HIPAA violation cases are compliance investigations that result from a data breach being reported to the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) or a privacy complaint being submitted to OCR via the complaints portal. When OCR identifies a violation of HIPAA, violation cases can be resolved in multiple ways. OCR may choose to take no action if the HIPAA-regulated entity has identified and voluntarily corrected the HIPAA violation.
If the HIPAA violation is not severe, OCR often chooses to provide technical assistance to help the regulated entity correct the violation. When there has been a serious violation of the HIPAA Rules or evidence is found suggesting widespread noncompliance, OCR may initiate a more extensive review. Serious violations are sometimes resolved with a financial penalty.
OCR will notify the regulated entity about the findings of the investigation and typically gives the regulated entity an opportunity to settle the alleged violations informally. These settlements involve a reduced financial penalty and generally include a corrective action plan (CAP) with specific measures the regulated entity must implement to ensure compliance with the HIPAA Rules.
The regulated entity will then be monitored for compliance with the HIPAA Rules by OCR for a set period, typically 1-3 years. If a regulated entity contests the findings and maintains that there was no wrongdoing, they have the opportunity to submit evidence to support a waiver of the proposed penalty. Should OCR determine that the evidence does not support a waiver, a civil monetary penalty will be imposed, but no CAP.
The regulated entity can request a hearing of its HIPAA violation case before an Administrative Law Judge. If the appeal is not successful, a civil monetary penalty will be imposed. Get The FREE HIPAA Compliance Checklist Immediate Delivery of Checklist Link To Your Email Address Please enable JavaScript in your browser to complete this form.
Business Email * Name * First Last Number * Company Name * Get Free Checklist Please Enter Correct Email Address Your Privacy Respected HIPAA Journal Privacy Policy There are many different types of HIPAA violation cases. For example: Failure to conduct a risk analysis Failure to create and monitor logs of activity in information systems containing ePHI Impermissible uses and disclosures of PHI Failure to comply with individuals’ rights under HIPAA Lack of Notice of Privacy Practices Failure to provide HIPAA training to the workforce and sanction failures Failure to provide security awareness training to the workforce Non-compliance with audit control standards Failure to develop a contingency plan Lack of physical or technical safeguards Business Associate Agreement failures Failure to comply with the General Provisions for Transactions Detailed below is a summary of all HIPAA violation cases that have resulted in civil monetary penalties or settlements with OCR, including cases that have been pursued by OCR after potential HIPAA violations were discovered during data breach investigations and investigations of complaints.
You can also use the article in conjunction with our free HIPAA Violations Checklist to understand what is required to ensure full HIPAA compliance. Use the form on this page to arrange to receive your copy of the checklist. OCR has increased its enforcement activities in recent years.
OCR stepped up enforcement of compliance with the HIPAA Rules in 2016, more than doubling the number of financial penalties imposed. In 2016, 12 entities agreed to settle their compliance investigations and pay a financial penalty, with one case seeing a civil monetary penalty imposed. The following three years saw similar numbers of financial penalties; however, there was another major increase in HIPAA fines in 2020 when 19 HIPAA violation cases were settled with OCR.
In 2022, OCR resolved 22 HIPAA violation cases with financial penalties, and while there was a dip in enforcement actions in 2023 to just 13 penalties, they rose to 16 in 2024 and 21 in 2025. The 2020 increase is largely due to OCR’s HIPAA Right of Access enforcement initiative, which was launched in late 2019. Since then, OCR has been cracking down on entities that have failed to provide individuals with timely access to their medical records.
As of January 2026, OCR has settled or imposed civil monetary penalties in more than 50 HIPAA violation cases under this compliance initiative. In 2024, OCR announced a new enforcement initiative targeting noncompliance with the risk analysis provision of the HIPAA Security Rule. Risk analysis failures are among the most commonly identified HIPAA violations.
In OCR’s last round of HIPAA audits in 2016 and 2017, most audited entities were not fully compliant with this important Security Rule provision, as they had either failed to conduct a HIPAA-compliant risk analysis, had not conducted one frequently enough, or their risk analyses were not comprehensive and/or accurate. Since this is the main focus of OCR when investigating hacking-related data breaches, not only will it help to improve compliance with this vital HIPAA Security Rule requirement, but it should also help to accelerate data breach investigations, allowing OCR to clear the backlog of investigations more rapidly.
Get The HIPAA Violations Checklist Free & Immediate Delivery of Checklist Link To Your Email Address Please enable JavaScript in your browser to complete this form. Business Email * Name * First Last Number * Company Name * Get Free Checklist Please enter your email correctly. Your Privacy Respected HIPAA Journal Privacy Policy OCR’s enforcement initiatives are effective at changing behavior, as can be seen by the falling numbers of penalties for HIPAA Right of Access violations in 2025.
In early 2026, OCR Director Paula M.
Originally published at hipaajournal.com
