How do the HIPAA Regulations Characterize a Deliberate Violation?

by

The HIPAA regulations characterize a deliberate violation by a covered entity or business associate as a conscious, intentional failure or reckless indifference to the obligation to comply with the administrative simplification provision violated. If a deliberate violation is identified and not corrected within 30 days, HHS’ Office for Civil Rights can impose the maximum possible penalty for a HIPAA violation.

The characterization of a deliberate HIPAA violation is defined in §160.401 of the HIPAA Administrative Simplification Regulations. The definition was introduced as a result of the HITECH Act and was added to the HIPAA Administrative Simplification Regulations by the Final Omnibus Rule in 2013 in order to distinguish between:

  • HIPAA violations that could not have been avoided,
  • HIPAA violations attributable to a lack of care, and
  • HIPAA violations attributable to willful neglect.

The 30 day correction clause was added to distinguish between HIPAA covered entities and business associates that cooperated with an HHS compliance inspections and took corrective action, and those that did not. The maximum penalty for a HIPAA violation was originally $1.5 million, but since 2015, the penalties have been adjusted for inflation. The current minimum and maximum penalties for HIPAA violations (August 2024) are:

Penalty TierLevel of CulpabilityMinimum Penalty per ViolationMaximum Penalty per ViolationAnnual Penalty Limit per Violation
Tier 1Lack of Knowledge$137$34,464$34,464
Tier 2Lack of Care$1,379$68,928$137,886
Tier 3Willful Neglect$13,785$68,928$344,638
Tier 4Willful Neglect not Corrected within 30 days$68,928$68,928$2,067,813

How do the HIPAA Regulations Characterize a Deliberate Violation by a Workforce Member?

The above penalties for HIPAA violations only apply to HIPAA covered entities and business associates. If a member of either’s workforce deliberately violates HIPAA, the penalty is whatever penalty appears in the regulated entity’s sanction policy. Sanctions can range from a verbal warning and additional HIPAA training to a suspension or termination of contract depending on the seriousness of the violation and whether it is a repeated event.

In cases in which a deliberate violation of HIPAA results in the wrongful disclosure of individually identifiable health information, the covered entity or business associate is required to notify the data breach to HHS’ Office for Civil Rights. The organization may also be required to report the violation to law enforcement or the State Attorney General depending on state privacy laws. If the violation is criminal, HHS’ Office for Civil Rights will refer the case to the Department of Justice.

The HIPAA regulations characterize a deliberate violation by a workforce member that results in a data breach appear in §1177 of the Social Security Act. This section applies to any workforce member who deliberately uses or causes to be used a unique health identifier, obtains individually identifiable health information relating to an individual or discloses individually identifiable health information to another person and false pretenses or with the intent to sell, transfer, or use the information for commercial advantage, personal gain, or malicious harm.

If found guilty, the Department of Justice is authorized to fine the workforce member up to $250,000 and imprison them for up to ten years. Several healthcare professionals have been imprisoned for what the HIPAA regulations characterize a deliberate violation of HIPAA. However, it is most often the case that workforce members are imprisoned for violations of state privacy or theft laws.

James Keogh

James Keogh has been writing about the healthcare sector in the United States for several years and is currently the editor of HIPAAnswers. He has a particular interest in HIPAA and the intersection of healthcare privacy and information technology. He has developed specialized knowledge in HIPAA-related issues, including compliance, patient privacy, and data breaches. You can follow James on Twitter https://x.com/JamesKeoghHIPAA and contact James on LinkedIn https://www.linkedin.com/in/james-keogh-89023681 or email directly at [email protected]