# HIPAA Breach Notification — Standards and References ## Primary Legal Sources ### Code of Federal Regulations - **45 CFR Part 164, Subpart D** — Notification in the Case of Breach of Unsecured Protected Health Information (§164.400-414) - **45 CFR §164.400** — Applicability - **45 CFR §164.402** — Definitions (breach, unsecured PHI, discovery) - **45 CFR §164.404** — Individual notification requirements - **45 CFR §164.406** — Media notification requirements - **45 CFR §164.408** — HHS Secretary notification requirements - **45 CFR §164.410** — Business associate notification to covered entity - **45 CFR §164.412** — Law enforcement delay provision - **45 CFR §164.414** — Administrative requirements and burden of proof ### Statutes - **HITECH Act §13402** — Notification in the Case of Breach (established breach notification requirement) - **HITECH Act §13402(h)** — Unsecured PHI and technologies rendering PHI unusable/unreadable ### Federal Register - **74 FR 42740** — Breach Notification for Unsecured PHI; Interim Final Rule (August 24, 2009) - **74 FR 19006** — Guidance Specifying the Technologies and Methodologies That Render PHI Unusable, Unreadable, or Indecipherable (April 27, 2009) - **78 FR 5566** — Omnibus Rule (final breach notification provisions with "low probability of compromise" standard) ## OCR Guidance - **OCR Breach Notification Rule Summary** — published at hhs.gov/hipaa/for-professionals/breach-notification - **OCR Breach Portal** — ocrportal.hhs.gov/ocr/breach/breach_report.jsf — public database of breaches affecting 500+ - **OCR Breach Reporting Portal Instructions** — step-by-step guide for HHS notification submission - **HHS Guidance on Unsecured PHI** — technologies and methodologies for the encryption/destruction safe harbor ## Encryption Safe Harbor - **NIST SP 800-111** — Guide to Storage Encryption Technologies for End User Devices (data at rest encryption standard) - **FIPS 140-2/140-3** — Security Requirements for Cryptographic Modules (encryption validation standard) - **NIST SP 800-88 Rev. 1** — Guidelines for Media Sanitization (destruction standard) ## State Breach Notification Laws - All 50 states, DC, Guam, Puerto Rico, and the US Virgin Islands have breach notification laws - State laws may impose additional requirements (shorter notification timelines, expanded definition of personal information, specific content requirements, credit monitoring mandates) - State AG notification requirements vary by jurisdiction