• The Korean Society of Law and Medicine
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• v.16 no.2
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• pp.3-26
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• 2015

Recently, Practicing of ghost surgery and duty of informed consent of doctors have become a big issue in the medical dispute and lawsuits. The ground of admitting the informed consent and the agreement(self-determination of patients) can be based on the dignity of man and the right to pursue his happiness guaranteed under Article 10 of the constitution in theory. However there are no explicit legal regulations on the duty of the informed consent and there is no substantive legal enactment on the informed consent, but there is a collision between self-determination of patients and the discretionary power of doctors. If the discretionary power on the duty of the informed consent was extended it may result in the infringement of the right of surgical patients, so called arbitrary medical treatment. Relating to this issue, New Jersey Supreme Court held that a patient has the right to determine not only whether surgery is to be performed on him, but also who shall perform it. Moreover it held that a surgeon who operates without the patient's consent engages in the unauthorized touching of another and, thus, commits a battery'. But there are no ghost surgery cases adopting battery theory in Korea, and professional negligence has been considered rather than the battery, regarding an absence of hostile intent to injure patient. Supreme Court of Korea held that a doctor who operates a medical procedure without the patient's valid prior consent based on wrong diagnosis commits professional negligence resulting in injury, and the patient's invalid consent do not preclude wrongfulness'. However, if a health care provider conducts a completely non-consensual treatment or substitute surgeon without consent, the action should be plead in battery, not negligence, but if a health care provider violate his duty of care in obtaining the consent of the patient by failing to disclosure all relevant information (risks) that a reasonable person would deem significant in making a decision to have the procedure, the action should be plead in negligence, not battery. Therefore, the scope of patients' self-determination can be protected by stating clearly the scope of the duty of the informed consent and the exemption of the informed consent legislatively, it is considered that it is valid to legislate the limitation of the discretionary power.

• Journal of Korean Neurosurgical Society
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• v.60 no.4
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• pp.385-390
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• 2017

The doctrine of informed consent, as opposed to medical paternalism, is intended to facilitate patient autonomy by allowing patient participation in the medical decision-making process. However, regrettably, the surgical informed consent (SIC) process is invariably underestimated and reduced to a documentary procedure to protect physicians from legal liability. Moreover, residents are rarely trained in the clinical and communicative skills required for the SIC process. Accordingly, to increase professional awareness of the SIC process, a brief history and introduction to the current elements of SIC, the obstacles to patient autonomy and SIC, benefits and drawbacks of SIC, planning of an optimal SIC process, and its application to cases of an unruptured intracranial aneurysm are all presented. Optimal informed consent process can provide patients with a good comprehension of their disease and treatment, augmented autonomy, a strong therapeutic alliance with their doctors, and psychological defenses for coping with stressful surgical circumstances.

• The Korean Society of Law and Medicine
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• v.13 no.1
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• pp.249-293
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• 2012

Inter-hospital transfer, depending on its medical and legal appropriateness, affect the prognosis of patients and can even lead to legal disputes. As Emergency Medical Service Act, any physician shall, in case where deemed that pertinent medical service is unavailable for such patient with the capacities of the relevant medical institution, transfer without delay such patient to another medical institution where a pertinent medical service is available. For medico-legally appropriate inter-hospital transfer, the head of a medical institution shall, in case where he transfers an emergency patient provide medical instruments and manpower required for a safe transfer of the emergency patient, and furnish the medical records necessary for a medical examination at the medical institution in receipt of such patient. And transfer process must comply with the requirements prescribed by executive rule such as attachment of the referral, provision of ambulance, fellow riders and informed consent of transfer. Those engaged in emergency medical service shall explain an emergency medical service to an emergency patient and secure his consent. In addition to the duty to inform about emergency medical service to the patient and his or her legally representative, there is also a duty for doctors to sufficiently explain to the patient and his or her legally representative during inter-hospital transfer that the need for the transfer, the medical conditions of the patient to be transferred and emergency treatment that will be provided by the hospital from which the patient is going to transferred. Likewise, the hospital to which the patient is transferred must be thoroughly informed about matters such as the patient's conditions, the treatment the patient was given and reasons for transfer by transferring doctors.

• The Korean Society of Law and Medicine
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• v.23 no.1
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• pp.37-80
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• 2022

By analyzing informed consent and the refusal of emergency medical treatment (called patient dumping) under the current Emergency Medical Service Act, this study suggests that an emergency medical professional is only liable for patient dumping if their duty to protect the patient's life takes precedence over the patient's right to self-determination. In emergency medical situations, as in general medical situations, medical treatment should be performed after the emergency medical professional informs the patient about the medical treatment, including its necessity and methods, and obtains consent from the patient. Refusing or evading the performance of emergency medical services on the excuse of the informed consent not considering a waiver or alteration of informed consent requirements without reasonable reasons violates the Emergency Medical Service Act and thus makes an emergency medical professional liable to administrative disposition or criminal penalty. In other words, depending on the existence of a waiver of alteration of the informed consent, patient dumping may be established. If the patient is a minor or has no decision-making ability, and their legal representative makes a decision against the patient's medical interests, the opinion of the legal representative is not unconditionally respected. A minor also has the right to decide over their body, and the decisions of their legal representatives should be in the patient's best interests. If the patient refuses treatment, in principle, the obligation of life protection of emergency medical professionals is the top priority. However, making these decisions in the aforementioned situations in the emergency medical field is difficult because of the absence of explicit regulations regarding these exceptional problems. This study aims to organize the following precedents of the Supreme Court of Korea. The court states that, when balancing the conflicting interests between the duty to provide emergency medical service and the duty to inform is unavoidable for emergency medical professionals, they should put the duty to protect the patient's life ahead of the duty to inform if the patient's life matters. Exceptionally, when a patient has seriously considered whether they should receive treatment before the emergency medical situation, their right to self-determination can be considered equal to the obligation of emergency medical professionals to provide emergency medical treatment. This research also suggests that an amendment of the Emergency Medical Service Act should include the following. First, the criteria for determining the decision-making ability of emergency patients should consist of medical content. Second, additional consent from a medical professional is unnecessary for first-aid treatment. Finally, new provisions for emergency medical obligations for minors, new provisions for the decision standard when there are conflicting opinions about the treatment of a patient, and new penalty provisions for professionals who suspend emergency medical examinations and treatments need to be established.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.145-173
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• 2016

A patient's Right to Self-Determination or his/her Right of Autonomy in the Republic of Korea has traditionally been understood as being composed of two elements. The first, is the patient's Right to Know as it pertains to the physician's Duty to Report [the Medical Situation] to the patient; the second, is the patient's Right to Consent and Right of Refusal as it pertains to the physician's Duty to Inform [for Patient's Consent]. The legal and ethical positions pertaining to the patient's autonomous decision, particularly those in the interest of the patient's not wanting to know about his/her own body or medical condition, were therefore acknowledged as passively expressed entities borne from the patient's forfeiture of the Right to Know and Right to Consent, and exempting the physician from the Duty to Inform. The potential risk of adverse effects rising as a result of applying the Informed Consent Dogma to situations described above were only passively recognized, seen merely as a preclusion of the Informed Consent Dogma or a denial of liability on part of the physician. In short, the legal measures that guarantee a patient's 'Wish for Ignorance' are not currently being understood and acknowledged under the active positions of the patient's 'Right Not to Know' and the physician's 'Duty to Consideration' (such as the duty not to inform). Practical and theoretical issues arise absent the recognition of these active positions of the involved parties. The question of normative evaluation of cases where a sizable amount of harm has come up on the patient as a result of the physician explaining to or informing the patient of his/her medical condition despite the patient previously waiving the Right to Consent or exempting the physician from the Duty to Inform, is one that is yet to be addressed; that of ascertaining direct evidence/legal basis that can cement legality to situations where the physician foregoes the informing process under consideration that doing so may cause harm to the patient, is another. Therefore it is the position of this paper that the Right [Not to Know] and the Duty [to Consideration] play critical roles both in meeting the legal normative requirements pertaining to the enrichment of the patient's Right to Self-Determination and the prevention of adverse effects as it pertains to the provision of [unwanted] medical information.

• KSII Transactions on Internet and Information Systems (TIIS)
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• v.15 no.12
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• pp.4400-4419
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• 2021

In the 4th Industrial Revolution, the healthcare industry is undergoing a paradigm shift from post-care and management systems based on diagnosis and treatment to disease prevention and management based on personal precision medicine. To optimize medical services for individual patients, an open ecosystem for the healthcare industry that allows the exchange and utilization of personal health records (PHRs) is required. However, under the current system of hospital-centered data management, it is difficult to implement the linking and sharing of PHRs in practice. To address this problem, in this study, we present the design and implementation of a patient-centered PHR platform using blockchain technology. This platform achieved transparency and reliability in information management by eliminating the risk of leakage and tampering/altering personal information, which could occur when using a PHR. In addition, the patient-consent system was applied to a PHR; thus, the patient acted as the user with ownership. The proposed blockchain-based PHR platform enables the integration of personal medical information with scattered distribution across multiple hospitals, and allows patients to freely use their health records in their daily lives and emergencies. The proposed platform is expected to serve as a stepping stone for patient-centered healthcare data management and utilization.

• Development and Reproduction
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• v.27 no.1
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• pp.47-56
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• 2023

Despite the commercialization of Next generation sequencing (NGS) gene testing, only a few studies have addressed the various ethical and legal problems associated with NGS testing in Korea Here, we reviewed the normative issues that emerged at each stage of the wet analysis and bioinformatics analysis of NGS gene testing. In particular, it was in mind to apply various international guidelines and the principles of bioethics to actual clinical practice. Considering the characteristics of NGS testing, wet analysis of additional testing can be justified if presumptive consent is recognized. Furthermore, the medical relationship between diseases needs to be established and it should be clear that the patient would have given consent if the patient had been aware of the correlation between genes. At the stage of bioinformatics analysis, the question of unsolicited findings arises. In case of unsolicited and relevant findings, according to American College of Medical Genetics and Genomics (ACMG), a recognized relationship between genes and diseases needs to be established. In case of unsolicited and not-relevant findings, it is almost impossible to determine whether knowing or not knowing the findings is more beneficial to the patient. However, it seems to be certain that the psychological harm an individual may suffer from such information is likely to be greater if the disease is severe and if there is no cure. The list of genes for which the ACMG guidelines impose reporting obligations is a good reference for judgment.

• The Korean Society of Law and Medicine
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• v.10 no.2
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• pp.11-36
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• 2009

This thesis introduces the trends of korean courts' ruling on damages in medical malpractice cases for past 10 years. First of all, Korean courts' ruling have had a tendency to pay only non-economic damages for not taking the informed consent. If a doctor cannot get the informed consent from a patient, he compensate only non-economic damages for the infringement of self-determination rights of patient. It's enough for the plaintiff to prove the infringement of self-determination rights, if the plaintiff just want to get non-economic damages. The Korean Supreme court have ruled that if plaintiffs want to get economic damages for the infringement of self-determination rights or informed consent, plaintiffs must prove that the infringement of self-determination rights is the proximate cause of the economic damages of patient. There is another tendency for the Korean Supreme court to limit the damages in medical malpractice cases on the ground of patient's diseases' dangerousness or patient's idiosyncrasy. In the past courts often limit the damages only to 70~80% of total damages, but now a days courts mostly limit the damages to 20~30%. This thesis also introduce the Korean courts' trends about Valuing damages in personal injury actions awarded for gratuitously rendered nursing and medical care.

• Journal of Korean Clinical Nursing Research
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• v.14 no.2
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• pp.59-70
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• 2008

Purpose: Purposes of this study were to promote understanding on mutually informed consent by comparing and analyzing the perception and experience of informed consent among physicians, nurses, and patients. Method: Participants in the study were 145 physicians, 300 nurses, and 178 patients from eight hospitals in Busan. To examine their understanding and experience with informed consent, all participants responded to a questionnaire. The collected data were analyzed using SPSS/PC 12.0 program. Results: On the necessity of informed consent, the affirmative percentages were 95.9% for physicians, 99.0% for nurses and 84.8% for patients. As to the most important reason for informed consent 47.6% of the physicians and 64.3% of the nurses answered 'because it is an occupational and ethical duty', while 46.6% of the patients answered 'because it is protection for physicians'. Regarding the legal decision maker for informed consent, 33.1% of the physicians, 27% of the nurses, and 42.1% of the patients answered that the legal decision-making right belonged to the 'patient'. The agreement rate on the necessity of providing a comprehensive explanation about informed consent was 89.0% for physicians, 98.3% for nurses, and 96.1% for patients. Conclusion: Most physicians, nurses, and even patients have inaccurate perceptions and inappropriate experience with informed consent.

• 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.