Final answer:
The HIPAA Final Rule or Omnibus Rule is a set of regulations issued by HHS in 2013 to strengthen privacy and security protections for health information. It amends HIPAA and establishes new requirements for handling protected health information.
Step-by-step explanation:
The HIPAA Final Rule, also known as the Omnibus Rule, refers to a set of regulations issued by the U.S. Department of Health and Human Services (HHS) in 2013 to strengthen privacy and security protections for health information. It amends the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and establishes new requirements for entities that handle protected health information (PHI).
The Omnibus Rule includes provisions related to breach notification, business associates, and the use and disclosure of PHI for marketing and fundraising purposes. It expands the definition of a business associate to include subcontractors who handle PHI on behalf of covered entities, and it strengthens the penalties for non-compliance with the HIPAA regulations.
For example, under the Omnibus Rule, if a healthcare provider experiences a breach of unsecured PHI, they must notify affected individuals, the media (for breaches affecting more than 500 individuals), and the HHS. Failure to comply with the breach notification requirements can result in significant financial penalties.