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Gaps Remain In US FDA's Response Procedures For Cybersecurity Events, OIG Says

FDA's policies and procedures do not adequately address how to handle post-market device cybersecurity events and the agency had not adequately tested its ability to respond to emergencies arising from such events, US HHS' investigative arm says. But the top cybersecurity official at FDA's device center says OIG's report is "incomplete and inaccurate."

Cyber attack (BeeBright/Shutterstock.com)

There are serious deficiencies in how US FDA handles post-market cybersecurity threats for medical devices, with gaps in certain standard operating procedures, a lack of testing what procedures are in place, and a lack of effective means of communicating with partner agencies to respond to threats and attacks, according to a recent Inspector General report.

In a report published by the US Office of Inspector General at the Department of Health and Human Services, investigators said they reviewed guidances and procedures that FDA's device center...

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