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Non-Covered Entity

Meaning

A non-covered entity is an individual or organization that is not directly regulated by the Health Insurance Portability and Accountability Act (HIPAA), meaning they are neither a healthcare provider, a health plan, nor a healthcare clearinghouse, nor a business associate of one of these. In the hormonal health and wellness sector, this category includes many popular direct-to-consumer genetic testing companies, wearable device manufacturers, and standalone wellness apps that collect sensitive physiological data, such as hormone tracking metrics or sleep patterns, outside of a clinical treatment context. This distinction is crucial because the health data collected by these entities often lacks the federal privacy protections afforded to traditional medical records.