IoT
8/30/2017
08:15 PM
Connect Directly
Twitter
RSS
E-Mail
50%
50%

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 [email protected] 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 Council's Cyber Statecraft Initiative and member of the US Department of Health and Human Service's Health Care Industry Cybersecurity Task Force, took to Twitter to show how those malfunction rates could look in human numbers:   

"[Tuesday's] safety communication is part of the FDA's 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 FDA's 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 didn't 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 patient's 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 manufacturer's 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 MedSec's 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:

 

Learn from the industry’s most knowledgeable CISOs and IT security experts in a setting that is conducive to interaction and conversation. Click for more info and to register.

Sara Peters is Senior Editor at Dark Reading and formerly the editor-in-chief of Enterprise Efficiency. Prior that she was senior editor for the Computer Security Institute, writing and speaking about virtualization, identity management, cybersecurity law, and a myriad ... View Full Bio

Comment  | 
Print  | 
More Insights
Comments
Newest First  |  Oldest First  |  Threaded View
REISEN1955
50%
50%
REISEN1955,
User Rank: Ninja
9/5/2017 | 3:06:12 PM
Unsettling
This writer has an implanted BOSTON SCIENTIFIC Defibulator - wireless access point at home to report data to Emory Hospital.  This particularly strikes home for me.  Vast implications in some ways. 
Duncan Jones
50%
50%
Duncan Jones,
User Rank: Author
8/31/2017 | 3:05:14 AM
If you think it's bad now...
Things will get even more interested in a post-quantum world, where we could see attacks on individuals who otherwise believed they had secure medical implants. Devices are being inserted now that won't see the light of day again for 15-20 years. I'd be amazed if they are being designed with the security challenges of two decades hence in mind.
Companies Blindly Believe They've Locked Down Users' Mobile Use
Dawn Kawamoto, Associate Editor, Dark Reading,  11/14/2017
Microsoft Word Vuln Went Unnoticed for 17 Years: Report
Kelly Sheridan, Associate Editor, Dark Reading,  11/14/2017
121 Pieces of Malware Flagged on NSA Employee's Home Computer
Kelly Jackson Higgins, Executive Editor at Dark Reading,  11/16/2017
Register for Dark Reading Newsletters
White Papers
Video
Cartoon
Current Issue
Managing Cyber-Risk
An online breach could have a huge impact on your organization. Here are some strategies for measuring and managing that risk.
Flash Poll
[Strategic Security Report] How Enterprises Are Attacking the IT Security Problem
[Strategic Security Report] How Enterprises Are Attacking the IT Security Problem
Enterprises are spending more of their IT budgets on cybersecurity technology. How do your organization's security plans and strategies compare to what others are doing? Here's an in-depth look.
Twitter Feed
Dark Reading - Bug Report
Bug Report
Enterprise Vulnerabilities
From DHS/US-CERT's National Vulnerability Database
CVE-2017-0290
Published: 2017-05-09
NScript in mpengine in Microsoft Malware Protection Engine with Engine Version before 1.1.13704.0, as used in Windows Defender and other products, allows remote attackers to execute arbitrary code or cause a denial of service (type confusion and application crash) via crafted JavaScript code within ...

CVE-2016-10369
Published: 2017-05-08
unixsocket.c in lxterminal through 0.3.0 insecurely uses /tmp for a socket file, allowing a local user to cause a denial of service (preventing terminal launch), or possibly have other impact (bypassing terminal access control).

CVE-2016-8202
Published: 2017-05-08
A privilege escalation vulnerability in Brocade Fibre Channel SAN products running Brocade Fabric OS (FOS) releases earlier than v7.4.1d and v8.0.1b could allow an authenticated attacker to elevate the privileges of user accounts accessing the system via command line interface. With affected version...

CVE-2016-8209
Published: 2017-05-08
Improper checks for unusual or exceptional conditions in Brocade NetIron 05.8.00 and later releases up to and including 06.1.00, when the Management Module is continuously scanned on port 22, may allow attackers to cause a denial of service (crash and reload) of the management module.

CVE-2017-0890
Published: 2017-05-08
Nextcloud Server before 11.0.3 is vulnerable to an inadequate escaping leading to a XSS vulnerability in the search module. To be exploitable a user has to write or paste malicious content into the search dialogue.