Already this year, major medtech makers including BD, Insulet and Zoll Medical have all alerted their customers to cybersecurity vulnerabilities in their medical devices that could potentially compromise sensitive health information or other personal data.
Hoping to prevent any such breaches is the FDA, which will now require medical device makers to submit information about their cybersecurity efforts alongside applications for regulatory clearance of their devices. The new requirements went live Wednesday, as a $1.7 trillion federal omnibus spending bill took effect, though the FDA said in an accompanying guidance that it doesn’t intend to begin enforcing them until Oct. 1, at which point devicemakers will “have had sufficient time” to adjust to the guidelines…..continue reading this article here
Article by: Andrea Park
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