---
title: "45 CFR 164.316 HIPAA: Policies and procedures and documentation requirements"
canonical: "https://dposchool.com/hipaa/section/164.316"
source: "https://www.ecfr.gov/current/title-45/section-164.316"
source_note: "Source: United States Code, title 42, published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov), release point 119-136. The editorial and statutory notes are not reproduced. Source: United States Code, title 42, published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov), release point 119-136. The editorial and statutory notes are not reproduced. Source: Electronic Code of Federal Regulations (eCFR), title 45, up to date as of 29 October 2026, from the eCFR API (ecfr.gov). The eCFR is an editorial compilation of the CFR and Federal Register amendments, not an official legal edition of the CFR."
text_as_of: "2026-10-29"
language: "en"
publisher: "DPO School"
---

45 CFR 164.316 HIPAA · Part 164: SECURITY AND PRIVACY · Subpart C: Security Standards for the Protection of Electronic Protected Health Information

# 45 CFR 164.316 HIPAA: Policies and procedures and documentation requirements

eCFR, up to date as of 29 October 2026. Retrieved 30 October 2026.

## Official text

A covered entity or business associate must, in accordance with § 164.306:

### 45 CFR 164.316(a)

**(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.

**(b)(1)** Standard: Documentation. (i) Maintain the policies and procedures implemented to comply with this subpart in written (which may be electronic) form; and

**(ii)** If an action, activity or assessment is required by this subpart to be documented, maintain a written (which may be electronic) record of the action, activity, or assessment.

#### 45 CFR 164.316(a)(2)

**(2)** Implementation specifications:

##### 45 CFR 164.316(a)(2)(i)

**(i)** Time limit (Required). Retain the documentation required by paragraph (b)(1) of this section for 6 years from the date of its creation or the date when it last was in effect, whichever is later.

##### 45 CFR 164.316(a)(2)(ii)

**(ii)** Availability (Required). Make documentation available to those persons responsible for implementing the procedures to which the documentation pertains.

##### 45 CFR 164.316(a)(2)(iii)

**(iii)** Updates (Required). Review documentation periodically, and update as needed, in response to environmental or operational changes affecting the security of the electronic protected health information.

## Source

Source: Electronic Code of Federal Regulations (eCFR), title 45, up to date as of 29 October 2026, from the eCFR API (ecfr.gov). The eCFR is an editorial compilation of the CFR and Federal Register amendments, not an official legal edition of the CFR.

Source credit: \[68 FR 8376, Feb. 20, 2003, as amended at 78 FR 5695, Jan. 25, 2013\]

[45 CFR 164.316 on eCFR](https://www.ecfr.gov/current/title-45/section-164.316)

eCFR, up to date as of 29 October 2026. Retrieved 30 October 2026.

This is reference material, not legal advice.

## Navigation

[HIPAA Navigator](https://dposchool.com/hipaa) / 45 CFR 164.316

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Next: [45 CFR 164.318 HIPAA: Compliance dates for the initial implementation of the security standards](https://dposchool.com/hipaa/section/164.318)

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