Who Is Responsible for Enforcing the HIPAA Security Rule?

The Department of Health and Human Services (HHS) is primarily responsible for enforcing the HIPAA Security Rule.

The HHS Office for Civil Rights (OCR) is the specific office within HHS that oversees the enforcement of the HIPAA Security Rule.

OCR conducts investigations and audits to ensure compliance with the HIPAA Security Rule, and can also impose penalties for non-compliance.

Covered entities and business associates must cooperate with OCR during investigations and audits.

The HIPAA Security Rule is enforced by several entities, but the main enforcer is the Office for Civil Rights (OCR) within the Department of Health and Human Services (HHS). OCR has the authority to investigate complaints and breach notifications.

In addition to OCR, state attorneys general and the Centers for Medicare and Medicaid Services (CMS) also have the power to enforce HIPAA. CMS is responsible for investigating covered entities that have failed to comply with the HIPAA Administrative Simplification Regulations.

OCR enforces HIPAA by investigating complaints and breach notifications, and can issue civil monetary penalties for violations. The amount of the penalty depends on the nature of the violation, the length of time it was allowed to continue, and the organization's cooperation during the investigation.

OCR plays a crucial role in enforcing the HIPAA Security Rule. It investigates complaints, conducts compliance reviews, and educates relevant entities about compliance requirements.

OCR prioritizes investigating data breaches that impact more than 500 people, but it also investigates organizations that have had multiple smaller breaches. Data breaches don't always mean an organization isn't compliant with HIPAA, but OCR considers breaches enough of a reason to investigate an entity covered by HIPAA.

OCR prefers to resolve HIPAA violations through voluntary compliance, where the organization at fault voluntarily corrects its compliance issues. If this doesn't happen, OCR will likely pursue legal action.

OCR breaks down HIPAA violations into four categories, in order of severity:

OCR has the authority to levy civil monetary penalties, which can vary according to the nature of the violation, the length of time the violation was allowed to continue, the number of individuals affected, and the organization’s cooperation during the investigation.

The Centers for Medicare and Medicaid Services (CMS) plays a crucial role in enforcing the HIPAA Administrative Simplification Regulations.

CMS is responsible for investigating covered entities that have failed to comply with the HIPAA Administrative Simplification Regulations.

CMS does not issue penalties against non-compliant entities unless they refuse to achieve compliance.

The Office for Civil Rights (OCR) isn't the only entity authorized to enforce HIPAA Rules. State attorneys general and the CMS also have authority to enforce HIPAA.

State attorneys general have the power to pursue civil monetary penalties against covered entities and business associates who are responsible for unauthorized uses and disclosures of Protected Health Information. Claims can be filed through federal district courts and resolved for up to $25,000 per violation.

The HITECH Act also granted state attorneys general the power to enforce HIPAA for data breaches occurring in their state, allowing them to file civil actions with the federal district courts.

Attorney Generals have the power to enforce HIPAA in their states, a power granted to them by the HITECH Act in 2008.

State Attorney Generals can investigate and take legal action against covered entities and business associates for HIPAA violations that impact residents within their states. They can pursue civil lawsuits, seek injunctions, and impose penalties for non-compliance.

State Attorney Generals can also obtain damages on behalf of state residents if their rights have been violated, with penalties of up to $25,000 per violation tier possible.

In 2021, New Jersey helped investigate the 2019 data breach at American Medical Collection Agency (AMCA), showing that Attorney Generals are becoming more active in enforcing HIPAA.

State Attorney Generals often collaborate with the OCR on HIPAA enforcement efforts, sharing information, coordinating activities, and working together to address widespread breaches and systemic issues.

Attorney Generals can also retain a portion of the fines issued against covered entities, which may incentivize them to become more involved in HIPAA enforcement.

Only a few states, such as Connecticut, Massachusetts, Indiana, Vermont, and Minnesota, have used this power to enforce HIPAA, but it's likely that more states will follow suit in the future.

State Attorney Generals can also use state-specific laws to enforce HIPAA, with some states having enacted their own laws that mirror HIPAA or provide additional protections.

The Federal Trade Commission plays a crucial role in protecting consumers' sensitive information. They enforce the Health Breach Notification rule, requiring companies to alert customers and the media within 60 calendar days of a breach.

The FTC takes action against companies that engage in deceptive practices related to protecting and securing Protected Health Information (PHI).

The Department of Health and Human Services (HHS) has the responsibility for enforcing HIPAA. HHS oversees the enforcement of HIPAA regulations.

Organizations must designate a privacy officer to review HIPAA policies and ensure compliance. This officer is responsible for overseeing the development and implementation of HIPAA rules within the organization.

The Office for Civil Rights (OCR) enforces HIPAA by investigating complaints and breach notifications. In most cases, investigations are resolved via voluntary corrective actions and technical assistance.

If a violation causes harm or the entity has a history of non-compliance, the OCR has the authority to issue civil monetary penalties. The amount of a penalty can vary depending on the nature of the violation and the organization's cooperation during the investigation.

The OCR can levy significant financial penalties against healthcare providers, health plans, and healthcare clearinghouses that are found in violating HIPAA's Rules. The penalty structure for HIPAA violations is divided into several different tiers.

Here are the categories of HIPAA violation:

The OCR has the power to waive a fee if the CE in question could not have been expected to avoid a data breach, a so-called “unknown violation”.

The person responsible for enforcing HIPAA in the workplace can depend on the organization's "status." If the organization is a covered entity, it's the Privacy Officer's job, although this responsibility can be delegated to another senior member of the workforce.

The Privacy Officer oversees the development and implementation of HIPAA rules within the organization. They also review HIPAA policies to ensure compliance. If the organization is a business associate, it's not required to designate a Privacy Officer. Instead, the Security Officer is responsible for enforcing HIPAA, although this responsibility can be delegated as well.

Organizations can delegate the responsibility of enforcing HIPAA to a department head or HR manager. However, if no Privacy Officer or Security Officer is designated, the organization's sanctions policy will determine the consequences for workforce HIPAA violations. Penalties can range from a verbal warning and/or HIPAA training to suspension and loss of employment.

Serious violations can also be reported to law enforcement agencies, particularly when they violate §1177 of the Social Security Act.