WHAT THIS BILL REGULATES · 2 REQUIREMENT TYPES
How Is This Bill Enforced
Verbatim statutory text on the left; plain-language analysis and a per-section checklist on the right. Numbered markers cross-link to the matching checklist row.
(1)–(3) 1 Sec. 8h. Diagnostic algorithm. Before using any diagnostic algorithm to diagnose a patient, the University of Illinois Hospital must first confirm all of the following: (1) The diagnostic algorithm has been certified by the Department of Public Health and the Department of Innovation and Technology. (2) The diagnostic algorithm has been shown to achieve as or more accurate diagnostic results than other diagnostic means. (3) The diagnostic algorithm is not the only method of diagnosis available to a patient.
This new section imposes three pre-use conditions on the University of Illinois Hospital before it may use any diagnostic algorithm on a patient. The hospital must confirm that the algorithm has been jointly certified by the Department of Public Health and the Department of Innovation and Technology, that it achieves diagnostic accuracy at least equal to other available diagnostic means, and that it is not the sole diagnostic method available to the patient. The bill does not define "diagnostic algorithm," leaving the term's scope uncertain — it could encompass anything from a simple clinical decision-support checklist to an advanced AI-based imaging analysis tool.
The certification requirement effectively creates a pre-market authorization gate, but the bill does not establish the certification process, the standards to be applied, or how accuracy is to be demonstrated. The requirement that the algorithm not be the only diagnostic method available introduces an alternative-availability condition that could preclude algorithmic diagnosis in clinical scenarios where no conventional alternative exists.
(1)–(3) 2 Sec. 6.34. Diagnostic algorithm. Before using any diagnostic algorithm to diagnose a patient, a hospital licensed under this Act must first confirm all of the following: (1) The diagnostic algorithm has been certified by the Department of Public Health and the Department of Innovation and Technology. (2) The diagnostic algorithm has been shown to achieve as or more accurate diagnostic results than other diagnostic means. (3) The diagnostic algorithm is not the only method of diagnosis available to a patient.
This section mirrors the obligations imposed on the University of Illinois Hospital in 110 ILCS 330/8h, extending identical pre-use conditions to all hospitals licensed under the Hospital Licensing Act. The three conditions — regulatory certification, demonstrated accuracy parity, and availability of alternative diagnostic methods — apply before any hospital may use a diagnostic algorithm on a patient.
Because this section is substantively identical to the University of Illinois Hospital provision, its practical effect is to ensure that both the single state-university hospital and the broader universe of privately and publicly licensed hospitals are subject to the same algorithmic diagnostic gating requirements.
3 Sec. 3.5. Diagnostic algorithm. A patient has the right to be told when a diagnostic algorithm will be used to diagnose him or her.
(1)–(2) 4 Before a diagnostic algorithm is used to diagnose a patient, the patient must first: (1) be presented with the option of being diagnosed without the diagnostic algorithm; and (2) consent to the diagnostic algorithm's use.
This section amends the Medical Patient Rights Act to establish three patient-facing rights when a diagnostic algorithm is used. First, the patient has the right to be told that a diagnostic algorithm will be used — a pre-decision notification requirement. Second, the patient must be presented with the option of being diagnosed without the algorithm, ensuring an alternative pathway is not merely available (as required by the hospital-side provisions) but is affirmatively offered to the patient. Third, the patient must consent to the algorithm's use before it is deployed.
Together with the hospital-obligation sections, this section creates a two-sided framework: hospitals must verify certification and accuracy before offering algorithmic diagnosis, and patients must be informed, offered an alternative, and must affirmatively consent before the algorithm is used. The consent and notification requirements have no specified form (written vs. oral) and no exception for emergency circumstances.