Tag Archives: FDA

Interesting viewpoints from this Journal of the American Medical Association article on FDA’s August 2017 notice re: cyber security issues with certain pacemakers, including:

• “This first widespread cybersecurity advisory involving a permanent medical device implant provides some insight into the ways in which the public experience with these types of medical device malfunctions might be improved.”
• “Communications regarding widely used products for which multiple vendors exist in the marketplace should serve as opportunities to highlight current FDA and industry standards,…

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Last week, the HHS Office of Inspector General released a damning report on FDA’s data security:  “The objective of this review was to determine whether the FDA’s network and external Web applications were vulnerable to compromise through cyber attacks.”  In short, they were vulnerable:

Overall, FDA needed to address cyber vulnerabilities on its computer network. Although we did not obtain unauthorized access to the FDA network,… More