• The Korean Society of Law and Medicine
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• v.20 no.1
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• pp.109-132
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• 2019

Recently, medical accidents related to surgical procedures have increased. In addition, the media reported that some of these accidents were involved in health crimes. Patient-advocate groups have called for mandatory establishment and management of CCTV in operating rooms. There is a lot of discussion among the interested parties, so it is necessary to review the relevant laws and regulations. The purpose of this study is to identify the characteristics of CCTV in operating rooms and to review legislations related to establishment and management of the CCTV in operating rooms. Medical institutions use CCTV for management of facilities and patient safety and install it in operating rooms optionally. The Constitution guarantees the privacy and the privacy of correspondence of every citizen, but it can be limited by the law for public welfare. Currently, however, there is no existing law about establishment and management of the CCTV in operating rooms and it can be defect of legal system. Under the current legislations, it is likely that the Self-determination can be violated due to the characteristic of healthcare provider when CCTV is mandatorily installed in operating room. In addition, the regulations on access and leakage of confidential information known by operator are insufficient. So that, the safety of the visual data might be threatened. Furthermore, unless the period and the place of storage of the visual data are clearly defined, it is highly unlikely to meet the original purpose of patient safety and prevention of medical accidents. This study is meaningful as there is few previous study on this topic although the need for legal review about this is growing and several bills are being proposed. It is expected that the results of this study can be utilized as basic data for enactment or amendment of the laws and regulations about establishment and management of CCTV in operating rooms.

• The Korean Society of Law and Medicine
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• v.24 no.2
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• pp.147-196
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• 2023

Advances in brain science have made it possible to stimulate the brain to treat brain disorder or to connect directly between the neuron activity and an external devices. Non-invasive neurotechnologies already exist, but invasive neurotechnologies can provide more precise stimulation or measure brainwaves more precisely. Nowadays deep brain stimulation (DBS) is recognized as an accepted treatment for Parkinson's disease and essential tremor. In addition DBS has shown a certain positive effect in patients with Alzheimer's disease and depression. Brain-computer interfaces (BCI) are in the clinical stage but help patients in vegetative state can communicate or support rehabilitation for nerve-damaged people. The issue is that the people who need these invasive neurotechnologies are those whose capacity to consent is impaired or who are unable to communicate due to disease or nerve damage, while DBS and BCI operations are highly invasive and require informed consent of patients. Especially in areas where neurotechnology is still in clinical trials, the risks are greater and the benefits are uncertain, so more explanation should be provided to let patients make an informed decision. If the patient is under guardianship, the guardian is able to substitute for the patient's consent, if necessary with the authorization of court. If the patient is not under guardianship and the patient's capacity to consent is impaired or he is unable to express the consent, korean healthcare institution tend to rely on the patient's near relative guardian(de facto guardian) to give consent. But the concept of a de facto guardian is not provided by our civil law system. In the long run, it would be more appropriate to provide that a patient's spouse or next of kin may be authorized to give consent for the patient, if he or she is neither under guardianship nor appointed enduring power of attorney. If the patient was not properly informed of the risks involved in the neurosurgery, he or she may be entitled to compensation of intangible damages. If there is a causal relation between the malpractice and the side effects, the patient may also be able to recover damages for those side effects. In addition, both BCI and DBS involve the implantation of electrodes or microchips in the brain, which are controlled by an external devices. Since implantable medical devices are subject to product liability laws, the patient may be able to sue the manufacturer for damages if the defect caused the adverse effects. Recently, Korea's medical device regulation mandated liability insurance system for implantable medical devices to strengthen consumer protection.

• The Korean Society of Law and Medicine
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• v.18 no.1
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• pp.237-264
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• 2017

With the onset of the Human Genome Project, social concerns about 'genetic information discrimination' have been raised, but the problem has not yet been highlighted in Korea. However, non-medical institutions' genetic testing which is related to disease prevention could be partially allowed under the revised "Bioethics and Safety Act" from June 30, 2016. In the case of one domestic insurance company, DTC genetic testing was provided for the new customer of cancer insurance as a complimentary service, which made the social changes related to the recognition of the genetic testing. At a time when precision medicine is becoming a new standard for medical care, discipline on genetic information discrimination has become a problem that can not be delayed anymore. Article 46 and 67 of the Bioethics Act stipulate the prohibition of discrimination on grounds of genetic information and penalties for its violation. However, these broad principles alone can not solve the problems in specific genetic information utilization areas such as insurance and employment. The United States, Canada, the United Kingdom, and Germany have different regulations that prohibit genetic information based discrimination. In the United States, Genetic Information Non-Discrimination Act takes a form that adds to the existing law about the prohibition of genetic information discrimination. In addition, the range of genetic information includes the results of genetic tests of individuals and their families, including "family history". Canada has recently enacted legislation in 2017, expanding coverage to general transactions of goods or services in addition to insurance and employment. The United Kingdom deals only with 'predictive genetic testing results of individuals'. In the case of insurance, the UK government and Association of British Insurers (ABI) agree to abide by a policy framework ('Concordat') for cooperation that provides that insurers' use of genetic information is transparent, fair and subject to regular reviews; and remain committed to the voluntary Moratorium on insurers' use of predictive genetic test results until 1 November 2019, and a review of the Concordat in 2016. In the case of employment, The ICO's 'Employment Practices Code (2011)' is used as a guideline. In Germany, Human Genetic Examination Act(Gesetz ${\ddot{u}}ber$ genetische Untersuchungen bei Menschen) stipulates a principle ban on the demand for genetic testing and the submission of results in employment and insurance. The evaluation of the effectiveness of regulatory framework, as well as the form and scope of the discipline is different from country to country. In light of this, it would be desirable for the issue of genetic information discrimination in Korea to be addressed based on the review of related regulations, the participation of experts, and the cooperation of stakeholders.

• Journal of Information Management
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• v.36 no.1
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• pp.125-154
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• 2005

Due to the development of Internet and the collection and usage of the individual information, the infringements of the personal data have been increased rapidly. Regarding the personal data protection in the medical industry, it is clearly described in 'Act on Promotion of Information and Communication Network Utilization and information Protection, etc.'. the law is ratified on the basis of the service provider, therefore, it has its own limitation to be applied to medical industry. Therefore, this paper is to set the security standard and to discuss the range of legal application and considerations on its basis for the domestic medical institution at the electronic medical record system. We exemplify specific applicable content of the electronic signature in the electronic medical record also, present a security assessment item in electronic medical system and set the criteria for the security standard in the medical industry.

• Journal of The Korea Institute of Healthcare Architecture
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• v.23 no.1
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• pp.37-46
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• 2017

Purpose: There is little information about China's medical service system and health care facilities in Korean medical architecture papers, which is inconvenient for scholars engaged in medical building research and comparison. Futhermore, the transformation of the notion of health and the ascension of the service needs show the lack of medical function, and then make functions of hospital construction are always in the state of dynamic renewal. Therefore, the purpose of this study is to analyze the Chinese medical service system and general hospital related laws and regulations for future research to provide effective analysis of data, and find shortcomings. Methods: This study was conducted by a research on law and regulation of China's medical service system and general Hospital. Results: At present hospital construction in China is in the period of rapid development and it exposes the layout of medical health facilities is not reasonable and the service does not reach the designated position and so on. Overall, it requires more detailed guidelines to enhance the quality of medical health services. Implications: It is expected that the research of this paper will provide effective reference for future research on Chinese medical architecture system and medical facilities, and can promote and perfect the construction of Chinese medical architecture theory system.

• Journal of Society of Preventive Korean Medicine
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• v.22 no.3
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• pp.45-60
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• 2018

Background : There have been a variety of healthcare systems related to CAM practitioners developed in each country. However, the European cases have not been widely introduced in Korea so far. In the case of Germany, CAM practices have been developed in the frame of "Heilpraktiker" system. Objectives : The objectives of this study were to review the historical development and current situation of German Heilpraktiker system and its conflicting relationship with Western medical doctors, in order to utilize it as basic data for the conflict resolution between Western- and KM doctors in Korea. Methods : The historical development, current regulations and education system of Heilpraktiker were assessed. Research articles, reports, government publications and websites dealing with this issue were searched for and analyzed. Results : Heilpraktiker system was developed within German historical and cultural situation where naturopathic traditions were reilluminated in connection with modernization process of the state under the influence of romanticism formulating German nationalism. Between the concept of "Kurierverbot"(prohibition on medical treatment by non-physicians) and "Kurierfreiheit"(freedom of medical treatment), Heilpraktiker achieved a limited but legitimated right to conduct non-biomedical treatments from the state in the process of the formulation of modern German medical system. In this process, the conflicts between medical doctors and heilpraktikers have been also growing up to now. Conclusions : Heilpraktiker system, officially recognized with the legislation of Heilpraktiker law in 1939, stands at a crossroads between the continual development through strengthening its professionality, and abolition of the system due to its lack of quality control and medical evidence mostly argued by Western medical doctors, which has considerable implications for Korean situations in terms of the conflicting relationship between KM- and Western medical doctors. In this regard, it is necessary to discuss the debates on the concept "Kurierfreiheit"(freedom of medical treatment) developed within German tradition of medical pluralism.

• The Korean Society of Law and Medicine
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• v.10 no.2
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• pp.309-341
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• 2009

According to a case of Supreme Court's Sentence No. 2009DA17417 (May 21, 2009), the Supreme Court judges that 'the right to life is the ultimate one of basic human rights stipulated in the Constitution, so it is required to very limitedly and conservatively determine whether to discontinue any medical practice on which patient's life depends directly.' In addition, the Supreme Court admits that 'only if a patient who comes to a fatal phase before death due to attack of any irreversible disease may execute his or her right of self-determination based on human respect and values and human right to pursue happiness, it is permissible to discontinue life-sustaining treatment for him or her, unless there is any special circumstance.' Furthermore, the Supreme Court finds that 'if a patient who is attacked by any irreversible disease informs medical personnel of his or her intention to agree on the refusal or discontinuance of life-sustaining treatment in advance of his or her potential irreversible loss of consciousness, it is justifiable that he or she already executes the right of self-determination according to prior medical instructions, unless there is any special circumstance where it is reasonably concluded that his or her physician is changed after prior medical instructions for him or her.' The Supreme Court also finds that 'if a patient remains at irreversible loss of consciousness without any prior medical instruction, he or she cannot express his or her intentions at all, so it is rational and complying with social norms to admit possibility of estimating his or her own intentions on withdrawal of life-sustaining treatment, provided that such a withdrawal of life-sustaining treatment meets his or her interests in view of his or her usual sense of values or beliefs and it is reasonably concluded that he or she could likely choose to discontinue life-sustaining treatment, even if he or she were given any chance to execute his or her right of self-determination.' This judgment is very significant in a sense that it suggests the reasonable orientation of solutions for issues posed concerning withdrawal of meaningless life-sustaining medical efforts. The issues concerning removal of medical instruments for meaningless life-sustaining treatment and discontinuance of such treatment in regard to medical treatment for terminal cases don't seem to be so much big deal when a patient has clear consciousness enough to express his or her intentions, but it counts that there is any issue regarding a patient who comes to irreversible loss of consciousness and cannot express his or her intentions. Therefore, it is required to develop an institutional instrument that allows relevant authority to estimate the scope of physician's medical duties for terminal patients as well as a patient's intentions to withdraw any meaningless treatment during his or her terminal phase involving loss of consciousness. However, Korean judicial authority has yet to clarify detailed cases where it is permissible to discontinue any life-sustaining treatment for a patient in accordance with his or her right of self-determination. In this context, it is inevitable and challenging to make better legislation to improve relevant systems concerning withdrawal of life-sustaining treatment. The State must assure the human basic rights for its citizens and needs to prepare a system to assure such basic rights through legislative efforts. In this sense, simply entrusting physician, patient or his or her family with any critical issue like the withdrawal of meaningless life-sustaining treatment, even without any reasonable standard established for such entrustment, means the neglect of official duties by the State. Nevertheless, this issue is not a matter that can be resolved simply by legislative efforts. In order for our society to accept judicial system for withdrawal of life-sustaining treatment, it is important to form a social consensus about this issue and also make proactive discussions on it from a variety of standpoints.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.177-219
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• 2016

A commercial advertisement is not only a way of competition but also a medium of communication. Thus, it is under the constitutional protection of the freedom of business (article 15 of the Constitution) as well as the freedom of press [article 21 (1) of the Constitution]. In terms of the freedom of business or competition, it should be noted that an unfair advertising (false or misleading advertisement) can be regulated as an unfair competition, while any restraint on advertising other than unfair one might be doubted as an unjustifiable restraint of trade. In terms of the freedom of press or communication, it is important that article 21 (2) of the Constitution forbids any kind of (prior) censorship, and the Constitutional Court applies this restriction even to commercial advertising. In this article, the applicability of these schemes to advertising of the so-called learned professions, especially physician, are to be examined, and some proposals for the reformation of the current regulatory regime are to be made. Main arguments of this article can be summarized as follows: First, the current regime which requires advance review of physician advertising as prescribed in article 56 (2) no. 9 of Medical Act should be reformed. It does not mean that the current interpretation of article 21 of the Constitution is agreeable. Though a commercial advertising is a way of communication and can be protected by article 21 (1) of the Constitution, it should not be under the prohibition of censorship prescribed by article 21 (2) of the Constitution. The Constitutional Court adopts the opposite view, however. It is doubtful that physician advertising needs some prior restraint, also. Of course, there exists severe informational asymmetry between physicians and patients and medical treatment might harm the life and health of patients irrevocably, so that medical treatment can be discerned from other services. It is civil and criminal liability for medical malpractice and duty to inform and not regulation on physician advertising, to address these differences or problems. Advance review should be abandoned and repelled, or substituted by more unproblematic way of regulation such as an accreditation of reviewed advertising or a self-regulation preformed by physician association independently from the Ministry of Health and Welfare or any other governmental agencies. Second, the substantive criteria for unfair physician advertising also should correspond that of unfair advertising in general. Some might argue that a learned profession, especially medical practice, is totally different from other businesses. It is performed under the professional ethics and should not persue commercial interest; medical practice in Korea is governed by the National Health Insurance system, the stability of which might be endangered when commercial competition in medical practice be allowed. Medical Act as well as the condition of medical practice market do not exclude competition between physicians. The fact is quite the opposite. Physicians are competing even though under the professional ethics and obligations and all the restrictions provided by the National Health Insurance system. In this situation, regulation on physician advertising might constitute unjustifiable restraint of competition, especially a kind of entry barrier for 'new physicians.'

• Journal of dental hygiene science
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• v.18 no.6
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• pp.357-366
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• 2018

The purpose of this study was to evaluate the validity of dental hygienist job according to judgment standard of medical practice in medical law. In this study, we conducted a self-administered questionnaire survey to evaluate the validity of dental hygienist job for 12 professors of dental college in Gangneung-Wonju National University from November 10 to 20, 2017. We investigated whether the dental hygienist job conforms to the three criteria of medical practice such as disease prevention and treatment, patient care, and health hazard. The response rates were scored and classified into four categories according to the final score. As a result of this study, dental hygienist job are classified into four categories according to judgment standard of medical practice. The higher the level of the category, the higher the degree of difficulty, and the higher the level of expertise and skills required. More than 50% of respondents answered that measuring the gingival pocket, bleeding on probing, professional tooth cleaning, oral health education, counseling after dental treatment are all three criteria for medical treatment. And these were classified into Level 4 group which requires the difficulty and expertise in the final score 4.3. It is necessary to develop and utilize standardized guidelines on the level of knowledge, education, and qualification standards required for dental practice in order to effectively allocate work among the dental personnel while ensuring the health rights of patients in the dental clinic field in Korea. In addition, there is a need to evaluate the various aspects of cost effectiveness, dental health service productivity, and health promotion contribution to dental hygienist jobs, And based on this evidence, it is necessary to continue to expand and adjust the dental hygienist job and to reorganize the dental workforce system.

• The Korean Society of Law and Medicine
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• v.24 no.2
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• pp.35-77
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• 2023

As the amendment to the Personal Information Protection Act, which newly established the basis for the right to request transmission of personal information, was promulgated through the plenary session of the National Assembly, MyData, which was previously applied only to the financial sector, could spread to all fields. The right to request transmission of personal information is the right of the information subject to be guaranteed for the realization of MyData. However, since the right to request transmission of personal information stipulated in the Personal Information Protection Act is designed to be applied to all fields, not a special field such as the medical field, it has many shortcomings to act as a core basis for implementing MyData in Medicine. Based on this awareness of the problem, this paper compares and analyzes major legal trends related to the right to portability of personal health information at home and abroad, and examines the limitations of Korea's Personal Information Protection Act and Medical Act in realizing Medical MyData. Under the Personal Information Protection Act, the right to request transmission of personal information is insufficient to apply to the medical field, such as the scope of information to be transmitted, the transmission method, and the scope of the person obligated to perform the transmission, etc.. Regulations on the right to access medical information and transmission of medical records under the Medical Act also have limitations in implementing the full function of Medical My Data in that the target information and the leading institution are very limited. In order to overcome these limitations, this paper prepared a separate and independent special law to regulate matters related to the use and protection of personal health information as a measure to improve the legal system that can effectively guarantee the right to portability of personal health information, taking into account the specificity of the medical field. It was proposed to specifically regulate the contents of the movement and transmission system of personal health information.