• Journal of Society of Preventive Korean Medicine
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• v.19 no.1
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• pp.35-46
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• 2015

Objective : This study aims to investigate legal and regulatory status of traditional and complementary medicine (T&CM) focusing on regulation on health practitioners and health practice in 33 countries. Method : 33 countries were selected based on several factors such as interest of Korean medical doctors, strategic importance, and distribution over the world. The questionnaire was distributed to Korean embassies in 33 countries in March 2014 through Ministry of Foreign Affairs, and the answers from those countries were collected from April to September. 24 countries that provided sufficient information were included in the analysis. Results : 18 countries have law or regulation on T&CM. Only five countries regulate T&CM practitioners as medical personnel or health practitioner by law, and 12 countries have regulation on license or certificate. Half of 24 countries recognize license of T&CM practitioners issued abroad. There are nine countries that recognize T&CM practice as medical practice, and four of them regulate acupuncture as medical practice by western medical doctors or a few health practitioners recognized by the government. There are six countries that do not recognize T&CM practice as medical practice by law, but regulate it as practice that affect public health, and these countries have law or regulation on T&CM. Conclusion : As T&CM have great impact on public health, many countries have recently legislated law or regulation on T&CM. Rapid change in regulatory status of T&CM affects globalization of Korean medicine. Thus, development of timely strategies will be essential for it.

• The Korean Society of Law and Medicine
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• v.11 no.1
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• pp.173-198
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• 2010

There is a system in Korea named "Advanced Practice Nurse System" qualified by the Minister of Health, Welfare and Family Affairs for Advanced Practice Nurse besides nurse licence. Medical practice is, in today's medical law, understood as a general concept colligating medical practice, nursing practice and midwife practice and so on, for it is defined as a deed of medical technique practiced by medical personnel. Referring to the fact that the Supreme Court recognizes medical personnel as people who have medical expert knowledge, nursing practice can be recognized as a region of medical business and therefore it is not necessary to prescribe nursing practice separately from the definition of medical practice on a precedent, because nurse belongs to medical personnel. According to the precedent regarding 'Unlicensed Medical Practice of Advanced Practice Nurse for Anesthesia' recently sentenced by the Supreme Court, the medical practice is only allowed a doctor because it is 'in need of special knowledge and experience because of high danger on human body' and it is judged to be an unlicensed medical practice prohibited in medical law if it is to be done by a nurse. When considering the actual situation that System for Advanced Practice Nurse for Anesthesia is established under the circumstance that an anesthetist is in want and therefore the operation has not been performed on time, and that it is being expected an anesthetist to be in need, it is necessary to legislate for the range of medical practice of Advanced Practice Nurse so that Advanced Practice Nurse System can be practically legalized, for the role of Advanced Practice Nurse has the great possibility of shrinking because the precedent has considered Advanced Practice Nurse for Anesthesia doing anesthetic operation in clinic today as a potential wrongdoer.

• The Korean Society of Law and Medicine
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• v.9 no.1
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• pp.385-411
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• 2008

The goal of medicine is to contribute to promoting national health by preventing diseases and providing treatment. The scope of modern medicine isn't merely confined to disease testing, treatment and prevention in accordance to that, and making experiments by using the human body is widespread. The advance in modern medicine has made a great contribution to valuing human dignity and actualizing a manly life, but there is a problem that has still nagged modern medicine: treatment and healing for terminal patients including cancer patients. In advanced countries, pain care and hospice medicine are already universal. Offering a helping hand for terminal patients to lead a less painful and more manly life from diverse angles instead of merely focusing on treatment is called the very hospice medicine. That is a comprehensive package of medical services to take care of death-facing terminal patients and their families with affection. That is providing physical, mental and social support for the patients to pass away in peace after living a dignified and decent life, and that is comforting their bereaved families. The National Hospice Organization of the United States provides terminal patients and their families with sustained hospital care and home care in a move to lend assistance to them. In our country, however, tertiary medical institutions simply provide medical care for terminal patients to extend their lives, and there are few institutional efforts to help them. Hospice medicine is offered mostly in our country by non- professionals including doctors, nurses, social workers, pastors or physical therapists. Terminal patients' needs cannot be satisfied in the same manner as those of other patients, and it's needed to take a different approach to their treatment as well. Nevertheless, the focus of medical care is still placed on treatment only, which should be taken seriously. Ministry for Health, Welfare & Family Affairs and Health Insurance Review & Assessment Service held a public hearing on May 21, 2008, on the cost of hospice care, quality control and demonstration project to gather extensive opinions from the academic community, experts and consumer groups to draw up plans about manpower supply, facilities and demonstration project, but the institutions are not going to work on hospice education, securement of facilities and relevant legislation. In 2002, Ministry for Health, Welfare & Family Affairs made an official announcement to introduce a hospice nurse system to nurture nurse specialists in this area. That ministry legislated for the qualifications of advanced nurse practitioner and a hospice nurse system(Article 24 and 2 in Enforcement Regulations for the Medical Law), but few specific plans are under way to carry out the regulations. It's well known that the medical law defines a nurse as a professional health care worker, and there is a move to draw a line between the responsibilities of doctors and those of nurses in association with medical errors. Specifically, the roles of professional hospice are increasingly expected to be accentuated in conjunction with treatment for terminal patients, and it seems that delving into possible problems with the job performance of nurses and coming up with workable countermeasures are what scholars of conscience should do in an effort to contribute to the development of medicine and the realization of a dignified and manly life.

• The Korean Society of Law and Medicine
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• v.12 no.1
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• pp.177-225
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• 2011

Verdicts related to major medical litigation given by the Seoul Central District Court, the Seoul High Court and the Supreme Court in 2010 were analyzed. It's shown that in cases of the medical negligence regarding the occurrence of neonatal cerebral palsy, the plaintiff claims were dismissed using criteria proposed by associations of Obstetrics and Gynecology and Pediatrics in US, and thereof the burden of plaintiffs to prove the medical negligence has increased. In addition, in case of that the expected survival period of infants gets longer, payments for treatment and nursing after survival period determined by judges are made and it was judged to compensate it as a periodical indemnity. In case for the explanation obligation the most frequently mentioned in the medical litigation, in addition to cases of invoking the existing theory of explanation obligation, verdicts to mention the instructions of theory regarding instruction explanation obligation and the possibility of compensation for damages on property are given. Particularly, in cases for a liability of reparation by exaggerating the effects and not disclosing the risks related to treatment with stem cells, even if the treatment not approved by Food and Drug Administration is in violation of the Pharmaceutical Affairs Law, it's not illegal as violation in Pharmaceutical Affairs Law itself. But there is a certain verdict to present the possibility of an extension of the theory of explanation obligation by acknowledging the liability of reparation caused by illegal acts with no explanations of effects and risks of treatment with stem cell by doctors and pharmaceutical companies. In an incident in which a mental patient fell and died through the opened door of the roof at the hospital, a liability of reparation was acknowledged due to defects in structure installation management and this verdict drew an attention since the overall management responsibility about patients including structures was acknowledged to the hospital besides the obligations on medical practice. In case of the verdict without giving the opportunity to state the opinion with respect to the main legal issues, the responsibility of the court was emphasized since the court did not fulfill the explanation obligations. There were some cases in which payments for nursing and caring to a patient in vegetative state during the plastic surgery was admitted. However, in dental-related incidents, the proportion of cases in which plaintiff won was low since the difficulty of proving may be reflected. In the area of administrative litigation, unlike the existing position regarding arbitrary medical charge cover collected from patients in hospital, the verdict to admit the legitimacy of collection of medical treatment was given and attracted the attention of people. Verdict in which the expression related to medical advertisement was not exaggerated disposed the original verdict and pointed out the problem of excessive regulations on medical advertisement. The effort to analyze the trend of verdicts of court through reviewing the decisions and to organize should be continued, but the full decision should be disclosed as a base, and people and systems to enable the all time monitoring should be prepared.

• The Korean Society of Law and Medicine
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• v.10 no.1
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• pp.171-211
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• 2009

Because Korea has the excellent informational technology, it was expected to be able to improve the accessibility to healthcare and compete with other nations in excellence through u-Healthcare. But we can't complete the excellent u-Healthcare because of the law to be able to use only the tele-counselling between doctor to doctor or doctor to nurse. First of all, we must complete the law to be able to use the improved u-Health containing of telemedicine between doctor to patient. Though other factors, the procurement of safe IT, the credibility to healthcare service provider containing of nutritionist and occupational therapist etc. are prepared for erecting u-Healthcare, we can get the final and decisive u-Health policy only by means of Law for supporting u-Healthcare's Activation. The important sections of Law for supporting u-Healthcare's Activation are as follows. Sec. 4 The Minister for Health, Welfare and Family Affairs and the dean of associated administrative division have to erect the combined plan for u-Healthcare's Activation. Sec. 11 Government and local autonomous entity can support the facility and equipment to be necessitated for using u-Healthcare to improve the medical accessibility of person in the region with poor medicine. Sec. 13 Doctor can support other doctor's medical action through IT and if there are not medical risk, doctor can give medical act directly to the special patients. Sec. 21 If pharmaceuticals is necessitated in u-Healthcare, remote doctor has to send the patient the electronic prescription and the pharmaceutist to receive the electronic prescription has to delivery the pharmaceuticals in accordance with patient's demand.

• The Korean Society of Law and Medicine
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• v.9 no.2
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• pp.339-382
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• 2008

Medical information is one of significant private information that includes in-dividual's own diverse information. Once opened, it exposes one's health condition and medical history to a third party, which could bring about serious troubles. On this account, the third parties are of much concerns about the information. If medical information collected through various routes is used with another purpose, oilier than the initial intention, it might cause serious results beyond one's control. Thus, it is essential to keep the information confidential. Also, the discrimination based on the medical information ought to be banned because it is likely to happen that exposed information socially stigmatizes a person, being discriminated in a work place or a school when he/she is employed or gets an insurance. In the current system, only medical institutions are responsible for protecting or securing medical records. Despite the information technology development and the increased interests in medical information, there are quite a few limitations in legal, technical, and administrative aspects. All kinds of organizations, involved in collecting and using the information, as well as medical institutions primarily producing and managing it should share the responsibilities.

• The Journal of Korean Medical History
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• v.26 no.2
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• pp.9-21
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• 2013

Purpose : The purpose of this study was to analyze the history and characteristics of laws and regulations of the medical and pharmaceutical system in Korea-focusing on the Korean (Oriental) medical and pharmaceutical system-from the modern period to the early days of the Republic. We reviewed how traditional notions and categories of Oriental medicine, which were regarded as experiential and conventional, became part of the current dualistic medical and pharmaceutical system, and examined problems and effects during the course of positioning. Methods : We classified the development of the medical and pharmaceutical laws and regulations chronologically, from the Korean Empire to the beginning of the Republic. The abolishment of the traditional medical system that was based on laws and regulations of the Joseon Dynasty, the implementation of dualistic medical system in the Korean Empire, the attempt to demolish Korean (Oriental) medicine under the Japanese colonial rule, and the process of developing a statute-based continental law system were thoroughly reviewed. Results : Although the dualistic medical system was specified in legislation via the enactment of the National Medical Services Law in 1951, we found that it was actually enacted in 1963, when the laws and systems regarding the educational institution of Korean (Oriental) medicine were stably established. Moreover, the dualistic pharmaceutical system was specified in legislation through the partial amendment of the Pharmaceutical Affairs Act in 1994, but we concluded that the actual enactment was rather in 2000, when the first Korean (Oriental) pharmacist was produced. Discussions and conclusions : An effort to establish a dualistic medical system of Korean (Oriental) medicine and Western medicine during the Korean Empire bore fruit a few decades later, after the Republic of Korea was founded. It means the basis for the legal system finally took shape in spite of the numerous attempts during the Japanese colonial era and the beginning of the Republic to abolish Korean (Oriental) medical and pharmaceutical system.

• Health Policy and Management
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• v.28 no.3
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• pp.301-307
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• 2018

The development of transport is being easily shared with people all over the world. It is necessary to appropriately and effectively revise the domestic quarantine law because the fatal infectious diseases are at risk of being easily shared. Today, Korea has an advanced quarantine system approved by World Health Organization, but it maintains partnerships with related ministries (Ministry of Foreign Affairs, Ministry of Justice, local medical institutions) and to introduce new medical technology (electronic quarantine) is important. And since the prevention of quarantine infectious diseases and prevention of the spread, in order to maintain international cooperation with the International Health Regulations, the quarantine law and the system should be amended and improved effectively and it is also a way to prepare for the outbreak of new quarantine infectious diseases. In the past, Korea has experienced great confusion during the past outbreak of swine flu and Middle East respiratory syndrome coronavirus. To prevent similar cases from recurring in the past, the revision of the quarantine law and the improvement of the system should be done to cope with the changing environment (new infections, increased number of overseas travelers, etc.).

• Journal of Pharmaceutical Investigation
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• v.34 no.3
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• pp.223-228
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• 2004

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to the drug products which are proven to be bioequivalent to the reference listed drugs. To expand the list of bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are the hot issues in Korea. Also, the KFDA has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drug products should be submitted to the KFDA for drug approval after July in 2004. Therefore, it is increasing the necessity to develop the bioequivalence-demonstrating methods for specific drug substances and preparations which require to conduct food-effect bioavailability or bioequivalence study. There are some differences between US and Japanese guidances of food-effect bioavailability and bioequivalence studies. In this paper, we examined the recently published US guidance about food-effect study and it will be a reference to make our own guidance about food-effect bioavailability and bioequivalence guidances in Korea.

• Journal of the Korea Safety Management & Science
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• v.12 no.3
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• pp.37-52
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• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).