FDA’s Kevin Fu is concerned about the increasing number and growing sophistication of cyberattacks on healthcare organizations, particularly their effect on medical devices and patient safety, reports MedTech Dive.
Fu noted that medical devices infected by ransomware can be disabled from properly performing critical clinical functions, which could lead to patient harm.
“If the device is not available to deliver patient care, that seems like a safety issue,” Fu said. “Let’s say there’s a potential adulteration of a product because of a cybersecurity incident. Maybe it’s ransomware that got in and encrypted the hard drive of a medical device. A real question is how do you know that the device still has integrity?”
Read more at MedTech Dive.