United States company to update pacemaker software against hacking risks

Violet Tucker
August 31, 2017

This access could be used to modify programming commands to the implanted pacemaker, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing.

The Food & Drug Administration released a recommendation for patients to visit their healthcare providers to discuss vulnerability and updates.

The update comes a year after the financial firm Muddy Waters shorted St. Jude's stock and announced what it said were grave cybersecurity vulnerabilities that render St. Jude heart-rhythm devices vulnerable to computer hacking.

But as a precaution, Abbott says that pacing dependent patients should be given the update in a facility where temporary pacing and a pacemaker generator are on hand. The FDA is not recommending the devices be removed or replaced.

Contact your Abbott representative, or Abbott's customer technical support hotline at 1‐800‐722‐3774 if you have any questions about the firmware update. The regulator criticized the company over its handling of the matter over concerns that hacks could cause the device to drain batteries at dangerously high rates leading to life threatening scenarios.

"FDA reminds patients, patient caregivers and healthcare providers any medical device connected to a communications network may have cybersecurity vulnerabilities that could be exploited by unauthorized users", officials said. The recall applied to devices implanted in the US, Canada, and Australia.

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Abbott Laboratories, which acquired Minnesota-based St. Jude Medical in January, released a software update on Tuesday meant to improve the cybersecurity protections for 465,000 implanted pacemakers in the United States.

The FDA said in October that two people had died in incidents associated with the devices and others had reported fainting or dizziness. This home monitor wirelessly reads and shares data stored on implanted cardiac devices.

This marks the second time Abbott has issued a cybersecurity-related update for its St. Jude cardiac devices. Those claims launched a testy legal battle between the investment firm and St. Jude Medical. But, as the FDA saw it, the device maker failed to follow its corrective and preventive action (CAPA) procedures and ensure all vulnerabilities were closed off.

Now, 12 months after Muddy Waters published the report, Abbott has identified and fixed another cybersecurity vulnerability.

The update is part of Merlin@home v8.2.2, but pacemakers manufactured from 28 August will already contain the security patch.

Other reports by Guamnewswatch

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