On October 2, 2014, the Food and Drug Administration (FDA) released a final guidance document titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”.  The FDA said that the “need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected devices, and the frequent electronic exchange of medical device-related health information.”  The FDA defines cybersecurity as “the process of preventing unauthorized access, modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.”  The cybersecurity of medical devices gained media attention last year when former Vice President Dick Cheney revealed that his doctor had the wireless function of Cheney’s implanted defibrillator replaced due to fears that a terrorist could hack the device and assassinate the Vice President. 

The guidance document identifies cybersecurity issues that manufacturers should consider when designing and developing their medical devices and information they should include when preparing their FDA medical device premarket submissions.Continue Reading FDA Releases Final Guidance on Cybersecurity in Medical Devices, Public Workshop to Follow on October 21-22, 2014