Advanced Safe Testing at Residence Telehealth Act of 2023, Sec. 2 ("Coverage and Payment for Certain Tests and Assistive Telehealth Consultations; Demonstration Program Under Certain State Medicaid Programs")

• 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.

• Unequal performance across groups
• Compromise of privacy
• 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 limited focus on privacy (2.1) and system safety (7.3). The document primarily addresses healthcare delivery mechanisms and payment structures rather than AI-specific risks. Coverage is concentrated in privacy concerns related to demographic data collection and potential system reliability issues with AI-driven medical devices.

Sector coverage

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

• Health Care & Social Assistance
• Public Administration (excl. National Security)

Minimal coverage — Brief mention but no specific mitigations, recommendations or governance measures relating to the sector are described.

• Trade, Transportation & Utilities
• Information
• Accommodation, Food & Other Services

All other sectors had no coverage in this document.

Sectors Summary

The document primarily governs the Health Care and Social Assistance sector through Medicare and Medicaid programs. It also has secondary coverage of the Information sector through telecommunications and telehealth services requirements.

Legislative Status

Hard Law

Legislative Status Summary

This is a binding federal statute establishing a Medicare demonstration program with mandatory requirements, specific payment structures, enforcement through reimbursement eligibility, and clear regulatory authority delegated to the Secretary of Health and Human Services.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Summary: This is federal legislation enacted by Congress, as indicated by the document title 'Advanced Safe Testing at Residence Telehealth Act of 2023' and the legislative structure amending the Social Security Act.

Target

• Entity Types: AI_Deployer, AI_Developer
• Summary: The document targets Medicare Advantage organizations that deploy AI-driven medical devices and telehealth systems, as well as developers of medical devices incorporating AI, machine learning, and software as a medical device (SaMD) technologies.

Enforcer

• Entity Types: AI_Governance_Actor
• Summary: The Secretary of Health and Human Services has primary enforcement authority through payment mechanisms, reimbursement eligibility requirements, and program administration. The FDA maintains approval authority for covered medical devices.

Monitor

• Entity Types: AI_Governance_Actor
• Summary: The statute mandates independent third-party evaluation of the demonstration program with specific evaluation objectives and reporting requirements to Congress.

AI Lifecycle Stages

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

• Collect and Process Data
• Verify and Validate
• Deploy
• Operate and Monitor

AI Lifecycle Summary

The document primarily addresses the Deploy and Operate and Monitor stages of the AI lifecycle for medical devices. It establishes coverage and payment mechanisms for AI-driven wearable devices and SaMD technologies that have already been approved by the FDA, focusing on their deployment in Medicare Advantage plans and ongoing monitoring through independent evaluation.

Technical Scope

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

• AI Models
• AI Systems
• Task-specific AI

Technical Scope Summary

The document explicitly mentions AI systems (wearable patient monitoring devices with AI), machine learning, and software as a medical device (SaMD). It does not mention frontier AI, general purpose AI, foundation models, or compute thresholds. The focus is on task-specific AI applications in medical diagnostics and monitoring.