As introduced: - Requires artificial intelligence devices of machine learning-enabled devices used in health care settings that meet the federal definition of medical device to be deployed and utilized in accordance with FDA regulations. - Requires an AI device to be used exclusively by a qualified end-user. - Requires deployers to implement and maintain a quality assurance program and ensure the safe, effective, and compliant use of AI devices in patient care. - Requires all relevant AI device-generated data to be reviewed for accuracy and validated by a qualified end-user. - Requires deployers of an AI device to conduct and document regular performance evaluations and risk assessments of the device. - Requires deployers to establish an AI governance group with representation from qualified end-users. - Requires deployers to maintain an updated inventory of deployed AI devices.
| Date | Chamber | Action |
|---|---|---|
Feb 4, 2025 | H | Second Reading referred to Rules |
Feb 3, 2025 | H | First Reading |
Feb 3, 2025 | H | Authored by Representative Alonso-Sandoval |
| Last Action | Feb 4, 2025 |
|---|---|
| Year | 2025 |
| Bill Type | Bill |
| Created | Mar 21, 2026 |
| Updated | Feb 5, 2025 |