CAN/DGSI 138, Patient-Visible and Accountable AI in Clinical Decision Support

The document specifies requirements for the governance, transparency, interoperability, and lifecycle management of human‑in‑the‑loop AI Clinical Decision Support Systems (AI‑CDSS).

This document applies to AI‑CDSS that are:
Human‑in‑the‑Loop: Systems that provide recommendations, risk scores, or summaries to a qualified clinician who retains final decision‑making authority. This design choice is in direct alignment with the TBS ADM Directive’s requirements for high‑impact decisions (classified as Levels III and IV), which mandate that the final decision must be made by a human.

Influencing Documented Care: The AI’s output influences a decision that is recorded in the patient’s official health record. This scope criterion ensures the standard focuses on AI that has a material impact on the formal record of care.

Patient‑Data‑Driven: The AI’s logic operates on the personal health information (PHI) of the specific patient for whom the decision is being made.

The document does not apply to:
Fully autonomous systems that make and execute clinical decisions without human oversight.
AI systems used exclusively for non‑clinical administrative tasks (e.g., back‑office billing optimization) or for research purposes not involving direct patient care decisions.

DATE POSTED: April 08, 2026

DEADLINE FOR COMMENTS: May 08 , 2026