Bio Tech: Medical Devices

Speaking with CBS News, Suzanne Schwartz, MD, who oversees medical device cybersecurity at the FDA, explained, “Any device can be hacked and that’s often not understood.”

In an interview with Sanjay Gupta on 60 Minutes in 2013, former U.S. Vice President Dick Cheney revealed that in 2007, his implanted heart defibrillator was modified that it so it couldn’t be hacked by terrorists trying to kill him remotely. Cheney’s cardiologist, Jonathan Reiner, MD, explained in the interview, “It seemed to me to be a bad idea for the vice president of the United States to have a device that maybe somebody…might be able to get into, hack into.” Alpine Security reports that “While there have been no reported cases of malicious intent so far, security enhancements for pacemakers and other implantable devices are being addressed by manufacturers and regulatory authorities through firmware updates.”

In a public statement released in 2018, FDA Commissioner Scott Gottlieb, MD, stated that “The FDA has been working to stay a step ahead of these changing cybersecurity vulnerabilities, including engaging with external stakeholders. In this way, we can help ensure the health care sector is well positioned to proactively respond when cyber vulnerabilities are identified in products that we regulate.”