Bill
Bill > HR7084
summary
Introduced
03/15/2022
03/15/2022
In Committee
03/16/2022
03/16/2022
Crossed Over
Passed
Dead
01/03/2023
01/03/2023
Introduced Session
117th Congress
Bill Summary
A BILL To amend the Federal Food, Drug, and Cosmetic Act to require, for purposes of ensuring cybersecurity, the inclu- sion 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.
AI Summary
This bill, the Protecting and Transforming Cyber Health Care Act of 2022 or the PATCH Act of 2022, amends the Federal Food, Drug, and Cosmetic Act to require medical device manufacturers to include information in their premarket submissions demonstrating a reasonable assurance of safety and effectiveness throughout the lifecycle of the device, particularly with respect to cybersecurity. The bill establishes minimum cybersecurity requirements, such as having a plan to monitor and address post-market vulnerabilities, implementing a coordinated vulnerability disclosure process, and providing updates and patches to address known vulnerabilities. The Secretary is authorized to establish exemptions and can find a device's cybersecurity information inadequate, leading to a determination of non-substantial equivalence. The bill also makes the failure to comply with these cybersecurity requirements a prohibited act and an adulteration or misbranding of the device.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (2)
Last Action
Referred to the Subcommittee on Health. (on 03/16/2022)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/117th-congress/house-bill/7084/all-info |
| BillText | https://www.congress.gov/117/bills/hr7084/BILLS-117hr7084ih.pdf |
| Bill | https://www.congress.gov/117/bills/hr7084/BILLS-117hr7084ih.pdf.pdf |
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