---
title: "45 CFR 160.401 HIPAA: Definitions"
canonical: "https://dposchool.com/hipaa/section/160.401"
source: "https://www.ecfr.gov/current/title-45/section-160.401"
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 160.401 HIPAA · Part 160: GENERAL ADMINISTRATIVE REQUIREMENTS · Subpart D: Imposition of Civil Money Penalties

# 45 CFR 160.401 HIPAA: Definitions

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

## Official text

As used in this subpart, the following terms have the following meanings:

Reasonable cause means an act or omission in which a covered entity or business associate knew, or by exercising reasonable diligence would have known, that the act or omission violated an administrative simplification provision, but in which the covered entity or business associate did not act with willful neglect.

Reasonable diligence means the business care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances.

Willful neglect means conscious, intentional failure or reckless indifference to the obligation to comply with the administrative simplification provision violated.

## 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: \[74 FR 56130, Oct. 30, 2009, as amended at 78 FR 5691, Jan. 25, 2013\]

[45 CFR 160.401 on eCFR](https://www.ecfr.gov/current/title-45/section-160.401)

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

This is reference material, not legal advice.

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[HIPAA Navigator](https://dposchool.com/hipaa) / 45 CFR 160.401

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