HIPAA Violation Penalties

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HIPAA violation penalties include civil monetary penalties assessed by the HHS Office for Civil Rights under a four-tier framework with inflation-adjusted per-violation amounts and calendar-year caps for identical violations, as well as separate criminal penalties that may apply to certain knowing conduct involving individually identifiable health information.

Civil monetary penalties apply when the HHS Office for Civil Rights determines that a HIPAA Covered Entity or Business Associate failed to comply with an administrative simplification requirement, including obligations under the HIPAA Privacy Rule, HIPAA Security Rule, and HIPAA Breach Notification Rule. The tier assigned depends on the level of culpability, ranging from lack of knowledge despite reasonable diligence through willful neglect that remains uncorrected after the allowed correction period. The number of violations and how the agency groups violations as identical requirements or prohibitions influence the final penalty amount.

For penalties assessed on or after January 28, 2026, the inflation-adjusted civil monetary penalty minimums are $145 per violation for Tier 1, $1,461 per violation for Tier 2, $14,602 per violation for Tier 3, and $73,011 per violation for Tier 4. The maximum penalty per violation is $73,011 for Tiers 1 through 3. The Tier 4 maximum penalty per violation is $2,190,294. The published annual limit for identical violations within a calendar year is $2,190,294.

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The HHS Office for Civil Rights has also applied a 2019 enforcement discretion approach related to annual penalty limits for Tiers 1 through 3 based on its interpretation of the HITECH Act penalty caps. Under that approach, the agency applies lower annual caps for identical violations in Tiers 1 through 3 while retaining the higher annual cap for Tier 4. Using the inflation-adjusted figures associated with that approach for 2026, the annual cap is $36,505.50 for Tier 1, $146,053 for Tier 2, $365,052 for Tier 3, and $2,190,294 for Tier 4. These annual caps affect total exposure when multiple violations of the same requirement occur within the same calendar year, including situations where a per-violation maximum exceeds the annual cap.

Penalty determination also considers case-specific factors described in HIPAA enforcement. The HHS Office for Civil Rights evaluates the nature and extent of the violation, the nature and extent of harm, and the entity’s compliance history and response posture. These factors interact with corrective action timing, documented risk analysis and risk management under the HIPAA Security Rule, and the presence or absence of policies, online HIPAA training, audit controls, and incident response procedures. A provider or Business Associate that discovers an issue and implements verifiable remediation can still face penalties, but corrective action influences the agency’s resolution strategy and penalty calculations.

Civil monetary penalties are one enforcement outcome, not the only enforcement outcome. Many matters resolve through settlement agreements or other resolution terms that include a payment and a corrective action plan. These resolutions can impose multi-year obligations such as policy updates, workforce training, risk analysis updates, regular reporting, and monitoring of safeguards. A corrective action plan can require operational changes such as access control improvements, audit log review procedures, encryption controls aligned with risk analysis decisions, and tightened procedures for workforce access and disclosures.

Criminal penalties are separate from civil enforcement and apply to certain knowing misconduct involving individually identifiable health information. Criminal cases can involve a person knowingly obtaining or disclosing individually identifiable health information in violation of law, with higher penalty levels when conduct involves false pretenses or intent to sell, transfer, or use the information for commercial advantage, personal gain, or malicious harm. Criminal enforcement can include fines and imprisonment and follows criminal justice processes rather than administrative investigation procedures.

HIPAA enforcement can also involve state-level action. State attorneys general have authority to bring civil actions on behalf of residents for certain HIPAA violations and to seek relief authorized by law. This enforcement channel can proceed independently from federal administrative enforcement and can increase exposure for organizations with multi-state operations or large incident footprints.

Organizations should also account for non-penalty impacts that follow a HIPAA violation finding or resolution. Corrective action obligations consume compliance resources, increase audit and monitoring requirements, and require sustained documentation and leadership oversight. Operational disruption can occur during system containment, restoration, and control redesign after security incidents involving electronic protected health information, and those operational impacts occur alongside regulatory outcomes.

HIPAA violation penalties therefore include tiered civil monetary penalties with inflation-adjusted ranges and annual caps, potential criminal penalties for certain knowing conduct, and enforcement resolutions that frequently impose ongoing compliance obligations beyond a payment.

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]