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FDA Proposes Cybersecurity Guidelines for Medical Devices

Stakeholders have 90 days to submit comments to the FDA

Ken Miller
Mon, 02/22/2016 - 16:42
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I wrote last month about the need to increase security for imaging devices in hospitals. The devices I cited store both personal and medical information about patients and should be subject to standard security measures. Very often they are not.

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Last month the U.S. Food and Drug Administration (FDA) issued proposed guidelines for post-market management of cybersecurity in medical devices. The guidelines provide best practices for assessing and managing cybersecurity vulnerabilities in medical devices and include situations involving both hacker access to patient records and hacker access to the devices themselves. Although a hacker’s ability to access our private information is alarming, it’s even more distressing to consider a hacker’s ability to increase or decrease IV drips, alter pacemaker functions, or change settings on an imaging device.

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