According to a email received from Stanley Nachimson, Senior Technical Advisor with the Office of E-Health Standards and Services, the Final Rule adopts the complete regulatory structure for implementing the civil money penalty authority of the Administrative Simplification part of HIPAA (SSA, section 1176), completing the structure begun when the Privacy Rule was issued in 2000 and expanded by the interim final procedural enforcement rules issued in 2003.
The Final Rule covers the enforcement process from its beginning, which will usually be a complaint or a compliance review, through its conclusion. A complaint or compliance review may result in informal resolution, a finding of no violation, or a finding of violation. If a finding of violation is made, a civil money penalty will be sought for the violation, which can be challenged by the covered entity through a formal hearing and appellate review process.
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