Items filtered by date: January 2016 - Stern Security

Top 10 Highlights of FDA’s Draft Guidance on Cybersecurity in Medical Devices

Background
On January 22nd, 2016, the Food and Drug Administration released a draft guidance document titled “Postmarket Management of Cybersecurity in Medical Devices”.  (Food and Drug Administration).  This important document addresses the need for security throughout the lifecycle of several medical devices.  Improving medical device security is a subset of President Obama’s February 19th, 2013 Executive Order 13636 – “Improving Critical Infrastructure Cybersecurity”.  

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