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Summary of the Omnibus Final Rule

Summary of the Omnibus Final Rule

The Omnibus Final Rule includes the following four final rules:

1. Final modifications to the HIPAA Privacy, Security, and Enforcement Rules mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act, and certain other modifications to make the Rules better, which were produced as a proposed rule on July 14, 2010.

Thus, the Omnibus Final Rule:

• Makes business associates of covered entities directly liable for compliance with certain of the HIPAA Privacy and Security Rules’ requirements.

• Strengthens the limitations on the use and disclosure of protected health information for marketing and fundraising purposes and prohibits the sale of protected health information without individual authorization.

• Expands individuals’ rights to receive electronic copies of their health information and to restrict disclosures to a health plan concerning treatment for which the individual has paid out of pocket in full.

• Requires modifications to, and redistribution of, a covered entity’s notice of privacy practices.

• Modifies the individual authorization and other requirements to facilitate research and disclosure of child immunization proof to schools, and to enable access to decedent information by family members or others.

• Adopts the additional HITECH Act enhancements to the Enforcement Rule not previously adopted in the October 30, 2009, interim final rule (referenced immediately below), such as the provisions addressing enforcement of noncompliance with the HIPAA Rules due to willful neglect.

2. Final rule accepting changes to the HIPAA Enforcement Rule to incorporate the increased and tiered civil money penalty structure provided by the HITECH Act, originally released as an interim final rule on October 30, 2009.

3. Final rule on Breach Notification for Unsecured Protected Health Information under the HITECH Act, which updates the breach notification rule’s ‘‘harm’’ threshold to a more objective standard and supplants an interim final rule published on August 24, 2009.

4. Final rule changing the HIPAA Privacy Rule as required by the Genetic Information Nondiscrimination Act (GINA) to prohibit most health plans from using or disclosing genetic information for underwriting purposes, which was published as a proposed rule on October 7, 2009.

United Nations


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