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  • Perspective
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The health risks of generative AI-based wellness apps


Artificial intelligence (AI)-enabled chatbots are increasingly being used to help people manage their mental health. Chatbots for mental health and particularly ‘wellness’ applications currently exist in a regulatory ‘gray area’. Indeed, most generative AI-powered wellness apps will not be reviewed by health regulators. However, recent findings suggest that users of these apps sometimes use them to share mental health problems and even to seek support during crises, and that the apps sometimes respond in a manner that increases the risk of harm to the user, a challenge that the current US regulatory structure is not well equipped to address. In this Perspective, we discuss the regulatory landscape and potential health risks of AI-enabled wellness apps. Although we focus on the United States, there are similar challenges for regulators across the globe. We discuss the problems that arise when AI-based wellness apps cross into medical territory and the implications for app developers and regulatory bodies, and we outline outstanding priorities for the field.

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Fig. 1: Generative AI multiplies edge cases.
Fig. 2: The continuum from constrained to unconstrained solutions.

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I.G.C. was supported in part by a Novo Nordisk Foundation grant for a scientifically independent International Collaborative Bioscience Innovation & Law Programme (Inter-CeBIL Programme, grant no. NNF23SA0087056).

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Correspondence to I. Glenn Cohen.

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I.G.C. serves on the bioethics advisory board of Illumina and on the bioethics council of Bayer and is an advisor to World Class Health. He was also compensated for speaking at events organized by Philips with the Washington Post and attending the Transformational Therapeutics Leadership Forum organized by Galen/Atlantica, and was retained as an expert in health privacy, reproductive technology and gender-affirming care lawsuits.

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De Freitas, J., Cohen, I.G. The health risks of generative AI-based wellness apps. Nat Med 30, 1269–1275 (2024).

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