The Food and Drug Administration ( FDA) has rules and guidelines for the regulation of wearable devices in certain conditions. Wearables for health monitoring has grown substantially in recent years and this might cause some privacy issues.
There are 3 main things that physicians need to keep in mind when it comes to health applications.
Be aware of an app or device’s regulatory status before recommending it to patients
Be aware of an app or device’s regulatory status before recommending it to patients
Help patients understand the information they receive
The general Fitbit type device for general consumers is not regulated but if specific health-focused application/devices provide recommendations and even a diagnosis there must be regulations according to the FDA.
See previous related articles on the privacy of data and HIPPA compliant wearables:
http://brightersight.ca/eds-blog/health-wearables-over-privacy/
http://brightersight.ca/eds-blog/hipaa-compliant-wearables/
Read more about FDA approvals for wearables: