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Digital Mental Health Tools and AI Therapy Chatbots

A Balanced Approach to Regulation

Bibliographic Data

ID20334609
AuthorsAmitabha Palmer (0000-0001-6362-4935), David Schwan (0000-0002-7142-7293)
Year2025
Volume55
Issue3
Pages15-29
Publication date2025-05-01
Open AccessYes
TypeARTICLE
VenueThe Hastings Center Report (JOURNAL)
Journal identifiersISSN: 0093-0334 • E-ISSN: 1552-146X
PublisherWiley (PUBLISHER • GB)
DOI10.1002/hast.4979
PMID40557918
OpenAlexW4411652176
LanguageEN
Citations received3
References cited27

Digital mental health tools (DMHTs) offer a potential solution to overcoming economic, cultural, and geographic barriers to the increasing demand for mental health care, but their adoption raises significant ethical, legal, and social concerns. This article identifies ethical risks related to DMHTs and, in this light, proposes three important criteria for evaluating regulatory approaches. These approaches should (a) ensure widespread access and (b) balance access with risk management while (c) acknowledging preexisting markets and digital self‐medication. Our analysis of three regulatory models—the laissez‐faire approach, a highly regulated approach, and the current U.S. Food and Drug Administration approach—reveals that none satisfactorily balances the promise of access with ethical risks. We therefore suggest modifications to the current FDA approach; these involve a voluntary certification program for nonprescription DMHTs, more‐stringent data safety and privacy practices, easily accessible diagnostic tools, continuous monitoring, and independent audits. These modifications secure the accessibility benefits of DMHTs while mitigating risks associated with widespread use

Audit · Balance (ability) · Business · Certification · Food and drug administration · Internet privacy · Mental health · Political science · Psychiatry · Public relations · Risk analysis (engineering) · Accounting · Computer Science · Digital Mental Health Interventions · Medicine · Neuroethics, Human Enhancement, Biomedical Innovations

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  • Governance of Direct‐to‐User Digital Mental Health Tools

    Open Access•Om D Panda, Charles E Binkley•The Hastings Center Report•2025

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    Open Access•Aditya Nrusimha Vaidyam, Hannah Wisniewski et al.•The Canadian Journal of Psychiatry•2019

  • Acceptability of artificial intelligence (AI)-led chatbot services in healthcare

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  • Cultural Identity and the Expression of Depression

    Open Access•Melissa Xue‐Ling Chang, Jolanda Jetten et al.•Journal of Community & Applied…•2016

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Citations per year3
Citation span2025 - 2026 (2)
Highly citedNo

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Open DOIOpen Access
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