Diabetes 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 to no coverage of AI risk domains. It is a healthcare policy document focused on Medicare coverage for diabetes technologies and does not address AI-specific risks. While it mentions algorithms in automated insulin delivery systems as medical devices requiring reimbursement, it does not discuss risks associated with AI systems such as discrimination, security vulnerabilities, misinformation, or system safety failures.

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.

• Information
• Scientific Research & Development Services
• Educational Services

All other sectors had no coverage in this document.

Sectors Summary

This document primarily governs the Health Care and Social Assistance sector, specifically Medicare coverage and reimbursement for diabetes technologies. It also has implications for the Scientific Research and Development Services sector regarding innovation in automated insulin delivery systems, and the Information sector regarding algorithms and software used in medical devices.

Legislative Status

Hard Law

Legislative Status Summary

This is a proposed federal statute (bill) from the United States Congress that would create binding legal obligations on the Secretary of Health and Human Services and establish enforceable Medicare coverage requirements. The document uses mandatory language throughout ('shall') and would have the force of law if enacted.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Summary: The document is a bill proposed by Congress, as indicated by the opening text 'Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled'.

Target

• Entity Types: AI_Governance_Actor, AI_Developer
• Summary: The document targets government agencies responsible for Medicare administration and healthcare providers who must certify diabetes technology use. It also implicitly targets developers of automated insulin delivery systems whose algorithms/software will be separately reimbursed under the new framework.

Enforcer

• Entity Types: AI_Governance_Actor
• Summary: The Secretary of Health and Human Services is given enforcement authority through rulemaking, guidance issuance, and oversight of Medicare administrative contractors. The document also references audit and oversight entities that will ensure compliance.

Monitor

• Entity Types: AI_Governance_Actor
• Summary: The Comptroller General is tasked with assessing barriers to diabetes technology access and reporting to Congressional committees. The Secretary collaborates in this monitoring effort.

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 deployment and operational monitoring stages of AI lifecycle for algorithms in automated insulin delivery systems. It focuses on ensuring Medicare reimbursement for deployed algorithms/software and establishing certification processes for ongoing use, rather than development, testing, or validation stages.

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 algorithms and software as components of automated insulin delivery systems. It does not use standard AI terminology like 'AI models' or 'AI systems' but refers to medical device algorithms that learn user behavior. There is no mention of frontier AI, general purpose AI, foundation models, generative AI, or compute thresholds.