6/1/2020
The Brazilian Health Regulatory Agency (Anvisa) has approved two applications for measuring heart rate, on May 25th.
The products were developed by Apple and registered in Brazil by Emergo Brazil Import. According to the Anvisa, these softwares help to monitor data related to user health through the Apple Watch.
One of the apps is the Irregular Rhythm Notification Feature, which performs data analysis of irregular and faster heart rhythms. This application will occasionally look at your heartbeat to check for an irregular rhythm that might be suggestive of atrial fibrillation (AFib).
The second application is similar to an electrocardiogram (ECG) and works in a similar way to a traditional heart rate test. So, it is able to create, record, store, transfer and display the heartbeat, identifying the occurrence of an arrhythmia.
Anvisa guidelines on applications
These softwares fall into the category of medical devices risk class II (medium risk). In this sense, the agency provides guidelines for the use of both of them:
- Applications should not replace traditional methods of diagnosing or treating heart disease;
- The electrocardiogram data should be for informational use only, requiring the evaluation of a qualified health professional;
- The electrocardiogram produced by the application is not for clinical use and cannot be used as a basis for diagnosis or treatment of heart disease;
- All notifications registered by the software must be reviewed by the qualified health professional for clinical decision making;
- Any cardiac discomfort should not be based on the aid of the applications, with the assistance of a qualified health professional being relevant;
- The arrhythmias evaluated by the RNRI devices are limited to the detection of only two types of arrhythmia, atrial fibrillation (AFib) and normal heart beat rhythm;
- Apple Watch is unable to collect data when the user is close to electromagnetic fields, such as anti-theft systems and metal detectors, among others;
- The application must also not be used by people under 22 years of age.
Our Regulatory team is at your disposal to deal with doubts related to this subject and other matters.
