American Medical Innovation and Investment Act of 2024 (Sec. 5)

• 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.

• Lack of capability or robustness

All other risk subdomains had no coverage in this document.

Risk Coverage Summary

The document has minimal coverage of risk domains, with brief implicit references to AI system safety (7.3) through requirements for payment guidance on medical devices. The focus is on establishing payment mechanisms rather than addressing AI risks directly.

Sector coverage

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

• Health Care & Social Assistance

All other sectors had no coverage in this document.

Sectors Summary

The document exclusively governs the Health Care and Social Assistance sector, specifically addressing Medicare payment requirements for AI-enabled remote monitoring devices used in patient management and treatment. No other economic sectors are regulated by this provision.

Legislative Status

Hard Law

Legislative Status Summary

This is a binding legislative provision 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 under the Social Security Act.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Entities: United States Congress
• Summary: The document is identified as a section of an Act of Congress, indicating that the United States Congress is the proposing authority for this legislative provision.

Target

• Entity Types: AI_Developer, AI_Deployer, AI_Infrastructure_Provider
• Entities: manufacturers and providers of remote monitoring devices with AI components; healthcare providers
• Summary: The guidance applies to entities that manufacture, provide, or use remote monitoring devices with AI components (such as continuous glucose monitors) that transmit information to healthcare providers for patient management and treatment.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: Secretary of Health and Human Services; Centers for Medicare & Medicaid Services (implied)
• Summary: The Secretary of Health and Human Services is explicitly mandated to issue guidance on Medicare payment requirements, which would be enforced through existing Medicare payment administration mechanisms.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: Secretary of Health and Human Services; Centers for Medicare & Medicaid Services (implied)
• Summary: The Secretary of Health and Human Services, through existing Medicare administration mechanisms, would 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 primarily addresses the Deploy and Operate and Monitor stages of the AI lifecycle, as it focuses on payment requirements for AI-enabled medical devices that are already in use and transmitting patient data to healthcare providers. There is no coverage of earlier stages like planning, data collection, or model building.

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 AI components in the context of remote monitoring devices but does not use specific terminology like AI models, AI systems, or any specialized AI categories. It refers to 'artificial intelligence component' in a general, functional manner without defining compute thresholds or model types.