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Regulatory Approaches to Cybersecurity Risk Management for AI-Enabled Medical Device Software in Korea, the United States, and the European Union: Comparative Document Analysis.

Observation and source date: 2026-07-30 (Asia/Shanghai). Bioprinting screening covered bioprinting, 3D bioprinting, biofabrication, bioink, bioprinted tissue, in situ bioprinting and explicitly linked additive manufacturing; inert implants, dental models, surgical guides and teaching models were excluded.

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A comparative analysis of ten regulatory documents finds that connected, updateable AI medical software brings cybersecurity risk into contact with conventional patient-safety risk management.

Evidence boundary: 文件分析描述的是监管框架，不检验某项设备的网络安全或临床安全表现。

Source: PMID:42531375