On January 17, 2013, the U.S. Department of Health and Human Services (“HHS”) released the much anticipated and long-awaited omnibus final rule modifying the HIPAA privacy, security, enforcement, and breach notification rules. This is the most significant and comprehensive federal rule issuance governing patient privacy since the inception of the HIPAA rules in the early 2000s.
Overview of the Rule
The omnibus final rule is actually comprised of four separate final rules, which HHS summarized in its rule making as follows:
Rule 1 – Final modifications to the HIPAA Privacy, Security, and Enforcement Rules mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act. According to HHS, these modifications:
- Make business associates of covered entities directly liable for compliance with certain of the HIPAA Privacy and Security Rules’ requirements.
- 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.
- 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.
- 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.
- Adopt the additional HITECH Act enhancements to the Enforcement Rule not previously adopted in the October 30, 2009, interim final rule (referenced in "Rule 2" immediately below), such as the provisions addressing enforcement of noncompliance with the HIPAA rules due to willful neglect.
Rule 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.
Rule 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.
Rule 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.
- The omnibus final rule is effective on March 26, 2013.
- Covered entities (such as hospitals, physicians, and medical practices) and business associates must comply with the applicable requirements of the final rule by September 23, 2013.
A link to the HHS press release announcing the rule, as well as a display copy of the 563 page rule, can be found here.
Attorneys in Taft's Health and Life Sciences practice group will be reviewing this important legal development. Future eBulletins will provide more information on the scope of this new law and how it will impact health care providers and their business partners. HIPAA policies and procedures, business associate agreements, and Notice of Privacy Practices will need to be reviewed and modified in the near future.