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QUOTED. 2 October 2019. Suzanne Schwartz.

Executive Summary

The US FDA is warning health-care providers and the medtech industry of serious vulnerabilities on certain operating systems used in medical devices that could allow malicious hackers to harm patients. See what the FDA's Suzanne Schwartz said about it here.

“While we are not aware of patients who may have been harmed by this particular cybersecurity vulnerability, the risk of patient harm if such a vulnerability were left unaddressed could be significant. It’s important for manufacturers to be aware that the nature of these vulnerabilities allows the attack to occur undetected and without user interaction. Because an attack may be interpreted by the device as a normal network communication, it may remain invisible to security measures.” – Suzanne Schwartz, deputy director, Office of Strategic Partnerships and Technology Innovation, US FDA’s Center for Devices and Radiological Health

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