45 C.F.R. § 160.410 Affirmative defenses.
Title 45 - Public Welfare
(a) As used in this section, the following terms have the following meanings: Reasonable cause means circumstances that would make it unreasonable for the covered entity, despite the exercise of ordinary business care and prudence, to comply with the administrative simplification provision violated. 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. (b) The Secretary may not impose a civil money penalty on a covered entity for a violation if the covered entity establishes that an affirmative defense exists with respect to the violation, including the following: (1) The violation is an act punishable under 42 U.S.C. 1320d–6; (2) The covered entity establishes, to the satisfaction of the Secretary, that it did not have knowledge of the violation, determined in accordance with the federal common law of agency, and, by exercising reasonable diligence, would not have known that the violation occurred; or (3) The violation is— (i) Due to reasonable cause and not willful neglect; and (ii) Corrected during either: (A) The 30-day period beginning on the date the covered entity liable for the penalty knew, or by exercising reasonable diligence would have known, that the violation occurred; or (B) Such additional period as the Secretary determines to be appropriate based on the nature and extent of the failure to comply.
Title 45: Public Welfare
PART 160—GENERAL ADMINISTRATIVE REQUIREMENTS
Subpart D—Imposition of Civil Money Penalties
§ 160.410 Affirmative defenses.
