---
kind: "section"
citation: "45 C.F.R. § 160.408"
title: "45"
number: "160.408"
heading: "Factors considered in determining the amount of a civil money penalty."
url: "https://uscodex.org/cfr/45/160.408"
---

# §160.408. Factors considered in determining the amount of a civil money penalty.


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

- (a) The nature and extent of the violation, consideration of which may include but is not limited to:
  - (1) The number of individuals affected; and
  - (2) The time period during which the violation occurred;
- (b) The nature and extent of the harm resulting from the violation, consideration of which may include but is not limited to:
  - (1) Whether the violation caused physical harm;
  - (2) Whether the violation resulted in financial harm;
  - (3) Whether the violation resulted in harm to an individual's reputation; and
  - (4) Whether the violation hindered an individual's ability to obtain health care;
- (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:
  - (1) Whether the current violation is the same or similar to previous indications of noncompliance;
  - (2) Whether and to what extent the covered entity or business associate has attempted to correct previous indications of noncompliance;
  - (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
  - (4) How the covered entity or business associate has responded to prior complaints;
- (d) The financial condition of the covered entity or business associate, consideration of which may include but is not limited to:
  - (1) Whether the covered entity or business associate had financial difficulties that affected its ability to comply;
  - (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
  - (3) The size of the covered entity or business associate; and
- (e) Such other matters as justice may require.

## Notes

### Amendments

[78 FR 5691, Jan. 25, 2013]

### Source

Source: 71 FR 8426, Feb. 16, 2006, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)); 5 U.S.C. 552; secs. 13400-13424, Pub. L. 111-5, 123 Stat. 258-279; and sec. 1104 of Pub. L. 111-148, 124 Stat. 146-154.

### Source

Source: 65 FR 82798, Dec. 28, 2000, unless otherwise noted.

### Amendments

[78 FR 5691, Jan. 25, 2013]