Medtech & Devices

FDA proposes updated cybersecurity recommendations to help ensure device manufacturers are adequately addressing evolving cybersecurity threats

Cybersecurity threats and vulnerabilities in todays modern medical devices are evolving to become more apparent and more sophisticated, posing new potential risks to patients and clinical operations, said FDA Commissioner Scott Gottlieb, M.D. The FDA has been working to stay a step ahead of these changing cybersecurity vulnerabilities, including engaging with external stakeholders. In this

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FDA to include cybersecurity bill of materials in medical device premarket guidance

As part of a series of announcements around medical device cybersecurity, FDA Commissioner Scott Gottlieb, M.D., said the agency plans to update premarket guidance in the coming weeks to recommend that manufacturers include a cybersecurity “bill of materials.” The agency also issued a new “playbook” for health systems responding to an attack.

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FDA Reveals Steps to Bolster Medical Device Cybersecurity

In a statement Monday, FDA Commissioner Scott Gottlieb, M.D., says the efforts are aimed at addressing growing cybersecurity threats and potential related patient safety worries for network-connected medical devices.”As the number of cyberattacks has increased, we’ve heard concerns about the potential for cybercriminals to attack patient medical devices,” Gottlieb says.Cybersecurity researchers continue to identify device

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Wireless and Scanning The Clarius Portable Ultrasound Review

We strongly believe that only digital health can bring healthcare into the 21st century and make patients the point-of-care. Can you imagine making an ultrasound scan on your kitchen table? No need for a doctors appointment, no waiting time, no travel costs. With the appearance of pocket-sized and user-friendly diagnostic devices, such as the Clarius

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Can a Watch Be a Medical Device?

For example, is it theoretically possible that the ECG results from the watch could be intercepted via the internet and then altered to potentially change a diagnosis?But security experts emphasize that this type of risk must be weighed against the potential life-saving benefits of the new consumer technology. And the Food and Drug Administration says

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FDA to Ramp Up Medical Device Cybersecurity Scrutiny

The Department of Health and Human Services’ Office of Inspector General’s report recommends that FDA better integrate the review of cybersecurity in the agency’s processes for premarket assessments of medical devices.In a statement provided to Information Security Media Group, FDA says it’s taking steps to bolster its “already robust premarket review of networked medical devices.”

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