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The U.S. Food and Drug Administration (FDA) recently released an alert addressing a set of cybersecurity flaws known as SweynTooth. The vulnerability affects Bluetooth Low Energy (BLE) wireless communication technology used in a range of medical devices. Unfortunately, the SweynTooth flaws allow hackers to remotely crash a device or access its data, disastrous for patients and hospitals that rely on the technology for medical purposes.


The original report: what is SweynTooth?

Researchers from Singapore first discovered and reported SweynTooth, a family of 12 cyber vulnerabilities, in 2019. The flaws impact a range of end-user products that utilize BLE (used to pair and exchange data between two devices) such as wearables, Internet of Things (IoT), and most critically, medical devices. Affected medical devices include insulin pumps, pacemakers, blood glucose monitors, ultrasound devices, drug delivery devices, and electrocardiograms. Related: Smart Device Security Needs Higher Priority in Healthcare In general, the SweynTooth viruses perform three main functions: they crash a device, stop the device’s ability to function properly, and/or provide unauthorized access. Fortunately, a breach through SweynTooth is impossible remotely over the Internet; in fact, a hacker must be in close vicinity to the device (in radio range) to attack.


Concern about medical devices

SweynTooth is not the first vulnerability to affect wireless/IoT devices and more than likely, not the last.

Related: FDA report on Cybersecurity

And unfortunately, the healthcare industry’s reliance on legacy systems and outdated software make connected medical devices prime targets for cyberattackers. The overall effectiveness of such devices and public safety are impacted. The FDA recommends that healthcare organizations conduct a risk assessment to:

  • evaluate the impact on devices
  • discuss the need for affected devices before and after patching
  • reduce risks to acceptable levels
  • monitor affected devices for signs of unusual behavior
  • report all problems to the FDA


Communication between manufacturers, the FDA, and users is vital until patches become available to all. A breach thankfully has yet to occur due to SweynTooth but healthcare organizations and patients must be vigilant and must discuss potential risks and problems thoroughly.


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