HEARTS Act of 2025

• Authority: United States Congress
• Parent authority: Federal government
• Jurisdiction: United States
• Collections: U.S. federal laws
• Most recent activity: Proposed
• Most recent activity date: 2025-02-13

Risk subdomain coverage

Minimal coverage — Brief mention but no specific mitigations, recommendations or governance measures relating to the risk subdomain are described.

• Lack of capability or robustness

All other risk subdomains had no coverage in this document.

Risk Coverage Summary

The document has minimal coverage of AI risk domains, with only subdomain 7.3 (Lack of robustness) receiving a score above 1. The primary focus is on animal research alternatives and the development of AI as a tool for biomedical research, rather than addressing AI-specific risks. The document mentions AI as one of several innovative nonanimal research methods but does not address the risks associated with AI systems themselves.

Sector coverage

Good coverage — Comprehensive governance measures or mitigations with clear procedures relating to the sector are explicitly described.

• Scientific Research & Development Services
• Public Administration (excl. National Security)

Minimal coverage — Brief mention but no specific mitigations, recommendations or governance measures relating to the sector are described.

• Educational Services
• Health Care & Social Assistance

All other sectors had no coverage in this document.

Sectors Summary

The document primarily governs the Scientific Research and Development Services sector, specifically biomedical and behavioral research conducted or funded by the National Institutes of Health. It also has implications for the Health Care and Social Assistance sector through its impact on medical research, and the Public Administration sector as it regulates federal agencies conducting research.

Legislative Status

Hard Law

Legislative Status Summary

This is a proposed federal statute (bill) that, if enacted, would create binding legal obligations on the National Institutes of Health and federally funded research entities. The document uses mandatory language throughout ('shall') and establishes specific requirements, reporting obligations, and institutional structures with legal force.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Entities: United States Congress; Senate and House of Representatives of the United States of America
• Summary: The document is explicitly proposed by Congress as indicated in the opening text 'Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled.' This is a federal legislative proposal.

Target

• Entity Types: AI_Governance_Actor, AI_Developer
• Entities: National Institutes of Health (NIH); federally funded researchers; covered reporting entities (any entity that receives Federal funds for research or testing and uses animals in research and testing); Federal department or agency that uses animals in research or testing
• Summary: The Act targets the NIH and all federally funded research entities that conduct animal research. It requires them to prioritize nonanimal methods including AI, report animal usage, and develop reduction plans. The Act also applies to federal departments and agencies conducting research.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: Secretary (of Health and Human Services); National Center for Alternatives to Animals in Research and Testing; Director of the National Center
• Summary: The Secretary is mandated to establish the National Center, whose Director has enforcement responsibilities including establishing standardized reporting processes, collecting information, and overseeing compliance with reporting requirements.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: National Center for Alternatives to Animals in Research and Testing; Director of the National Center
• Summary: The National Center is explicitly tasked with collecting information on animal usage in federally funded research and making it publicly available. Covered entities must report to the Center and update their reports every two years to measure progress in reducing animal use.

AI Lifecycle Stages

Lifecycle stages covered by the documents, as defined in the OECD Framework for the Classification of AI Systems

• Plan and Design
• Build and Use Model
• Verify and Validate
• Deploy
• Operate and Monitor

AI Lifecycle Summary

The document addresses multiple AI lifecycle stages with primary focus on Build and Use Model (developing AI as a nonanimal research method) and Deploy (implementing AI methods in research settings). It also covers Plan and Design through research proposal guidelines, and Operate and Monitor through ongoing reporting and progress tracking requirements.

Technical Scope

Terms relating to technical scope that are mentioned or implicitly referenced in the document

No technical scope terms identified.

Technical Scope Summary

The document explicitly mentions AI (artificial intelligence) as one of several innovative nonanimal research methods but does not provide detailed definitions or classifications of AI types. It does not mention AI models, AI systems, frontier AI, general purpose AI, task-specific AI, foundation models, generative AI, predictive AI, open-weight models, or compute thresholds. The focus is on AI as a research tool rather than AI governance per se.