The most eagerly awaited — if not anxiety-laden — set of regulations in the healthcare spectrum arrived late Thursday: HHS issued modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules.
“This final rule is comprised of four final rules,” HHS explains in the document (PDF), “which have been combined to reduce the impact and number of times certain compliance activities need to be undertaken by the regulated entities.”
[See also: Data breach leads to $1.7M fine for Alaska DHSS]
Without any more ado, then, and directly from the HHS document linked to above, here are those four:
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:
- 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 immediately below), 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.
“These changes are consistent with, and arise in part from, the Department’s obligations under Executive Order 13563 to conduct a retrospective review of our existing regulations for the purpose of identifying ways to reduce costs and increase flexibilities under the HIPAA Rules,” HHS explains in the document.
Leon Rodriguez, HHS Office for Civil Rights Director, said in a prepared statement: “This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented." Rodriguez continued that the modifications "not only greatly enhance a patient’s privacy rights and protections, but also strengthen the ability of my office to vigorously enforce the HIPAA privacy and security protections, regardless of whether the information is being held by a health plan, a healthcare provider, or one of their business associates.”