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FDA to re-examine medical-device security risks
Modern Healthcare

The Food and Drug Administration will begin looking at external security vulnerabilities of the software in medical equipment after inquiries from congressional investigators. A report issued Thursday by the Government Accountability Office found that for wireless medical devices, the FDA “did not consider information security risks from intentional threats as a realistic possibility until recently.” Agency officials told the authors of the GAO report that they plan to re-examine their evaluations of software used in medical devices and add an assessment of “information security risks.”