45 CFR 160.308 - Compliance reviews.
(a) The Secretary will conduct a compliance review to determine whether a covered entity or business associate is complying with the applicable administrative simplification provisions when a preliminary review of the facts indicates a possible violation due to willful neglect.
(b) The Secretary may conduct a compliance review to determine whether a covered entity or business associate is complying with the applicable administrative simplification provisions in any other circumstance.
Title 45 published on 18-Oct-2017 12:32
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 45 CFR Part 160 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2017-21424 RIN CMS-0037-WN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Withdrawal of proposed rule. As of October 4, 2017, the proposed rule published January 2, 2014, at 79 FR 298, is withdrawn. 45 CFR Parts 160 and 162 This document withdraws the January 2, 2014, proposed rule that would have required a controlling health plan (CHP) to submit information and documentation demonstrating that it is compliant with certain standards and operating rules adopted by the Secretary of Health and Human Services (the Secretary) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This proposed rule would have also established penalty fees for a CHP that failed to comply with the certification of compliance requirements.
GPO FDSys XML | Text type regulations.gov FR Doc. 2016-18680 RIN 0991-AC0 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary, Centers for Medicare & Medicaid Services, Administration for Children and Families, Office of the Inspector General Interim final rule. This rule is effective on September 6, 2016. 42 CFR Part 3 The Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2014-15102 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary 45 CFR Part 160
GPO FDSys XML | Text type regulations.gov FR Doc. 2014-04828 RIN CMS-0037-N DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Proposed rule; extension of the comment period. The comment period for the proposed rule published in the January 2, 2014 Federal Register (79 FR 298) is extended to April 3, 2014. 45 CFR Parts 160 and 162 This document extends the comment period for the Administrative Simplification: Certification of Compliance for Health Plans proposed rule, which was published in the January 2, 2014 Federal Register . The comment period for the proposed rule, which would have ended on March 3, 2014, is extended to April 3, 2014.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-31318 RIN 0938-AQ85 CMS-0037-P DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Proposed rule. To be assured consideration, comments must be received at one of the addresses provided, no later than 5 p.m. on March 3, 2014. 45 CFR Parts 160 and 162 This proposed rule would require a controlling health plan (CHP) to submit information and documentation demonstrating that it is compliant with certain standards and operating rules adopted by the Secretary of Health and Human Services (the Secretary) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This proposed rule would also establish penalty fees for a CHP that fails to comply with the certification of compliance requirements.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-13472 RIN 0945-AA03 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Final rule. This final rule is effective on June 7, 2013. 45 CFR Parts 160 and 164 These technical corrections address certain inadvertent errors and omissions in the HIPAA Privacy, Security, and Enforcement Rules that are located at 45 CFR parts 160 and 164.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-09602 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Advance notice of proposed rulemaking. Submit comments on or before June 7, 2013. 45 CFR Parts 160 and 164 On January 16, 2013, President Barack Obama announced a series of Executive Actions to reduce gun violence in the United States, including efforts to improve the Federal government's background check system for the sale or transfer of firearms by licensed dealers, called the National Instant Criminal Background Check System (NICS). Among those persons disqualified from possessing or receiving firearms under Federal law are individuals who have been involuntarily committed to a mental institution; found incompetent to stand trial or not guilty by reason of insanity; or otherwise have been determined, through a formal adjudication process, to have a severe mental condition that results in the individuals presenting a danger to themselves or others or being incapable of managing their own affairs (referred to below as the “mental health prohibitor”). Concerns have been raised that, in certain states, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule may be a barrier to States' reporting the identities of individuals subject to the mental health prohibitor to the NICS. The Department of Health and Human Services (HHS or “the Department”), which administers the HIPAA regulations, is issuing this Advance Notice of Proposed Rulemaking (ANPRM) to solicit public comments on such barriers to reporting and ways in which these barriers can be addressed. In particular, we are considering creating an express permission in the HIPAA rules for reporting the relevant information to the NICS by those HIPAA covered entities responsible for involuntary commitments or the formal adjudications that would subject individuals to the mental health prohibitor, or that are otherwise designated by the States to report to the NICS. In addition, we are soliciting comments on the best methods to disseminate information on relevant HIPAA policies to State level entities that originate or maintain information that may be reported to NICS. Finally, we are soliciting public input on whether there are ways to mitigate any unintended adverse consequences for individuals seeking needed mental health services that may be caused by creating express regulatory permission to report relevant information to NICS. The Department will use the information it receives to determine how best to address these issues.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-01073 RIN 0945-AA03 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 The Department of Health and Human Services (HHS or “the Department”) is issuing this final rule to: Modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Enforcement Rules to implement statutory amendments under the Health Information Technology for Economic and Clinical Health Act (“the HITECH Act” or “the Act”) to strengthen the privacy and security protection for individuals' health information; modify the rule for Breach Notification for Unsecured Protected Health Information (Breach Notification Rule) under the HITECH Act to address public comment received on the interim final rule; modify the HIPAA Privacy Rule to strengthen the privacy protections for genetic information by implementing section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA); and make certain other modifications to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (the HIPAA Rules) to improve their workability and effectiveness and to increase flexibility for and decrease burden on the regulated entities.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-132 RIN 0938-AQ11 CMS-0024-IFC DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Interim final rule with comment period. Effective Date: These regulations are effective on January 10, 2012. The incorporation by reference of the publications listed in this interim final rule with comment period is approved by the Director of the Office of the Federal Register January 10, 2012. Compliance Date: The compliance date for this regulation is January 1, 2014. Comment Date: To be assured consideration, comments must be received at one of the addresses provided below on or before March 12, 2012. 45 CFR Parts 160 and 162 This interim final rule with comment period implements parts of section 1104 of the Affordable Care Act which requires the adoption of a standard for electronic funds transfers (EFT). It defines EFT and explains how the adopted standards support and facilitate health care EFT transmissions.