45 CFR 160.410 - Affirmative defenses.

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There is 1 rule appearing in the Federal Register for 45 CFR 160. View below or at eCFR (GPOAccess)
§ 160.410 Affirmative defenses.
(a) For violations occurring prior to February 18, 2009, 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 violations, 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 first 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.
(b) For violations occurring on or after February 18, 2009, 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 violations, including the following:
(1) The violation is an act punishable under 42 U.S.C. 1320d-6; or
(2) The covered entity establishes to the satisfaction of the Secretary that the violation is—
(i) Not due to willful neglect; and
(ii) Corrected during either:
(A) The 30-day period beginning on the first 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.
[74 FR 56131, Oct. 30, 2009]

Title 45 published on 2013-10-01

The following are only the Rules published in the Federal Register after the published date of Title 45.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-06-27; vol. 79 # 124 - Friday, June 27, 2014
    1. 79 FR 36432 - General Administrative Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary
      45 CFR Part 160

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United States Code
Statutes at Large

Title 45 published on 2013-10-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 45 CFR 160 after this date.

  • 2014-06-27; vol. 79 # 124 - Friday, June 27, 2014
    1. 79 FR 36432 - General Administrative Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary
      45 CFR Part 160