HIPAA Breach Notification Rule Overview (45 CFR 164.400-414)
When unsecured PHI is accessed, used, or disclosed in a manner not permitted, the entity must follow individual, HHS, and (in some cases) media notification requirements within defined timelines.
Primary source
45 CFR 164.400-414 — eCFR →https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-D
Verified May 23, 2026 · This is the authoritative regulator URL. The summary below is a research aid; the linked source controls.
Additional sources
45 CFR 164.400-414 — Subpart D of the HIPAA Administrative Simplification regulations — sets the rules for notifying individuals, HHS, and (for large breaches) the media when unsecured protected health information is breached.
The rule's gate is the definition of "breach" at 164.402: an acquisition, access, use, or disclosure of unsecured PHI not permitted by the Privacy Rule is presumed to be a breach unless the entity demonstrates a low probability of compromise via the four-factor risk assessment. "Unsecured" means not rendered unusable, unreadable, or indecipherable to unauthorized persons through encryption or destruction per the HHS Breach Notification Guidance.
Once a breach is determined, three notification tracks run:
- Individual notification within 60 days of discovery (164.404).
- HHS notification within 60 days for breaches affecting 500+ individuals; annually for smaller breaches via the HHS portal (164.408).
- Media notification for breaches affecting 500+ residents of a state or jurisdiction (164.406).
Business associates must notify the covered entity within 60 days of discovery (164.410). The covered entity then runs the individual notification clock.
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Related across the archive
- RegulationHIPAA HHS and Media Breach Notification (45 CFR 164.406-408)Notification timing and content for HHS (annual for smaller breaches, 60 days for 500+) and the prominent media (500+ in a state or jurisdiction).
- RegulationHIPAA Breach Definition and Four-Factor Risk Assessment (45 CFR 164.402)Definition of breach and the four-factor low-probability-of-compromise assessment that determines whether a non-permitted use or disclosure triggers notification.
- RegulationHIPAA Individual Breach Notification (45 CFR 164.404)Required content, methods, and 60-day deadline for notifying affected individuals after a breach of unsecured PHI.
- GlossaryHIPAA Breach Notification RuleThe federal rule at 45 CFR Part 164 Subpart D requiring covered entities and business associates to notify affected individuals, HHS, and sometimes the media after a breach of unsecured PHI.
- ComplianceBreach Risk Assessment: The 4-Factor Analysis Required by 45 CFR 164.402After a possible PHI incident, the four-factor breach risk assessment at 45 CFR 164.402 determines whether you notify. Do it in writing, do it on the record.
- SRAThe HIPAA Breach Notification Rule, ExplainedThe four-factor risk assessment at 45 CFR 164.402, the 60-day individual notice clock at 164.404, the HHS/media notice paths, and the small-practice annual report under 164.408(c).
- ComplianceHIPAA Breach Notification: The 60-Day Window Step-by-StepFrom discovery you have 60 calendar days to notify individuals, HHS, and possibly media. Here is the procedure that actually protects the practice.
- BillingBusiness Associate Agreement Checklist for Small PracticesA working checklist for small practices to identify which vendors need a Business Associate Agreement, what clauses the BAA must contain, and how to track them.
Last reviewed May 23, 2026 · Citation verified May 23, 2026
Research aid, not legal advice. This summary is an administrative research aid prepared by D3rx. It does not certify compliance, provide legal advice, replace counsel, or guarantee an audit outcome. For authoritative regulatory text follow the primary source link at the top of this page. The practice remains responsible for reviewing, adopting, and maintaining its compliance program.