Tag Archives: ISAO

Office of the National Coordinator Issues Guidance After NotPetya Attack

Following the most recent ransomware attack, known as NotPetya, (among other nicknames), many health care entities were victims of the ransomware, which prompted the Office of the National Coordinator (ONC) to issue guidance to assist health care entities in the aftermath. In two separate warnings/updates, ONC provides guidance to health care entities on what to … Continue Reading

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR part 806), which require device manufacturers and importers to report certain device corrections and removals to the FDA. Most actions taken by … Continue Reading
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