Alyssa Lane
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 established national standards for the protection of health information, outlining privacy rules and security provisions that must be adhered to by covered entities. These include health plans, healthcare clearinghouses, and healthcare providers that conduct certain transactions electronically. HIPAA violations can result in civil and criminal penalties, with fines ranging from $100 to $250,000 and potential imprisonment. Covered entities and individuals who “knowingly disclose identifiable health information without authorisation may face legal consequences. Understanding what constitutes a HIPAA violation is important, as the potential costs of non-compliance are substantial, and violations can be inadvertently committed by medical professionals.
| Characteristics | Values |
|---|---|
| HIPAA violation definition | Non-compliance with any “required” standard or any “addressable” standard for which an equally effective substitute has not been implemented, or a documented reason for this lack of implementation |
| HIPAA Privacy Rule | Establishes a set of national standards for the protection of certain health information |
| Covered entities | Health plans, healthcare clearinghouses, health care providers that conduct certain transactions electronically |
| HIPAA violation penalties | Varying fines and/or imprisonment |
| Complaint process | File a complaint with the Office for Civil Rights (OCR) within 180 days of the violation |
| OCR review | OCR reviews the information and determines if the covered entity violated HIPAA requirements |
| Non-compliance consequences | OCR will attempt to resolve the case with the covered entity; failure to comply with HIPAA can result in civil and criminal penalties |
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What You'll Learn
HIPAA complaint process
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was introduced primarily to ensure employees could maintain healthcare coverage between jobs. The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is responsible for enforcing the HIPAA Privacy and Security Rules.
The OCR can investigate complaints against covered entities (health plans, health care clearinghouses, or health care providers that conduct certain transactions electronically) and their business associates. Anyone can file a complaint if they believe there has been a violation of the HIPAA Rules. The complaint must be filed within 180 days of when the complainant knew that the act or omission occurred. The OCR may extend the 180-day period if the complainant can show "good cause". The complaint must be filed in writing by mail, fax, email, or via the OCR Complaint Portal. The OCR cannot investigate complaints filed without a name and contact information on the complaint.
The complaint must include the name, full address, and telephone number of the person, agency, or organization believed to have violated health information privacy rights or committed another violation of the Privacy or Security Rule. It must also include a brief description of what happened, how, why, and when the violation occurred. If filing a complaint on someone else's behalf, the name of that person must also be provided.
HIPAA violation penalties range from $100 to $250,000 per violation, with an annual maximum of $100,000 to $250,000 for repeat violations. Criminal violations of HIPAA are handled by the Department of Justice (DOJ).
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Criminal liability
The Health Insurance Portability and Accountability Act (HIPAA) was introduced to ensure employees could maintain healthcare coverage between jobs. HIPAA violations are enforced by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). The OCR investigates complaints and can refer criminal violations to the Department of Justice (DOJ) for prosecution.
Criminal penalties for HIPAA violations can include fines, imprisonment, or both. The severity of the penalty depends on the nature and extent of the violation and the harm resulting from it. The penalties for criminal violations of HIPAA are substantial and include fines of up to $50,000 and up to one year in prison. Offenses committed under false pretenses allow penalties to be increased to a $100,000 fine and up to 5 years in prison. Offenses committed with the intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm permit fines of $250,000 and imprisonment of up to 10 years.
In practice, many criminal cases involving HIPAA violations are not charged as such. For example, in a case from Louisiana, three individuals pled guilty to bank larceny charges after an employee at a medical clinic released protected health information (PHI) that resulted in an identity theft scheme. In another case, a Georgia pediatric cardiologist pleaded guilty to disclosing protected health information about his patients to a pharmaceutical company representative.
To avoid criminal liability, covered entities should take sufficient HIPAA compliance measures, including ongoing training and awareness, active enforcement of internal sanctions, and maintenance of up-to-date policies and procedures.
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HIPAA Privacy Rule
The Health Insurance Portability and Accountability Act (HIPAA) was introduced in 1996 to ensure employees could maintain healthcare coverage between jobs. The U.S. Department of Health and Human Services (HHS) issued the HIPAA Privacy Rule to implement the requirement of the Act. The Privacy Rule standards address the use and disclosure of individuals' health information, which is referred to as "protected health information". The Rule applies to health plans, healthcare clearinghouses, and healthcare providers that conduct certain transactions electronically. It requires appropriate safeguards to protect the privacy of protected health information and sets limits and conditions on the use and disclosure of such information without an individual's authorization.
The Privacy Rule gives individuals rights over their protected health information, including the right to examine and obtain a copy of their health records, to direct a covered entity to transmit their protected health information to a third party, and to request corrections. The Rule is designed to be flexible and comprehensive to cover the diverse uses and disclosures that need to be addressed in the healthcare marketplace. It is important to note that the Privacy Rule does not prohibit a doctor from sending medical test results to another doctor without the patient's permission if the information is needed for treatment.
The HHS's Office for Civil Rights (OCR) is responsible for enforcing the HIPAA Privacy Rule and reviewing complaints alleging violations. OCR can only investigate complaints that allege an action or omission that fails to comply with the Privacy or Security Rules. Complaints must be filed within 180 days of when the complainant knew that the act or omission occurred, and the complainant must provide their name and contact information. If a complaint describes an action that could be a violation of the criminal provision of HIPAA, OCR may refer it to the Department of Justice (DOJ) for investigation.
HIPAA violations can result in civil and criminal penalties, with fines ranging from $100 to $250,000 per violation and potential imprisonment for up to 10 years in cases of offenses committed with malicious intent. The secretary of HHS has discretion in determining the penalty amount based on the nature and extent of the violation and the resulting harm. Entities that adopt recognised security practices will be considered by OCR as a mitigating factor when determining penalties and may be subject to less extensive audits and investigations.
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HIPAA Security Rule
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was introduced to ensure that employees could maintain healthcare coverage between jobs. The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is responsible for enforcing the HIPAA Privacy and Security Rules.
The HIPAA Security Rule establishes national standards to protect individuals' electronic personal health information (ePHI) that is created, received, used, or maintained by a covered entity. It requires appropriate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of ePHI. The Security Rule complements the privacy standards established in the Privacy Rule, and the requirements of the Breach Notification Rule. Together, these rules help to protect the privacy and security of protected health information (PHI).
The Security Rule incorporates the concepts of scalability, flexibility, and generalization, recognising that security is an evolving target. The regulations do not expect the same security precautions from small or rural providers as from large covered entities with significant resources. HHS is focused more on what needs to be done rather than how it should be accomplished. The security regulations consist of a 3-tiered system of requirements:
- A series of standards or legal requirements that all entities are expected to meet.
- Implementation specifications that provide detailed instructions and steps to comply with the standards. Some of these are required, while others are only addressable, meaning that an equally effective alternative can be implemented if necessary.
- Documentation requirements, which mandate that policies and procedures be created, implemented, and updated as needed, with accompanying documentation. These documents must be retained for at least six years.
To assist with the risk-assessment process, HHS has developed a downloadable "Security Risk Assessment Tool". Entities that adopt recognised security practices will be considered by OCR when determining financial penalties for data security incidents, and may be subject to less extensive audits and investigations.
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HIPAA violation penalties
HIPAA violations can result in civil and criminal penalties. The Office for Civil Rights (OCR) enforces compliance through audits and investigations, penalizing violations like unauthorized PHI access, lack of encryption, and delayed breach notifications. The Department of Justice (DOJ) handles criminal penalties for HIPAA violations.
The penalty structure for a HIPAA violation is tiered, based on the knowledge a covered entity had of the violation. The OCR sets the penalty based on a number of “general factors” and the seriousness of the HIPAA violation. Ignorance of HIPAA Rules is no excuse for failing to comply with HIPAA Rules. It is the responsibility of each covered entity to ensure that HIPAA Rules are understood and followed.
Civil penalties for HIPAA violations range from USD 100 to USD 50,000 per violation, with an annual maximum of USD 1.5 million for repeat violations. The secretary is prohibited from imposing civil penalties (except in cases of willful neglect) if the violation is corrected within 30 days (this time period may be extended at HHS’ discretion).
Criminal penalties for HIPAA violations can result in fines and imprisonment. Criminal penalties are up to USD 50,000 and one year in prison for obtaining or disclosing PHI; up to USD 100,000 and up to five years in prison for obtaining PHI under "false pretenses"; and up to USD 250,000 and up to ten years in prison for obtaining or disclosing PHI with the intent to sell, transfer or use it for commercial advantage, personal gain or malicious harm.
In addition to financial penalties, corrective action plans may be required to address compliance deficiencies. State attorneys general can also bring civil actions, resulting in monetary damages. Covered entities may be required to adopt a corrective action plan to bring policies and procedures up to the standards demanded by HIPAA.
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Frequently asked questions
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was introduced primarily to ensure employees could maintain healthcare coverage between jobs and not be discriminated against for pre-existing conditions.
A HIPAA violation is any failure to comply with the HIPAA regulations – which can include the unauthorized access, use, or disclosure of Protected Health Information (PHI), the failure to provide patients with access to their PHI, a lack of safeguards to protect PHI, the failure to conduct regular risk assessments, or insufficient workforce training on the HIPAA rules.
Failure to comply with HIPAA can result in civil and criminal penalties. Criminal violations of HIPAA are handled by the DOJ and can result in fines of up to $50,000 and imprisonment of up to 1 year. Civil penalties are determined based on a tiered structure and the nature and extent of the violation.
If you believe that your health information privacy rights have been violated, you can file a complaint with the Office for Civil Rights (OCR). You will need to provide the name and contact information of the covered entity or business associate involved, as well as a brief description of what happened and how you believe your privacy rights were violated.
The Department of Health and Human Services (HHS) has investigated over 20,000 cases of potential HIPAA violations. If non-compliance is found, entities must implement corrective measures. In addition to the cost of implementing these measures, organizations may also face severe financial penalties for HIPAA violations.
