Breach Notification Rule and Omnibus Rule of 2013
Last updated
Last updated
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.