Preserving Telehealth, Hospital, and Ambulance Access Act, Sec. 105 (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
• Lack of transparency or interpretability

All other risk subdomains had no coverage in this document.

Risk Coverage Summary

The document has minimal coverage of risk domains, primarily addressing AI system safety and limitations (7.3, 7.4) through its focus on assessing capabilities and limitations of wearable medical devices. There is implicit coverage of human-computer interaction risks (5.1) related to clinical decision-making reliance. The document is primarily a mandate for assessment rather than regulation of specific risks.

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
• Information
• 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 implications for the Scientific Research and Development Services sector through the technology assessment mandate, and potentially the Information sector given the AI and data processing components of wearable medical devices.

Legislative Status

Hard Law

Legislative Status Summary

This is a binding legislative provision enacted by the United States Congress that creates a mandatory reporting obligation on the Comptroller General with specific deadlines and requirements.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Entities: United States Congress
• Summary: The document is a section of an Act passed by the United States Congress, which has the legislative authority to enact such provisions.

Target

• Entity Types: AI_Developer, AI_Deployer
• Summary: The document indirectly targets developers and deployers of wearable medical devices that use AI for clinical decision-making, though it does not impose direct obligations on them. The assessment will examine their products and practices.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: United States Congress
• Summary: Congress has oversight authority over the Comptroller General and will receive the report, giving it enforcement authority over the reporting requirement.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: Comptroller General of the United States; Government Accountability Office
• Summary: The Comptroller General (head of the GAO) 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 AI lifecycle stages with primary focus on Verify and Validate (assessment of capabilities and limitations) and Operate and Monitor (examining devices used in clinical settings). It also implicitly covers Build and Use Model through examination of AI augmentation capabilities, and Plan and Design through policy options for development.

Technical Scope

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

• Predictive AI
• Task-specific AI

Technical Scope Summary

The document explicitly mentions artificial intelligence in the context of wearable medical devices but does not define or distinguish between AI models, AI systems, or specific types of AI. It focuses on AI's role in augmenting clinical decision-making capabilities without specifying technical architectures or compute thresholds.