Guidance advises manufacturers on how to continue monitoring the devices once they are sold.
The US Food and Drug Administration (FDA) has issued guidelines on post-market cybersecurity monitoring of medical devices as a follow-up to the 2014 pre-market guidance, Information Security Media Group (ISMG) reports.
The FDA’s guidelines are voluntary, and outline steps for manufacturers to continue ensuring cybersecurity of the devices after marketing and improving critical infrastructure cybersecurity via the National Institute of Standards and Technology standards.
The guidance comes in the wake of the recent controversy surrounding allegations by Muddy Waters Capital and MedSec Holdings that pacemaker devices manufactured by St. Jude Medical had cybersecurity flaws.
“Central to these recommendations is FDA’s belief that medical device manufacturers should implement a structured and comprehensive program to manage cybersecurity risks,” says FDA’s Suzanne Schwartz, adding the agency will continue to work on providing further advisories when needed.
Kevin Fu of Virta Laboratories said the guidance “responds to many of the medical device security issues highlighted in reports by the National Academies and the NIST Information Security and Privacy Advisory Board over the last six years.”
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