How serious is the risk? And what are leaders doing to keep patients and health care information systems safe from attack? The network effect And in October 2018, after hackers showed they could remotely manipulate another popular pacemaker, the manufacturer temporarily shut down part of its Internet network while working to secure the devices. In 2017, for the first time, the FDA recalled an implantable pacemaker because of concerns that it could be hacked. In 2013, partly in response to these hackers’ revelations, the FDA issued its first guidance on cybersecurity and medical devices, and it has since issued several more advisories as concern over implantable or wearable medical devices intensifies. They too could be tinkered with to administer dangerous or fatal doses of drugs to a patient. A third hacker turned his attention to drug infusion pumps. Using a laptop, he demonstrated that it was possible to send a lethal electric shock to a patient via a pacemaker.
At the Black Hat USA security conference in 2011, he demonstrated that it wasn’t difficult to take control of an insulin pump and deliver a lethal dose to a patient.Ī year later, another hacker showed that pacemakers were also vulnerable to attack. Radcliffe, who has diabetes, was curious to see if he could hack his implantable insulin pump. It came from a hacker named Jay Radcliffe.
The first warning came not from researchers or from the Food and Drug Administration (FDA).
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