This post is part of our series on key aspects of the final HITECH omnibus rule published by the U.S. Department of Health and Human Services (HHS) in the Federal Register on January 25, 2013. Previous posts are available here. The regulations are effective March 26, 2013, but covered entities and business associates have until September 23, 2013, to comply with most new requirements.
The final HITECH omnibus rule adopts a number of modifications to Subparts C and D of Part 160 (HIPAA Enforcement Rule) to implement Section 13410 of the HITECH Act. Most significantly, the rule includes modifications to implement Section 13410(a) of the HITECH Act, which requires HHS to formally investigate a complaint if a preliminary investigation indicates a possible violation due to willful neglect, and to impose a civil money penalty for a violation due to willful neglect.