SaMD에 대한 휴리스틱 기반 사용적합성 평가 가이드라인 개발
Development of Guideline for Heuristic Based Usability Evaluation on SaMD
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In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.
Abstract
In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.
참고문헌 (37)
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