The Food and Drug Administration (FDA) is working to strengthen the cybersecurity of medical devices in the wake of computer-hacking threats, according to a report by the Star Tribune.
According to the report, FDA staff members are examining companies’ “preparations for potential computer-hacking threats to devices that millions of Americans depend on.” The plans were recently detailed in an audit report by the U.S. Department of Health and Human Services’ Office of the Inspector General.
Under these suggested guidelines, the FDA will begin asking questions about a device’s cybersecurity during the device-approval process.
“The FDA has been ramping up its cyber enforcement in recent years, starting in 2013 with the formation of a ‘cybersecurity working group’ and the publication of rules in 2014 for how the FDA expects manufacturers to develop long-term plans for medical device cybersecurity,” the report read. “FDA guidelines say manufacturers should submit a cybersecurity hazard analysis with device applications and include plans for how to issue future software updates.”
To read the full report, click the link below.
Danielle covers Clinical Innovation & Technology as a senior news writer for TriMed Media. Previously, she worked as a news reporter in northeast Missouri and earned a journalism degree from the University of Illinois at Urbana-Champaign. She's also a huge fan of the Chicago Cubs, Bears and Bulls.