Will the expanding 'wearables' industry target mental health next?

By Anastasia Climan, RDN, CD-NFact-checked by Davi ShermanPublished February 23, 2026

Industry Buzz

The risks are the same as with any other provision of health services: privacy, security and adequacy of the services provided … advertising and liability as well.

—Robin Feldman, JD

The past decade has seen a steady rise in wearable devices, which range from fitness trackers to medical monitoring devices. As the technology becomes more sophisticated, some wearables have even been approved by the FDA. ^[]

Recent regulatory changes and a growing public focus on mental health may mean more “trackers” that go beyond a workout’s calorie burn. Here’s how this shift could impact mental healthcare.

Government regulation of wearables

A major catalyst for this shift is recent changes to FDA guidance that have eased regulatory requirements for certain digital health tools.

In January 2026, the FDA updated its guidance on Clinical Decision Support Software. ^[] This update stated that noninvasive wearable devices designed for wellness purposes won’t require traditional FDA approval.

Qualifying devices can’t make any diagnostic or treatment claims. This move reflects a risk-based regulatory approach meant to spur innovation while protecting consumers.

Potential benefits

Traditional psychiatric care relies on periodic visits: a patient sees a clinician on a scheduled basis and adjusts treatment based on the patient’s subjective recall and on brief snapshots of their behavior.

However, wearables capture continuous data on everyday life: They can measure multiple metrics, such as heart rate variability, sleep disturbances, and activity levels, which can correlate with emotional states and stress responses.

Early research suggests that the use of wearables is associated with reduced psychological distress. ^[] While wearing the device, users are more likely to engage in self-care and to perceive themselves as more health-conscious.

AI and predictive capabilities

Beyond stress and sleep, some startups and academic research are exploring sensor-based digital health technologies (sDHTs). ^[] These devices can track signals related to emotional states, anxiety, and mood disorders in real time.

AI and machine learning are being used to interpret patterns that might precede clinical symptoms. Ideally, the future of wearables will offer early warning signals before a mental health crisis happens.

Remaining hurdles

The FDA’s relaxed stance applies to wellness wearables, not to devices that diagnose, treat, or manage psychiatric conditions. ^[]

High-risk AI-enabled mental health tools that make autonomous clinical recommendations are still subject to full oversight. Several states in the US have moved to restrict the use of AI in mental health treatment. ^[]

Data privacy and clinical validation are other obstacles. Mental health data are deeply personal, and existing privacy laws like HIPAA don’t always cover consumer wearables. ^[]

“The risks are the same as with any other provision of health services: privacy, security and adequacy of the services provided … advertising and liability as well,” said Robin Feldman, JD, Arthur J. Goldberg Distinguished Professor of Law and director of the AI Law & Innovation Institute at University of California Law San Francisco. ^[]

Additionally, health systems have yet to establish standards for integrating wearable mental health data into clinical workflows without overwhelming providers or risking mistakes.

Despite these challenges, the path ahead seems pretty clear. As sensors improve, AI becomes more sophisticated, and regulatory frameworks continue to adapt, wearables may increasingly be used to target mental health. The first likely step is to monitor wellness via stress, sleep, and other lifestyle metrics.

Whether clinical care follows remains to be seen. So far, the FDA’s loosening of regulations for low-risk devices is a significant step toward a stronger focus on personal well-being.

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