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国会关于自主开处方人工智能的提议与美国食品药品监督管理局(FDA)的随意削减预算同时出现,令人惊愕。

Consternation as Congress proposal for autonomous prescribing AI coincides with the haphazard cuts at the FDA.

作者信息

Gilbert Stephen, Dai Tinglong, Mathias Rebecca

机构信息

Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany.

Carey Business School, Johns Hopkins University, Baltimore, MD, USA.

出版信息

NPJ Digit Med. 2025 Mar 18;8(1):165. doi: 10.1038/s41746-025-01540-2.

DOI:10.1038/s41746-025-01540-2
PMID:40102664
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11920405/
Abstract

We live in interesting regulatory times. In January, a bill was introduced to the US Congress proposing that AI “can qualify as a practitioner eligible to prescribe drugs” if overseen by the States and FDA. This a bold and contentious move. Even proponents of AI’s swift integration into medicine must recognize the deep paradox: this proposal emerges even as the FDA’s world-leading infrastructure for AI oversight faces dismantling.

摘要

我们生活在监管形势多变的时代。今年1月,一项法案被提交至美国国会,提议如果人工智能受到各州和美国食品药品监督管理局(FDA)的监管,那么它“有资格成为一名有资格开药的从业者”。这是一个大胆且有争议的举措。即使是支持人工智能迅速融入医学领域的人也必须认识到这一深刻的矛盾:这项提议出现之际,FDA领先全球的人工智能监管体系却面临着被拆解的局面。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/313e/11920405/533d37e5c0eb/41746_2025_1540_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/313e/11920405/533d37e5c0eb/41746_2025_1540_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/313e/11920405/533d37e5c0eb/41746_2025_1540_Fig1_HTML.jpg

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FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.美国食品药品监督管理局对医疗保健和生物医学领域人工智能监管的看法。
JAMA. 2025 Jan 21;333(3):241-247. doi: 10.1001/jama.2024.21451.
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