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.
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:
Read more: What is the OCR and what does it do?
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:
Read also: Understanding HIPAA violations and breaches
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.
Additionally, the Secretary of HHS has the discretion to adjust penalty amounts depending on the specific circumstances of each case.
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:
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.
Related: What are the penalties for breaching HIPAA?
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.
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.
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.
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.
There are various tools and resources available to help healthcare providers maintain HIPAA compliance, such as:
Learn more: FAQs: All about HIPAA breaches