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HIPAA Omnibus Rule Expected Within 90 Days - Pending Review at OMB

Written by: Dianne Bourque and Stephanie Willis

Officials from the Department of Health and Human Services Office for Civil Rights (OCR) announced March 26 that the long-awaited rule updating Health Insurance Portability and Accountability Act (HIPAA) regulations has been sent to the Office of Management and Budget (OMB).  The omnibus rule, which covers four previously released proposed and interim final rules, is expected to take a full 90 days permitted for OMB review.

The omnibus rule will include the final rules for the following: 

  • the breach notification rule ( the interim final rule was released in August 2009);
  • the final HIPAA enforcement rule (the interim final rule was released in October 2009);
  • the final rule implementing the Health Information Technology for Economic and Clinical Health (HITECH) Act's changes to the HIPAA privacy and security standards (the notice of proposed rulemaking was released in July 2010); and
  • a final rule implementing the Genetic Information Nondiscrimination Act's modifications to HIPAA's privacy rule (the proposed rule was released in October 2009). 

OCR Deputy Director for Health Information Privacy, Susan McAndrew, made the announcement at the 20th National HIPAA Summit.  If OMB does take the full 90 days for its review, the final rule will be issued in late June 2012.

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Dianne specializes in counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research, and counsels health care clients on the HIPAA Privacy Rule and Security Standards.