• Journal of radiological science and technology
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• v.44 no.5
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• pp.525-534
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• 2021

In order to provide high-quality medical services to the public and contribute to the improvement of public health, it is necessary to enact an independent law according to the work of radiological technologists. Therefore, this study intends to review the regulations related to radiographers in the Medical Service Technologists, etc. Act. and to present opinions and directions for enactment of individual laws for radiological technologists. An online survey was conducted to 15,000 radiological technologists working in medical institutions and education sites in Korea; 1,027 people (6.85%) responded. The questionnaire consisted of 3 questions on demographic characteristics, 5 questions on the scope of work, and 12 questions on the revision of the Medical Service Technologists, etc. Act. and the establishment of the Radiological Technologist Independent Act. Reliability and factor analysis were performed on 9 questions measured on a Likert 5-point scale in "Revision of the Medical Service Technologists, etc. Act. and the establishment of the Radiological echnologist Independent Act" among the questionnaire items. Reliability for the total 9 questions was Chronbach α=0.728. There was a high perception that the regulations related to radiological technologists were insufficient in the current Medical Service Technologists, etc. Act., and the perception that examinations performed by radiological technologists at medical institutions were included in medical practice was high. If the Radiological Technologist Independent Act is enforced, a high percentage of respondents said that they could receive legal protection through the institutionalization of the scope of work, that the status of radiological technologists would be improved, and the scope of work would be expanded. The response that the scope of work of radiological technologists should be included was the highest at 96.6%. In the analysis according to demographic characteristics, it was found that 96.7% of the respondents were agreed regardless of the factors. Radiological technologists will have to work hard to secure the public health by coping with new radiology devices, procedures and treatment methods. Therefore, as the results of this study, it is expected that the enactment and implementation of the Radiological Technologist Independent Act will contribute to the improvement of the quality of treatment for patients and to the public health.

• The Journal of Bigdata
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• v.8 no.1
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• pp.111-129
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• 2023

With the diffusion of digital innovation, the adoption of innovative medical technologies based on artificial intelligence is increasing in the medical field. This is driving the launch and adoption of AI-based SaMD(Software as a Medical Device), but there is a lack of research on the factors that influence the adoption of SaMD by medical institutions. The purpose of this study is to identify key factors that influence medical institutions' decisions to adopt AI-based SaMDs, and to analyze the weights and priorities of these factors. For this purpose, we conducted Delphi surveys based on the results of literature studies on technology acceptance models in healthcare industry, medical AI and SaMD, and developed a research model by combining HOTE(Human, Organization, Technology and Environment) framework and HABIO(Holistic Approach {Business, Information, Organizational}) framework. Based on the research model with 5 main criteria and 22 sub-criteria, we conducted an AHP(Analytical Hierarchy Process) analysis among the experts from domestic medical institutions and SaMD providers to empirically analyze SaMD adoption factors. The results of this study showed that the priority of the main criteria for determining the adoption of AI-based SaMD was in the order of technical factors, economic factors, human factors, organizational factors, and environmental factors. The priority of sub-criteria was in the order of reliability, cost reduction, medical staff's acceptance, safety, top management's support, security, and licensing & regulatory levels. Specifically, technical factors such as reliability, safety, and security were found to be the most important factors for SaMD adoption. In addition, the comparisons and analyses of the weights and priorities of each group showed that the weights and priorities of SaMD adoption factors varied by type of institution, type of medical institution, and type of job in the medical institution.

• 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.