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45 CFR 160.312 - Secretarial action regarding complaints and compliance reviews.

There is 1 rule appearing in the Federal Register for 45 CFR 160. Select the tab below to view, or View eCFR (GPOAccess)
§ 160.312
Secretarial action regarding complaints and compliance reviews.
(a) Resolution when noncompliance is indicated. (1) If an investigation of a complaint pursuant to § 160.306 or a compliance review pursuant to § 160.308 indicates noncompliance, the Secretary will attempt to reach a resolution of the matter satisfactory to the Secretary by informal means. Informal means may include demonstrated compliance or a completed corrective action plan or other agreement.
(2) If the matter is resolved by informal means, the Secretary will so inform the covered entity and, if the matter arose from a complaint, the complainant, in writing.
(3) If the matter is not resolved by informal means, the Secretary will—
(i) So inform the covered entity and provide the covered entity an opportunity to submit written evidence of any mitigating factors or affirmative defenses for consideration under §§ 160.408 and 160.410 of this part. The covered entity must submit any such evidence to the Secretary within 30 days (computed in the same manner as prescribed under § 160.526 of this part) of receipt of such notification; and
(ii) If, following action pursuant to paragraph (a)(3)(i) of this section, the Secretary finds that a civil money penalty should be imposed, inform the covered entity of such finding in a notice of proposed determination in accordance with § 160.420 of this part.
(b) Resolution when no violation is found. If, after an investigation pursuant to § 160.306 or a compliance review pursuant to § 160.308, the Secretary determines that further action is not warranted, the Secretary will so inform the covered entity and, if the matter arose from a complaint, the complainant, in writing.

Title 45 published on 2012-10-01

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.

  • 2013-01-25; vol. 78 # 17 - Friday, January 25, 2013
    1. 78 FR 5566 - Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary
      Final rule.
      Effective date: This final rule is effective on March 26, 2013. Compliance date: Covered entities and business associates must comply with the applicable requirements of this final rule by September 23, 2013.
      45 CFR Parts 160 and 164

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
USC : Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

§ 552 - Public information; agency rules, opinions, orders, records, and proceedings

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 1302 - Rules and regulations; impact analyses of Medicare and Medicaid rules and regulations on small rural hospitals

§ 1320d - Definitions

42 USC § 1320d–5 - General penalty for failure to comply with requirements and standards

42 USC § 1320d–4 - Requirements

42 USC § 1320d–3 - Timetables for adoption of standards

42 USC § 1320d–2 - Standards for information transactions and data elements

42 USC § 1320d–1 - General requirements for adoption of standards

42 USC § 1320d–6 - Wrongful disclosure of individually identifiable health information

42 USC § 1320d–8 - Processing payment transactions by financial institutions

42 USC § 1320d–7 - Effect on State law

Title 45 published on 2012-10-01

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

  • 2013-01-25; vol. 78 # 17 - Friday, January 25, 2013
    1. 78 FR 5566 - Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary
      Final rule.
      Effective date: This final rule is effective on March 26, 2013. Compliance date: Covered entities and business associates must comply with the applicable requirements of this final rule by September 23, 2013.
      45 CFR Parts 160 and 164