Former U.S. Vice President Dick Cheney revealed in an interview with the CBS news magazine program 60 Minutes that he had his implantable cardioverter defibrillator (ICD) modified after implantation to turn off the wireless remote programming feature.
The skeptic in me wants to believe that Mr. Cheney was just drumming up publicity on his nationwide press tour to promote his latest book. Recent events in cyberspace, however, including the news that the U.S. National Security Agency has the ability to eavesdrop on the mobile phone conversations of the leaders of other countries has caused my to revise my beliefs. There are untold numbers of hackers around the world, all looking for a way to disrupt the status quo. So there is no shortage of motives for someone to try to hack the VP’s defibrillator.
[SPOILER ALERT] In the second season of the hit Showtime cable TV series Homeland (I’m a big fan, by the way), Nicholas Brody, the ex-prisoner-of-war/Marine Sergeant/Congressman/semi-terrorist cooperates with a Bin Laden-like figure to assassinate the Cheney-like Vice President by remotely manipulating his implanted defibrillator.
After Cheney made his revelation, there was much discussion about whether such an action was technically possible. The jury seems to be divided. It’s at least plausible enough to be the major plot point of Season 2 of Homeland. And apparently the possibility of hacker bad guys doing harm was the motivation for Cheney to deactivate the function in his device.
In the Homeland episode, Brody had to find a device code unique to the Vice President, then relay that to a remote hacker. The hacker executed some code that disrupted the device. The audience was not informed as to exactly how the bad code made its way to the implanted device. In real life, experts say that a programmer device must be in close proximity to the patient in order to wirelessly access the defibrillator. Apparently, Vice President Cheney wasn’t taking any chances!
Mr. Cheney had his defibrillator modified in 2007 while he was still in office. He has since undergone a heart transplant and presumably had the defibrillator removed.
Takeaways: As medical devices become increasingly complicated, the opportunities for negative outcomes – accidental and malicious – increase proportionally. Notwithstanding the dangers to the patient, this sort of negative publicity can have devastating consequences for a company, particularly an early stage company.
An ICD with wireless remote access obviously has the power to kill but other devices can be just as deadly. Be sure to conduct a thorough Failure Mode and Effects Analysis (FMEA) during the development process. Seriously consider involving computer experts, including security consultants, as additional resources. You should also consult key opinion leader physicians and patient groups to get objective third party viewpoints about risks and mitigations.
Lastly, have a disaster plan in effect for unthinkable scenarios like the one in Homeland. And make sure the CEO reviews and approves the plan.