§160.408. Factors considered in determining the amount of a civil money penalty.
45 C.F.R. § 160.408
In determining the amount of any civil money penalty, the Secretary will consider the following factors, which may be mitigating or aggravating as appropriate:
The nature and extent of the violation, consideration of which may include but is not limited to:
The number of individuals affected; and
The time period during which the violation occurred;
The nature and extent of the harm resulting from the violation, consideration of which may include but is not limited to:
Whether the violation caused physical harm;
Whether the violation resulted in financial harm;
Whether the violation resulted in harm to an individual's reputation; and
Whether the violation hindered an individual's ability to obtain health care;
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:
Whether the current violation is the same or similar to previous indications of noncompliance;
Whether and to what extent the covered entity or business associate has attempted to correct previous indications of noncompliance;
How the covered entity or business associate has responded to technical assistance from the Secretary provided in the context of a compliance effort; and
How the covered entity or business associate has responded to prior complaints;
The financial condition of the covered entity or business associate, consideration of which may include but is not limited to:
Whether the covered entity or business associate had financial difficulties that affected its ability to comply;
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
The size of the covered entity or business associate; and
Such other matters as justice may require.
Notes, amendments, and revision history
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]