What is the Origin of Health Data Breach Notification?

The requirement was established under the Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted in 2009, which significantly expanded the enforcement and scope of HIPAA. The Breach Notification Rule was specifically designed to ensure that patients are aware when their sensitive medical and physiological data, including hormonal profiles, is at risk due to a security incident.

What is the Mechanism of Health Data Breach Notification?

The process is triggered when a security incident results in a potential breach of unsecured PHI. An investigation determines if a low probability of compromise exists; otherwise, notification is required. The mechanism mandates reporting breaches affecting fewer than 500 individuals to the Secretary of Health and Human Services annually, and breaches affecting 500 or more individuals immediately, ensuring rapid regulatory oversight and public awareness.

Health Data Breach Notification ∞ Area

Health Data Breach Notification

Meaning

Health Data Breach Notification is a mandatory regulatory requirement obligating Covered Entities and Business Associates to inform affected individuals, and often government agencies, when their unsecured Protected Health Information (PHI) has been compromised, acquired, or disclosed without authorization. This is a critical component of transparency and accountability in the healthcare and wellness sectors. The notification must be prompt and contain specific details about the nature of the breach and steps individuals can take to protect themselves.