# 45 C.F.R. § 160.401 (2026): Definitions

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_401

## Section

- **Citation:** 45 C.F.R. § 160.401 (2026)
- **Heading:** Definitions
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 45 CFR: Public Welfare / Part 160: GENERAL ADMINISTRATIVE REQUIREMENTS / Subpart D: Imposition of Civil Money Penalties / § 160.401: § 160.401   Definitions.

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

## Nearby sections

- [45 C.F.R. § 160.400 (2026) § 160.400   Applicability.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_400.md)
- [45 C.F.R. § 160.401 (2026) § 160.401   Definitions.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_401.md)
- [45 C.F.R. § 160.402 (2026) § 160.402   Basis for a civil money penalty.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_402.md)
- [45 C.F.R. § 160.404 (2026) § 160.404   Amount of a civil money penalty.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_404.md)
- [45 C.F.R. § 160.406 (2026) § 160.406   Violations of an identical requirement or prohibition.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_406.md)
- [45 C.F.R. § 160.408 (2026) § 160.408   Factors considered in determining the amount of a civil money penalty.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_408.md)
- [45 C.F.R. § 160.410 (2026) § 160.410   Affirmative defenses.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_410.md)
- [45 C.F.R. § 160.412 (2026) § 160.412   Waiver.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_412.md)
- [45 C.F.R. § 160.414 (2026) § 160.414   Limitations.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_414.md)
- [45 C.F.R. § 160.416 (2026) § 160.416   Authority to settle.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_416.md)
- [45 C.F.R. § 160.418 (2026) § 160.418   Penalty not exclusive.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_418.md)
- [45 C.F.R. § 160.420 (2026) § 160.420   Notice of proposed determination.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_420.md)
- [45 C.F.R. § 160.422 (2026) § 160.422   Failure to request a hearing.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_422.md)
- [45 C.F.R. § 160.424 (2026) § 160.424   Collection of penalty.](https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_424.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T45_P160_S160_401. Check the current official text before relying on it. Not legal advice.