PubMed

2025年の放射線学における人工知能医療機器：EU、米国、中国における規制シナリオ

PMID: 41832928 · 2026-03-15

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学術誌European radiology

年2026-03-15

PMID41832928

抄録

In the last decade, advanced AI methods were applied to radiology, providing tools for clinical practice. Regulations across countries are a relevant topic, considering that AI tools must be regarded as medical devices. We describe the regulatory scenarios in the EU, USA, and China. For the EU, we considered the 2017 Medical Device Regulation, including AI tools as "active" medical devices, the 2018 General Data Protection Regulation, protecting data privacy, and the risk-based approach by the 2

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