The Food and Drug Administration has released final guidance on the post-market management of cybersecurity in medical devices. Of particular concern is the growing number of networked medical devices, the vulnerabilities of which could potentially put patient safety at risk.
“Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats,” states the FDA’s guidance. “The exploitation of vulnerabilities may represent a risk to health and typically requires continual maintenance throughout the product life cycle to assure an adequate degree of protection against such exploits. Proactively addressing cybersecurity risks in medical devices reduces the overall risk to health.”
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