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Non-Covered Entity Compliance

Meaning

Non-Covered Entity Compliance refers to the mandatory adherence to federal and state health data privacy and security regulations by wellness clinics, direct-to-consumer laboratories, and other health-related businesses that do not qualify as “Covered Entities” under the Health Insurance Portability and Accountability Act (HIPAA). In the hormonal health space, this means that even if a clinic does not bill insurance, it must still comply with other applicable laws, such as the FTC’s Health Breach Notification Rule and various state consumer data protection statutes. This compliance ensures a baseline level of data protection for clients whose sensitive physiological information falls outside the traditional HIPAA framework.