HIPAA Frequently Asked Questions

Common questions about HIPAA compliance and healthcare data security

TXLLabs does not outsource software development, and all software is written and remains in the United States. This is critical for HIPAA compliance because when vendors outsource development or testing overseas, those overseas teams need access to your data to test the software. This creates a significant HIPAA violation risk as your Protected Health Information may be accessed, stored, or processed in countries without adequate data protection laws or HIPAA compliance requirements. By keeping all development and testing within the US, TXLLabs ensures that your PHI never leaves secure, HIPAA-compliant environments.

No, Git (including GitHub, GitLab, and other public Git hosting services) is not HIPAA compliant. These platforms lack the necessary Business Associate Agreements (BAAs), encryption requirements, access controls, and audit logging needed for HIPAA compliance. Additionally, public repositories can expose sensitive code and data. TXLLabs uses an internal, fully HIPAA-compliant system that includes proper encryption, access controls, audit logging, and all required safeguards to protect Protected Health Information (PHI) in accordance with HIPAA regulations.

Ask your vendor if they use Git. Many healthcare software vendors rely on Git-based version control systems, which can create significant HIPAA compliance risks if not properly managed. Additionally, many vendors outsource their code development and use Git to share that code overseas with overseas developers without ever vetting the vendor or ensuring proper HIPAA compliance measures are in place. This means your healthcare software code - which may contain PHI patterns, database schemas, or even actual PHI - could be accessed by unvetted developers in foreign countries with no Business Associate Agreements or HIPAA compliance requirements.

Git is a distributed version control system that allows developers to track changes in code and collaborate on software projects. When developers use Git, code changes are replicated across multiple computers and servers around the world. This distributed nature means that your healthcare data and code can be stored on servers in various countries, potentially violating HIPAA requirements for data residency and security. Even if a vendor claims to use "private" Git repositories, the fundamental architecture of Git means data can be spread across multiple locations globally, making it nearly impossible to guarantee that Protected Health Information remains within secure, HIPAA-compliant boundaries.

A BAA is a written contract between a covered entity and a business associate that ensures the business associate will appropriately safeguard PHI. Business associates include vendors, contractors, and service providers who have access to PHI in the course of their work. However, it's important to understand that having a BAA does not mean their software is HIPAA compliant - it simply means they will cover you (provide protection and assume liability) in the event of a breach or violation. You should still verify that the software itself has proper security measures, encryption, access controls, and other HIPAA-required safeguards.

All data is stored in US data centers only. TXLLabs operates three data centers located in Dallas/Fort Worth (DFW), Texas; Richmond, Virginia; and San Diego, California. This ensures that all Protected Health Information (PHI) remains within the United States and complies with HIPAA requirements for data residency and security.

PHI is any information that can be used to identify a patient and relates to their health status, healthcare provision, or payment for healthcare. This includes names, addresses, Social Security numbers, medical record numbers, diagnoses, treatment information, and any other identifiable health data.

The main HIPAA rules are: (1) Privacy Rule - governs the use and disclosure of PHI, (2) Security Rule - requires safeguards to protect electronic PHI, (3) Breach Notification Rule - requires notification of breaches of unsecured PHI, and (4) Enforcement Rule - establishes penalties for violations.

The minimum necessary rule requires covered entities to make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose. This means only accessing, using, or disclosing the minimum amount of PHI needed for a specific task.

A breach is an impermissible use or disclosure of PHI that compromises its security or privacy. However, not all incidents are breaches - if the PHI is encrypted or the disclosure was unintentional and made in good faith, it may not be considered a breach.

Covered entities must notify affected individuals within 60 days of discovering a breach. If the breach affects more than 500 individuals, they must also notify the Department of Health and Human Services (HHS) and local media within 60 days. Smaller breaches must be reported to HHS annually.

The Security Rule requires covered entities to implement administrative, physical, and technical safeguards to protect electronic PHI. This includes access controls, encryption, audit logs, workforce training, and risk assessments.

While encryption is not strictly required by HIPAA, it is considered an "addressable" safeguard. If you choose not to encrypt, you must document why and implement an equivalent alternative measure. Encrypted data is also exempt from breach notification requirements if lost or stolen.

Yes, patients have the right to access, inspect, and obtain copies of their PHI. Covered entities must provide access within 30 days of the request and may charge a reasonable fee for copies. Patients also have the right to request amendments to their records.

A risk assessment is a systematic evaluation of potential risks and vulnerabilities to the confidentiality, integrity, and availability of PHI. It's required by the Security Rule and should be conducted regularly to identify and address security gaps.

Yes, but you must use secure, encrypted email when transmitting PHI. Standard email is not secure and could result in a breach if PHI is sent unencrypted. Many healthcare organizations use encrypted email services or patient portals for secure communication.

HIPAA violations can result in civil penalties ranging from $127 to $63,973 per violation, with an annual maximum of $1,919,173. Criminal penalties can include fines up to $250,000 and imprisonment up to 10 years for intentional violations.

Yes, HIPAA requires covered entities to train all workforce members on HIPAA policies and procedures. Training should be provided upon hire, when policies change, and periodically thereafter. Documentation of training is required.

A Notice of Privacy Practices (NPP) is a document that explains how a covered entity uses and discloses PHI, patient rights regarding their PHI, and the entity's legal duties. Covered entities must provide the NPP to patients and obtain acknowledgment of receipt.

Generally, you can share PHI with family members or others involved in the patient's care if the patient agrees or doesn't object, or if it's in the patient's best interest and they're unable to agree. However, you should always verify the patient's wishes when possible.

Audit logs record who accessed PHI, when, and what actions were taken. They're required by the Security Rule and help detect unauthorized access, investigate breaches, and demonstrate compliance. Logs should be regularly reviewed and protected from tampering. TXLLabs implements comprehensive audit logging at the database record level, ensuring that every access, modification, and deletion of PHI is tracked and recorded with complete detail for full compliance and security.

HIPAA requires covered entities to designate a Privacy Officer (and Security Officer for electronic PHI) responsible for developing and implementing privacy policies, training staff, handling complaints, and ensuring compliance. This can be a dedicated role or assigned to existing staff.

Immediately investigate the incident, document your findings, and take corrective action. If it's a breach of unsecured PHI, follow breach notification procedures. Report violations to your Privacy Officer and maintain documentation of the incident and response.

HIPAA compliance should be reviewed regularly - at least annually, or whenever there are significant changes to your operations, systems, or regulations. Regular risk assessments, policy reviews, and staff training updates are essential for maintaining compliance.