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Could medical devices be vulnerable to unauthorized users?

Earlier this summer, automaker Chrysler Fiat came under fire for not moving quickly enough to protect vehicles that have computer systems could be infiltrated by remote users. In fact, Wired magazine highlighted how a Jeep was taken over by hackers and even driven into a ditch while a helpless driver was inside.

It is one thing for a car to be compromised, but it is another for a medical device could be hacked. Indeed, it sounds a bit like science fiction or an episode of “Homeland”, but according to a recent report, it could actually happen. 

There are countless medical devices in U.S. hospitals, as well as those implanted in patients, that could be controlled remotely by unauthorized users. This includes infusion pumps, hearing aids, pacemakers and the like. Additionally the possibility of these devices being hacked can put millions of Americans in danger. It also prompted the Food and Drug Administration to recommend guidelines for device makers to make their products more secure. In fact, the FDA has known about this brewing danger for years.

Just like automakers, medical device makers have a duty to use reasonable care in making their devices safe for their intended uses. This includes making them safe from hackers. Should a device maker fail in adhering to this duty, and a patient is harmed as a result, the device maker could be held liable.

It remains to be seen whether device makers will heed the warnings provided by the FDA as future devices are brought to market. 

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