FDA announces first-ever recall of a medical device due to cyber risk


This week, the FDA took the unprecedented step of recalling a medical device – a pacemaker – because it was found to be vulnerable to cyber threats. The recall arose from an investigation by the FDA in February that highlighted a number of areas of non-compliance. While there are no known reports of patient harm related to the implanted devices affected by the recall, the step was taken as a preventative measure. A firmware update has been developed (and approved by the FDA) that can be applied during a patient visit with their healthcare provider.

Medical device vulnerabilities have been on the FDA’s radar for some time. In July 2015, the FDA issued an Alert highlighting cyber risks related to infusion pumps. Then, at the end of 2016, it issued what it called “guidance” on the post-market management of cybersecurity for medical devices. But aside from market pressure, there was no enforcement mechanism for any of these alerts and statements. To make matters worse, a recent study revealed that only 51 percent of medical device manufacturers and 44 percent of healthcare organizations currently follow the FDA guidance to reduce or mitigate device security risks. Many thought leaders in the healthcare security space have been pushing for greater governance of medical devices as more and more security vulnerabilities and back doors to these devices have been discovered.

While “homicide by medical device” may seem like a far-fetched Hollywood-esque scenario right now, it’s not completely out of the realm of possibility. “The potential for immediate patient harm arising from hackers gaining control of a pacemaker is obvious, even if the ability to do so on a mass scale is theoretical,” Fussa pointed out. “For example, imagine a ransomware attack that threatens to turn off pacemakers unless a bitcoin ransom is paid. In this week’s recall alone, 465,000 devices are affected. An attack of this type would pose an immediate risk to all of these patients and would likely overwhelm the ability to respond.”

While it’s good news that the FDA is acting to protect patients from harm due to cyberattack, connected devices continue to pose a threat to both patients and facilities. There’s been no shortage of press on the subject, and most healthcare executives are keenly aware of the problem. However, very few have an effective or scalable solution.

Many hospital systems have in excess of 350,000 medical devices, before you even start to count the implantable ones that leave with patients. Most of these devices were never designed with security in mind, and many have multiple ways in which they can be compromised by a hacker. The fact that we are not aware of any reported patient deaths yet is a good thing, but the industry has a very short window to secure its medical device arsenal before hospitals and patients get held to ransom. Health systems need to be looking at segmentation as a compensating security control to prevent attacks, until the medical device industry catches up.

Do you have a plan in place to secure your facility’s medical devices? Are you able to segment and isolate traffic to them?

Do you have visibility into who and what is communicating with your biomed systems and do you have ransomware protection?

Having specific answers to these questions will be key to a strong, ongoing defense against attacks.

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