Section § 164.308(a)(1)Security management process
What it says
(1)(i) Standard: Security management process. Implement policies and procedures to prevent, detect, contain, and correct security violations.
(ii) Implementation specifications:
(A) Risk analysis (Required). Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity or business associate.
(B) Risk management (Required). Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with § 164.306(a).
(C) Sanction policy (Required). Apply appropriate sanctions against workforce members who fail to comply with the security policies and procedures of the covered entity or business associate.
(D) Information system activity review (Required). Implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports.
HIPAA, the United States rules protecting health information, § 164.308(a)(1)
What is in the packs for this
From HIPAA Security Rule Readiness. Each one helps with this requirement.
- Excel
Security Rule Safeguard Register
Its Framework References cite this section. Lists the 22 Security Rule standards and their 41 implementation specifications in plain words, required or addressable, with an owner and the evidence to keep. - Word
Security Risk Analysis Method
Its Framework References cite this section. Sets out a repeatable method for the security risk analysis: the inventory of electronic patient information, threats, vulnerabilities, ratings and the signed record. - Excel
HIPAA Gap & Remediation Tracker
Its Framework References cite this section. Tracks the gaps found against the readiness items, with priority, owner, deadline and status. - Excel
HIPAA Security Rule Readiness Self-Assessment
Its Framework References cite this section. Rates readiness against the Security Rule items and returns the blocking gaps, in counts and with no score. - PowerPoint
HIPAA Management Briefing Deck
Its Framework References cite this section. Tells leaders what HIPAA asks of security, what must be shown, and the six decisions needed from them.
Text: 45 CFR Part 164, from the Electronic Code of Federal Regulations (eCFR) as it stood on 6 October 2026.