What is the difference between PHI and Consumer Health Information?

The test is pretty simple: if your device or application currently shares or will share the user’s personal health data held in the app or device with a covered entity such as a doctor then you are dealing with protected health information and need HIPAA compliance software.

If you are building a wearable device or application that collects health information, but is not intended to share date with a covered entity at any point in time then you do not need to be HIPAA compliant.

For example, the Nike FuelBand is not HIPAA compliant because it does not track data considered protected health information because you can’t transmit that data from the device to a covered entity.