Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act 2025 (Section 217 "Report on Wearable Medical Devices")

• 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
• 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 mentions of AI system safety (7.3 - lack of robustness) and human-computer interaction (5.1 - overreliance). The focus is on assessing capabilities and limitations rather than governing specific risks. Coverage is limited to 2-3 subdomains at minimal levels.

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.

• Scientific Research & Development Services

All other sectors had no coverage in this document.

Sectors Summary

The document primarily governs the Health Care and Social Assistance sector through its focus on wearable medical devices used in clinical decision-making. It also has minimal coverage of Scientific Research and Development Services through the mandated technology assessment.

Legislative Status

Hard Law

Legislative Status Summary

This is a binding legislative provision enacted by the United States Congress that mandates the Comptroller General to conduct a technology assessment and submit a report to Congress within a specified timeframe.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Entities: United States Congress
• Summary: The document is Section 217 of the Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act 2025, which is enacted by the United States Congress as the legislative authority.

Target

• Entity Types: AI_Developer, AI_Deployer
• Entities: Developers and users of wearable medical devices
• Summary: The assessment targets wearable medical devices used in clinical decision-making, which would be developed by medical device manufacturers and deployed by healthcare providers.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: United States Congress
• Summary: Congress has oversight authority over the Comptroller General and receives the mandated report, providing implicit enforcement through its legislative and oversight powers.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: Comptroller General of the United States; Government Accountability Office
• Summary: The Comptroller General is explicitly tasked with conducting the technology assessment and monitoring the capabilities and limitations of wearable medical devices.

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 lifecycle stages with primary focus on deployment and operational monitoring of wearable medical devices. It covers the use of AI models in clinical settings, validation of treatment accuracy, and ongoing assessment of capabilities and limitations.

Technical Scope

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

• AI Systems

Technical Scope Summary

The document explicitly mentions artificial intelligence in the context of augmenting wearable medical device capabilities. It focuses on AI systems used in clinical decision-making but does not specify particular AI model types, compute thresholds, or distinguish between frontier, general purpose, or task-specific AI.