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HIPAA Omnibus Rule
The Omnibus Rule is not really a separate new rule for HIPAA, but rather the finalization of several Interim Final Rules (IFRs) that were already in existence that draw heavily from the HITECH Act. The HIPAA Omnibus Rule went into effect on September 23, 2013. The HHS summarized the 500+ pages of the rule as follows:
"This omnibus final rule is comprised of 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 improve the Rules, which were issued as a proposed rule on July 14, 2010. These modifications:
a. Make Business Associates of Covered Entities directly liable for compliance with certain of the HIPAA Privacy and Security Rules' requirements.
b. Strengthen the limitations on the use and disclosure of protected health information for marketing and fundraising purposes, and prohibit the sale of protected health information without individual authorization.
c. Expand 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.
d. Require modifications to, and redistribution of, a Covered Entity's notice of privacy practices. Modify 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.
e. Adopt the additional HITECH Act enhancements to the Enforcement Rule not previously adopted in the October 30, 2009, interim final rule, such as the provisions addressing enforcement of noncompliance with the HIPAA Rules due to willful neglect.
2. Final rule adopting changes to the HIPAA Enforcement Rule to incorporate the increased and tiered civil money penalty structure provided by the HITECH Act, originally published 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 replaces the breach notification rule's "harm" threshold with a more objective standard and supplants an interim final rule published on August 24, 2009.
4. Final rule modifying 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."