HIPAA penalties for non-compliance can include civil monetary penalties assessed under a tiered structure, settlement agreements and corrective action plans imposed through enforcement actions, required breach notifications and remedial measures under the HIPAA Breach Notification Rule, and criminal fines and imprisonment for certain unlawful acts involving protected health information.
Civil monetary penalties are administered through the HHS Office for Civil Rights enforcement process and are tied to the nature and extent of the violation, the number of affected individuals, and the organization’s conduct. The penalty framework applies tiers based on culpability, ranging from violations where the entity did not know and would not have known with reasonable diligence to violations reflecting willful neglect that is not timely corrected. Penalties are calculated on a per-violation basis and are subject to annual limits for violations of the same requirement or prohibition within a calendar year, with amounts adjusted over time through federal rulemaking.
Enforcement outcomes often include corrective action obligations in addition to, or instead of, monetary penalties. These obligations can require changes to policies and procedures, workforce training, risk analysis and risk management actions under the HIPAA Security Rule, access control improvements, audit and monitoring enhancements, vendor contract remediation, and periodic reporting to regulators. Investigations may arise from complaints, breach reports, or compliance reviews, and the scope can expand to evaluate broader compliance controls beyond the triggering event.
Criminal penalties may apply when an individual knowingly obtains or discloses protected health information in violation of the law, including conduct involving false pretenses or actions intended for personal gain or malicious harm. Criminal cases are handled through the Department of Justice and can result in fines and imprisonment, with maximum penalties increasing based on the intent and circumstances. Separate from federal enforcement, state attorneys general may bring civil actions to enforce HIPAA requirements, and organizations can also face contractual consequences, workforce sanctions, and operational disruption following non-compliance findings.