• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.173-206
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• 2019

This research examines the characteristic of regulation on Japanese clinical research in recent years. First, Japan has had a severe punishment policy on research misconduct like Korea, but, in recent days, Japan has changed the direction of research ethics policy from restriction to research publicness securement by educational training, in addition, Act of Clinical Research, effected April 2018, has recruited excellent researchers, and then integrated clinical research and medicine clinical trial through raising transparency of funding and integrating ethics screening by mandating announcement on funding information of clinical research. Second, Japan has integrated and organized ethics guideline from dual system that consists of ethics guideline on dynamic research(here after, referred to as 「dynamic guideline」) and ethics guideline on clinical research(here after, referred to as 「clinical guideline」) to ethics guideline on medical research aimed at human(here after, referred to as 「integrated guideline」), thus, it complements repetition and deficit of ethics guideline needed in clinical research and dynamic research, and it has risk evaluation system for protecting human subjects, and also it clarifies the concept of 「invasiveness」, a preliminary consideration of evaluation. 「Evaluation issue of risk and profit」, common contents of international regulation related clinical research, is the method to check whether the research is designed appropriately or not, this is the method for Institutional Review Board to decide whether the risk on human subjects could be justified, and also this is the important standard for future human subjects to participate in clinical trial. Therefore, it is meaningful to define 「invasiveness」 concept, a preliminary consideration of risk evaluation for human subjects. This research examines Japanese clinical trial focusing on change of awareness on prevention of research misconduct, efficiency improvement of research through research screening and integration of human subjects, and clarification and extension of range of 「invasiveness」 concept, a preliminary of risk evaluation to protect human subjects.

• The Korean Society of Law and Medicine
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• v.19 no.2
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• pp.235-261
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• 2018

The Medical law stipulates regulations about the physician's duty to inform to contribute to patient's self-determination. This law was most recently revised on December 20, 2016, and came into effect on June 21, 2017. There has been much controversy about this, and it has been questioned whether or not it will be effective for physicians to comply with the duty to inform. Therefore, this study investigated perceptions of physicians of whether they observed the duty to inform and their legal judgment about that duty, and analyzed how the revision of the medical law may have affected the legal cognition of physician's duty to inform. This study was conducted through an online questionnaire survey involving 109 physicians over 2 weeks from March 29 to April 12, 2018, and 108 of the collected data were used for analysis. The questionnaire was developed by revising and supplementing the previous research (Lee, 2004). It consisted of 41 items, including 26 items related to the experience of and legal judgment about the duty to inform, 6 items related to awareness of revised medical law, and 9 items on general characteristics. The data were analyzed using SAS 9.4 program and descriptive statistics, Chi-square test, Fisher's exact test and Binary logistic regression were performed. The results are as follows. • Out of eight situations, the median number of situations that did not fulfill the duty to inform was 5 (IQR, 4-6). In addition, 12 respondents (11%) answered that they did not fulfill the duty to inform in all eight cases, while only one (1%) responded that he/she performed explanation obligations in all cases. • The median number of the legal judgment score on the duty to inform was 8 out of 13 (IQR, 7-9), and the scores ranged from a minimum of 4 (4 respondents) to a maximum of 11 (3 respondents). • More than half of the respondents (n=26, 52%) were unaware of the revision of the medical law, 27 (25%) were aware of the fact that the medical law had been revised, 20(18%) had a rough knowledge of the contents of the law, and only 5(5%) said they knew the contents of the law in detail. The level of awareness of the revised medical law was statistically significant difference according to respondents' sex (p<.49), age (p<.0001), career (p<.0001), working type (p<.024), and department (p<.049). • There was no statistically significant relationship between the level of awareness of the revised medical law and the level of legal judgment on the duty to inform. These results suggest that efforts to improve the implementation and cognition of physician's duty to inform are needed, and it is difficult to expect a direct positive effect from the legal regulations per se. Considering the distinct characteristics of medical institutions and hierarchical organizational culture of physicians, it is necessary to develop a credible guideline on the duty to inform within the medical system, and to strengthen the education of physicians about their duty to inform and its purpose.

• The Korean Society of Law and Medicine
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• v.24 no.4
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• pp.67-101
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• 2023

The utilization of generative AI in the medical field is also being rapidly researched. Access to vast data sets reduces the time and energy spent in selecting information. However, as the effort put into content creation decreases, there is a greater likelihood of associated issues arising. For example, with generative AI, users must discern the accuracy of results themselves, as these AIs learn from data within a set period and generate outcomes. While the answers may appear plausible, their sources are often unclear, making it challenging to determine their veracity. Additionally, the possibility of presenting results from a biased or distorted perspective cannot be discounted at present on ethical grounds. Despite these concerns, the field of generative AI is continually advancing, with an increasing number of users leveraging it in various sectors, including biomedical and life sciences. This raises important legal considerations regarding who bears responsibility and to what extent for any damages caused by these high-performance AI algorithms. A general overview of issues with generative AI includes those discussed above, but another perspective arises from its fundamental nature as a large-scale language model ('LLM') AI. There is a civil law concern regarding "the memorization of training data within artificial neural networks and its subsequent reproduction". Medical data, by nature, often reflects personal characteristics of patients, potentially leading to issues such as the regeneration of personal information. The extensive application of generative AI in scenarios beyond traditional AI brings forth the possibility of legal challenges that cannot be ignored. Upon examining the technical characteristics of generative AI and focusing on legal issues, especially concerning the protection of personal information, it's evident that current laws regarding personal information protection, particularly in the context of health and medical data utilization, are inadequate. These laws provide processes for anonymizing and de-identification, specific personal information but fall short when generative AI is applied as software in medical devices. To address the functionalities of generative AI in clinical software, a reevaluation and adjustment of existing laws for the protection of personal information are imperative.

• The Korean Journal of Air & Space Law and Policy
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• v.30 no.2
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• pp.403-425
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• 2015

The Chicago Convention and Annexes have become the basis of aviation safety regulations for every contracting state. Generally, the State's aviation safety regulations refer to the Standards and Recommended Practices(SARPs) provided in the Annexes of the Chicago Convention. In order to properly reflect international aviation safety regulations, constant studies of the aviation fields are of paramount importance. This Paper is intended to identify the main differences between korean and foreign regulation and suggest a few amendment proposals on Mixed-fleet Flying(at or more two aircraft type operation) of flight crew. Comparing with these regulations, the korean regulations and implementations have some insufficiency points. I suggest some amendment proposals of korean regulations concerning Mixed-fleet Flying that flight crew operate aircraft of different types. Basically an operator shall not assign a pilot-in-command or a co-pilot to operate at the flight controls of a type of airplane during take-off and landing unless that pilot has operated the flight controls during at least three take-offs and landings within the preceding 90 days on the same type of airplane or in a flight simulator. Also, flight crew members are familiarized with the significant differences in equipment and/or procedures between concurrently operated types. An operator shall ensure that piloting technique and the ability to execute emergency procedures is checked in such a way as to demonstrate the pilot's competence on each type or variant of a type of airplane. Proficiency check shall be performed periodically. When an operator schedules flight crew on different types of airplanes with similar characteristics in terms of operating procedures, systems and handling, the State shall decide the requirements for each type of airplane can be combined. In conclusion, it is necessary for flight crew members to remain concurrently qualified to operate multiple types. The operator shall have a program to include, as a minimum, required differences training between types and qualification to maintain currency on each type. If the Operator utilizes flight crew members to concurrently operate aircraft of different types, the operator shall have qualification processes approved or accepted by the State. If applicable, the qualification curriculum as defined in the operator's Advanced Qualification Program could be applied. Flight crew members are familiarized with the significant differences in equipment and/or procedures between concurrently operated types. The difference among different types of airpcrafts decrease and standards for these airpcrafts can be applied increasingly because function and performance have been improved by aircraft manufacture company in accordance to basic aircraft system in terms of developing new aircrafts for flight standard procedure and safety of flight. Also, it becomes more necessary for flight crews to control multi aircraft types due to various aviation business and activation of leisure business. Nevertheless, in terms of flight crew training and qualification program, there are no regulations in Korea to be applied to new aircraft types differently in accordance with different levels. In addition, it has no choice different programs based on different levels because there are not provisions to restrict or limit and specific standards to operate at or more than two aircraft types for flight safety. Therefore the aviation authority introduce Flight Standardization and/or Operational Evaluation Board in order to analysis differences among aircraft types. In addition to that, the aviation authority should also improve standard flight evaluation and qualification system among different aircraft types for flight crews to apply reasonable training and qualification efficiently. For all the issue mentioned above, I have studied the ICAO SARPs and some state's regulation concerning operating aircraft of different types(Mixed-fleet flying), and suggested some proposals on the different aircraft type operation as an example of comprehensive problem solving. I hope that this paper is 1) to help understanding about the international issue, 2) to help the improvement of korean aviation regulations, 3) to help compliance with international standards and to contribute to the promotion of aviation safety, in addition.