Section § 164.316(a)Policies and procedures
What it says
(a) Standard: Policies and procedures. Implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications, or other requirements of this subpart, taking into account those factors specified in § 164.306(b)(2)(i), (ii), (iii), and (iv). This standard is not to be construed to permit or excuse an action that violates any other standard, implementation specification, or other requirements of this subpart. A covered entity or business associate may change its policies and procedures at any time, provided that the changes are documented and are implemented in accordance with this subpart.
HIPAA, the United States rules protecting health information, § 164.316(a)
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 Documentation & Evidence Checklist
Its Framework References cite this section. Lists the documents and records to keep ready, the paragraph of the Rule behind each, and how long each must be kept. - 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.
Text: 45 CFR Part 164, from the Electronic Code of Federal Regulations (eCFR) as it stood on 6 October 2026.