The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that establishes national standards for protecting the privacy and security of individuals’ health information. The law applies to healthcare providers, health plans, and healthcare clearinghouses, as well as to their business associates who handle patient information. To ensure compliance with HIPAA regulations, there are several entities involved in enforcement. In this blog, we will explore the rules and entities that enforces HIPAA.
- 1 Who Enforces HIPAA?
- 2 Other HIPAA Enforcer Involved
- 3 Rules Of HIPAA Enforcement
- 4 Penalties For Violating HIPAA Under OCR
- 5 Tips For Maintaining HIPAA Compliance
- 6 Conclusion
Who Enforces HIPAA?
The enforcement of the Health Insurance Portability and Accountability Act (HIPAA) is primarily the responsibility of the Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR). The OCR is responsible for investigating complaints of HIPAA violations and enforcing compliance with the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule.
In addition to the HHS and OCR, state attorneys general also have the authority to enforce HIPAA regulations within their respective states. They may bring civil actions against entities that violate HIPAA, seeking damages, injunctions, and other remedies.
Other HIPAA Enforcer Involved
Apart from the Department of Health and Human Services (HHS) and the Office for Civil Rights (OCR), there are other entities that enforces HIPAA regulations. These include:
- Centers for Medicare and Medicaid Services (CMS): The CMS is responsible for enforcing the HIPAA administrative simplification rules that apply to healthcare providers and health plans that participate in Medicare and Medicaid programs.
- Federal Trade Commission (FTC): The FTC has authority over entities that are compliant with HIPAA but handle personal health information, such as mobile health apps and wearable devices.
- State Health Departments: State health departments are responsible for investigating HIPAA violations that occur within their jurisdiction and can work with the OCR to enforce HIPAA regulations.
- Office of the Inspector General (OIG): The OIG has the authority to investigate and prosecute criminal violations of HIPAA, such as fraudulent billing practices.
It is important to note that covered entities and their business associates must comply with HIPAA regulations, regardless of which entity is responsible for enforcement. Failure to comply can result in significant penalties and legal consequences.
Rules Of HIPAA Enforcement
The enforcement of HIPAA is governed by a set of rules that dictate how investigations are conducted and penalties are imposed. The following are some of the key rules of HIPAA enforcement:
- Complaints: Firstly, the Office for Civil Rights (OCR) can initiate investigations based on complaints received from individuals, other entities, or media reports to enforces HIPAA. Individuals have the right to file a complaint if they believe their rights under HIPAA have been violated.
- Investigation: Secondly, the OCR will investigate complaints to determine if a covered entity or business associate has violated HIPAA regulations. The OCR has the authority to request documents and conduct interviews with relevant parties as part of its investigation.
- Notification: If the OCR determines that a covered entity or business associate has violated HIPAA regulations, it will notify the entity in writing of the alleged violation and give them an opportunity to respond.
- Settlement: If the OCR and the covered entity or business associate agree on the terms of a settlement, the OCR will enter into a resolution agreement that outlines the corrective action that must be taken, the timeline for completion, and any monetary penalties that will be imposed.
- Administrative Hearing: If the covered entity or business associate disputes the OCR’s findings or the proposed penalty, they have the right to request an administrative hearing. An administrative law judge will preside over the hearing and issue a final decision.
- Appeal: Finally, if the covered entity or business associate disagrees with the outcome of the administrative hearing, they have the right to appeal to a federal court.
Above all, it is important for covered entities and business associates to understand these rules and cooperate with the OCR during investigations to avoid potential penalties and legal consequences.
Penalties For Violating HIPAA Under OCR
If a covered entity or business associate violates HIPAA regulations, the OCR may impose civil monetary penalties (CMPs) and require corrective action.
The penalties for violating HIPAA under OCR are based on the level of culpability of the covered entity or business associate. The following are the four categories of HIPAA violations:
- Tier 1: When the covered entity or business associate did not know about the violation and could not have known about it even with reasonable diligence, the penalty can range from $119 to $59,522 per violation.
- Tier 2: When the violation was due to reasonable cause and not willful neglect, the penalty can range from $1,191 to $59,522 per violation.
- Tier 3: When the violation was due to willful neglect that is corrected within a specified time period, the penalty can range from $11,904 to $59,522 per violation.
- Tier 4: When the violation was due to willful neglect that is not corrected, the penalty can be up to $59,522 per violation.
Overall, in addition to CMPs, the OCR can also require covered entities and business associates to implement corrective action plans to address the underlying issues that led to the violation. These corrective action plans can include revising policies and procedures, conducting staff training, and implementing new security measures to protect individual health information.
Tips For Maintaining HIPAA Compliance
Here are four tips for maintaining HIPAA compliance:
Conduct Regular Risk Assessments
Regular risk assessments help covered entities and business associates identify potential vulnerabilities in their systems and processes that could result in a breach of protected health information (PHI). By conducting risk assessments on a regular basis, entities can proactively address these vulnerabilities and implement appropriate safeguards to protect PHI.
Implement Policies and Procedures
HIPAA requires covered entities and business associates to have written policies and procedures in place to protect PHI. These policies and procedures should address access controls, data backup and recovery, incident response, and workforce training, among other areas. Entities should review and update their policies and procedures regularly to ensure they remain up to date with changes in HIPAA regulations and best practices.
Train Your Workforce
HIPAA requires covered entities and business associates to train their workforce on their policies and procedures for protecting PHI. Workforce training should include information on how to identify and report potential security incidents, how to handle PHI appropriately, and how to protect the privacy and security of PHI. Entities should provide regular training to their workforce and document training completion.
Respond to Incidents Appropriately
In the event of a breach of PHI, covered entities and business associates must respond appropriately to minimize the impact of the breach. This includes reporting the breach to the affected individuals, the OCR, and, in some cases, the media. Entities should also conduct a thorough investigation of the breach to determine the cause and take appropriate corrective action to prevent future incidents.
Overall, by following these tips, covered entities and business associates can maintain compliance with HIPAA regulations and protect the privacy and security of individuals’ health information.
In conclusion, enforcing HIPAA is primarily the responsibility of the Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR). The OCR investigates complaints of HIPAA violations and enforces compliance with the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule. By following HIPAA regulations and cooperating with the OCR during investigations, covered entities, and business associates can ensure compliance with HIPAA and protect the privacy and security of individuals’ health information. If you are looking to implement any of the Infosec compliance frameworks such as SOC 2 compliance, HIPAA, ISO 27001, and GDPR compliance, Impanix can help. Book a Free consultation call with our experts or email us at [email protected] for inquiries.