FDA Seeks Comment on Guidelines to Prevent Hacking of Medical Devices

December 3, 2020

The Food and Drug Administration (FDA) recently published a draft paper, Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework and is seeking input on best practices when healthcare providers communicate with patients and caregivers about maintaining cybersecurity for medical devices. According to the agency, the increased use of connected medical devices—such as implantable glucose monitors and blood pressure monitors that download data to doctors’ offices, and even hospital systems, increases the potential for hacking. The new guidance proposal follows 2018 draft guidance on managing cybersecurity in medical devices.

David Finn, Executive Vice President at CynergisTek, offered his expertise for this piece, which details the FDA’s recent paper, called Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework. The FDA is seeking input on best practices when healthcare providers communicate with patients and caregivers about maintaining cybersecurity for medical devices.

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