Implantable Cardiac Devices Could Be Vulnerable To Hackers, FDA Warns (vice.com)

The U.S. Food and Drug Administration warned on Monday that pacemakers, defibrillators and other devices manufactured by St. Jude Medical, a medical device company based in Minnesota, could have put patients' lives at risk, as hackers could remotely access the devices and change the heart rate, administer shocks, or quickly deplete the battery. Thankfully, St. Jude released a new software patch on the same day as the FDA warning to address these vulnerabilities. Motherboard reports: St. Jude Medical's implantable cardiac devices are put under the skin, in the upper chest area, and have insulated wires that go into the heart to help it beat properly, if it's too slow or too fast. They work together with the Merlin@home Transmitter, located in the patient's house, which sends the patient's data to their physician using the Merlin.net Patient Care Network. Hackers could have exploited the transmitter, the manufacturer confirmed. "[It] could (...) be used to modify programming commands to the implanted device," the FDA safety communication reads. In an emailed response to Motherboard, a St. Jude Medical representative noted that the company "has taken numerous measures to protect the security and safety of our devices," including the new patch, and the creation of a "cyber security medical advisory board." The company plans to implement additional updates in 2017, the email said. This warning comes a few days after Abbott Laboratories acquired St. Jude Medical, and four months after a group of experts at Miami-based cybersecurity company MedSec Holding published a paper explaining several vulnerabilities they found in St. Jude Medical's pacemakers and defibrillators. They made the announcement at the end of August 2016, together with investment house Muddy Waters Capital.

Comments

A lack of software freedom can be lethal & sca

[jbn-o]

Karen Sandler, Executive Director of the Software Freedom Conservancy, has an enlarged heart (hypertrophic cardiomyopathy) and is at risk of suddenly dying (due to a medical condition called "sudden death"). She has no symptoms. She has given a talk about this many times at tech conferences, you should be able to find a copy of her talk online quite easily. She calls herself a "cyborg lawyer running on proprietary software" because she needs to wear a pacemaker/defibrillator device on her heart which keeps her heart beating within a predetermined acceptable range (not too slow, not too fast) by shocking her heart until it beats at an acceptable rhythm. Sandler said she's been shocked before and it's like being kicked in the chest and it takes the wind out of her for a while, requiring her to take some time for recovery.

She knew of software freedom and figured on these weaknesses in these devices, some of which can be controlled remotely at some distance, because all of them run on proprietary software. She tried to get the source code, even offering to sign a non-disclosure agreement to do so, and nobody would share the code with her. She said she was the only one to ask her doctors about what ran on the device. She therefore chose an older model which requires the "programmer" device which sends a signal to the pacemaker/defibrillator be quite close to her body so that she'd probably know if someone were doing things to her device. The lack of software freedom and full user control (ownership) of the device is quite obviously a health risk and possibly lethal. Don't let anyone tell you a lack of software freedom isn't serious.

An interesting thing happened during her pregnancy, which she explained in an update to her talk: She learned that a pregnant woman's heart sometimes naturally races. For most women of childbearing age this isn't a problem as they're unlikely to need a pacemaker/defibrillator, so their heart can occasionally race without serious consequences. For Sandler this racing triggers the device to shock her back into an "acceptable" heart rhythm. It appears that the pacemaker/defibrillator device makers didn't test this device on women young enough to be of childbearing age but they're apparently happy to sell the devices for implanting into users of any age. This lack of testing in combination with the lack of software freedom means the device manufacturers aren't doing due diligence and they're preventing younger women, such as Sandler, from looking out for their own interests—avoiding "sudden death". One can only imagine what horrible multiply lethal outcome could predictably result for a pregnant woman with the same condition Sandler has whose heart races when she was driving while receiving a shock from her non-free pacemaker/defibrillator device. Don't let anyone tell you a lack of software freedom isn't serious.

Re:The FDA is part of the problem.

[TheRaven64]

I agree with your heading, but not with the rest of your post. The problem is that the FDA requires that the company have the software certified as safe by a third party, but places very few rules on what this entails. In a lot of cases, the people certifying the software don't even have access to the code: they read the design docs, but nothing else. There's no red teaming of medical device software before widespread deployment and no auditing by the FDA. The FDA is happy to certify such devices as 'safe' with nothing like enough information to be able to honestly make that claim.