美國人工智慧軟體醫材立法趨勢簡介【醫事綜探】 試閱
Brief Introduction to AI/ML SaMD Regulatory in US
本文簡介美國近年對人工智慧軟體醫材之立法趨勢，針對自適應性人工智能之實時數據建模及變更，以產品全週期方法論為基礎，配合軟體預認證計畫，建立品質系統及優良機器學習範例標準，並列舉各界提出之相關衍生爭議。
This article briefly introduced the regulatory to Artificial Intelligence (AI)/Machine Learning (ML) Software as Medical Device in United States recent years, which is focused on model training and tuning, modification from data for re-training and real-time performance monitoring of adaptive AI/ML, and is based on Total Product Lifecycle Approach and the Digital Health Software Precertification Program, in order to establish Culture of Quality and Organization Excellence Systems and Good Machine Learning Practices. It also lists out the public feedback to this legal framework and discusses on the related issues.
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