Report Faults FDA For Oversight Of Device Cybersecurity

Law360, New York (July 20, 2012, 5:44 PM EDT) -- The U.S. Food and Drug Administration is not adequately tracking possible security and privacy defects in medical device software, a reflection in part of a potentially flawed recall system, researchers said in a study published Thursday.

Experts from Harvard Medical School and the University of Massachusetts Amherst's computer science department examined FDA enforcement reports, recall notices and adverse event reports for cybersecurity or privacy problems in medical devices. The researchers did not find a single recall in the previous nine years related to patient security or...
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