FDA’s Four Required Security Views for Medical Devices

The article explains that new FDA guidance requires manufacturers to provide four security-architecture views when submitting connected medical devices. The Global System View maps all components and data flows. The Multi-Patient Harm View shows how design prevents a breach from affecting multiple patients. The Updateability & Patchability View details how secure updates are delivered throughout the device’s life. The Security Use Case Views demonstrate how security controls behave in real clinical workflows. 

https://bluegoatcyber.com/blog/examining-the-fdas-recommended-security-architecture-views-for-medical-device-security/

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