A Breach Under HIPAA: What You Need to Know About Compliance

A breach under HIPAA can be a nightmare for healthcare organizations. HIPAA, or the Health Insurance Portability and Accountability Act, requires covered entities to protect the confidentiality, integrity, and availability of electronic protected health information (ePHI).

Covered entities must implement administrative, technical, and physical safeguards to ensure the confidentiality, integrity, and availability of ePHI. This includes ensuring that all employees have a clear understanding of HIPAA policies and procedures.

In the event of a breach, covered entities must provide notification to affected individuals, the Secretary of HHS, and the media if the breach affects more than 500 individuals. The notification must include the date of the breach, the date of the discovery, and a description of the types of ePHI involved.

For another approach, see: Hipaa Release Date

The HIPAA Breach Rule is a set of standards that establish the need for covered entities and their associates to inform individuals whose information might have been leaked.

These standards are found in Sections 164.402-414 of the Code of Federal Regulations (CFR), which is a specific part of the law that outlines the requirements for healthcare organizations to protect patient data.

The Breach Notification Rule in HIPAA has two main goals: to protect individuals and increase accountability.

Here are the specific goals of the Breach Notification Rule:

Notification procedures are a crucial aspect of handling a breach under HIPAA. You must notify impacted individuals promptly and no later than 60 days after the breach is discovered.

To provide a breach notification, you'll need to include a concise description of the incident, detailing the dates of the breach and discovery (if known) alongside the types of unsecured PHI involved. This can be done through a written notice sent by first-class mail or via email if the individual has consented to be contacted via email.

The notification must also include recommendations for affected individuals to safeguard themselves, such as credit monitoring. Additionally, you'll need to provide a summary of the covered entity's actions taken to investigate the breach, mitigate potential harm, and prevent similar occurrences in the future.

Check this out: Hipaa Email Disclaimer

A toll-free phone number should be included for individuals to inquire if their information might be involved in the breach. The contact number needs to remain active for at least 90 days.

If the contact information of over 10 affected individuals is outdated, you must publish the notice on your website or broadcast the notice where each individual resides for at least 90 days.

Protected Health Information (PHI) is a crucial concept to understand when it comes to HIPAA breaches. PHI is any individually identifiable health information, including medical records, test results, and billing information.

The HIPAA Privacy Rule defines PHI using 18 identifiers, such as names, dates of birth, Social Security numbers, and medical record numbers. This means that any information that could potentially identify a patient is considered PHI.

Videos and images containing PHI are also protected by the HIPAA Privacy Rule, as is PHI that's stored electronically. This includes digital files, emails, and text messages that contain PHI.

Suggestion: Hipaa Privacy Act

To determine if a breach has occurred, you must consider whether the PHI was impermissibly used, accessed, or disclosed. If the PHI was not properly secured and was accessed or disclosed without authorization, it's considered a breach.

Here are the 18 identifiers of PHI as defined by the HIPAA Privacy Rule:

If a breach occurs, you must notify the Secretary of Health and Human Services (HHS) and provide a notification to the affected individuals. The timing and manner of the notification depend on the number of individuals affected.

Take a look at this: Hipaa Breach Notice

If a business associate is responsible for a breach, they must notify the covered entity within 60 days of discovering the breach. This is a crucial step in ensuring that affected individuals are notified and that the breach is properly handled.

The business associate must provide identification of each affected individual to the covered entity, as well as communicate as many details as possible about the breach. This information is essential for the covered entity to comply with the Breach Notification Rule.

Here are the key responsibilities of a business associate in the event of a breach:

The business associate must also provide the covered entity with any other available information that is required to be included in notification to the individual under § 164.404(c). This information should be provided as soon as possible, either at the time of the initial notification or afterwards as it becomes available.

As a business associate, you play a crucial role in helping covered entities comply with the Breach Notification Rule. A business associate is responsible for notifying the covered entity of a breach within 60 days of discovering it.

The notification should include identification of each affected individual, as well as as many details as possible about the breach. This information is crucial for the covered entity to notify affected individuals, notify HSS, and potentially contact the media.

A business associate is deemed to have knowledge of a breach if it's known to any employee, officer, or agent, except the person responsible for the breach. This means that if any of your team members are aware of the breach, you're responsible for notifying the covered entity.

The notification should be provided without unreasonable delay and in no case later than 60 calendar days after discovery of a breach. This timeline is crucial to ensure that affected individuals are notified promptly.

The notification should include a list of affected individuals, if possible, and any other relevant information that the covered entity would need to notify affected individuals. This information should be provided as soon as possible, either at the time of the initial notification or afterwards as it becomes available.

Here's a summary of the key points:

A covered entity or business associate may waive breach notification requirements if they reasonably believe the unauthorized PHI recipient wouldn't have been able to retain the information.

This means that if a business associate has good reason to believe the unauthorized recipient wouldn't have been able to keep the PHI, they might not need to send out breach notifications.

Exceptions to a breach under HIPAA exist. In fact, there are three specific scenarios that don't require a breach notification.

One of these exceptions is unintentional access or use of protected health information (PHI) by an employee, made in good faith and within the scope of their authority.

Accidental disclosure of PHI between authorized persons is another exception. This means if PHI is shared accidentally between people who are supposed to have access to it, it's not considered a breach.

The third exception is when an organization is confident that the person who obtained or accessed the PHI will not retain or compromise the data.

Here are the three exceptions in a nutshell:

If any of these exceptions apply, a covered entity isn't required to notify affected parties or HHS under the Breach Notification Rule.

If a covered entity discovers a breach of unsecured protected health information, it must notify the Secretary of the HHS. This notification should follow the guidelines outlined in 164.404(a)(2).

Covered entities and their business associates must display adherence to the HIPAA rules or prove that the PHI use wasn’t a breach. They must keep a record of smaller breaches involving less than 500 individuals, and at the end of each calendar year, the Secretary must receive a report from the covered entities containing all such breaches that occurred during the previous year.

For larger breaches impacting at least 500 individuals, the covered entity must notify the Secretary at the same time they notify affected individuals under 164.404(a). The notification format should follow the instructions provided on the HHS website.

For another approach, see: Under Hipaa a Covered Entity Is Defined as

The severity of a breach depends on four key factors. These factors help determine the level of risk and the necessary response to a breach.

The type of PHI exposed plays a significant role in determining severity. Information like a patient's full name, address, and diagnosis is more sensitive than basic details like height or weight.

The identity of the unauthorized party also affects severity. A curious coworker poses less risk than a criminal selling medical data on the black market.

PHI acquisition versus viewing is another crucial factor. If there is unauthorized access, acquisition, or viewing of PHI, the covered entity must assess whether this incident constitutes a breach.

The covered entity must investigate whether the unauthorized individuals who accessed the PHI actually looked at or retained the information.

Here are the four factors in detail:

The covered entity is usually obligated to notify patients if their PHI has been compromised. This notification should explain the nature of the breach, the information potentially exposed, and steps being taken to address the vulnerability and prevent future incidents.

Secureframe helps with compliance by training employees on HIPAA requirements and best practices.

This training ensures that employees understand the importance of keeping sensitive information safe.

Secureframe also keeps track of vendors and associates that have access to Protected Health Information (PHI), reducing the risk of unauthorized access.

By monitoring individual PHI safeguards, Secureframe helps organizations stay on top of their compliance efforts.

This proactive approach to compliance can help organizations avoid costly fines and penalties associated with HIPAA rule violations.

For your interest: Hipaa Training

Administrative Requirements are a crucial part of HIPAA compliance. Covered entities must follow specific administrative requirements outlined in § 164.530(b), (d), (e), (g), (h), (i), and (j) when dealing with patient data privacy under this subpart.

Workforce training is a key aspect of administrative requirements. Covered entities must implement a program to train their workforce on HIPAA Privacy Rule requirements, including understanding patients' rights, how to handle protected health information (PHI), and how to comply with the entity's privacy policies and procedures.

Complaint procedures are also essential. Covered entities must have a process for patients to submit complaints about how their PHI is handled, including designating a contact person or office to receive complaints and having a clear procedure for investigating and responding to them.

Sanctions are another important aspect of administrative requirements. Covered entities must have policies and procedures to address workforce violations of the HIPAA Privacy Rule, which may include disciplinary action or termination depending on the severity of the violation.

On a similar theme: Hipaa Need to Know Rule

Mitigation plans are also required. Covered entities must have a plan to mitigate any potential harm caused by unauthorized disclosures of PHI, which could involve notifying affected patients, taking steps to prevent future breaches, and reporting the incident to the HHS.

Confidential communications must also be provided. Covered entities must provide patients with different ways to request confidential communications about their PHI, such as allowing them to request information by physical mail or through a secure online portal.

Documentation is also a must. Covered entities must document their HIPAA Privacy Rule compliance efforts, including maintaining records of workforce training, complaints received, and any actions taken in response to violations or breaches.

Here is a summary of the administrative requirements:

These administrative requirements are essential for covered entities to follow in order to maintain HIPAA compliance and protect patient data.