---
title: "45 CFR 160.408 HIPAA: Factors considered in determining the amount of a civil money penalty"
canonical: "https://dposchool.com/hipaa/section/160.408"
source: "https://www.ecfr.gov/current/title-45/section-160.408"
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 160.408 HIPAA · Part 160: GENERAL ADMINISTRATIVE REQUIREMENTS · Subpart D: Imposition of Civil Money Penalties

# 45 CFR 160.408 HIPAA: Factors considered in determining the amount of a civil money penalty

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

## Official text

In determining the amount of any civil money penalty, the Secretary will consider the following factors, which may be mitigating or aggravating as appropriate:

### 45 CFR 160.408(a)

**(a)** The nature and extent of the violation, consideration of which may include but is not limited to:

#### 45 CFR 160.408(a)(1)

**(1)** The number of individuals affected; and

#### 45 CFR 160.408(a)(2)

**(2)** The time period during which the violation occurred;

### 45 CFR 160.408(b)

**(b)** The nature and extent of the harm resulting from the violation, consideration of which may include but is not limited to:

#### 45 CFR 160.408(b)(1)

**(1)** Whether the violation caused physical harm;

#### 45 CFR 160.408(b)(2)

**(2)** Whether the violation resulted in financial harm;

#### 45 CFR 160.408(b)(3)

**(3)** Whether the violation resulted in harm to an individual's reputation; and

#### 45 CFR 160.408(b)(4)

**(4)** Whether the violation hindered an individual's ability to obtain health care;

### 45 CFR 160.408(c)

**(c)** The history of prior compliance with the administrative simplification provisions, including violations, by the covered entity or business associate, consideration of which may include but is not limited to:

#### 45 CFR 160.408(c)(1)

**(1)** Whether the current violation is the same or similar to previous indications of noncompliance;

#### 45 CFR 160.408(c)(2)

**(2)** Whether and to what extent the covered entity or business associate has attempted to correct previous indications of noncompliance;

#### 45 CFR 160.408(c)(3)

**(3)** How the covered entity or business associate has responded to technical assistance from the Secretary provided in the context of a compliance effort; and

#### 45 CFR 160.408(c)(4)

**(4)** How the covered entity or business associate has responded to prior complaints;

### 45 CFR 160.408(d)

**(d)** The financial condition of the covered entity or business associate, consideration of which may include but is not limited to:

#### 45 CFR 160.408(d)(1)

**(1)** Whether the covered entity or business associate had financial difficulties that affected its ability to comply;

#### 45 CFR 160.408(d)(2)

**(2)** Whether the imposition of a civil money penalty would jeopardize the ability of the covered entity or business associate to continue to provide, or to pay for, health care; and

#### 45 CFR 160.408(d)(3)

**(3)** The size of the covered entity or business associate; and

### 45 CFR 160.408(e)

**(e)** Such other matters as justice may require.

## 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: \[78 FR 5691, Jan. 25, 2013\]

[45 CFR 160.408 on eCFR](https://www.ecfr.gov/current/title-45/section-160.408)

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

This is reference material, not legal advice.

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