Breach Notification Rule and Omnibus Rule of 2013

What is the Breach Notification Rule of 2013?

The Breach Notification Rule of 2013 is a federal regulation that requires covered entities and business associates to notify individuals when their protected health information (PHI) is breached. This rule was issued by the U.S. Department of Health and Human Services (HHS) and applies to all PHI held or transmitted by a covered entity or business associate.

What is the Omnibus Rule of 2013?

The Omnibus Rule of 2013 is a federal regulation that updates the HIPAA Privacy and Security Rules. It strengthens the privacy and security protections for individuals’ health information by expanding the definition of protected health information, providing new rights to individuals to access and receive copies of their health information, imposing new restrictions on the use and disclosure of PHI, and implementing stronger enforcement of the HIPAA rules.

What does the Breach Notification Rule require?

The Breach Notification Rule requires covered entities and business associates to notify individuals, in writing, of any breach of their protected health information. A breach is defined as the acquisition, access, use, or disclosure of protected health information that is not permitted under the HIPAA Privacy Rule.

What is the timeline for notification under the Breach Notification Rule?

Covered entities and business associates must provide notification of a breach within 60 days of discovering the breach. The notification must include the details of the breach, the type of information involved, steps individuals can take to protect themselves from potential harm, and contact information for the covered entity or business associate.

What is the penalty for non-compliance with the Breach Notification Rule?

Under the Breach Notification Rule, covered entities and business associates may be subject to civil monetary penalties if they fail to notify individuals of a breach. The amount of the penalty depends on the level of negligence and the nature and extent of the breach.

What rights do individuals have under the Omnibus Rule?

Answer: Under the Omnibus Rule, individuals have the right to access their health information, receive copies of their health information in an electronic format, and request restrictions on how their PHI is used and disclosed. Individuals also have the right to receive an accounting of disclosures of their PHI.

What are the privacy and security requirements under the Omnibus Rule?

Answer: The Omnibus Rule requires covered entities and business associates to implement administrative, physical, and technical safeguards to protect the privacy and security of individuals’ PHI. These safeguards include policies and procedures to protect PHI, such as employee training, risk assessments, and data security plans.

What is the penalty for non-compliance with the Omnibus Rule?

Answer: Under the Omnibus Rule, covered entities and business associates may be subject to civil monetary penalties if they fail to comply with the privacy and security requirements. The amount of the penalty depends on the level of negligence and the nature and extent of the violation.

What are the implications of the Breach Notification and Omnibus Rules?

Answer: The Breach Notification and Omnibus Rules have significant implications for covered entities and business associates. They must ensure that they are compliant with the requirements of the rules or risk facing civil monetary penalties. In addition, the rules provide individuals with new rights to access and receive copies of their health information.

How can organizations ensure compliance with the Breach Notification and Omnibus Rules?

Answer: Organizations should ensure that they are familiar with the requirements of the Breach Notification and Omnibus Rules and develop policies and procedures to comply with them. They should also train employees on the requirements of the rules, conduct regular risk assessments, and implement measures to protect the privacy and security of individuals’ PHI.