Maintaining Innovation and Safe Technologies Act

• 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

All other risk subdomains had no coverage in this document.

Risk Coverage Summary

This document has minimal risk domain coverage, focusing narrowly on Medicare payment guidance for AI-enabled remote monitoring devices in healthcare. It does not substantively address AI risks, harms, or safety measures beyond establishing a payment 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.

• Agriculture, Mining, Construction & Manufacturing
• Professional & Technical Services
• Public Administration (excl. National Security)

All other sectors had no coverage in this document.

Sectors Summary

This document primarily governs the Health Care and Social Assistance sector, specifically addressing Medicare payment for AI-enabled remote monitoring devices used in patient care. It also has implications for the Manufacturing sector (medical device manufacturers) and potentially Professional and Technical Services (healthcare providers using these devices).

Legislative Status

Hard Law

Legislative Status Summary

This is a binding legislative act from the United States Congress that mandates the Secretary of Health and Human Services to issue guidance by a specific deadline, using mandatory language ('shall') and establishing legal obligations.

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 a Congressional bill enacted by the Senate and House of Representatives, as indicated in the enacting clause.

Target

• Entity Types: AI_Developer, AI_Deployer, AI_Infrastructure_Provider
• Entities: Manufacturers and providers of remote monitoring devices with AI components; continuous glucose monitor manufacturers
• Summary: The document targets entities that produce and provide remote monitoring devices with AI components, such as continuous glucose monitors, that transmit health data to providers for patient management.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: Secretary of Health and Human Services; Department of Health and Human Services
• Summary: The Secretary of Health and Human Services is explicitly directed to issue guidance and establish payment requirements, giving this entity enforcement authority over Medicare payment compliance.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: Secretary of Health and Human Services; Centers for Medicare & Medicaid Services
• Summary: The Secretary of Health and Human Services, through Medicare administration, will monitor compliance with payment requirements for AI-enabled remote monitoring devices.

AI Lifecycle Stages

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

• Deploy
• Operate and Monitor

AI Lifecycle Summary

The document focuses primarily on the Deploy and Operate and Monitor stages of the AI lifecycle, as it addresses payment requirements for AI-enabled devices that are already in use and transmitting patient data to healthcare providers. There is minimal coverage of earlier lifecycle stages.

Technical Scope

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

• AI Systems
• Task-specific AI

Technical Scope Summary

The document explicitly mentions AI components in the context of remote monitoring devices but does not define or distinguish between AI models, AI systems, or specific types of AI. It uses general terminology referring to 'artificial intelligence component' without technical specifications or compute thresholds.