HR 1108119th CongressIn Committee

Diagnostics Testing Preparedness Plan Act of 2025

Introduced: Feb 7, 2025

Standard Summary

Comprehensive overview in 1-2 paragraphs

H.R. 1108, the Diagnostics Testing Preparedness Plan Act of 2025, would amend the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to develop, publicly release, and regularly update a comprehensive plan for rapidly developing, validating, authorizing, manufacturing, procuring, and distributing diagnostic tests during public health emergencies. The plan would cover scenarios involving chemical, biological, radiological, or nuclear threats and emerging infectious diseases that could trigger or threaten a declared public health emergency. The bill aims to improve coordination among government, industry, state and local authorities, tribes, and private entities to ensure rapid testing capacity and accessibility, including adoption of new technologies and robust supply chains. The Secretary would have authority to contract with public or private partners to build domestic testing capacity. A public release is due within one year of enactment, with updates at least every three years thereafter. In short, the bill seeks to institutionalize a formal, regularly updated playbook for fast, scalable diagnostic testing in emergencies, with an emphasis on domestic capacity, new testing technologies, efficient distribution, and public-private collaboration.

Key Points

1Diagnostic Testing Preparedness Plan mandatory: The Secretary must develop, publicly release, and update a comprehensive plan for rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, plus scaling testing capacity during emergencies.
2Triggers and scope: The plan applies to chemical, biological, radiological, or nuclear threats and emerging infectious diseases that could cause or threaten a public health emergency declared under the Public Health Service Act.
3Purposes and processes: The plan should facilitate test development and use, describe streamlined processes across development to distribution, and promote coordination among public and private entities to speed testing during emergencies.
4Considerations for implementation: The plan must consider domestic capacity (including partnerships with public/private entities), novel testing technologies and platforms (high-throughput lab diagnostics, point-of-care, and at-home tests), medical supply needs and vulnerabilities, and strategies for rapid distribution and scalable laboratory capacity, with drills/exercises to assess these strategies.
5Coordination and capacity building: The Secretary should coordinate with industry, laboratories, distributors, states, local governments, and Tribes, and may contract with public or private entities to increase domestic testing capacity for immediate public health response.

Impact Areas

Primary group/area affected: U.S. public health system (HHS, state/local health departments, tribal health), diagnostic test manufacturers, clinical and reference laboratories, and medical product distributors. The bill shapes planning, coordination, and capacity-building activities that directly affect how tests are developed, authorized, manufactured, and distributed during emergencies.Secondary group/area affected: The general public (through better access to testing during emergencies), healthcare providers who rely on diagnostic testing, and the broader supply chain (equipment, supplies, and component parts) associated with testing.Additional impacts: Potentially faster and more centralized coordination across public and private sectors in emergency responses; increased emphasis on domestic manufacturing capacity; requirements for transparency and ongoing evaluation through drills and exercises to ensure readiness. The bill does not specify funding, but it authorizes contracting for capacity building, which could have budgetary implications in future appropriations.

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