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FDA Reveals Steps to Bolster Medical Device Cybersecurity

October 2, 2018

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In its ongoing quest to improve the state of medical device cybersecurity, the Food and Drug Administration has announced a number of key moves – including the release of a new security playbook, plans to leverage information sharing and analysis organizations, and an effort to update its 2014 premarket guidance for manufacturers.

In a statement Monday, FDA Commissioner Scott Gottlieb, M.D., says the efforts are aimed at addressing growing cybersecurity threats and potentially 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.

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