows is problematic as to this system. Although a patient applied for using the premium medical treatment system and the patient also chose his or her own doctor specifically, another doctor who was not selected as premium doctor could make a medical accident. Then, is the another doctor liable for damages because the accident was a medical malpractice or a breach of medical contract? In this study, we are going to examine the problems related with the premium medical treatment system. First, we examine the current law related to the system. Second, we look into the economic explanation duty and its application to the premium medical treatment system. Finally, we examine a real judgment case about a medical practice against the premium medical treatment system and we propose our solution to this case.

Ob das Erbitten der Behandlung durch einen Dritten einen Behandlungsvertrag oder lediglich eine Gesch${\ddot{a}}$ftsf${\ddot{u}}$hrung ohne Auftrag darstellt, richtet sich nach dem allgemeinen Grundsatz der Auslegung der Willenserkl${\ddot{a}}$rung. Auch wenn ein Dritter f${\ddot{u}}$r eine andere Person die Behandlung erbittet, l${\ddot{a}}$sst sich dadurch kein zwingender R${\ddot{u}}$ckschluss ziehen, dass daraus eine vertragliche Pflicht auf Verg${\ddot{u}}$tung anhand der Behandlung an den Behandlungserbitter entsteht. Das Erbitten der Behandlung eines Dritten stellt n${\ddot{a}}$mlich weder einen Antrag dar, noch ensteht dadurch ein Rechtsgesch${\ddot{a}}$ft zwischen dem Behandlungerbitter und dem Behandelnden. Stellt das Erbitten der Behandlung durch den Dritten eben kein Rechtsgesch${\ddot{a}}$ft dar, handelt es sich um eine Behandlung ohne gesetzliche Pflichten. Dadurch ist f${\ddot{u}}$r den Behandelten eine Gesch${\ddot{a}}$ftsf${\ddot{u}}$hrung ohne Auftrag er${\ddot{o}}$ffnet. Wird das Erbitten der Behandlung als Antrag ausgelegt, ist dies ein Antrag eines echten oder unechten Vertrags zugunsten Dritter, oder der Behandlungserbitter hat als Vertreter des Patienten oder Unterhaltspflichtigen als Vertretende, einen Behandlungsvertrag abgeschlossen. Wenn der Vertragspartner die Tatsache kennt oder kennen musste, dass es sich um einen Vertreter handelt, ist die Vertretungshandlung wirksam.

As the number of medical disputes regarding nurses has increased after medical disputes have increase, there is a need for a study on it. However, the legal relationship between nurses and patients has not yet been analyzed. Recently, the role and function of nurses are expanded according to the development of the science of nursing; moreover their activity and limitation of responsibility are also expanded. For this reason, the medical disputes regarding nurses have been increasing. However, the majority of these kind of dispute are just passed over because their practice is usually considered to be a mere action to assist doctor's role. In addition, nurse practice is not a secondary action of doctor's role, but forms part of a medical treatment. Of course, nurses handle many secondary tasks after doctors finish their medical treatment. But this is only part of the whole tasks of nurses. Furthermore, the general details of their medical treatment are not different from those of doctors because they also belong to the medical service personnel. Considering these features of nurse and the medical condition in South Korea, their task is becoming increasingly developed and specialized and they are also establishing their own field. With this stream of times, there is a growing interest in enacting a Nursing Practice Act, in other words, the independent law on nurse for the sake of patient safety and national health promotion. Then, their responsibility will distinctly be expanded as much more. That is, the time that nurses practice their medical care by following doctors' order and also pass over their responsibility to doctors is closed. Thus, this study examines the features and responsibilities of nursing practice, and discusses an institutional framework to efficiently cope with the legal disputes between nurses and patients. It aims to throw light on the decision making on nurse-patient disputes in future.

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.

Because the health care or medical sector has such characteristics as publicity, professionality, and exclusivity, it cannot be left to the free market system. As a consequence, the state has restricted the establishment of medical institutions in order to protect the life and health of people. Also, the medical law has regulated to permit the establishment of medical institutions by only medical personnel and a few corporate bodies and to ban the establishment of medical institutions under disguised ownership as well as double opening of medical institutions by medical personnel. Nevertheless, there are still many cases that non-medical personnel have dominantly established medical institutions under disguised ownership of other medical personnel or nonprofit corporation. Because they are willing to recover their investment costs as soon as possible, these illegally established medical institutions are likely to make patients undergo unnecessary tests or to perform the excessive treatments and, as a result, are likely to cause infringement on the health and lives of the people. In addition, even if the misconduct is uncovered, the rate at which the costs already paid is very low and, as a result, the damages are straightly connected to the people's loss. On the other hand, there are also increasing number of cases that medical personnel or nonprofit corporations are establishing medical institutions against the medical law regulations. The examples of this illegality are also the double opening of medical institutions and the establishment of medical institutions under disguised ownership by medical personnel or nonprofit corporations. And the damages in these cases may not differ from those in the above cases. In this study, regarding medical law regulations restricting opening a medical institution, I will review the intent of those regulations, the type of violations and criminal punishments, and the possibility of recovery from unlawful profit by the National Health Insurance Act. And then, I would like to find a way for rational improvement of each.

Dans le contentieux m$\acute{e}$dical, il est difficile de prouver l'existence d'un lien de causalit$\acute{e}$ entre la faute m$\acute{e}$dicale et les pr$\acute{e}$judices subis par la victime. R$\acute{e}$partir bien de façon raisonnable la charge de la preuve du lien causal est alors une des questions pr$\acute{e}$occup$\acute{e}$es par la doctrine cor$\acute{e}$enne. La Cour supr$\hat{e}$me cor$\acute{e}$enne semble toutefois facilliter l'indemnisation des victimes dans les cas o$\grave{u}$ la responsabilit$\acute{e}$ du m$\acute{e}$decin a ${\acute{e}}t{\acute{e}}$ mise en cause, et cela en admettant des fois une solution op$\acute{e}$rant un renversement de la charge de la preuve du lien causal. Une telle attitude a ${\acute{e}}t{\acute{e}}$ m$\hat{e}$me affirm$\acute{e}$e dans un arr$\hat{e}$t rendu r$\acute{e}$cemment en cas de dommage caus$\acute{e}$ par le fait du produit de sant$\acute{e}$, notamment pour le cas de contamination virale par voie de transfusion. La Cour a $\acute{e}$galement reconnu que l'action se pr$\acute{e}$scrit $\grave{a}$ partir du moment de la consolidation du pr$\acute{e}$judice. Aux termes de cette $\acute{e}$tude, on pourra constater que le juge français reconna$\hat{i}$t aussi l'assouplissement de la charge de la preuve du lien de causalit$\acute{e}$ en mati$\acute{e}$re d'action m$\acute{e}$dicale. Il faudra toutefois souligner que le ph$\acute{e}$nom$\acute{e}$ne ne soit pas g$\acute{e}$n$\acute{e}$ralis$\acute{e}$ en droit français, d'autant plus que la pr$\acute{e}$somption de l'existence de la causalit$\acute{e}$ en la mati$\grave{e}$re a $\acute{e}$t$\acute{e}$ admise de mani$\grave{e}$re restrictive par la l$\acute{e}$gislation sp$\acute{e}$cifique. Tel $\acute{e}$tait notamment le cas pour les accidents de la contamination par le virus du sida ou de l'h$\acute{e}$patite C survenus apr$\grave{e}$s la transfusion. En d$\acute{e}$finitive, on peut dire qu'en droit français, le principe est maintenu en cas de manquement $\grave{a}$ une obligation de r$\acute{e}$sultat n$\acute{e}$e du contrat m$\acute{e}$dical, tandis que la Cour de cassation admet parfois en mati$\grave{e}$re de droit commun de la responsabilit$\acute{e}$ contractuelle la pr$\acute{e}$somption de causalit$\acute{e}$ en cas d'inex$\acute{e}$cution des obligations de r$\acute{e}$sultat. En fait, la pr$\acute{e}$somption de causalit$\acute{e}$ dans le contentieux m$\acute{e}$dical pourra mener les m$\acute{e}$decins $\grave{a}$ se diriger vers les traitements d$\acute{e}$fensifs. Cette situation peut m$\hat{e}$me conduire $\grave{a}$ emp$\hat{e}$cher le d$\acute{e}$veloppement de la science m$\acute{e}$dicale, enfin $\grave{a}$ une situation d$\acute{e}$savantageuse aux patients. Il y a alors lieu de se m$\acute{e}$fier des int$\acute{e}$r$\hat{e}$ts d$\acute{e}$s$\acute{e}$quilibr$\acute{e}$s entre le m$\acute{e}$decin et le patient. De ce point de vue, on peut estimer que le droit français donne des suggestions aux juristes cor$\acute{e}$ens dans la recherche des solutions plus ad$\acute{e}$quates en ce qui concerne la charge de la preuve du lien causal en mati$\acute{e}$re de responsabilit$\acute{e}$ m$\acute{e}$dicale.

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.

Supreme Court of Korea has been mitigating the burden of proof on the malpractice and causal relation by a patient in accordance with the practical transfer of such burden of proof on causal relation as well as relieving a doctor's burden of proof on mistake in the civil damage claim suits on the malpractice. However, a prosecutor shall strictly prove the causal relation between malpractice and unfavorable results as well as a doctor's mistake in the criminal cases for making a doctor accept the professional negligence resulting in death or injury in accordance with In Dubio Pro Reo principles. Furthermore, it shall not be allowed to relieve the burden of proof on malpractice and causal relation which has been frequently applied in the civil proceedings. Nevertheless, it was widely known that the front-line courts accepted the malpractice and causal relation by quoting the legal principles on relieving the burden of proof on malpractice and causal relation applied in the civil cases even in criminal cases with no or insufficient proof on malpractice or causal relation. However, the latest precedents in Supreme Court explicitly declared the opinion that there was no reason to apply the legal principle to relieve the burden of proof on the malpractice and causal relation in the criminal cases requiring the proof 'which doesn't cause any reasonable doubt' on malpractice and causal relation in accordance with the legal principles 'favorable judgment for a defendant in case of any doubt' on the basis of the strict principle of 'nulla poena sine lege.' Accordingly, Supreme court definitely clarified that there would be no reason to relieve the burden of proof on malpractice and causal relation in criminal cases by reversing several original judgments accepting malpractice and causal relation even though there were no strict evidence.