Bill > HB1915

This bill establishes comprehensive regulations for the use of artificial intelligence (AI) devices in healthcare settings. It defines key terms such as "AI device" (a medical device with machine learning capabilities that supports medical diagnosis or treatment), "deployer" (the healthcare facility responsible for implementing the AI device), and "qualified end-user" (a licensed physician trained to independently use the device and assess its outputs). The bill mandates that AI devices must be deployed in accordance with FDA regulations and used exclusively by qualified end-users. Deployers are required to implement a Quality Assurance Program, continuously review device-generated data, and conduct regular performance evaluations. The legislation emphasizes that qualified end-users retain the authority to amend or overrule AI device outputs based on their professional judgment. Deployers must establish an AI governance group, maintain an updated inventory of AI devices, document use cases and training procedures, and participate in national AI assessment registries when possible. The State Department of Health is authorized to enforce the act and impose penalties for non-compliance. Importantly, the bill requires detailed documentation of device performance, including tracking instances where AI recommendations are overridden, and ensures that all documentation complies with medical record-keeping requirements. The act is set to become effective on November 1, 2025, providing healthcare facilities time to prepare for implementation.

http://www.oklegislature.gov/BillInfo.aspx?Bill=hb1915&Session=2600