HHS releases final privacy rule

The U.S. Department of Health and Human Services (HHS) released the final omnibus rule designed to strengthen the privacy and security protections for health information established under HIPAA. The rule enhances patients' privacy protections, provides individuals new rights to their health information and strengthens the government’s ability to enforce the law.

“Much has changed in healthcare since HIPAA was enacted over 15 years ago,” said HHS Secretary Kathleen Sebelius. “The new rule will help protect patient privacy and safeguard patients’ health information in an ever-expanding digital age.”

The changes in the final rulemaking provide the public with increased protection and control of personal health information (PHI). The HIPAA Privacy and Security Rules have focused on healthcare providers, health plans and other entities that process health insurance claims but the final rule expands many of the requirements to business associates (BAs) of these entities that receive PHI, such as contractors and subcontractors. Some of the largest breaches reported to HHS have involved BAs. 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 HITECH Breach Notification requirements by clarifying when breaches of unsecured health information must be reported to HHS.

Under the rule, patients can ask for a copy of their EMR 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 individual’s health information without their permission.

“This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented,” said HHS Office of 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 healthcare provider or one of their business associates.”

The final rule also reduces burden by streamlining 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 BAs up to one year after the 180-day compliance date to modify contracts to comply with the rule.

Watch for more details and analysis of this final rule from CIT.