Healthy Technology 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: 2025-01-07

Risk subdomain coverage

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

• Overreliance and unsafe use
• Loss of human agency and autonomy
• Governance failure
• 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 brief implicit mentions of approximately 3-4 subdomains. The primary focus is on legal authorization for AI prescribers rather than risk mitigation. Limited implicit coverage relates to AI system safety (7.3), governance frameworks (6.5), and potentially human-computer interaction risks (5.1, 5.2).

Sector coverage

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

• Health Care & Social Assistance

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

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

All other sectors had no coverage in this document.

Sectors Summary

This legislation primarily governs the Health Care and Social Assistance sector by authorizing AI/ML technologies to prescribe drugs. It also has implications for the Information sector (AI/ML technology developers) and Professional and Technical Services sector (healthcare IT systems). The Scientific Research and Development Services sector is implicitly governed through FDA approval requirements.

Legislative Status

Hard Law

Legislative Status Summary

This is a binding federal statute proposed to amend existing law (Federal Food, Drug, and Cosmetic Act) with mandatory legal obligations enforceable through existing FDA regulatory mechanisms.

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 explicitly identifies Congress as the proposing body through the standard legislative enactment clause.

Target

• Entity Types: AI_Developer, AI_Deployer
• Summary: The legislation targets entities that develop and deploy artificial intelligence and machine learning technologies for drug prescription purposes. These would be AI developers creating the prescription systems and healthcare deployers implementing them.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA); State authorities
• Summary: The FDA is explicitly referenced as the federal enforcement body through its approval/clearance/authorization mechanisms under specific sections. State authorities are also enforcers through their statutory authorization requirements.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA); State authorities
• Summary: The FDA and state authorities would monitor compliance through their existing regulatory oversight mechanisms for medical devices and practitioner licensing, though specific monitoring provisions are not detailed in this brief amendment.

AI Lifecycle Stages

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

• Verify and Validate
• Deploy
• Operate and Monitor

AI Lifecycle Summary

The document primarily addresses the Deploy stage by establishing legal authorization for AI/ML prescription technologies. It implicitly covers Verify and Validate through FDA approval requirements, and Operate and Monitor through ongoing state authorization requirements. The focus is on deployment authorization rather than development processes.

Technical Scope

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

• AI Models
• AI Systems
• Task-specific AI

Technical Scope Summary

The document explicitly mentions both artificial intelligence and machine learning technologies as the systems being regulated. It does not specify particular AI types (frontier, general purpose, task-specific, etc.) or technical thresholds. The focus is on AI/ML systems capable of prescribing drugs.