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HIPAA164.308 — Security Incident Procedures

§164.308(a)(6)

Security Incident Procedures

HIPAA · 45 CFR Part 164 · Last verified August 2026

Objective

Identify and respond to suspected or known security incidents, mitigate harmful effects, and document incidents and outcomes.

Points of focus

  • Recognize and route events that may involve ePHI
  • Contain and mitigate harmful effects
  • Document investigation, response, and lessons learned

Implementation notes

Add ePHI scope, affected individuals, acquisition indicators, and legal escalation to incident templates; preserve cloud and application evidence and exercise the handoff between engineering, privacy, and customer teams. Operationalize recognize and route events that may involve ephi in ticketing, IdP, or GRC workflows with named owners — not only in a static policy PDF. Retain incident response plan with hipaa decision points with reviewer identity, population scope, dates, and remediation outcomes auditors can sample. A recurring failure mode is that the engineering incident process restores service but never assesses ephi compromise Revisit after material architecture, vendor, data-flow, or leadership changes and document the decision.

Audit tip: Sample incident response plan with hipaa decision points with dates and named reviewers. Be ready to walk through how you detect and correct: the engineering incident process restores service but never assesses ephi compromise

Evidence auditors typically request:

  • Incident response plan with HIPAA decision points
  • Incident tickets, timelines, and ePHI impact assessments
  • Tabletop exercise records and corrective actions

Common gaps

  • The engineering incident process restores service but never assesses ePHI compromise
  • Evidence is spread across chat and ephemeral logs with no durable incident record

Cross-Framework Mapping

FrameworkRequirementImplementation note
HIPAA§164.308(a)(6)This control
SOC 2CC6.1, CC7.2SOC 2 evidence can support the safeguard, but HIPAA scope and Required/Addressable analysis remain distinct.
ISO 27001A.5.15, A.8.15ISO controls offer reusable operational evidence without replacing the Security Rule analysis.
GDPRArticle 32Article 32 overlaps for ePHI that is also EU personal data, subject to each law's scope.

Primary sources

Frequently Asked Questions

Security Incident Procedures applies to the systems and commitments in your Security Rule scope. Translate the requirement into concrete operating workflows — recognize and route events that may involve ephi — with evidence stored where auditors and customers can sample it.

Lead with incident response plan with hipaa decision points and pair it with incident tickets, timelines, and ephi impact assessments. Samples should show who performed the control, when, against which population, and what changed as a result.

Teams often fail because the engineering incident process restores service but never assesses ephi compromise Close the loop with dated operating records and test the control on a realistic production path.

Control operation can often be shared across SOC 2, ISO 27001, GDPR, and HIPAA — but each framework uses different vocabulary and accountability. Maintain an explicit crosswalk rather than assuming equivalence.

Review at least annually and after material product, vendor, or data-flow changes. High-risk or privileged paths may need quarterly sampling even when the criterion does not prescribe a cadence.

Framework versions referenced in this page:

  • HIPAA — 45 CFR Part 164

Last verified: August 2026 · Primary sources linked above