House bill HR7084-117

Energy and Commerce Committee

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

• Last activity on Mar 16, 2022

• Introduced Mar 15, 2022

• By Rep. Burgess, Michael C. [R-TX-26]

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Main Subject: Health

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.

S3983-117, HR7667-117,

House committee actions Actions

Committee
Mar. 16 2022	Referred to the Subcommittee on Health.

House floor actions Actions

IntroReferral
Mar. 15 2022	Referred to the House Committee on Energy and Commerce.

Library of Congress Actions

IntroReferral
Mar. 15 2022	Introduced in House Introduced in House

House bill HR7084-117

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

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