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HIPAA violations & enforcement

Farah Amod Sep 24, 2024 3:29:56 AM

HIPAA Compliance

Maintaining HIPAA compliance is challenging but necessary for safeguarding patient data. Knowing how enforcement works, what penalties can be imposed, and the best practices to follow enables healthcare providers to address potential violations effectively and build a culture of compliance within their organizations.

The role of the Office for Civil Rights (OCR)

At the heart of HIPAA enforcement lies the Office for Civil Rights (OCR), a division of the U.S. Department of Health and Human Services (HHS). The OCR must enforce the HIPAA privacy and security rules, ensuring that covered entities and business associates adhere to the established standards. Through a multifaceted approach, the OCR fulfills this mandate by:

Investigating complaints filed with the agency
Conducting compliance reviews to assess the HIPAA-related practices of covered entities and business associates
Providing educational resources and outreach programs to foster a deeper understanding of HIPAA requirements

Uncovering HIPAA violations

When the OCR gathers information during its investigative process, it meticulously examines the data to determine if a covered entity has violated the provisions of the HIPAA privacy and security rules. In cases where noncompliance is identified, the OCR will work with the entity to:

Achieve voluntary compliance
Implement corrective actions
Negotiate a resolution agreement

The tiered civil penalty structure

HIPAA violations can result in civil monetary penalties (CMPs) imposed by the OCR. These penalties are structured in a tiered system, with the severity of the violation and the nature and extent of the resulting harm determining the final amount.

Unknowing violations: $100 - $50,000 per violation, with an annual maximum of $25,000 for repeat offenses
Reasonable cause violations: $1,000 - $50,000 per violation, with an annual maximum of $100,000 for repeat offenses
Willful neglect violations (corrected): $10,000 - $50,000 per violation, with an annual maximum of $250,000 for repeat offenses
Willful neglect violations (uncorrected): $50,000 per violation, with an annual maximum of $1.5 million

Additionally, the Secretary of HHS has the discretion to adjust penalty amounts depending on the specific circumstances of each case.

Criminal penalties for HIPAA violations

In addition to civil penalties, HIPAA violations can result in criminal charges, handled by the Department of Justice (DOJ). The severity of the criminal penalties depends on the nature of the offense:

Knowingly obtaining or disclosing PHI: Up to $50,000 fine and 1 year in prison.
Obtaining PHI under false pretenses: Up to $100,000 fine and 5 years in prison.
Obtaining PHI with intent to sell, transfer, or use for commercial advantage, personal gain, or malicious harm: Up to $250,000 fine and 10 years in prison.

The "knowing" element in the criminal provisions refers to the individual's awareness of the actions constituting the offense, not necessarily their knowledge of the HIPAA statute itself.

Covered entities and criminal liability

According to the Scope Of Criminal Enforcement Under 42 U.S.C. § 1320d-6, “If the covered entity is not an individual, general principles of corporate criminal liability will determine the entity's liability and that of individuals within the entity, including directors, officers, and employees. Finally, certain conduct of these individuals and that of other persons outside the covered entity, including of recipients of protected information, may be prosecuted in accordance with principles of aiding and abetting liability and of conspiracy liability.”

This means criminal penalties for HIPAA violations extend beyond just the covered entities themselves. Individuals, such as directors, employees, or officers of a covered entity, can also be held directly criminally liable under the concept of "corporate criminal liability." Additionally, even if an individual is not directly liable under HIPAA, they can still be charged with conspiracy or aiding and abetting the violation.

Exclusion from Medicare

The HHS also has the authority to exclude covered entities from participating in the Medicare program if they fail to comply with the HIPAA transaction and code set standards by the mandated deadlines.

FAQs

Does HIPAA apply to my organization?

HIPAA applies to all covered entities, which include health plans, healthcare clearinghouses, and healthcare providers who transmit any health information in electronic form. If your organization falls into one of these categories, you are subject to HIPAA compliance requirements.

Do I need patient consent to share protected health information (PHI)?

Generally, you need to obtain patient consent before sharing their PHI, with some exceptions. These exceptions include sharing PHI for treatment, payment, or healthcare operations, as well as certain public health and safety activities. It's important to familiarize yourself with the specific consent requirements outlined in the HIPAA privacy rule.