The Department of Homeland Security's Cybersecurity and Infrastructure Security Agency warned in an advisory that cardio defibrillators from medical device company Medtronic can be modified while still implanted in patients. Without access control, the defibs can't differentiate between authorized and unauthorized instructions.
The Food and Drug Administration outlines what manufacturers have to do to develop secure medical devices on the draft of its premarket guidance. The FDA laid out recommendations on what information to provide when submitting the devices for premarket approval.