FDA Slams St. Jude Medical For Ignoring Security Flaws In Medical Devices

chicksdaddy quotes a report from The Security Ledger: The U.S. Food and Drug Administration issued a letter of warning to medical device maker Abbott on Wednesday, slamming the company for what it said was a pattern of overlooking security and reliability problems in its implantable medical devices at its St. Jude Medical division and describing a range of the company's devices as "adulterated," in violation of the U.S. Federal Food, Drug and Cosmetic Act, the Security Ledger reports. In a damning warning letter, the FDA said that St. Jude Medical knew about serious security flaws in its implantable medical devices as early as 2014, but failed to address them with software updates or by replacing those devices. The government found that St. Jude, time and again, failed to adhere to internal security and product quality guidelines, a lapse that resulted in at least one patient death. St. Jude Medical, which is now wholly owned by the firm Abbott, learned of serious and exploitable security holes in the company's "high voltage and peripheral devices" in an April, 2014 "third party assessment" commissioned by the company. But St. Jude "failed to accurately incorporate the findings of that assessment" in subsequent risk assessments for the affected products, including Merlin@home, a home-based wireless transmitter that is used to provide remote care for patients with implanted cardiac devices, the FDA revealed. Among the security flaws: a "hardcoded universal unlock code" for the company's implantable, high voltage devices. The report casts doubt on a defamation lawsuit St. Jude filed against the firm MedSec Holdings Ltd over its August, 2016 report that warned of widespread security flaws in St. Jude products, including Merlin@home. The MedSec report on St. Judes technology was released in conjunction with a report by the investment firm Muddy Waters Research, which specializes in taking "short" positions on firms. At the time, MedSec said that the security of the company's medical devices and support software was "grossly inadequate compared with other leading manufacturers," and represents "unnecessary health risks and should receive serious notice among hospitals, regulators, physicians and cardiac patients." St. Judes has called the MedSec allegations false, but it now appears that the company had heard similar warnings raised by its own third-party security auditor more than a year prior. Read more of this story at Slashdot.
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