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類別: STANDARDS
醫療器材網路安全
保護聯網醫療器材免受未授權存取、數據洩露和惡意攻擊的實踐。FDA根據2023年PATCH法案要求在上市前提交中包含網路安全文件。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
Medical device cybersecurity covers design, labeling, and postmarket management of threats to device safety/effectiveness—especially for connected and software devices.
PROCESS / STEPS
- Threat model during design; apply secure development practices.
- Document SBOM and updateability where expected.
- Plan coordinated vulnerability disclosure and patches as FSCA when needed.
- Monitor field signals for exploit patterns.
EXAMPLES
- Connected infusion pumps and imaging systems are frequent cybersecurity focus areas.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 醫療器材網路安全 across 27 authorities in real time.
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