“[The benefits of remote monitoring have] been held up over the years with just being able to diagnose something early,”

Bill Aerts, Medtronic’s former director of product security until 2016, is now the executive director at the Archimedes Center for Healthcare and Device Security at the University of Michigan, which was founded by the researcher who, in 2008, co-authored the first major paper on cardiac device security. “Like anything else,” Aerts told me, the level of security built into such devices “was a matter of demand and costs.” He went on to say, “It took a while to educate the engineering community about these risks… Then the boss says, ‘No, that’s going to cost too much to add that extra functionality [security features].’ And so that took a while to get people to believe that, yes, it’s worth investing in.”

Cheney’s special treatment wasn’t disclosed until 2013, when he and his cardiologist collaborated on a book about his heart saga titled — what else — Heart. The sensationalism of the claim, that the vice president could invite a terror attack through his own heart, made it somehow easier for doctors and manufacturers to dismiss the concerns of average patients. Who are you to worry? You’re not Dick Cheney, after all.

In 2018, researchers Billy Rios and Jonathan Butts from cybersecurity firm Whitescope demonstrated that they could hack into both cardiac devices and insulin pumps built by Medtronic, with potentially deadly results: They could shock a patient’s heart into cardiac arrest or administer a lethal amount of insulin. They told Wired that the devices lacked basic security functions: Medtronic’s MiniMed line of insulin pumps used radio frequencies that were easy to figure out, and there was no encryption on communications between the pumps and their remote controls. Rios and Butts also discovered that the company’s pacemakers didn’t use code signing, a standard security function that authenticates the legitimacy of things like software updates.

The company took more than a year and a half to respond to the security concerns flagged by Rios and Butts and was apparently reluctant to offer solutions. “They are more interested in protecting their brand than their patients,” Rios told CNBC at the time. In an article from CBS News, Butts put it bluntly: “We’ve yet to find a device that we’ve looked at that we haven’t been able to hack.”

But as remote monitoring has become more widespread, concerns about the cybersecurity of the practice have only grown. Since 2011, the FDA has issued at least 11 warnings and many recalls on pacemakers and ICDs over concerns relating to cybersecurity and safety. This includes the 2017 notice for St. Jude devices that I found just before my surgery. The security defect affected at least a half-million patients and was ultimately resolved by a software patch sent directly to their remote monitors.

Device companies and doctors are often quick to insist that the cybersecurity concern is overblown. For years, they’ve maintained that while the routers can communicate with and gather data from patient devices, they can’t actually control the devices or deliver reprogramming directives. Dr. Rob Kowal, chief medical officer for cardiac rhythm and heart failure at Medtronic, told OneZero, “[Remote programming is] not possible,” at least with his company’s current home routers.

Some patients who experience a needless shock to the heart will suffer no obvious or immediate side effects. Some may have psychological side effects, like anxiety or depression related to the fear the device will shock them again. And then there are the more serious consequences. In 2017, Boston Scientific disclosed that a patient had died when their ICD malfunctioned. The device’s memory had been corrupted after exposure to radiation similar to what someone might be exposed to in radiation treatment for cancer. But the patient hadn’t received any such treatment, and Boston Scientific wasn’t able to establish where this exposure might’ve come from. The FDA’s public database of medical device reports contains pages of entries regarding the deaths of ICD and pacemaker patients, citing everything from lead fracture to memory failure, but these reports often decline to cite a device problem as firmly causal in a patient’s death. It is hard to pin down a number of deaths related directly to ICDs because autopsies are rarely performed, and U.S. law requires family consent for device removal after death.

There are two kinds of connections involved in remote monitoring: the connection from the patient’s implanted device to the router, which is often Bluetooth, and the connection from the router back to the data portal seen by the physician, which can use anything from a home Wi-Fi network to a hardline Ethernet cable or a phone line. Manufacturers insist that these channels have now been made secure.

Manufacturers like Medtronic often advise that patients keep their monitors turned on and connected so this sort of patch or upgrade can be delivered. But patches, often quietly sent to the devices, can leave patients in the dark: There is no streamlined process to let patients know when a vulnerability has been identified in their specific device or when a patch might be on its way. And researchers have argued that retroactive patches are no replacement for baked-in security. “The main concern is if vendors continuously rely on reactively resorting to pushing patches instead of securing their devices by design,” Fotis Chantzis, a security engineer who used to hack medical devices for a major health care institution and the lead author of Practical IoT Hacking: The Definitive Guide to Attacking the Internet of Things, told OneZero. “Usually these patches fix a particular vulnerability,” he continued, “but keep in mind that there is also this view of the security community that every bug can potentially be exploited given the right circumstances.”

Devices misfire, sans hacking, all the time. A 2017 study published by the American Heart Association found that during a two-year period, about 10% of ICD patients experienced shocks of some kind. But within that population, 38% of shocks delivered by the device were inappropriate—meaning patients were cardioverted or defibrillated when they didn’t need to be.

For the general public, concerns around medical device cybersecurity first emerged in 2008, not long after the debut of remote monitoring. But I and hundreds of thousands of other patients were never given the option of a custom ICD with the wireless function disabled. Instead, we live with the knowledge that it could be hacked, with few people taking our concerns seriously.

Have you heard the one about Dick Cheney? Talk to a cardiac device patient long enough and they’re bound to bring it up. The former vice president first got an ICD in 2001. In 2007, as the battery ran down, he needed to have it replaced. At the time, Cheney was a candidate to be one of the first patients to wear an ICD with wireless monitoring. But there was a problem: national security. Even before independent hackers raised the alarm, his doctors were worried that a potential terrorist could gain access and trigger the ICD to shock him to death. Cheney and his doctor decided to disable the wireless function before implantation, which required a custom adjustment from Medtronic.

To be clear: There is no documented evidence that a patient’s ICD or pacemaker has ever been hacked for malicious purposes. But the potential for hacking is hardly theoretical. What exists for now are two parts of an equation that have been proven independently: 1) Devices can be hacked; and 2) devices can cause unintentional and catastrophic harm. Put together, they would equal an opportunity for direct control over a patient’s life and safety in a way never previously seen in medicine.

But many related FDA warnings have warned that hackers could, in fact, assume control and reprogram a patient’s device. Researchers and white hat hackers have demonstrated that the connections from the device to the router and from the router to the data portal are exploitable. Hackers have made headlines over the past decade-plus by exposing vulnerabilities in pacemakers and ICDs from every major developer, including St. Jude’s (now Abbott), Medtronic, and Boston Scientific.

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