HealthLaw IQBETA

HIPAA Breach Notification

The HIPAA Breach Notification Rule requires covered entities and business associates to notify affected individuals, HHS, and in some cases the media, when unsecured protected health information is breached. A breach is the acquisition, access, use, or disclosure of PHI in a way not permitted by the Privacy Rule that compromises the security or privacy of the PHI.

Citation: 45 C.F.R. Part 164 Subpart D
Sections: 41
Words indexed: 41,659
Applies to: All covered entities and business associates

Key Points

Notification to individuals must happen within 60 days of discovering the breach

Breaches affecting 500+ individuals in a state require media notification

Breaches affecting 500+ individuals must be reported to HHS immediately; smaller breaches reported annually

A risk assessment using four factors determines whether notification is required

PHI that is encrypted per NIST standards is considered 'secured' and not subject to breach notification

HHS publishes all breaches affecting 500+ on the 'Wall of Shame' (breach portal)

Key Areas

Breach Definition

What constitutes a breach vs. permitted disclosure

Notification Requirements

Who to notify, when, and what to include

Risk Assessment

Four-factor test for determining breach notification

Key Provisions

164.402

Definitions (Breach)

Defines what constitutes a breach and the three exceptions: unintentional access by workforce, inadvertent disclosure between authorized persons, and good-faith belief the recipient cannot retain the information.

164.404

Notification to Individuals

Content requirements (what happened, what data, what you're doing about it, what they should do) and timing (within 60 days of discovery, not occurrence).

164.406

Notification to Media

Required when 500+ residents of a single state or jurisdiction are affected. Must be provided to prominent media outlets.

164.408

Notification to HHS

500+ individual breaches: notify HHS contemporaneously. Under 500: annual log submitted within 60 days of calendar year end.

All Regulation Sections

Part 164HIPAA: Security and Privacy(41)