Beware Of Malware: FDA On Cybersecurity Risks

Law360, New York (July 1, 2013, 11:25 AM EDT) -- On June 13, 2013, the U.S. Food and Drug Administration issued an alert and draft guidance recommending that medical device manufacturers and health care facilities take measures to protect against cyberattacks that could compromise device performance and patient safety.

The alert identifies specific cybersecurity risks associated with medical devices, including the introduction of malware into medical equipment or unauthorized access to devices’ configuration settings. The draft guidance focuses on the development and documentation of cybersecurity management in medical device premarket submissions.

Medical Device Cybersecurity Incidents and...
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