Anvisa issues alert on health monitoring via smartwatches and wearables

The Brazilian Health Regulatory Agency (Anvisa) has issued an alert regarding the use of smartwatches, smart rings, and other wearable devices for health purposes. The agency emphasizes that while these devices can monitor data such as sleep quality, heart rate, and blood oxygen levels, they are primarily designed as wellness accessories or sports aids and cannot replace professional medical evaluations.

Anvisa clarifies that devices intended to support diagnoses, track diseases, or measure clinical parameters—such as blood pressure, glucose levels, oximetry, electrocardiograms, or irregular heart rhythm notifications—must undergo specific regulatory processes to ensure safety and accuracy. The agency warns that relying solely on wearable data to indicate the presence or absence of health issues is insufficient and potentially dangerous, noting that incorrect measurements, such as in glucose monitoring, could lead to improper medical decisions.

In the consumer market, various wearable options are currently available, including Samsung Galaxy models featuring AI-driven health analysis, the Samsung Galaxy Fit3, and Xiaomi’s Redmi Watch 5 Active, which offer features ranging from stress monitoring to heart rate tracking.