Diagnostics Testing Preparedness Plan Act of 2025

Bill Number

H.R. 1108

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-02-07: Referred to the House Committee on Energy and Commerce.

Last Updated

2025-06-16T11:33:14Z

AI-Generated Summary

Purpose

The Diagnostics Testing Preparedness Plan Act of 2025 aims to strengthen the United States' readiness for public health emergencies by requiring the Secretary of Health and Human Services (HHS) to create and maintain a comprehensive plan for quickly developing, approving, producing, acquiring, and distributing diagnostic tests. This focuses on threats like chemical, biological, radiological, nuclear risks, or emerging infectious diseases that could trigger a public health emergency declaration.

Key Provisions

• Development of the Plan: The HHS Secretary must create a publicly available plan outlining processes for the rapid development, validation (scientific confirmation of accuracy), authorization (official approval for use), manufacturing, procurement (purchasing), distribution, and scaling of diagnostic tests during emergencies.
• Purposes of the Plan:
• Promote the creation and use of diagnostic tests.
• Detail step-by-step procedures for rapid testing processes and capacity expansion.
• Encourage teamwork between government and private sector groups to speed up testing during crises.
• Required Considerations in the Plan:
• Building domestic testing capabilities, including through public-private partnerships.
• Incorporating new technologies like high-throughput lab tests (high-volume processing), point-of-care tests (quick results at clinics or sites), and at-home tests to make testing more accessible and efficient.
• Addressing supply chain needs for testing equipment, materials, and parts, including potential shortages.
• Strategies for fast distribution at local, regional, or national levels, and scaling lab capacity.
• Evaluating these strategies through practice drills and exercises.
• Coordination Requirements: The Secretary must work with industry players (e.g., device makers, labs, distributors), state and local governments, Indian Tribes, and other relevant groups to develop and implement the plan.
• Capacity Building: HHS can enter contracts with public and private organizations to boost U.S.-based capabilities for test development and distribution, especially to state, local, and Tribal health departments for immediate emergency responses.
• Deadlines:
• Initial plan must be publicly released within one year of the bill's enactment.
• Plan must be updated at least every three years thereafter.

Significant Changes to Existing Law

This bill completely rewrites Section 319B of the Public Health Service Act (42 U.S.C. 247d-2), replacing its prior content with a more detailed and actionable framework. Previously, this section addressed general coordination for countermeasures in emergencies; the new version shifts focus specifically to diagnostic testing preparedness, adding mandatory planning, technology integration, supply chain assessments, and regular updates to address gaps exposed in past emergencies like COVID-19.

Potential Impacts

• On Government Agencies: HHS will face new responsibilities for plan development, coordination, and contracting, potentially increasing administrative workload but improving emergency response efficiency. State, local, and Tribal health departments could gain better access to tests and resources.
• On Citizens: Faster and more accessible diagnostic testing during outbreaks could lead to quicker disease detection, isolation, and treatment, reducing public health risks and saving lives. It may also enhance equity in testing access through at-home and point-of-care options.
• On International Relations: While primarily domestic, the plan could indirectly support global health efforts by strengthening U.S. capacity to handle cross-border threats like pandemics, potentially aiding international collaborations without direct foreign policy changes.

Main Stakeholders Affected

• Federal Government: Primarily HHS and its Secretary, along with agencies involved in public health emergencies (e.g., CDC, FDA for validation and authorization).
• State, Local, and Tribal Entities: Health departments that will receive support for testing during emergencies.
• Private Sector: Diagnostic test manufacturers, clinical and reference labs, medical distributors, and technology developers who must collaborate and may secure contracts for capacity building.
• Public: Citizens and healthcare providers benefiting from improved testing availability.

Notable Legal, Constitutional, or Political Implications

• Legal: The bill builds on existing emergency powers under the Public Health Service Act without expanding them, ensuring processes align with FDA authorization standards. It promotes transparency through public plan releases, which could invite legal challenges if implementation lags deadlines.
• Constitutional: No direct conflicts; it supports the federal government's role in public health under the Commerce Clause (regulating interstate threats) and general welfare promotion.
• Political: Emphasizes proactive preparedness, likely motivated by lessons from recent pandemics, fostering bipartisan support (as seen in cosponsors from both parties). It could influence future emergency funding debates but avoids partisan mandates.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Miller-Meeks, Mariannette [R-IA-1]

Cosponsors (3)

Rep. Schrier, Kim [D-WA-8], Rep. Crenshaw, Dan [R-TX-2], Rep. Carson, André [D-IN-7]

Recent Actions

• 2025-02-07: Referred to the House Committee on Energy and Commerce.
• 2025-02-07: Introduced in House
• 2025-02-07: Introduced in House

Bill Versions

• Diagnostics Testing Preparedness Plan Act of 2025 — issued 2025-02-07 — PDF (5 pages)