In a scenario that could have been swiped from a spy series like “Homeland,” the U.S. Food and Drug Administration issued a safety alert last week about the vulnerability to hacking of up to 750,000 implantable heart defibrillators used to correct life-threatening arrhythmias, raising novel considerations for in-house and outside counsel.
The March 21 alert warned health care providers and individuals using certain Medtronic implantable cardiac defibrillators of cybersecurity weaknesses in their wireless technology that could leave the devices exposed to hacking. The FDA said it had received no reports of patient harm related to the vulnerability.
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