The Food and Drug Administration (FDA) recently released industry guidance for the postmarket management of cybersecurity in medical devices. We are pleased to see the FDA address medical device cybersecurity given the increasing frequency and severity of cyberattacks against healthcare organizations. A recent report shows cyberattacks against healthcare organizations increased 63% in 2016, a trend expected to continue in 2017. Medical device cybersecurity is an urgent issue we must address to help protect healthcare organizations from dangers such as ransomware and data breaches. However, while the recently released FDA guidance provides good recommendations for the primary medical device market, it overlooks a large, growing segment of medical devices: the secondary market.
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