FDA Raises Medical Device Standards to Prevent Cybersecurity Breaches

The Food and Drug Administration is raising the bar for medical device security in order to lower the risk of potentially life-threatening hacks of these devices.

 

The draft guidelines will allow the FDA to block devices that are not equipped with safety measures or lifetime security update plans.

 

As of yet, there are no reports of patient harm from equipment malfunction or deliberately targeted hacks, but since there is little emphasis placed identifying and documenting this type of incident, it is difficult to be certain, according to an article in The News Journal. 

 

In addition to preventing cybersecurity breaches, the FDA also hopes to lower the possibility that wireless medical devices are affected by complications from system glitches, malware and portable viruses.