淺論人工智慧時代醫療器材軟體的風險與管理思維

Risks and Regulatory Approach of Software as Medical Device in the Era of Artificial Intelligence

將AI與醫療結合的醫療AI為一種新醫療趨勢，以AI與機器學習為基礎發展的醫療器材軟體雖然可能提升醫療的品質，但也可能因為其具有持續學習與更新的特質，而引發風險。傳統用於確保醫療器材的安全性與有效性的管理架構，顯然不足以因應這個新科技產品的應用所衍生的議題。為此，本文試圖分析我國的相關法規與美國FDA的研擬的產品全週期管理架構，以探討人工智慧時代醫療器材軟體的風險與管理思維。
To apply artificial intelligence in healthcare is a global trend. Software as medical device which is developed based on AI and machine learning may have potential to improve the quality of healthcare yet generate risks to patients. The regulatory framework to ensure the safety and effectiveness of traditional medical device may be insufficient to address the issues generated by this new products. This paper tends to consider the nature an appropriate regulatory approach that can balance the benefit and risk of software as medical device in the era of AI by addressing the relevant regulations of Taiwan as well as the total product lifecycle regulatory framework proposed by the FDA.