ABSTRACT

Food and Drug Administration's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices   [open pdf - 6MB]

"We conducted this audit because OIG [Office of Inspector General] had identified ensuring the safety and effectiveness of medical devices and fostering a culture of cybersecurity as top management challenges for HHS [Health and Human Services]. We also considered public and Congressional interest in medical device cybersecurity risks to patients and the Internet of Things. The Food and Drug Administration (FDA) is the HHS operating division responsible for assuring that legally marketed medical devices are safe and effective. Our objective was to determine the effectiveness of FDA's plans and processes for timely communicating and addressing cybersecurity medical device compromises in the postmarket phase."

Report Number:
A-18-16-30530
Publisher:
Date:
2018-10
Copyright:
Public Domain
Retrieved From:
Government Publishing Office: http://www.gpo.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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