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 has in place to tackle
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