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US FDA warns of cyber threats to medical devices

Most of the infections are reportedly due to malicious software, or malware.

By CBR Staff Writer

The US Food and Drug Administration (FDA) has urged manufacturers of medical devices and medical facilities to improve security to defend against potential cyber threats that could manipulate the devices or patient privacy.

The US FDA warned that hackers with malicious intentions could launch malware into the equipment, thus gaining access to configure settings in medical devices or hospital networks.

FDA Center for Devices and Radio-logical Health deputy director for science William Maisel was cited by Reuters as saying that over the past year, the agency is increasingly aware of cyber security vulnerabilities in incidents reported.

"Hundreds of medical devices have been affected, involving dozens of manufacturers," Maisel said.

Most of the infections are reportedly due to malicious software, or malware.

According to the FDA report, there are 300 medical devices that are vulnerable to cyber attacks, such as insulin pumps, implantable cardioverter defibrillators, anesthesia devices, drug infusion pumps, ventilators, and pacemakers.

Some of the listed devices can also be remotely accessed via the Internet, the FDA report said.

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The report also revealed some devices incorporate embedded computer systems that are configurable and are interconnected through hospital networks, the Internet, smart phones and other medical equipment that upload data to manufacturers.

FDA is also working with other US agencies and manufacturers responsible for being alert about detecting risks and hazards linked to their medical devices.

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