Enhanced Medical Device Safety: New Cybersecurity Requirements for Manufacturers.
New regulations aim to improve the safety of medical devices that use software or connect to the internet. Manufacturers will be required to ensure their cybersecurity throughout the device's lifecycle, reducing risks to patient safety. Citizens can expect their medical devices to be better protected against security vulnerabilities.
Key points
Manufacturers of medical devices must actively monitor and fix security vulnerabilities.
Regular software updates and patches will be required to protect devices from new threats.
Manufacturers must provide a list of all software components used in the device, increasing transparency.
Devices that fail to meet new cybersecurity requirements may be deemed substantially inequivalent or adulterated, preventing sale.
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