FDA Invites Feedback on Communicating Cybersecurity Risks

The Food and Drug Administration (FDA) has published a discussion paper on communicating cybersecurity vulnerabilities to patients, in preparation for the October 2020 meeting of the Patient Engagement Advisory Committee of the FDA’s Center for Devices and Radiologic Health. The FDA has recognized that cybersecurity risks pose significant patient safety concerns for connected medical devices. The term “connected medical devices” includes medical devices that are connected to the internet, to hospital networks, or to other medical devices. Examples are sensor-based technologies such as wearables, to implantable medical devices such as pacemakers.

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