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June 18, 2013

HIPAA Omnibus Rule Reference Chart

Mintz Levin is pleased to provide this section-by-section analysis of the HIPAA Omnibus Rule.

The chart lists provisions of the proposed privacy, security, and enforcement rules mandated by the Health Information Technology for Electronic and Clinical Health Act (“HITECH”) published in a proposed rule on July 14, 2010; the interim final enforcement rule—including HITECH’s new, tiered penalty structure—published on October 30, 2009; and the interim final breach notification rule published pursuant to HITECH on August 24, 2009 (collectively, “Proposed Rules”) and compares them to the same regulatory provisions published on January 17, 2013 as part of the Omnibus Rule (“Final Rule”). Note that this summary does not include revisions under the Genetic Information Nondiscrimination Act (GINA), also published in the Final Rule.

For quick reference, our chart indicates whether or not there were changes between the Proposed Rules and the Final Rule and includes commentary on certain notable provisions.

We hope that this summary will serve as a useful tool as we all begin the process of understanding new requirements under HIPAA.

» View the chart.

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About the Author

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...

(617) 348-1614

About the Author

Associate

Prior to joining Mintz Levin, Kimberly was an associate at Arent Fox LLP. Her practice focused on health care and corporate matters such as mergers and acquisitions, financings, regulatory compliance, licensing, reimbursement, and privacy.

Kimberly's experience includes negotiating, reviewing, and drafting agreements, including stock and asset purchase agreements, operations transfer agreements, and loan agreements. She has also advised health care clients with respect to HIPAA, HITECH, fraud and abuse issues, Medicare and Medicaid reimbursement, food and drug laws, and state...

(212) 692-6706

Contributors

Member

Ellen is a Member in the firm’s Health Law Section. She specializes in providing regulatory and strategic advice to health care clients of all types, including hospitals, long-term care facilities, hospices, retail pharmacies, PBMs, and pharmaceutical manufacturers. She represents clients in Medicare, Medicaid, and third-party payor audits and investigations; in the development of corporate compliance programs, HIPAA, privacy and security compliance initiatives; and in the negotiation and implementation of Corporate Integrity Agreements. She also provides strategic and regulatory...

(617) 348-1662

About the Author

Associate

Julie’s practice involves a variety of regulatory, transactional, and fraud and abuse matters.

Julie advises health care clients of all types, including managed care organizations, pharmacy benefit managers, retail pharmacies, hospitals, physician groups, and clinical laboratories on a variety of regulatory issues. She works closely with Medicare Advantage Organizations (MAOs), Medicare Part D Plan Sponsors and first tier and downstream entities to address regulatory and compliance matters that arise as a result of participating in Medicare Part D. She provides regulatory...

202-585-3521

About the Author

Project Analyst

James attended Boston College and received his BA in History and Political Science. His senior honors thesis investigated the polarization of America’s two main political parties through an historical analysis of the national health care debate since 1970, which received the distinction of a Scholar of the College project from Boston College.

617-542-6000

About the Author

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.

(202) 434-7437

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