Anvisa warns smart rings and watches cannot replace medical diagnosis

The Brazilian National Health Surveillance Agency (Anvisa) has issued an alert regarding the use of smartwatches and smart rings for health monitoring. While these devices can track indicators such as sleep quality, heart rate, and blood oxygenation, Anvisa emphasizes that the data provided should not replace professional medical evaluations or clinical exams.

The agency warns that information from these devices must not be used to confirm or rule out diseases, define treatments, or alter medication. There is a specific risk regarding inaccurate results for parameters used in clinical decisions; for instance, incorrect glucose readings could lead to improper insulin use. Currently, Anvisa notes there are no smartwatches or rings authorized for non-invasive glucose or oximetry measurements.

Regulatory requirements depend on the device's intended purpose. Products marketed solely for wellness or sports support do not require Anvisa regulation. However, equipment or software presented as tools for medical diagnosis, monitoring, or clinical decision-making is subject to specific sanitary regulations. Anvisa also oversees the software used to analyze sensor data, noting that no medical software is currently regulated specifically to use only data from smart rings.