Privacy and Data Protection Policies for Wearable Devices in Monitoring Mental Health Conditions

Wearable devices such as smartwatches, fitness trackers, and EEG headbands have become powerful tools for continuous monitoring of mental health conditions, including depression, anxiety, bipolar disorder, and stress, by collecting physiological signals (heart rate variability, skin conductance, sleep patterns) and behavioral data (activity, voice analysis); however, the sensitive nature of mental health data raises profound privacy and data protection concerns, particularly when devices are used outside clinical settings. This narrative review synthesizes regulatory frameworks, ethical guidelines, empirical studies, and policy analyses up to December ۲۰۲۵, revealing that while GDPR in Europe, CCPA in California, and HIPAA in the United States provide some baseline protections, most countries—including Iran—lack specific legislation addressing mental health data generated by consumer wearables. Current policies often classify such data as “health data” only when processed by medical professionals, leaving consumer-grade devices in a regulatory grey zone where manufacturers rely on vague privacy policies, opt-in consent, and self-reported data minimization. Risks include unauthorized data sharing with third parties (advertisers, insurers, employers), re-identification from aggregated datasets, and misuse for discrimination or profiling. Empirical evidence shows that ۷۰–۸۵% of users are unaware of data-sharing practices, and ۶۰–۷۵% express concern over mental health data being used against them. Facilitators include emerging standards such as ISO/IEC ۲۷۷۰۱ for privacy management, the EU AI Act’s high-risk classification for mental health AI, and voluntary frameworks like the MHRA’s Digital Mental Health Code of Conduct. Recommendations emphasize enacting mental health-specific legislation, mandating privacy-by-design, requiring explicit granular consent for sensitive inferences, enforcing data localization in vulnerable jurisdictions, and establishing independent oversight bodies. Without robust, tailored policies, the transformative potential of wearable mental health monitoring risks being undermined by breaches of trust and ethical violations.

کلیدواژه ها:

Wearable devices ، Mental health monitoring ، Privacy policies ، Data protection ، GDPR ، Sensitive health data.