Security Incident Procedures 45 CFR 164.308(a)(6)
The Security Incident Procedures standard requires written procedures to identify, respond to, mitigate, and document every suspected or known security incident that affects ePHI.
What the regulation requires
Note that the Security Rule defines a security incident broadly: any attempted or successful unauthorized access, use, disclosure, modification, or destruction of information, or interference with system operations in an information system. That includes failed login attempts and probing scans, not only confirmed breaches.
Implementation specifications
Response and Reporting
Identify and respond to suspected or known security incidents; mitigate, to the extent practicable, harmful effects of security incidents that are known to the regulated entity; and document security incidents and their outcomes. (164.308(a)(6)(ii))
How Petronella implements this safeguard
Every Petronella HIPAA engagement maps 45 CFR 164.308(a)(6)(i) to documented evidence in your environment. This is what that looks like in practice for the security incident procedures standard:
- Written Incident Response Plan aligned to NIST SP 800-61 Revision 3 with named roles, escalation tree, and decision criteria for breach determination under 164.402.
- Annual tabletop exercise covering ransomware, business email compromise, lost device, and AI/LLM impermissible disclosure scenarios.
- 24/7 IR retainer with an SLA-bound response time and forensic preservation procedures.
- Breach notification workflow: 60-day individual clock, immediate HHS notice for incidents affecting 500+ individuals, prominent media notice, OCR portal submission.
Built on top of ComplianceArmor for documentation, training records, and BAA inventory, with optional HIPAA managed IT services for the technical safeguard layer and vCISO services for the named Security Official role.
Where most practices fall short
OCR resolution agreements, HHS audit reports, and our own engagements show the same handful of gaps under 45 CFR 164.308(a)(6)(i). We surface these before they become a finding.
- IR plan exists but has not been tested in years - so when an actual incident hits, the team improvises (cited in the $5.5 million Memorial Healthcare settlement).
- Incidents minor enough to be handled by IT are not documented at all, leaving no record of patterns.
- 60-day breach notification clock blown because the four-factor risk analysis under 164.402 was not done quickly enough.
- No procedure for AI / LLM-based impermissible disclosures, which are increasingly common.
Related HIPAA safeguards
Security Incident Procedures interacts with several other Security Rule standards. Cover them together for a defensible program.
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