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Governance of Direct‐to‐User Digital Mental Health Tools

Emphasizing Transparency over Paternalism

Bibliographic Data

ID20334268
AuthorsOm D Panda, Charles E Binkley (0000-0001-9290-9876)
Year2025
Volume55
Issue3
Pages29-33
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.5009
PMID40557920
OpenAlexW4411652260
LanguageEN
Citations received1
References cited11

Digital mental health tools are increasingly used outside traditional clinical settings, creating an engagement paradigm beyond the existing regulatory scope, as noted by Amitabha Palmer and David Schwan in their article “Digital Mental Health Tools and AI Therapy Chatbots: A Balanced Approach to Regulation.” Introducing the direct‐to‐user concept (which concerns individuals as autonomous agents navigating self‐regulation, enhancement, and meaning making), we propose a shift from paternalism and rigid standards critiqued by Palmer and Schwan toward a human‐centered governance approach in which radical transparency, individual agency, and shared accountability are themselves the standards. Transparency enables informed choice through intelligible disclosure of data, validity, and incentives, which empower users to assess trade‐offs based on personal goals and values. Evolving accountability frameworks, such as voluntary certification with collective liability, reinforce the scalability and ethics of this model, which can also be broadly applied to other digital health tools and cognitive‐enhancement technologies. This governance framework fosters individualized, participatory ecosystems to make this new generation of tools more accessible

Accountability · Agency (philosophy) · Business · Computer security · Corporate governance · Data science · Digital health · Economics · Engineering ethics · Health care · Incentive · Knowledge management · Mental health · Participatory sensing · Paternalism · Political science · Public relations · Sociology · Transparency (behavior) · Computer Science · Digital Mental Health Interventions · Engineering · Ethics and Social Impacts of AI · Neuroethics, Human Enhancement, Biomedical Innovations · Psychology

  • Ethical issues in multi-agent AI systems for healthcare

    Open Access•Zhibin Xie, Hongyu Wang et al.•Frontiers in Public Health•2026

  • Barriers to and Facilitators of User Engagement With Digital Mental Health Interventions

    Open Access•Judith Borghouts, Elizabeth V Eikey et al.•Journal of Medical Internet…•2021

  • Digital Mental Health Tools and AI Therapy Chatbots

    Open Access•Amitabha Palmer, David Schwan•The Hastings Center Report•2025

  • Who, If Not the FDA, Should Regulate Implantable Brain-Computer Interface Devices

    Open Access•Charles E Binkley, Michael S Politz et al.•The AMA Journal of Ethic•2021

Citations per year1
Citation span2026 - 2026 (1)
Highly citedNo

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