Regulating Mental Health Wearables: Compliance, Validation, and Market Potential

What’s Driving the Demand for Mental Health Technology?

Globally, the prevalence of mental health conditions, including stress, depression and anxiety, has dramatically grown since the COVID-19 pandemic. However, many people delay or avoid getting treatment because of judgement, lack of access, cost, or lack of interest. Around 3.76% of people worldwide suffer from anxiety, an estimate that has been largely stable since 1990.

According to the World Health Organisation (WHO), depression affects about 264 million people worldwide, is a major cause of disability, and raises the risk of suicide if neglected. Depression affects one’s physical and mental well-being, increasing the risk of diseases including diabetes, heart disease, and stroke. Whether it occurs during specific seasons (seasonal depression) or after childbirth (postpartum depression), it places a significant strain on people and health care systems.

The rising financial, social, and psychological consequences of mental disorder are putting more and more pressure on healthcare practitioners to embrace innovative technology that can improve patient outcomes, detection, and care. Wearable technology is beginning to address treatment gaps in places with limited psychiatric resources. It offers quick, convenient, and adaptable alternatives for tracking and assisting with mental health care.

How Do Wearables Support Mental Health Care?

According to a UK study, wearables are tiny, sensor-equipped devices which are worn on or placed near to the human body will impact up to 80% of patient treatments by 2040, underscoring their revolutionary potential in the fields of mental health and other medical specialities. These gadgets have the ability to continuously track, maintain, collect and share the health data in real time, including vital information on mood, heart-rate variability (HRV), emotional stress, sleep, and galvanic skin response (GSR), all of which can be challenging to track with desktops or smartphones. As a result, wearable technology for mental health can be a helpful complement to conventional therapy, giving patients greater control over their issues and giving therapists access to more useful data.

How Are Mental Health Wearables Classified?

Wearable sensors can be classified based on a number of factors. First, “signal type” refers to the type of data gathered, which might include physical signals like light, noise, or electrical impulses as well as chemical signals like sweat. Second, signal origin makes a distinction between data generated internally by the body, such as blood pressure, and data obtained from external sources. Third, the body position of the sensor determines whether it is worn on the skin, brain, or heart, based on the measurement that is needed. Fourth, continuity describes how often data is recorded. Some sensors, such as the electrocardiogram (ECG), record readings continuously, while others do so relatively less often. It is necessary to understand these classifications in order to design wearables that offer accurate and meaningful health tracking.

What Are the Benefits of Mental Health Wearables?

Smartwatches, smart wristbands, neckbands, and even virtual reality headsets are some of the devices being studied to monitor symptoms, detect potentially deteriorating warning signs, promote treatment compliance, and personalise treatment strategies. Recent studies indicate that wearable sensors are becoming more and more popular among researchers as viable tools for monitoring mental health.

According to a study reported in Frontiers in Digital Health, emotion-sensing wearables provide continuous mental health support when combined with technological solutions and counselling, leading to improvements in overall quality of life and a reduction of depression and anxiety of over 50%. Smart, artificial intelligence (AI)-driven wearable device with sensors like electroencephalogram (EEG) is increasingly being utilised to evaluate mental health issues in people with neurological disorders to aid in detection and therapy. Additionally, it monitors blood pressure, activity level, and sleeping patterns. These wearables enhance reliability and accuracy, which helps clinicians diagnose mental health conditions in people of all ages.

Combining wearable technology and telemedicine can enable patients obtain psychological treatment from the comfort of their own homes, especially those who reside in distant regions or have mobility challenges. This method facilitates the evaluation of mental health over time, encourages adherence to prescribed drugs and treatments, and enables personalised digital therapy.

But there are drawbacks as well, like concerns about privacy and data security, and the potential loss of in-person interactions, which are often crucial for delivering quality mental health care. It is essential to combine digital and conventional methods, safeguard sensitive data, and guarantee fair access in order to make full use of this approach.

What Compliance Standards Apply to Mental Health Devices?

Although wearable technology for mental health holds significant promise, there are numerous practical, ethical, and legal obstacles to overcome.

Wearables with a health focus, whether for heart issues or mental health, are found where medical science, technology, and regulation meet. According to the Food and Drug Administration (FDA), any item sold as a gadget for tracking, diagnosing, or treating a condition qualifies as a medical device in the US. Before becoming available in the market, this classification places strict standards on clinical evidence, safety testing, labelling, and ongoing monitoring.

The Medical Device Regulation (MDR 2017/745) in Europe imposes similar strict requirements and links CE mark approval to strong General Data Protection Regulation (GDPR) protections. For a wearable to be marketed for medical usage, users’ personal information must be protected.

Security and privacy concerns are an additional burden in both areas. Devices handling sensitive health data must follow by Health Insurance Portability and Accountability Act (HIPAA) in the US and GDPR in Europe, especially when it comes to cloud storage, international transfers, and data sharing with medical professionals. Without strong protections and explicit user authorisation, the data could be hacked, misused, or used for financial gain. Non-compliance can hinder patient and doctor trust and prevent access to public health services or insurance coverage.

Additionally, there are significant ethical concerns with ongoing surveillance. Although constant monitoring can aid in care, but it can also make users feel pressurised or watched, which might make them feel more anxious rather than less. It is crucial to have clear, informed consent, as well as the option to withdraw. Equity and accessibility are other barriers. People with low incomes, who are often the groups most in need of mental health support, may not be able to afford many wearables because of their high cost and dependence on smartphones or access to the web. Some wearables eliminate the requirement for constant internet access by storing data locally and only periodically transferring it to smartphones or the cloud.

Lastly, adhering to regulatory requirements is one of the main issues of technological devices. Unlike standard wellness applications, medical-grade wearables capable of diagnosing or treating ailments must comply to strict medical device regulations. Although these standards provide clinical confidentiality and reliability, but they also lengthen the time, cost, and complexity of development.

Can Wearables Transform Global Mental Health Care?

Wearable devices for mental health are developing quickly, despite its early stages. These solutions are evolving from straightforward data tracking to proactive, tailored assistance. Wearables can be integrated with electronic health records, telehealth services, and even virtual reality therapies to enable personalised digital interventions, remote mentoring, and real-time doctor notifications. Developments in artificial intelligence and machine learning may make it possible to forecast emergencies, such as the probability of self-harm. If there is more supporting data, stronger privacy regulations, and greater user acceptability, wearables could improve outcomes and close major gaps in mental health care globally.

References

Şahin Tokatlıoğlu, T., Oflaz, F. and Semiz, B. (2025). Wearable Technologies and Psychiatry: Strengths, Weaknesses, Opportunities, and Threats Analysis. Cyprus Journal of Medical Sciences. doi:https://doi.org/10.4274/cjms.2025.2024-60.

Hassan, L., Milton, A., Sawyer, C., Casson, A.J., Torous, J., Davies, A., Bernalyn Ruiz-Yu and Firth, J. (2025). Utility of Consumer-Grade Wearable Devices for Inferring Physical and Mental Health Outcomes in Severe Mental Illness: Systematic Review. JMIR Mental Health, [online] 12,
pp.e65143–e65143. doi:https://doi.org/10.2196/65143.

Borghare, P.T., Methwani, D.A. and Pathade, A.G. (2024). A Comprehensive Review on Harnessing Wearable Technology for Enhanced Depression Treatment. Cureus, [online] 16(8). doi:https://doi.org/10.7759/cureus.66173.

Alhejaili, R. and Alomainy, A. (2023). The Use of Wearable Technology in Providing Assistive Solutions for Mental Well-Being. Sensors (Basel, Switzerland), [online] 23(17), p.7378. doi:https://doi.org/10.3390/s23177378.

Gomes, N., Pato, M., Lourenço, A.R. and Datia, N. (2023). A Survey on Wearable Sensors for Mental Health Monitoring. Sensors, [online] 23(3), p.1330. doi:https://doi.org/10.3390/s23031330.

Aashay Kekatpure, Faye, A., Deepa Sangolkar, Ahluwalia, I., Kadam, S. and Kale, Y. (2024). Wearable devices in psychiatry: A novel way of mental health monitoring. AIP conference proceedings, [online] 3188, pp.080034–080034. doi:https://doi.org/10.1063/5.0245012.

O’Hara, D. (2021). Wearable technology for mental health. [online] Apa.org. Available at: https://www.apa.org/members/content/wearable-technology.

Brönneke, J.B., Müller, J., Mouratis, K., Hagen, J. and Stern, A.D. (2021). Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring. Sensors, 21(14), p.4937.

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.