Posted On: April 10, 2025

Navigating HIPAA Regulation: What Federal Agency Enforces HIPAA?

The Health Insurance Portability and Accountability Act (HIPAA) was created to ensure the privacy and security of individuals' protected health information (PHI). HIPAA applies to covered entities such as healthcare providers, health plans, healthcare clearinghouses, and their business associates who have access to PHI. Several federal agencies play important roles in enforcing HIPAA regulations and ensuring compliance.

In this blog, we’ll discuss who mandates HIPAA and what federal office is responsible for enforcing it.

What Is HIPAA?

HIPAA, or the Health Insurance Portability and Accountability Act, is a U.S. law enacted in 1996 designed to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. It establishes national standards for safeguarding medical records and other personal health information, ensuring confidentiality, integrity, and access controls within healthcare.

How Did HIPAA Evolve?

The Health Insurance Portability and Accountability Act (HIPAA), enacted in 1996, has undergone several changes over the past decade to align with the dynamic healthcare environment.

HIPAA's initial emphasis was on the transferability of health insurance and safeguarding confidential health data. However, after the enactment of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, HIPAA's purview broadened to encompass the protection of electronic health records (EHRs) and other forms of health information technology in terms of privacy and security.

Following the HITECH Act, healthcare providers were obligated to inform individuals if their confidential health data was compromised, enabling them to pursue legal recourse in cases of data mismanagement. Furthermore, the HITECH Act escalated the sanctions for HIPAA infractions, which have grown progressively more expensive.

The HIPAA Omnibus Rule, passed in 2013, resulted in significant overhauls to the HIPAA Privacy, Security, and HIPAA Breach Notification Rules. The alterations encompassed granting individuals greater authority over their health data, granting patients access to their own information, and implementing new safeguards to prevent the inappropriate dissemination of sensitive health information, such as genetic data.

The most recent amendments to HIPAA were introduced in February 2021 with the adoption of the 21st Century Cures Act, which incorporates measures for the exchange of health data for research objectives and the safeguarding of patient data during storage or transmission.

In general, HIPAA has become more inclusive, with the guidelines now affording individuals increased authority over their confidential health data and heightened safeguards against the unauthorized disclosure of such information.

Who Enforces HIPAA?

So, what agency enforces HIPAA? HIPAA is enforced by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). Its responsibilities include examining grievances and enforcing the HIPAA Privacy and Security Rules.

HIPAA is a federal statute that demands that covered entities, including health care providers, health plans, and health care clearinghouses, safeguard the confidentiality of individuals' health data.

Furthermore, the legislation obligates these entities to grant individuals certain rights concerning their health information.

What Are the OCR’s Enforcement Powers?

The OCR enforces HIPAA compliance through various powers, including investigating potential HIPAA violations, issuing civil monetary penalties, and imposing corrective action plans on offending entities. The OCR can also seek injunctions to prevent ongoing non-compliance, ensuring that covered entities and business associates adhere to HIPAA's privacy and security requirements.

Who Enforces HIPAA's Privacy Provisions in Non-Criminal Cases?

The enforcement of HIPAA's privacy provisions in non-criminal cases is the responsibility of the HHS Office for Civil Rights.

Additionally, the OCR is tasked with furnishing technical assistance and advice to covered entities to ensure that they conform to HIPAA's regulations. Upon receiving reports of violations, the OCR may conduct investigations and issue civil monetary penalties or mandate corrective action plans.

The enforcement of HIPAA's criminal provisions falls under the purview of the HHS Office of Inspector General (OIG). The OIG has the authority to pursue legal action against individuals or organizations who have knowingly and deliberately contravened HIPAA and may also refer criminal cases to the Justice Department.

State attorneys general are also responsible for enforcing HIPAA, and they possess the power to enforce both the privacy and security provisions of the law. They can examine grievances and take the necessary measures as warranted.

To summarize, the HHS Office for Civil Rights is accountable for enforcing HIPAA's privacy regulations in non-criminal situations, while the HHS Office of Inspector General is responsible for enforcing the criminal provisions of HIPAA.

Who Regulates HIPAA?

Other agencies involved in regulating HIPAA include the Centers for Medicare and Medicaid Services (CMS), which is the federal agency in charge of managing the Medicare and Medicaid healthcare programs. Through its Office of eHealth Standards and Services (OESS), CMS oversees the enforcement of HIPAA. OESS is responsible for examining grievances, carrying out audits, and providing guidance to assist entities in complying with HIPAA.

The Federal Trade Commission (FTC) is an autonomous agency of the U.S. government that is committed to safeguarding consumers from deceitful and unjust practices. To enforce HIPAA, the FTC relies on its Health Breach Notification Rule, which mandates that entities report breaches of unprotected protected health information to impacted individuals within 60 days.

The FTC collaborates with the Department of Health and Human Services (HHS) to disseminate information on safeguarding health information.

How Has HIPAA Regulation Evolved?

Since its enactment in 1996, the federal government has been responsible for supervising and enforcing HIPAA.

Here’s a look at how HIPAA regulation has evolved.

1996
- The Department of Health and Human Services (HHS) oversees HIPAA, as it formulates the regulations and furnishes guidance to covered entities.
2003
- The Office for Civil Rights (OCR) was created within HHS to specialize in enforcing HIPAA.
2009
- The Department of Labor (DOL) and the Centers for Medicare and Medicaid Services (CMS) become involved in enforcing HIPAA, providing compliance guidance, and conducting audits.
2013
- The Office of the National Coordinator for Health Information Technology (ONC) is established to ensure that electronic health records (EHRs) comply with HIPAA regulations.
Present Day
- The primary enforcer of HIPAA is still HHS, with the OCR at the forefront of the effort. The OCR investigates complaints, carries out audits, and imposes penalties for violations.
- The DOL also guides HIPAA compliance and may impose fines for violations related to employee benefit plans.
- The CMS and ONC are tasked with ensuring that electronic health records (EHRs) comply with HIPAA regulations.

As a result of the growing significance of safeguarding health information in the digital era and the necessity for more rigorous oversight to ensure compliance, the federal government's involvement in overseeing and enforcing HIPAA has increased significantly since 1996.

What Are HIPAA Violation Consequences?

HIPAA violations can result in serious penalties for covered entities and business associates, ranging from monetary fines to criminal charges. The Office for Civil Rights (OCR) categorizes violations into four tiers based on the level of negligence involved. Fines can range from $100 to $50,000 per violation, up to a maximum of $1.5 million per year for repeated violations of the same provision.

Severe violations can also lead to criminal penalties, with individuals potentially facing jail time if found guilty of willful neglect or wrongful disclosure of protected health information (PHI). Additionally, violators may be subject to corrective action plans, mandated audits, and reputational damage that can impact their standing in the healthcare community.