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

Article By:

Dianne J. Bourque

Stephanie D. Willis

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

posted on: Friday, March 30, 2012

Administrative & Regulatory / Consumer Protection / Health Law & Managed Care

All Federal

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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 20^th National HIPAA Summit. If OMB does take the full 90 days for its review, the final rule will be issued in late June 2012.

About the Author

Dianne J. Bourque

Of Counsel

Dianne is Of Counsel in the firm’s Health Law Section. She advises a variety of health care clients on a broad range of issues, including licensure, regulatory, contractual, and risk management matters, and patient care. A large part of Dianne’s practice involves counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research, including patient consent, access to and use of tissue and associated patient information, and the Institutional Review Board process. She also counsels health care clients and other business entities...

DBourque@mintz.com

(617) 348-1614

www.mintz.com/people/50/Dianne_J_Bourque

About the Author

Stephanie D. Willis

Associate

Stephanie is an Associate in the Washington, D.C. office, practicing in the Health Law Section.

Prior to joining Mintz Levin, Stephanie was an associate counsel in the Department of Health and Human Services’ Office of Counsel to the Inspector General. There, her practice focused on health care enforcement matters involving the False Claims Act, the Social Security Act, the Physician Self-Referral Act, the anti-kickback statute, the EMTALA, and other administrative actions.

SDWillis@Mintz.com

(202) 434-7437

www.mintzlevin.com/people/677/Stephanie_D_Willis