FDA aims to prevent hacking of medical devices

FDA issues draft recommendations to prevent hacking of medical devices, disruption of care

Associated Press

The Food and Drug Administration wants makers of medical devices to design future products to prevent hackers from targeting them and disrupting patient care.

A draft of the agency's recommendations — what the FDA calls guidance — was posted on its website Thursday.

The draft directs manufacturers to create security controls to ensure that only authorized people can access information on medical devices, that the data on them cannot be changed improperly and that the data can be accessed and used quickly when it is needed.

The need for such cyber security, the agency wrote, has increased because many medical devices now can be connected to another medical device, the Internet, another network or portable media such as a CD or USB drive.

"These, in turn, have the potential to result in patient illness, injury, or death," the draft recommendation stated.

The draft did not mention any cases in which patients have been harmed.

Comments from industry, medical professionals and the public must be submitted within 90 days.

View Comments