FDA ISSUES SOFTWARE 'UPDATE' TO ADDRESS PACEMAKER CYBERSECURITY RISKS

Abstract

"Cybersecurity risks in networked medical devices are constantly evolving, which means medical device manufacturers and hospitals must be vigilant in the face of changing threats in order to protect patient safety," said William Maisel, acting director of the Office of Device Evaluation, in an FDA statement issued Monday (Aug. 28). "The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's RF-enabled implantable cardiac pacemakers and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user (i.e. someone other than the patient's physician) to access a patient's device using commercially available equipment," according to the agency.