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Promulgation of the medical practice rule without specific definition in Medical Law has brought about many constitutional issues. The major issue is that the law has the government punish unlicensed medical practice without defining what it is. Instead, the law chooses a license-centered structure of criminal punishment for medical malpractice, saying “no one can practice medicine without the government-approved license.”This regulation violates the rule of “void for vagueness” based on the principle of “nulla poena nullum crimen sine lege.” Judicial interpretation should be required for a citizen to understand the Medical Law provision intuitively. In addition, the law infringes upon the freedom of occupation of the unlicensed and the licensed who wish to extend his or her practice area for “holistic medicine.” The central issue of the law is that it was established under no ground of professionalism even though medical practice has been understood professional. The government has centrally controlled the medical field for its needs. Lastly, the current law violates the right of medical selection of the consumers of medicine. Because patients have the right of health and life, they have to hold the latitude of selection for medical treatments. Especially, they should have an opportunity for considering the Complementary and Alternative Medicine if they want. But under the current rules, this medicine is not permitted. To correct those problems, a new provision for the definition of medical practice should be adopted at once.

Recently, there has been fierce argument between oriental and western doctors in the medical field. The use of medical devices has particularly come to the fore lately. Appropriate medical devices are required to diagnose and treat patients' conditions or illnesses accurately. At issue recently in medical device sector are diagnostic instruments using radiation, magnetic resonance imaging, ultrasound, IPL(Intense Pulse Light), and instruments used for tonometry. Relating to this issue, Association of Korean Oriental Medicine and The Association of Korean Medicine are sharply opposed. It is predicted that more accusations of this kind will be seen in the future. As oriental medicine contends, ultrasonic imaging itself seems to cause no harm to humans and its use may have an advantage for national health. The use of western diagnostic equipment can expand the diagnostic range of oriental doctors. However, unless new legislation is made, it is against the law for oriental doctors to use this equipment. Both law and medical science require grounds and predictability on the correctness of a decision and all of its consequences. Additionally, oriental medicine's use of ultrasounds and other medical devices should be established by standards and grounds which make same the diagnosis with repetition. Therefore, the scope of oriental medicine can be expanded following a revision of the Oriental Medicine Promotion Act and it is estimated that the state of national health will be greatly improved by the mutual respect of both sides of the health profession.

The Medical Affairs Law regulates that Medical Doctor and Korean Medical Doctor(KMD) can practice in the boundary of each licence. But there is no clear provision to explain what practice in the boundary of MD’s permitted region and what is KMD’s. Moreover practice over the boundary of licence could be punished as a violation of the Law. KMD’s use of medical devices have been objects of legal conflicts in the field. Because there is no clear provision in the Law, judical precedents have played the role as practical and final regulations. In this study, analyses on some judical precedents could show some rationales whether an issued KMD's use of medical devices is in the boundary of license. The courts considered the theories based on the practice, the level of required specialty and education, and the probability of danger to a patient. The judical precedents should be reviewed more precisely in the respects that it is adaptable in “the written law system”and it is desirable to divide boundaries between MD’s and KMD’s.

Compared with medical cases and health care law from other countries there has been a lot of progress on medical law, especially on medical precedents in Korea. However, in recent years, medical precedents tend to reflect a realistic position of health care providers, rather than normative position of the victim. The burden of proof to prove strict liability is given to patients in civil law suits by courts, patients generally has the burden of proof. The rate of claims to prove the negligence of medical malpractice is falling significantly. Even if the error is acknowledged, it is not enough to get right to be relief for patients by increasing limitations of liability or ratio of patient's own negligence. Compensation fee is included in medical fees and risk of medical malpractice actions contributes ultimately to a health care consumer. In conclusion, author represents a major the new upgrade of above mentioned problem. By advising that court should assess actively for the perspective of victim for medical negligence we will be able to exercise remedies of patients' rights and to prevent recurring medical accidents and also contribute to medical advances.

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.

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.

While the local health insurance and the employment-based insurance were integrated in July 2000, the insured is divided into employment-based insured and the local insured and the relevant premium has been applied to both groups. The health insurance premium having the feature of social solidarity has to be determined depending on income, that is, the ability to pay in accordance with the principles of social insurance. While employment-based insurance premium has been determined depending on the earned income, the local insurance premium for the local insured has been determined by scoring gross income(evaluated income), property and possession of automobiles. A variety of improvement approaches has been implemented including introduction of the employment-based insurance premium ceiling system (2002) and the change of property scoring system for the local insured (2006). However, the health insurance system which was merged in 2000 has been implemented up to now without significant change even though there were lots of socio-demographic change including increase of income level and the population structure such as low birth and aging. In other words, it is required to implement the premium rating system securing the income-based equity. Nevertheless, it was inevitable to apply the diverse rating standards in the early stage because it was very difficult to verify the income of the self-employed. Although the income verification rate was significantly increased from 23% in 1989 to 44% in 2010, the irrational standards including property, automobiles, living standard and activity rate have been still applied to the local insured because it is difficult to secure the validity of insurance premium rating system and it severely lacks of security. This paper investigated whether the current insurance premium rating system for the local insured imposing the premium on the basis of ‘gender’ and ‘age’ complies with the basic human rights secured by the current Constitution of the Republic of Korea with respect to the practical and theoretic irrationality of insurance premium rating system and standards for he local insured. In accordance with the analysis results, this paper proposed the approach to improve the system.

Because of unpredictability and high possibility of abnormal results by clinical trials compared to general medical behaviors, a procedure for ensuring with sufficient explanations by investigators must be secured. Therefore, in a sequence of clinical trials, what kinds of scope, stage, and method of explanations provided by investigators, including doctors or researchers, to trial subjects are closely related to the compensation for damages by violation of liability for explanation. In case of application of clinical trials to patients who have critical illness such as cancer, issues of ｢Quality of Life｣ regarding trial subjects, cancer patients, should be discussed. Especially, in case of clinical trials for terminal cancer patients, the right of subjects' self- determination, which is a fundamental principle in medical behaviors, should be discussed. The right of self- determination includes participation in clinical trials for the possibility of life-sustaining even a little bit, or no participation in clinical trials in order to have a time for completing the rest of his life. Like this, if the extent and scope of explanations related to the issues of ｢Quality of Life｣ are raised as main issues, the evaluation of ｢Quality of Life｣ , should be a prerequisite. In many occasions, realistically, despite bad results such as deaths or serious adverse drug reactions after clinical trials, it may not be easy for compensating to trial subjects or their survivors, who requested civil compensation for damage. Futhermore, in abnormal results after concealment of clinical trials or performance of clinical trials without permission, and in the case of trial subjects' failures of proving proximate cause between the clinical trials and abnormal results, problematic results such as no protection to the trial subjects could be occurred. In performing clinical trials, investigators should provide sufficient explanations for trial subjects and secure voluntary informed consents from the trial subjects. Therefore, clinical trials without trial subjects' permissions and the informed consent process violate trial subjects' rights of self-determination, and the investigators shall be liable for compensation for damages. Then, issues might be addressed are what are essential contents of patients' ｢rights of self-determination｣ infringed by clinical trials without subjects' permissions. Two perspectives about patients' rights of self-determination might be considered. One perspective regards physical distress of patients (subjects) from therapies without sufficient explanations as the crux of the matter. The other perspective regards infringement of human dignity caused by being subjects without permission as the crux of the matter irrespective of risks' big and small influences. This research follows perspective of the latter. Forming constant fiduciary relation between investigators (doctors) and subjects (patients) pursuant medical contracts, and in accordance with this fiduciary relation, subjects, who are patients, have expectations of explanations and treatments by the best ways. If doctors and patients set this forth as a premise, doctors should assume civil liability when doctors infringe patients' expectations.

The conventional medical appraisal which was done in the process of medical lawsuit was requested from the court to the designated hospital and was delivered as a pattern of one question and one answer in each. However, the comprehensiveness of medical appraisal which was pursued, for example, in Korea Medical Dispute Mediation and Arbitration Agency, could be guaranteed in terms of in-depth medical analysis as well as the broader capacity of the causality estimation besides. The comprehensiveness of appraisal would also include how well organized hospital system of medical care is and how well correlated job system among medical staffs, when medical dispute was happened at the hospital. This comprehensiveness will exert a big contribution on making a demonstrative medical care to prevent from the medical dispute and it could achieve the national plan of building the patient safety net which is effective in restoring the worsened quality of contemporary medical service. Therefore, the comprehensiveness of medical appraisal has to be designed to go forward interdisciplinary fused speciality rather than one division of medicine, which is also aiming at the reliable and consistent appraisal with the supreme dignity from one window. In addition to that, the objective and concrete frame of comprehensive appraisal under the computed connection has to be deliberated to make itself possible in collaboration with positive participation of medical community. The comprehensiveness of medical appraisal would serve to expand not only the capacity of speciality but also the ability of influence on a restorative justice, so that it give effect to an increased number of mediation and arbitration rather than medical lawsuit as well as a decreased number of the social cost and social conflict.

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.

The right to self-determination in regard to one’s body is a key element of human dignity, privacy and freedom. It is constitutionally enshrined in the guarantee of human dignity, in the general right of personality and, most concretely of all, in the right to physical integrity. In principle No-one may trespass another person's body against his will, whether this act improves his physical condition or not. This right of self- determination applies equally to healthy and to sick people. Hence everyone has the right either to permit or to refuse a medical treatment, unless he can not make a rational decision. If the person does not consent himself, for whatever reason, another one must do for him as guardian. Representation in consent to medical treatment is therefore the exception of self-determination rule. This article explored, 1. who can consent to the medical treatment in the case of the mentally incapacitated adult and the infant, 2. what kind of consent to the medical treatment can the deputy determinate for the mentally incapacitated adult and the infant, 3. when the deputy can not determinate without permission of the court, and 4. what can the doctor do in the case of conflict between minors and guardians.

한 자료에 의하면 2011년 미국의 의료비 지출 총액은 국내총생산의 약 18 퍼센트에 달하였으며, 그 비율은 다른 대다수 선진국의 두 배에 해당하는 것이었다. 그중 메디케어 비용은 전체 의료비의 21 퍼센트인 5540억 달러 였는 데, 환자의 최후 6 개월에 들어간 의료비는 그 5540억 달러의 28 퍼센트 (전체 의료비의 5.9 퍼센트)인 1700억 달 러에 달하였다. 이러한 말기의료의 고비용성은 어떤 사유에 기인하며, 그 해소 방안은 무엇인가. 지난 수십 년 간의 의료경제학적 연구는 말기의료가 일반적으로 공급민감성을 지니며 비용대비 효율성이 매우 낮다는 결론에 도달하였다. 의료서 비스 공급의 양은 질병의 정도나 환자의 선호도와는 무관하고, 그보다는 의료서비스 공급자원에 민감하게 반응한 다는 것이다. 이는 말기의료에서는 의료자원이 과용된다는 것을 의미한다. 한편 "더 많은 의료처치에 더 나은 효용"이라는 일반적인 추론과는 반대로, 많은 의료처치의 결과는 오히려 매우 부정적인 것이었다. 실제 환자들의 선호와 관심사는 격렬한 말기의료가 기도하는 것과는 아주 달랐던 것이다. 이 논문은 먼저 말기의료에서의 공급민감성의 원인을 분석한다. 그 원인으로는 격렬한 치료와 그 효용성에 대한 일반적인 오해, 의사들의 환자에 대한 직업적인 사명의식, 환자 자신의 말기의료 의향결정의 부재, 의사들의 법적 책임에 대한 우려, 의료기관의 경영차원에서의 관리전략 등을 들 수 있다. 다음으로, 논문에서는 말기의료의 공급민감성에서 연유하는 과잉진료에 대한 현실적 해결책을 제시한다. 그 해결 책은 두 가지 측면으로 나누어서 들 수 있는데, 하나는 사전의료의향서 제도의 활성화 방안이고, 다른 하나는 의 료기관 경영관리전략적 관점에서의 방안이다. 우선 사전의료의향서의 활용도를 제고하기 위해서 다음과 같은 구체적 노력이 필요하다. 즉 의사들의 말기의료에 대한 태도를 바꾸도록 하는 새로운 의료윤리 교육 실시, 의사와 환자 간 말기의료에 대한 소통 기회의 강화, 환자 와 말기의료에 대한 대화를 적극적으로 실천하는 의사에 대한 보상제도 도입, 일반 공공에 대한 관련 교육 확대, 온라인 등록시스템과 같은 용이하고도 공식적인 사전의료의향서 등록체제의 구축 확대 등이 필요하다. 경영관리적 측면에서는 대체 전략이 필요하다. 예컨대 불필요한 비용을 절감하고 의료공급자로서의 가치를 재정 립하는 등의 새로운 재무전략과 경영교육계획 등이 고려되어야 할 것이다. 효과적으로 말기의료의 경제적 문제점을 해소하고 환자에게 더 나은 의료경험을 제공하기 위해서는 의료·환자·국 가 등 모든 부문에서 관행과 오해에서 비롯된 신조가 시급히 수정되어야 하고, 그 기초 위에서 제도와 문화가 개 선되어야 하는 것이다.

According to one Medicare report, in the US, total federal spending on health care expends almost 18 percent of the nation's GDP, about double what most industrialized nations spend on health care. And in 2011, Medicare spending reached close to $554 billion, which amounted to 21 percent of the total spent on U.S. health care in that year. Of that $554 billion, Medicare spent 28 percent, or about $170 billion, on patients' last six months of life. So what are the reasons of this high cost in EOL care and its possible solutions?Much spendings of Medicare on End-of-Life care for the terminally ill/chronically ill in the US has led health economics experts to assess the characteristics of the care. Decades of study shows that EOL care is usually supply-sensitive and poor in cost-effectiveness. The volume of care is sensitively depending on the supply of resources, rather than the severity of illness or preferences of patients. This means at the End-of-Life care, the medical resources are being overused. On the other hand, opposed to the common assumption, "The more care the better utility", the study shows that the outcome is very poor. Actually the patient preference and concerns are quite the opposite from what intense EOL care would bring about. This study analyzes the reasons for the supply-sensitiveness of EOL care. It can be resulted from the common misconception about the intense care and the outcome, physicians' mission for patients, lack of End-of-Life Care Decision which helps the patients choose their own preferred treatment intensity. It also could be resulted from physicians' fear of legal liabilities, and the management strategy since the hospitals are also seeking for financial benefits. This study suggests the possible solutions for over-treatment at the End-of-Life resulting from supply-sensitiveness. Solutions can be sought in two aspects, legal implementation and management strategy. In order to implement advance directive properly, active ethics education for physicians to change their attitude toward EOL care and more conversations about end-of-life care between physicians and patients is crucial, and incentive system for the physicians who actively have the conversations with patients will also help. Also, the general education towards the public is also important in the long run, and easy and official advance directive registry system - such as online registry - has to be built and utilized more widely. Alternative strategies in management are also needed. For example, the new strategic cost management and management education, such as cutting unnecessary costs and resetting values as medical providers have to be considered. In order to effectively resolve the problem in EOL care for the terminally ill/chronically ill and provide better experience to the patients, first of all, the misconception and the wrong conventional wisdom among doctors, patients, and the government have to be overcome. And then there should be improvements in systems and cultures of the EOL care.