Artificial intelligence related safety issues associated with FDA medical device reports

作者：Jessica L. Handley, Seth A. Krevat, Allan Fong, Raj M. Ratwani · 发表于：npj Digital Medicine · 年份：2024 · DOI：10.1038/s41746-024-01357-5 · 被引用次数：16 · 研究领域：Artificial Intelligence in Healthcare and Education、Ethics in Clinical Research、Biomedical Ethics and Regulation

The Biden 2023 Artificial Intelligence (AI) Executive Order calls for the creation of a patient safety program. Patient safety reports are a natural starting point for identifying issues. We examined the feasibility of this approach by analyzing reports associated with AI/Machine Learning (ML)-enabled medical devices. Of the 429 reports reviewed, 108 (25.2%) were potentially AI/ML related, with 148 (34.5%) containing insufficient information to determine an AI/ML contribution. A more comprehensive approach is needed.