In a statement Monday, FDA Commissioner Scott Gottlieb, M.D., says the efforts are aimed at addressing growing cybersecurity threats and potential related patient safety worries for network-connected medical devices.”As the number of cyberattacks has increased, we’ve heard concerns about the potential for cybercriminals to attack patient medical devices,” Gottlieb says.Cybersecurity researchers continue to identify device vulnerabilities in non-clinical, research-based settings, demonstrating how bad actors could gain the capability to exploit these same weaknesses, thereby acquiring access and control of medical devices, Gottlieb notes.”The FDA isn’t aware of any reports of an unauthorized user exploiting a cybersecurity vulnerability in a medical device that is in use by a patient. But the risk of such an attack persists,” he says.

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