Diagnostics Testing Preparedness Plan Act of 2025
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
This bill directs the Department of Health and Human Services (HHS) to create and maintain a plan for quickly developing and distributing diagnostic tests in response to public health emergencies, such as chemical, biological, radiological, or nuclear threats, or emerging infectious diseases. The plan must consider domestic testing capacity, new technologies, and medical supply needs, and it will be updated every three years. HHS will coordinate with various entities, including manufacturers, laboratories, and state and local governments, to ensure effective implementation.
Key provisions
- Requires HHS to develop and publish a diagnostic testing preparedness plan.
- The plan must address rapid development, validation, authorization, manufacture, procurement, and distribution of tests.
- The plan should consider domestic testing capacity, novel technologies, and medical supply needs.
- HHS must coordinate with industry, states, localities, Tribes, and other relevant entities.
- The Secretary can contract with entities to increase domestic capacity for diagnostic testing.
- The initial plan must be released within one year of enactment.
- The plan must be updated at least every three years.
Who is affected
- Department of Health and Human Services (HHS)
- Medical Device Manufacturers
- Clinical and Reference Laboratories
- State and Local Governments
- Tribal Health Departments
Bill text
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