FDA guidance tackles medical device cybersecurity issues

FDA outlines cybersecurity recommendations for medical device manufacturers
The Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to monitor, identify and address cybersecurity vulnerabilities once devices enter the market.

The FDA says cybersecurity threats are a growing concern and present a potential risk to the safety and effectiveness of medical devices. Although controls can be included in the design of new products to help prevent these risks, the evolving nature of cyber threats calls for more diligence regarding maintaining and upgrading products to continually protect them against risk.

Recommendations made in the draft guidance include adopting a coordinated vulnerability disclosure policy and practice, and understanding, assessing and detecting the presence and impact of vulnerability. The draft guidance is open for public comment.

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Joint Commission posts new resources on Physical Environment Portal
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