The U.S. Department of Health and Human Services (HHS) announced changes Jan. 17, 2013, designed to strengthen the privacy and security protections for health information established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
According to HHS, the final omnibus rule enhances a patient’s privacy protections, provides individuals new rights to their health information and strengthens the agency’s ability to enforce the law.
This final rule is effective March 26, 2013. Covered entities and business associates must comply with the applicable requirements of this final rule by Sept. 23, 2013.
This omnibus final rule is comprised of the following four final rules:
- 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 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.
- 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 Oct. 30, 2009.
- 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 Aug. 24, 2009.
- 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 Oct.7, 2009.
The HIPAA Privacy and Security Rules have focused on health care providers, health plans and other entities that process health insurance claims. The changes expand many of the requirements to business associates of these entities that receive protected health information, such as contractors and subcontractors. According to HHS, some of the largest reported breaches have involved business associates. Penalties are increased for noncompliance based on the level of negligence with a maximum penalty of $1.5 million per violation. The changes also are designed to strengthen the HITECH Breach Notification requirements by clarifying when breaches of unsecured health information must be reported to HHS.
According to the rulemaking, the risk assessment has been modified “to focus more objectively on the risk that the protected health information has been compromised. Thus, breach notification is not required under the final rule if a covered entity or business associate, as applicable, demonstrates through a risk assessment that there is a low probability that the protected health information has been compromised, rather than demonstrate that there is no significant risk of harm to the individual as was provided under the interim final rule.”
“Much has changed in health care since HIPAA was enacted over 15 years ago,” HHS Secretary Kathleen Sebelius says in a statement announcing the revisions. “The new rule will help protect patient privacy and safeguard patients’ health information in an ever expanding digital age.”
HHS Office for Civil Rights Director Leon Rodriguez adds, “This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented. These changes 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 health care provider or one of their business associates.”
The new rules also are designed to expand individual rights. Patients can ask for a copy of their electronic medical record in electronic form. When individuals pay by cash, they can instruct their provider not to share information about their treatment with their health plan. The final omnibus rule sets new limits on how information is used and disclosed for marketing and fundraising purposes and prohibits the sale of an individuals’ health information without their permission, HHS says.
According to HHS, the final rule is expected to streamline individuals’ ability to authorize the use of their health information for research purposes. The rule makes it easier for parents and others to give permission to share proof of a child’s immunization with a school and gives covered entities and business associates up to one year after the 180-day compliance date to modify contracts to comply with the rule.
The final omnibus rule is based on statutory changes under the HITECH Act, enacted as part of the American Recovery and Reinvestment Act of 2009, and GINA, which clarifies that genetic information is protected under the HIPAA Privacy Rule and prohibits most health plans from using or disclosing genetic information for underwriting purposes.
The rulemaking can be viewed in the Federal Register at www.federalregister.gov/public-inspection.