PHI, Medical Devices, And Wellness Apps: Navigating The Blurred Lines Of Connected Health

The regulatory and privacy distinctions between medical devices and wellness apps are increasingly ambiguous, creating risks and responsibilities for manufacturers. While connected health tools now collect medical-adjacent data at a vast scale, determining if this information qualifies as protected health information (PHI) depends on factors beyond what is collected, including how the product is marketed and whether it involves a covered entity.

The core difference between a medical device and a wellness tool hinges on its intended use. Medical devices are intended for diagnosis, treatment, or prevention of disease and are FDA-regulated, generating PHI subject to HIPAA. Wellness apps, intended for general fitness or lifestyle support, are generally unregulated by the FDA and the data they generate is not PHI under HIPAA, though it is still sensitive personal information subject to various state and federal privacy laws.

As wellness features become more clinically adjacent, developers must implement robust safeguards like encryption and secure deletion, and provide clear, transparent privacy communications to meet consumer expectations and regulatory standards, even without HIPAA.

Discover the key regulatory differences, data protection expectations, and compliance pathways.