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HB 1816

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2025 Regular Session Introduced by Ellen McLaughlin

Arkansas HB 1816 would bar health providers and insurers from using AI in care or medical records unless FDA-approved and verified by a quality-assurance lab.

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Bill Summary · HB 1816

Summary — HB 1816 (2025)

Status: Died in Committee (introduced January 10, 2025)
Primary sponsor: Rep. L. Johnson

Purpose / Intent

The bill would broadly prohibit healthcare providers and healthcare insurers from using artificial intelligence (AI) in delivering health care services or in generating medical records unless two conditions are met: (1) the AI is approved by the U.S. Food and Drug Administration (FDA) and (2) the AI is verified by a “quality assurance laboratory.” The apparent intent is to limit deployment of AI in clinical care and records to systems that have undergone federal regulatory approval and independent verification.

Key provisions

  • Adds a new section to Arkansas Code Title 17, Chapter 80 (proposed 17-80-123).
  • Definitions:
    • “Artificial intelligence” — machine-based systems that make predictions, recommendations, or decisions for human-defined objectives.
    • “Health benefit plan” — broadly defined to include individual, group, indemnity, managed care plans, and state-funded programs (explicitly includes Arkansas Medicaid and the "Arkansas Health and Opportunity for Me" program), with enumerated exclusions (e.g., dental-only, vision-only, long-term-care-only, etc.).
    • “Healthcare insurer” — insurers, hospital/medical service corporations, HMOs issuing health benefit plans in the state (with similar exclusions).
    • “Healthcare provider” — any individual or entity licensed in the state to provide healthcare services.
    • “Quality assurance laboratory” — an entity/facility that tests and evaluates AI performance for accuracy, reliability, safety, and ethical considerations.
  • Operative requirement (subsection (b)): A healthcare provider or insurer shall not use AI in care delivery or for generation of medical records unless the AI is FDA-approved and verified by a quality assurance laboratory.

Who would be affected

  • Healthcare providers licensed in the state.
  • Healthcare insurers issuing health benefit plans in the state, including state-funded programs (e.g., Medicaid).
  • Patients receiving care that currently (or in future) relies on AI-driven decision support, documentation tools, or automated record-generation.
  • AI developers/vendors, and independent testing/verification labs (market for QA verification).
  • Regulators and procurement entities within state programs.

Potential impacts and considerations

  • Operational: Would restrict use of many clinical AI tools (clinical decision support, automated documentation/transcription, triage/chatbots, imaging/diagnostic aids) until FDA approval and third‑party verification are obtained.
  • Compliance costs: Insurers/providers and AI vendors may face additional testing, verification, and administrative costs; may slow adoption of AI innovations.
  • Ambiguities: The bill does not specify accreditation standards or recognition criteria for “quality assurance laboratories,” timelines for verification, enforcement mechanisms, or penalties for noncompliance.
  • Regulatory overlap: Requiring FDA approval may be redundant for some AI types already subject to other regulatory frameworks (e.g., tools classified as medical devices vs. non-device clinical decision support).
  • Patient safety vs. access tradeoffs: Could increase assurance of safety/accuracy but also delay deployment of beneficial tools.

Procedural history (selected)

  • Introduced: January 10, 2025.
  • Committee activity included hearings and a committee substitute considered in March 2025; testimony recorded and matter left pending.
  • Withdrawn by author on April 14, 2025; official status recorded as Died In Committee.

Note: The provided document bundle contains text fragments and entries from other bills and jurisdictions (including an unrelated Illinois HB 1816 and an initial bill title referencing an appropriation for Hinds County). The summary above focuses on the Arkansas-draft text that would add 17-80-123 and regulate AI use in healthcare.

Compiled from official sources — confirm details with the bill’s official record.

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