As more coding and revenue cycle tools that use AI continue to be established as core infrastructure for hospitals, health systems, and physician practices, one of the most common questions asked is whether or not this is HIPAA compliant? It is no longer enough for healthcare organizations to simply know what HIPAA compliance AI means in the context of coding.
In this guide, we'll cover what HIPAA compliance AI truly entails in medical coding, why an AI coding tool could be a potential HIPAA violation if not done right, and how to make sure your AI agent complies with HIPAA regulations.
What Does HIPAA Compliance Actually Require?
Prior to discussing HIPAA compliance AI, it is important to start from a point that discusses the requirements of HIPAA itself, because AI does not affect the framework but merely the approach to its application.
The HIPAA Privacy Rule regulates the uses and disclosures of PHI. The HIPAA Security Rule requires administrative, physical, and technical safeguards of the integrity of ePHI (encryption, access control, auditing, and risk analysis, among others). When an AI coding tool creates, receives, maintains, or transmits PHI or ePHI on behalf of a covered entity or business associate, the applicable HIPAA Privacy and Security Rule requirements apply.
As of December 2024, HHS has proposed changes to the HIPAA Security Rule, which will require covered entities and business associates to have stronger cybersecurity standards as part of the rule, among other changes. However, these are only proposals, and the existing HIPAA Security Rule is still in place. Organizations considering AI providers must be aware of this distinction.
Can AI in Medical Coding Be HIPAA Compliant?
Yes. Compliance is not a guarantee, and being "HIPAA compliant" in vendor marketing materials does not make compliance automatic. For AI in medical coding to be HIPAA-compliant AI, the way it is built and implemented matters more than the technology itself's ability to work with PHI.
There are several requirements for an AI coding tool to be HIPAA-compliant AI that typically should be fulfilled:
- First, when an AI vendor qualifies as a business associate because it creates, receives, maintains, or transmits PHI on behalf of a covered entity, the parties generally need a HIPAA-compliant Business Associate Agreement.
- Second, organizations should verify how the vendor protects ePHI in transit and at rest, including encryption and other safeguards appropriate to the organization's risk analysis.
- Third, it is necessary to know exactly who – and in more detail, what process – accessed PHI and when for what purposes.
- Fourth, access to PHI should be limited to the minimum necessary to perform the intended function, consistent with the organization's policies and HIPAA requirements.
- Lastly, any model training or data storage process should meet the requirements set by HIPAA with regard to the use of PHI especially if the third party uses any data from the clients to refine its own AI models.
Where AI Coding Tools Can Introduce HIPAA Risk
Even if HIPAA compliance AI tools are implemented with good intentions, there are several elements that need attention to ensure compliance and avoid risk:
- Third-party LLM architecture. There are numerous coding platforms for AI development based on third-party LLM infrastructure. If any PHI is sent to a third party LLM provider without having an adequate BAA signed for that particular transfer, the organization will be at risk despite any other HIPAA-compliant solutions employed in-house.
- Training an AI model on the basis of PHI. Using the client's PHI as a base for training an AI tool without proper de-identification and without any restrictions in the contract may put an organization at risk of HIPAA Privacy Rule violations beyond standard processing.
- Insufficient audit trail for AI decisions. Traditional HIPAA compliance procedures include audit logs accessible to humans. In the case of HIPAA-compliance AI, it means having similar auditability for AI processes – proving that PHI accessed and how.
- Cross-border data processing. Some AI technologies process data in other countries in the cloud region. Organizations should understand where PHI is processed and stored and evaluate the applicable contractual, security, and privacy requirements, including any state or international requirements.
- Shadow AI systems. Organizations should also account for the risk of employees using unapproved consumer AI tools to process PHI.







