Some pacemakers, ultrasounds vulnerable to hackers, FDA warns
'Connected devices have inherent risks'
Some medical devices that use Bluetooth technology may be vulnerable to hackers, federal health officials are warning.
The cybersecurity threats, dubbed SweynTooth, may enable someone in a patient's immediate vicinity to interfere with Bluetooth low-energy communications that let medical equipment such as pacemakers, stimulators and insulin pumps pair with another device and exchange information, the U.S. Food and Drug Administration said in a notice Tuesday.
The hacker might be able to crash the device, cause it to stop working or access capabilities typically available only to the wearer, the agency said. A spokesperson told FOX Business that anyone trying to tamper with the device wouldn't be able to hack it remotely; he or should would have to be within Bluetooth range.
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“Medical devices are becoming increasingly connected, and connected devices have inherent risks, which make them vulnerable to security breaches,” said Dr. Suzanne Schwartz, deputy director of the agency's office of partnerships and technology innovation. "These breaches potentially impact the safety and effectiveness of the device and, if not remedied, may lead to patient harm.”
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Although the FDA has not received any reports SweynTooth has been used to hack medical devices yet, the agency cautioned that the software is publicly available.
Microchips from several manufacturers are affected, but the producers have already begun assessing risks and possible patches, the agency said. Some have been released already.
As a precaution, the agency is urging manufacturers to alert health care providers and patients about medical devices that might be affected by SweynTooth. Likewise, patients themselves should check their devices with healthcare providers to determine whether they're safe.
Similar technology is found in large devices, such as ultrasound equipment in hospitals; consumer wearables including smartwatches and Fitbits; and smart-home devices that can be controlled through Amazon's Alexa and similar technology.