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FDA Issues Draft Guidance on Management of Cybersecurity in Medical Devices
Categories: FDA, Medical Device, Privacy and Security Law
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The FDA issued a new Draft Guidance today to ensure medical devices - an increasing potential target for hackers - are better protected from unauthorized digital access.

According to the FDA’s draft guidance issued today, “Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the US and globally. Such cyberattacks and exploits can delay diagnoses and/or treatment and may lead to patient harm.”

Under the proposed draft guidance manufacturers will be required to ...

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