The U.S. Department of Health and Human Services (HHS) has published a final omnibus rule that strengthens the privacy and security protections for health information established under the Health Insurance Portability and Accountability Act (HIPAA).

The final rule enhances a patient's privacy protections, provides individuals new rights to their health information, and strengthens the government's ability to enforce the law.

The changes provide the public with increased protection and control of personal health information. Many of HIPAA's requirements have been expanded to business associates that receive protected health information, such as contractors and subcontractors. According to HHS, some of the largest breaches reported to the agency 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 strengthen the Health Information Technology for Economic and Clinical Health (HITECH) Breach Notification requirements by clarifying when breaches of unsecured health information must be reported to HHS.

Individual rights are expanded in several ways. Patients can ask for a copy of their electronic medical record in an electronic form. When individuals pay by cash they can instruct their provider not to share information about their treatment with their health plan. The 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.

The final rule also streamlines 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 the Genetic Information Nondiscrimination Act of 2008 (GINA).

View the rule in the Federal Register