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Purpose <p>Artificial intelligence will continue to become more central within mental healthcare delivery, but not without hazards, necessitating policy that ensures public health is at the forefront of innovation. This paper examines the existing policy landscape for regulating mental health uses of artificial intelligence. The paper reviews and examines existing policies from the Food and Drug Administration (FDA), Federal Trade Commission (FTC), Center for Medicare and Medicaid Services (CMS), and individual US states and then considers how these fit together.</p> Findings <p>The FDA, CMS, FTC, and individual states are simultaneously moving forward with policy proposals and enforcement actions largely independent of one another but with significant overlapping regulatory jurisdictions. Policy on mental health uses for AI have been developed in a patchwork manner and are a lower regulatory priority than medical AI uses.</p> Summary <p>While innovation in mental health AI marches forward, there is a lack of mental health specific regulatory schema, and a lack of communication between government stakeholders. This leaves mental health AI in a place of regulatory uncertainty with hazards for patients and providers alike. The authors propose a coordinated policy hub for mental health AI, a Center for Collaborative AI in Behavioral Health (C-CAIBH), which can modulate between these different government stakeholders, other policymakers, industry, clinicians, and patients.</p>

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Policy in Flux: Addressing the Regulatory Challenges of AI Integration in US Mental Health Services

  • 期刊论文

  • 发表日期：

    2025年6月16日

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  • Kelila Kahane,
  • J. Nicholas Shumate,
  • John Torous

摘要

Purpose

Artificial intelligence will continue to become more central within mental healthcare delivery, but not without hazards, necessitating policy that ensures public health is at the forefront of innovation. This paper examines the existing policy landscape for regulating mental health uses of artificial intelligence. The paper reviews and examines existing policies from the Food and Drug Administration (FDA), Federal Trade Commission (FTC), Center for Medicare and Medicaid Services (CMS), and individual US states and then considers how these fit together.

Findings

The FDA, CMS, FTC, and individual states are simultaneously moving forward with policy proposals and enforcement actions largely independent of one another but with significant overlapping regulatory jurisdictions. Policy on mental health uses for AI have been developed in a patchwork manner and are a lower regulatory priority than medical AI uses.

Summary

While innovation in mental health AI marches forward, there is a lack of mental health specific regulatory schema, and a lack of communication between government stakeholders. This leaves mental health AI in a place of regulatory uncertainty with hazards for patients and providers alike. The authors propose a coordinated policy hub for mental health AI, a Center for Collaborative AI in Behavioral Health (C-CAIBH), which can modulate between these different government stakeholders, other policymakers, industry, clinicians, and patients.