Healthy Technology Act of 2023

• Authority: United States Congress
• Parent authority: Federal government
• Jurisdiction: United States
• Collections: U.S. federal laws
• Most recent activity: Defunct
• Most recent activity date: 2025-01-03

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
• 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 authorizing AI to prescribe drugs, which touches on system safety (7.3 lack of robustness), governance (6.5), and potentially human-computer interaction (5.1 overreliance). Coverage is very limited as this is a short enabling statute rather than a comprehensive risk mitigation framework.

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
• Public Administration (excl. National Security)

All other sectors had no coverage in this document.

Sectors Summary

The document primarily governs the Health Care and Social Assistance sector by authorizing AI/ML technologies to prescribe pharmaceutical drugs. It also has implications for the Information sector (AI/ML technology developers) and Professional and Technical Services (companies developing healthcare AI solutions).

Legislative Status

Hard Law

Legislative Status Summary

This is a binding federal statute (Act of Congress) that amends the Federal Food, Drug, and Cosmetic Act to create new legal definitions and requirements. It uses mandatory language and creates legally enforceable obligations through FDA regulatory pathways.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Entities: United States Congress
• Summary: The document is titled as an Act and references Congressional authority to amend federal law. The authority is listed as 'United States Congress' in the document information.

Target

• Entity Types: AI_Developer, AI_Deployer
• Entities: Developers and deployers of artificial intelligence and machine learning technologies for pharmaceutical prescription
• Summary: The Act applies to entities developing and deploying AI and machine learning technologies that prescribe pharmaceutical drugs, requiring them to obtain FDA approval and state authorization.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA); State authorities
• Summary: The FDA is responsible for approving, clearing, or authorizing AI/ML technologies under specified sections, while State authorities must authorize prescription capabilities pursuant to state statutes.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA); State regulatory authorities
• Summary: The FDA monitors compliance through its existing medical device and drug regulatory framework (sections 510(k), 513, 515, 564), while state authorities monitor compliance with state prescription laws.

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 covers the Deploy stage by establishing authorization requirements for AI/ML technologies to prescribe drugs. It implicitly touches on Verify and Validate through FDA approval requirements, and Operate and Monitor through ongoing state authorization requirements.

Technical Scope

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

• Task-specific AI

Technical Scope Summary

The document explicitly mentions both 'artificial intelligence' and 'machine learning technology' as the technologies authorized to prescribe drugs. It does not specify whether these are general purpose, task-specific, generative, or predictive AI, nor does it mention models, systems architecture, compute thresholds, or open-source considerations.