Usually, when we think of dangerous medical devices we think of products that are poorly manufactured or improperly tested. However, today’s advanced wireless technology has presented a whole new threat: hackers.
Recently, a U.S. Government Accountability Office report indicated that wireless medical devices that do things such as monitor heart rhythms of a cardiac patient and adjust the amount of insulin a diabetic receives could be at risk of outside tampering because they lack security walls.
In fact, during a presentation at the annual Black Hat computer security conference last August, a researcher was able to hack into his own insulin pump and disable it as he stood on stage. He said security is something the medical device industry has not paid enough attention to.
The government’s recent report agreed. The report now stands to put pressure on the FDA, the agency that oversees medical device manufacturing, to take action. The report stated that the FDA needs to “consider information security risks resulting from intentional threats when reviewing manufacturers’ submissions for new devices.” Currently, the FDA focuses on only unintentional threats.
As of yet, there haven’t been any reports of medical device hacking among the general public, but that doesn’t mean it couldn’t happen in the near future, researchers warn. They stress that in many cases, the hacking could be life-threatening, so medical device manufacturers need to address the matter right away.
If medical device manufacturers don’t heed these warnings, it is possible that they could face product liability lawsuits if patients are harmed by wireless device hacking.
Source: Star Tribune, “FDA told to act on wireless hacks,” James Walsh, Sept. 27, 2012