St. Jude Pacemaker Gets Firmware Update Intended as a Recall

The devices that were the subject of a vulnerability disclosure debate last summer now have an FDA-approved fix.

Abbott Laboratories, the new owner of St. Jude Medical (STM), has issued a firmware update for STM pacemaker devices that addresses vulnerabilities
exposed one year ago by security research firm MedSec
.
As the
US Food & Drug Administration (FDA) stated
in a safety communication Tuesday, the FDA approved last week a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers.
The fix is largely to shore up weak RF protocol security that left RF-enabled pacemakers vulnerable to remote unauthorized access. According to Abbott, the firmware update is part of a software release for the Merlin@Home monitoring device that also includes data encryption, operating system patches, and disabling network connectivity features. As of Monday, all new devices manufactured will have the new firmware installed already.
This is not exactly a call for emergency rips-and-replaces of all patients pacemakers, though. According to the
FDA safety communication
Tuesday, The FDA and Abbott do NOT recommend prophylactic removal and replacement of affected devices.
Patients must visit their healthcare provider in person to receive the firmware update. Abbott Laboratories advises healthcare providers discuss the potential risks with patients first — both the security risks of attackers exploiting vulnerable firmware and potential complications that could be caused during the firmware update process.
The
advisory
cites these rates of malfunctioning during the process:
reloading of previous firmware version due to incomplete update (0.161%)
loss of currently programmed device settings (0.023%),
complete loss of device functionality (0.003%),
and loss of diagnostic data (not reported).
Roughly 465,000 devices are affected by this firmware update, according to the FDA. Joshua Corman, director of the Atlantic Councils Cyber Statecraft Initiative and member of the US Department of Health and Human Services Health Care Industry Cybersecurity Task Force, took to Twitter to show how those malfunction rates could look in human numbers:
[Tuesdays] safety communication is part of the FDAs ongoing work with Abbott to ensure they are properly addressing identified cybersecurity risks and adequately protecting their devices against potential future cybersecurity vulnerabilities, said William Maisel, acting director of the Office of Device Evaluation and chief scientist in the FDAs Center for Devices and Radiological Health,
in a statement
. Because all networked medical devices are potentially vulnerable to cybersecurity threats, the FDA has been working diligently with device manufacturers and other stakeholders to ensure the benefits of medical devices to patients continue to outweigh any potential cybersecurity risks.
Earlier in the year, the FDA acknowledged that there were real vulnerabilities in the devices but didnt recommend doing anything because there was no firmware fix and the device benefits far outweighed swapping the device for something more secure, says Veracode CTO Chris Wysopal. Now that there is a fix from the manufacturer, they are recommending a firmware update on the patients next visit to their doctor.
What we are seeing, says Wysopal, is the same type of risk calculus around safety that goes into a motor vehicle recall being used in a medical device recall. If there was a more serious risk to the medical device, we might see the FDA advising patients to immediately visit their doctor. This situation shows with IoT safety and security are becoming synonymous in many cases.
The product recall is a tangible result one year after MedSec chose a controversial method of vulnerability disclosure. Rather than full public disclosure or cooperative disclosure, MedSec partnered with Muddy Waters to release only part of the vulnerability information and then short-sell St. Jude Medical, allowing them to profit off a drop in the manufacturers stock. (MedSec CEO Justine Bone has
since said
she thought it was the right move but would not plan to do it again.)
There was debate about whether MedSecs decision had been wise both ethically and strategically. Had it released too much information, or not enough? Would other medical device manufacturers be scared into improving security after this example, or would the event simply jeopardize trusted relationships built with other security researchers? Would this create an entirely new, expensive trend in vulnerability disclosure? MedSec said St. Jude put
profits over patients
, but critics thought MedSec had done the same itself.
One year later, the questions remain. The vulnerability now has an FDA-approved fix, but that might also have been the case if MedSec had gone through the FDA to begin with last summer.
Consumers are just waking up to the fact that medical devices can get recalls, says Wysopal, who recently co-presented a session with Bone at Black Hat USA 2017 about using the market to create better security. This Abbott event will cause medical device manufacturers to get ahead of security problems and put more effort into designing and testing their products to be free from security issues. This is the market working. It is unfortunate that patients have to be at risk before many businesses learn this lesson.
Related Content:
Cardiac Implant Flaw Patched But Holes Remain
MedSec/Muddy Waters & The Future of IoT Security
St. Jude Sues Muddy Waters, MedSec
7 Hardware & Firmware Hacks Highlighted at Black Hat 2017

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St. Jude Pacemaker Gets Firmware Update Intended as a Recall