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The Health Insurance Portability and Accountability Act (HIPAA) was passed in 1996 to simplify healthcare administration, reduce the risk of fraud and data abuse, and improve the protection of patients’ sensitive health information.
If your organization handles protected health information (PHI) and is subject to HIPAA, compliance isn't optional, it's a legal requirement. Failure to meet HIPAA standards can result in significant penalties, including civil fines and criminal charges, depending on the nature, severity, and intent behind the violation.
This guide outlines the non-compliance penalties you could face and your responsibilities under HIPAA. We’ll also cover:
- Who must comply with HIPAA
- Who enforces HIPAA
- What constitutes a HIPAA violation
Who must comply with HIPAA requirements?
All individuals and organizations that directly handle protected health information must comply with HIPAA. PHI refers to identifiable health information that is transmitted or maintained in electronic or paper form, such as a patient’s name, diagnosis, billing information, and treatment plans.
All covered entities must comply with HIPAA. Covered entities include:
- Healthcare providers, such as hospitals, clinics, and doctors
- Health plans, such as insurance companies and health maintenance organizations (HMOs)
- Healthcare clearinghouses, which process health-related transactions including billing and claims management
In addition to covered entities, business associates (BA) must also comply. Business associates are third-party individuals or organizations that handle PHI on behalf of covered entities. Examples include billing services, cloud storage providers, and third-party claims administrators.
To ensure that both covered entities and business associates responsibly handle such sensitive patient information, they are required to establish a business associate agreement (BAA)—a legal contract that outlines business associates’ responsibilities for safeguarding PHI.
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Who enforces HIPAA requirements?
HIPAA enforcement is primarily the responsibility of the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), which manages civil enforcement actions. The Department of Justice (DoJ) enforces criminal violations involving deliberate misuse or unauthorized disclosures of PHI.
Here are the main actions the OCR takes to enforce HIPAA compliance:
- Investigating complaints: When a complaint about a potential HIPAA violation is filed, the OCR investigates the case to determine if any rules were broken and whether the reason for the violation was lack of knowledge or willful neglect. It also determines what corrective measures may be necessary.
- Performing compliance reviews: Even if no complaint has been made, the OCR may audit and review an organization’s privacy and security practices to ensure they meet HIPAA requirements.
- Conducting education and outreach: To prevent violations, the OCR offers training, guidance, and resources to educate organizations about HIPAA standards and best practices.
The OCR isn’t the only authority responsible for civil enforcement. As of February 2009, the Health Information Technology for Economic and Clinical Health Act (HITECH) allows state attorneys general to investigate and fine organizations for HIPAA non-compliance in their jurisdictions.
What is a HIPAA violation?
A HIPAA violation occurs when a covered entity or business associate fails to comply with HIPAA’s regulations, most commonly involving the Privacy, Security, or Breach Notification Rules.
Violations generally fall into two categories, outlined in the table below:
{{cta_withimage39="/cta-blocks"}} | The Healthcare compliance checklist
Common HIPAA violations to avoid
Many HIPAA violations result from simple oversights, outdated practices, or weak internal procedures—you can read about them in detail in the 2025 Vanta HIPAA Violations Survey. Understanding these common mistakes can help organizations take practical steps to lower their risk of non-compliance.
The table below outlines five common HIPAA violations, explains how they typically occur, and suggests measures you can take to avoid them:
“
Business Associates failure to identify all vendors and subcontractors to manage thorough oversight over established roles and responsibilities is a common failure in managing HIPAA compliance."
What are the consequences of HIPAA non-compliance?
The OCR can issue different corrective measures depending on the type and severity of the HIPAA violation. For less severe violations, especially when an organization fully cooperates, OCR typically resolves the issue through informal measures, such as:
- Voluntary compliance: The organization voluntarily solves the issue without any formal enforcement
- Corrective action: The organization must take specific steps, outlined by the OCR, to address the problem and create a plan to prevent it from happening again
For more serious or repeated violations, even when an organization is cooperative, the OCR may use formal enforcement measures. This may include a resolution agreement, which is a formal settlement between the OCR and the organization, typically involving a monetary penalty and a detailed corrective action plan (CAP) to ensure future compliance. If an organization continues to be non-compliant, the outcome may include:
- Civil penalties imposed by the OCR
- Criminal charges prosecuted by the DoJ
1. Civil penalties
Civil penalties are mainly issued when violations remain unresolved for a long time or when the OCR identifies multiple areas of non-compliance. They are structured into a four-tier system to determine the penalty amount based on how severe the violation is and the level of knowledge or negligence involved.
The table below outlines the current structure of HIPAA violation civil penalties:
Note: While the table above reflects official penalty amounts, the OCR issued a Notice of Enforcement Discretion in 2019 stating the annual penalty limits in three of the penalty tiers would be reduced according to the HITECH Act’s language. As such, the maximum and annual penalty limits could be considerably lower, especially taking into account annual inflation increases.
Annual penalty caps apply per HIPAA provision. This means that if an organization violates multiple requirements from the Privacy, Breach Notification, and Security rules, fines can be applied separately for each, significantly increasing the total possible penalty.
In some cases, if an organization can demonstrate that the violation was unavoidable and beyond its control despite reasonable diligence, the OCR may decide to waive the fine.
2. Criminal charges
Criminal penalties only apply when it’s proven that a covered entity or business associate knowingly violated HIPAA. The DoJ investigates and prosecutes these cases, which can result in substantial fines and even imprisonment.
Criminal HIPAA violations are classified into three tiers:
*Note: "Knowingly" refers to intentionally carrying out the action, such as accessing or disclosing PHI, not necessarily knowing that the act violates HIPAA.
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
How to avoid HIPAA non-compliance
Staying compliant with HIPAA is a multi-layered, ongoing process that demands methodical oversight and preparation. Organizations must implement numerous regulatory workflows, such as access logging, compliance monitoring, breach reporting, and evidence collection.
Managing these tasks manually often leads to delays, inefficiencies, and increased risk of non-compliance due to point-in-time reporting and slow incident response. Over time, the growing workload can also overwhelm security teams and divert attention from other strategic tasks.
Many organizations address these challenges by leveraging automation tools that drastically streamline HIPAA compliance efforts. By automating eligible workflows, companies can reduce operational risks, improve response times, and ensure a more consistent, scalable approach to HIPAA compliance.
Support effective, ongoing HIPAA compliance with Vanta
Vanta is an end-to-end trust management solution designed to help organizations achieve continuous HIPAA compliance through clear guidance and resources. With the help of Vanta’s tools, you can automate your HIPAA compliance workflows, reducing the manual workload for your team.
Vanta’s HIPAA suite can help you minimize the chance of violating regulations through tools like Instant Gap Assessment. This tool identifies gaps in your security posture, allowing you to proactively address them before they become a liability. You’ll also benefit from built-in features such as:
- Automated evidence collection through 375+ integrations
- Centralized dashboard for easy monitoring
- Ready-to-use policy templates
- Prescriptive guidance and training resources
If your organization is already compliant with frameworks like SOC 2, ISO 27001, or HITRUST, Vanta’s in-built evidence cross-mapping can align your evidence with HIPAA requirements. This way, you can streamline your compliance process across multiple standards within one platform and avoid duplicative work.
Schedule a custom demo today to see how Vanta’s HIPAA product can streamline compliance efforts.
{{cta_simple18="/cta-blocks"}} | HIPAA product page
A note from Vanta: Vanta is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
Introduction to HIPAA
HIPAA violations and penalties: What happens when you’re not compliant
Introduction to HIPAA
Looking to streamline the work for HIPAA compliance?
The Health Insurance Portability and Accountability Act (HIPAA) was passed in 1996 to simplify healthcare administration, reduce the risk of fraud and data abuse, and improve the protection of patients’ sensitive health information.
If your organization handles protected health information (PHI) and is subject to HIPAA, compliance isn't optional, it's a legal requirement. Failure to meet HIPAA standards can result in significant penalties, including civil fines and criminal charges, depending on the nature, severity, and intent behind the violation.
This guide outlines the non-compliance penalties you could face and your responsibilities under HIPAA. We’ll also cover:
- Who must comply with HIPAA
- Who enforces HIPAA
- What constitutes a HIPAA violation
Who must comply with HIPAA requirements?
All individuals and organizations that directly handle protected health information must comply with HIPAA. PHI refers to identifiable health information that is transmitted or maintained in electronic or paper form, such as a patient’s name, diagnosis, billing information, and treatment plans.
All covered entities must comply with HIPAA. Covered entities include:
- Healthcare providers, such as hospitals, clinics, and doctors
- Health plans, such as insurance companies and health maintenance organizations (HMOs)
- Healthcare clearinghouses, which process health-related transactions including billing and claims management
In addition to covered entities, business associates (BA) must also comply. Business associates are third-party individuals or organizations that handle PHI on behalf of covered entities. Examples include billing services, cloud storage providers, and third-party claims administrators.
To ensure that both covered entities and business associates responsibly handle such sensitive patient information, they are required to establish a business associate agreement (BAA)—a legal contract that outlines business associates’ responsibilities for safeguarding PHI.
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Who enforces HIPAA requirements?
HIPAA enforcement is primarily the responsibility of the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), which manages civil enforcement actions. The Department of Justice (DoJ) enforces criminal violations involving deliberate misuse or unauthorized disclosures of PHI.
Here are the main actions the OCR takes to enforce HIPAA compliance:
- Investigating complaints: When a complaint about a potential HIPAA violation is filed, the OCR investigates the case to determine if any rules were broken and whether the reason for the violation was lack of knowledge or willful neglect. It also determines what corrective measures may be necessary.
- Performing compliance reviews: Even if no complaint has been made, the OCR may audit and review an organization’s privacy and security practices to ensure they meet HIPAA requirements.
- Conducting education and outreach: To prevent violations, the OCR offers training, guidance, and resources to educate organizations about HIPAA standards and best practices.
The OCR isn’t the only authority responsible for civil enforcement. As of February 2009, the Health Information Technology for Economic and Clinical Health Act (HITECH) allows state attorneys general to investigate and fine organizations for HIPAA non-compliance in their jurisdictions.
What is a HIPAA violation?
A HIPAA violation occurs when a covered entity or business associate fails to comply with HIPAA’s regulations, most commonly involving the Privacy, Security, or Breach Notification Rules.
Violations generally fall into two categories, outlined in the table below:
{{cta_withimage39="/cta-blocks"}} | The Healthcare compliance checklist
Common HIPAA violations to avoid
Many HIPAA violations result from simple oversights, outdated practices, or weak internal procedures—you can read about them in detail in the 2025 Vanta HIPAA Violations Survey. Understanding these common mistakes can help organizations take practical steps to lower their risk of non-compliance.
The table below outlines five common HIPAA violations, explains how they typically occur, and suggests measures you can take to avoid them:
“
Business Associates failure to identify all vendors and subcontractors to manage thorough oversight over established roles and responsibilities is a common failure in managing HIPAA compliance."
What are the consequences of HIPAA non-compliance?
The OCR can issue different corrective measures depending on the type and severity of the HIPAA violation. For less severe violations, especially when an organization fully cooperates, OCR typically resolves the issue through informal measures, such as:
- Voluntary compliance: The organization voluntarily solves the issue without any formal enforcement
- Corrective action: The organization must take specific steps, outlined by the OCR, to address the problem and create a plan to prevent it from happening again
For more serious or repeated violations, even when an organization is cooperative, the OCR may use formal enforcement measures. This may include a resolution agreement, which is a formal settlement between the OCR and the organization, typically involving a monetary penalty and a detailed corrective action plan (CAP) to ensure future compliance. If an organization continues to be non-compliant, the outcome may include:
- Civil penalties imposed by the OCR
- Criminal charges prosecuted by the DoJ
1. Civil penalties
Civil penalties are mainly issued when violations remain unresolved for a long time or when the OCR identifies multiple areas of non-compliance. They are structured into a four-tier system to determine the penalty amount based on how severe the violation is and the level of knowledge or negligence involved.
The table below outlines the current structure of HIPAA violation civil penalties:
Note: While the table above reflects official penalty amounts, the OCR issued a Notice of Enforcement Discretion in 2019 stating the annual penalty limits in three of the penalty tiers would be reduced according to the HITECH Act’s language. As such, the maximum and annual penalty limits could be considerably lower, especially taking into account annual inflation increases.
Annual penalty caps apply per HIPAA provision. This means that if an organization violates multiple requirements from the Privacy, Breach Notification, and Security rules, fines can be applied separately for each, significantly increasing the total possible penalty.
In some cases, if an organization can demonstrate that the violation was unavoidable and beyond its control despite reasonable diligence, the OCR may decide to waive the fine.
2. Criminal charges
Criminal penalties only apply when it’s proven that a covered entity or business associate knowingly violated HIPAA. The DoJ investigates and prosecutes these cases, which can result in substantial fines and even imprisonment.
Criminal HIPAA violations are classified into three tiers:
*Note: "Knowingly" refers to intentionally carrying out the action, such as accessing or disclosing PHI, not necessarily knowing that the act violates HIPAA.
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
How to avoid HIPAA non-compliance
Staying compliant with HIPAA is a multi-layered, ongoing process that demands methodical oversight and preparation. Organizations must implement numerous regulatory workflows, such as access logging, compliance monitoring, breach reporting, and evidence collection.
Managing these tasks manually often leads to delays, inefficiencies, and increased risk of non-compliance due to point-in-time reporting and slow incident response. Over time, the growing workload can also overwhelm security teams and divert attention from other strategic tasks.
Many organizations address these challenges by leveraging automation tools that drastically streamline HIPAA compliance efforts. By automating eligible workflows, companies can reduce operational risks, improve response times, and ensure a more consistent, scalable approach to HIPAA compliance.
Support effective, ongoing HIPAA compliance with Vanta
Vanta is an end-to-end trust management solution designed to help organizations achieve continuous HIPAA compliance through clear guidance and resources. With the help of Vanta’s tools, you can automate your HIPAA compliance workflows, reducing the manual workload for your team.
Vanta’s HIPAA suite can help you minimize the chance of violating regulations through tools like Instant Gap Assessment. This tool identifies gaps in your security posture, allowing you to proactively address them before they become a liability. You’ll also benefit from built-in features such as:
- Automated evidence collection through 375+ integrations
- Centralized dashboard for easy monitoring
- Ready-to-use policy templates
- Prescriptive guidance and training resources
If your organization is already compliant with frameworks like SOC 2, ISO 27001, or HITRUST, Vanta’s in-built evidence cross-mapping can align your evidence with HIPAA requirements. This way, you can streamline your compliance process across multiple standards within one platform and avoid duplicative work.
Schedule a custom demo today to see how Vanta’s HIPAA product can streamline compliance efforts.
{{cta_simple18="/cta-blocks"}} | HIPAA product page
A note from Vanta: Vanta is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
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