Some of the largest breaches reported to HHS have involved business associates, the department said. Additionally, penalties are increased for noncompliance based on the level of negligence with a maximum penalty of $1.5 million per violation. The changes also strengthen the Health Information Technology for Economic and Clinical Health Breach Notification requirements by clarifying when breaches of unsecured health information must be reported to HHS.

Individual rights are also expanded. Patients can ask for a copy of their 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 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.

The final rule also streamlines individuals' ability to authorize the use of their health information for research purposes. HHS says 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.

“This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented,” said HHS Office for Civil Rights Director Leon Rodriguez. “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 rules were called for under the 2009 federal economic stimulus package's HITECH Act and the Genetic Information Nondiscrimination Act.