The Trump administration has finalized a rule eliminating certain federal transparency requirements for artificial intelligence (AI) tools integrated into certified electronic health record (EHR) systems. The change, included in the October 2026 Health Data, Technology, and Interoperability (HTI-5) final rule, removes requirements for developers to provide standardized information about how certain clinical decision-support algorithms are developed, tested, and intended to be used.
Under the previous requirements, developers were expected to provide information commonly referred to as AI model cards or “nutrition labels,” including details about algorithm performance, limitations, and potential risks.
HHS maintains that these requirements created unnecessary administrative burdens and could discourage innovation, citing limited evidence that the disclosures improved patient care. However, healthcare organizations have expressed concern that eliminating these requirements could make it more difficult to evaluate AI tools for clinical accuracy, reliability, and potential bias.
As AI applications expand in gastroenterology, including computer-assisted polyp detection, endoscopic image analysis, and clinical decision support, transparency remains important to informed adoption and patient safety. Although the rule removes specific EHR certification requirements, it does not eliminate applicable FDA oversight of AI-enabled medical devices.