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www.fdanews.com/articles/145854-nist-panel-fda-should-regulate-device-cybersecurity-hacking-risks

NIST Panel: FDA Should Regulate Device Cybersecurity, Hacking Risks

April 24, 2012
The potential for hacking into software-operated medical devices could pose a serious patient safety risk, a board convened by the National Institute of Standards and Technology (NIST) maintains. But industry downplays the likelihood of problems. A lack of cybersecurity measures means that devices could be hacked into or infected with viruses, Daniel Chenok, chairman of the NIST’s Information Security and Privacy Advisory Board (ISPAB), said in a March 30 letter to Office of Management and Budget (OMB) Acting Director Jeffrey Zients.
Devices & Diagnostics Letter