FDA finalizes guidelines on medical device, patient data security

October 1, 2014

In a move to bolster the health care sector's security regarding patient data and medical devices, the U.S. Food and Drug Administration (FDA) has finanlized guidance meant to better protect patient health and personal information.

The new guidelines, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” are aimed at manufacturers in the hope that they will consider any cybersecurity risks posed to medical devices during the “design and development” stages of production, according to a recent release.

The guidance also recommends that documentation be sent to the FDA on “the risks identified and controls in place to mitigate” them, in addition to plans regarding “patches and updates to operating systems and medical software.”

The health care sector has been plagued with cybersecurity issues, many attributed to personnel issues.
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