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PHI outside Medical Settings

Meaning

PHI outside Medical Settings refers to any Protected Health Information that is collected, processed, or stored by entities that are not traditional healthcare providers, health plans, or healthcare clearinghouses, and thus fall outside the direct jurisdiction of HIPAA’s Covered Entity definition. In the hormonal wellness space, this often includes data collected by fitness trackers, wellness apps, and direct-to-consumer lab companies that manage sensitive physiological metrics like hormone levels and sleep patterns. While not federally protected by HIPAA, this data is still inherently sensitive and is increasingly being regulated by state-level consumer protection statutes and the FTC’s Health Breach Notification Rule. This recognition is key to understanding modern data privacy risk.