On October 30, 2009, the Department of Health and Human Services published an Interim Final Rule addressing HIPAA Enforcement. The Interim Final Rule, effective November 30, 2009, defines the terms "reasonable cause", "reasonable diligence", and "willful neglect" and relates those definitions to the applicable civil money penalties in the event of a violation. The Interim Final Rule also provides for affirmative defenses for covered entities with respect to such violations. Finally, Interim Final Rule provides the ability for the Secretary to waive civil money penalties in certain circumstances.

Posted by Paul J. Welk, Esquire