To amend the Federal Food, Drug, and Cosmetic Act to require, for purposes of ensuring cybersecurity, the inclusion in any premarket submission for a cyber device of information to demonstrate a reasonable assurance of safety and effectiveness throughout the lifecycle of the cyber device, and for other purposes.
Protecting and Transforming Cyber Health Care Act of 2022 or the PATCH Act of 2022
This bill requires premarket applications for cyber devices (i.e., medical devices that include software or connect to the internet) to include information relating to cybersecurity, including plans to monitor for cybersecurity risks and address vulnerabilities through regular product updates.
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