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KMID : 1142820230070020028
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Bio, Ethics and Policy
2023 Volume.7 No. 2 p.28 ~ p.54
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Normative Categories of Medical Artificial Intelligence and Legal Issues with User Restriction
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Bae Hyun-A
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Abstract
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Defining medical artificial intelligence (AI) within the framework of healthcare laws and regulations requires due consideration of the legal concept of healthcare. Since healthcare as a concept varies across the legal system, the concept of medical AI may also vary. Thus, it is necessary to determine the actual users of medical AI in various contexts, depending on the services provided and their content. Medical AI can be differently categorized depending on its scope of application, including (non-medical) healthcare services, software as a medical device (SaMD), and medical practices, such as diagnostic procedures involving such SaMD. Further, certain applications of medical AI should be limited to medical personnel or physicians, considering the risks associated with medical devices, and the proficiency of users. Medical AI has been developed to assist medical per- sonnel in medical practice. Recent health policies considering the unique characteristics of medical AI have deregulating its approval processes and lowered barriers to entry for service providers?differentiating medical AI from other medical devices. In conclusion, considering the variegated conceptual nature of medical practice within the medico-legal system, the criteria for judging medical practice beyond those licensed by medical person- nel, and the technological innovations in automated medical devices’ safety and efficacy, it may be practically challenging to restrict the use of medical AI to traditionally licensed medical personnel. Instead, it may be necessary to diversify the legally approved users of medical AI.
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KEYWORD
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medical artificial intelligence, non-medical healthcare services, medical devices, stake- holders
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