Medical device manufacturers tackle cybersecurity.

PositionCYBERSECURITY

It appears medical devices are not immune to the risks associated with cyber attacks. After all, many medical devices contain configurable embedded computer systems that can be vulnerable to breaches.

Although the U.S. Federal Drug Administration (FDA) is not aware of any targeted devices or of any injury or death as a result of a cyber attack, it said it has become aware of cybersecurity vulnerabilities and incidents that could directly impact medical devices or hospital network operations.

"Over the last year, we've seen an uptick that has increased our concern," said William Maisel, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health. "The type and breadth of incidents has increased."

He said officials used to hear about problems only once or twice a year, but "now we're hearing about them weekly or monthly."

The Department of Homeland Security (DHS), which is working with the FDA to reduce these vulnerabilities, recently received reports from two researchers that found potential weaknesses in 300 medical devices produced by about 50 vendors, an official told DelawareOnline.

The FDA has been working closely with DHS and other agencies and manufacturers to identify, communicate, and mitigate vulnerabilities and incidents as they are identified, but the agency is asking device manufacturers to do more.

Specifically, the FDA recommends that manufacturers "review their cyber-security...

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