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FDA: Cybersecurity Vulnerabilities May Affect Medical Devices

Providers asked to identify devices; patients potentially affected by 12 Bluetooth-associated vulnerabilities

FRIDAY, March 6, 2020 (HealthDay News) — SweynTooth cybersecurity vulnerabilities may affect medical devices, according to a U.S. Food and Drug Administration safety communication.

“SweynTooth” includes a family of 12 vulnerabilities associated with Bluetooth Low Energy, a wireless communication technology. Unauthorized users can exploit these vulnerabilities to crash or deadlock a device or bypass security functions.

The FDA is recommending a set of steps that health care providers can take to minimize risk. Providers can work with device manufacturers to determine which medical devices could be affected by these vulnerabilities and to develop risk mitigation plans. Patients using potentially affected devices should be advised about steps they can take to reduce risk and to seek medical help right away if operation or function of their medical device changes unexpectedly. If possible, providers should monitor medical devices for any signs of unusual behavior.

“The FDA is not aware of any confirmed adverse events related to these vulnerabilities,” the agency says, but cautions that “software to exploit these vulnerabilities in certain situations is already publicly available.”

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