检查人工智能软件作为医疗器械的标签指南:对澳大利亚皮肤科移动应用程序的审查和分析。
Examining labelling guidelines for AI-based software as a medical device: A review and analysis of dermatology mobile applications in Australia.
机构信息
School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Victorian Melanoma Service, Alfred Health, Melbourne, Victoria, Australia.
出版信息
Australas J Dermatol. 2024 Aug;65(5):409-422. doi: 10.1111/ajd.14269. Epub 2024 May 1.
In recent years, there has been a surge in the development of AI-based Software as a Medical Device (SaMD), particularly in visual specialties such as dermatology. In Australia, the Therapeutic Goods Administration (TGA) regulates AI-based SaMD to ensure its safe use. Proper labelling of these devices is crucial to ensure that healthcare professionals and the general public understand how to use them and interpret results accurately. However, guidelines for labelling AI-based SaMD in dermatology are lacking, which may result in products failing to provide essential information about algorithm development and performance metrics. This review examines existing labelling guidelines for AI-based SaMD across visual medical specialties, with a specific focus on dermatology. Common recommendations for labelling are identified and applied to currently available dermatology AI-based SaMD mobile applications to determine usage of these labels. Of the 21 AI-based SaMD mobile applications identified, none fully comply with common labelling recommendations. Results highlight the need for standardized labelling guidelines. Ensuring transparency and accessibility of information is essential for the safe integration of AI into health care and preventing potential risks associated with inaccurate clinical decisions.
近年来,基于人工智能的软件作为医疗器械(SaMD)发展迅速,特别是在皮肤科等视觉专业领域。在澳大利亚,治疗用品管理局(TGA)对基于人工智能的 SaMD 进行监管,以确保其安全使用。这些设备的正确标签对于确保医疗保健专业人员和公众了解如何使用它们并准确解释结果至关重要。然而,在皮肤病学中,针对人工智能 SaMD 的标签指南缺乏,这可能导致产品无法提供有关算法开发和性能指标的重要信息。本综述考察了视觉医学专业领域现有的人工智能 SaMD 标签指南,特别关注皮肤病学。确定了常见的标签建议,并将其应用于现有的皮肤病学人工智能 SaMD 移动应用程序,以确定这些标签的使用情况。在所确定的 21 个基于人工智能的 SaMD 移动应用程序中,没有一个完全符合常见的标签建议。结果强调了标准化标签指南的必要性。确保信息的透明度和可及性对于安全地将人工智能融入医疗保健以及防止与不准确的临床决策相关的潜在风险至关重要。