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Canadian regulators may soon face new questions about the role of autonomous artificial intelligence ("AI") in healthcare delivery, as the state of Utah has launched a pilot program that allows AI to refill certain prescriptions for chronic conditions without any human prescriber intervening. While no Canadian province currently allows AI to independently prescribe or refill medications, this development offers an important point of comparison for future Canadian policy discussions.
Utah's pilot program operates through a state‑supported online platform.1 To access the service, patients must confirm they are physically in Utah and provide both a selfie and a photo ID. Once authenticated, the platform displays the patient's current medications and their eligibility for refills. Patients are then invited to interact with AI chatbots, which ask about the patient's pharmacy, symptoms, other drugs taken, and changes to medical history. The AI uses this information to determine whether a refill is appropriate.
Certain safeguards are built into this initiative. The pilot is limited to refills of the 190 commonly prescribed drugs and explicitly excludes opioids, injectables, ADHD treatments, and other high‑risk categories.2 For each drug class, physicians must review the first 250 AI‑generated prescriptions before the system can operate without mandatory review. The Utah Office of Artificial Intelligence Policy administers the program and is authorized to create "mitigation agreements" allowing the temporary relaxation of rules requiring physician involvement while the state monitors the pilot.3
Proponents argue that AI prescriptions could reduce cost and improve access, particularly in underserved rural areas where access to physicians is limited. However, critics caution that risks remain, including errors, misuse, and missed warning signs that a physician might otherwise catch.4
Utah intends to publish program data, and observers expect other jurisdictions to watch the outcomes closely.
Canadian Context
While no Canadian province currently permits AI to independently prescribe or refill medications, Canadian regulators have begun exploring the responsible use of AI in clinical decision‑making.
At the federal level, software that supports, influences, or automates clinical decision‑making. including prescribing recommendations, would likely be regulated by Health Canada as Software as a Medical Device (SaMD) under the Medical Devices Regulations. These devices are subject to evidentiary requirements regarding their safety and efficacy as well as post‑market surveillance.
While automated prescription renewals are not yet captured, the Guidance Document: Software as a Medical Device (SaMD): Classification Examples, provides the examples of Class II non-IVDD SaMD which similar assist patients and physicians in virtual therapeutic management:
Software intended for health care professionals that uses an algorithm to analyze patient information, such as blood pressure, heart rate, weight, and age to determine which treatment plan is likely to be most effective in treating the patient's condition. These patient-specific treatment recommendations would otherwise not be available to the health care professional. The healthcare professional cannot independently review the calculations made by the algorithm.
Moreover, Health Canada's 2025 Pre-market guidance for machine learning-enabled medical devices sets out expectations for change protocols, transparency, and cybersecurity for adaptive algorithms. See the Fasken bulletin Pre-Market Considerations for Machine Learning-Enabled Medical Devices for more information.
Provincial health professional regulators have issued guidance emphasizing that AI cannot replace professional judgement, only supplement it. For example, the College of Physicians and Surgeons of Ontario ("CPSO") issued Advice to the Profession: Using Artificial Intelligence in Clinical Practice, providing that "AI is meant to complement clinical care, not replace medical expertise" and advises that, when using tools like AI scribes, triage systems, and software which may assist in clinical decision making, the core expectations of physicians remain unchanged. Physicians who use AI are expected to be mindful of their legal and professional obligations, including privacy and confidentiality, how patient data will be transferred, stored, and used, and whether reasonable safeguards are in place to protect patient data. At present, no Canadian regulator has signaled willingness to permit autonomous AI prescribing, even for refills.
Additionally, federal, provincial, and territorial governments (excluding Quebec) have endorsed Pan-Canadian AI for Health (AI4H) Guiding Principles, which emphasize person‑centricity, transparency, and ensuring AI is deployed with safeguards to protect the public.
Takeaways
Utah's pilot program represents a major development in the integration of AI into healthcare delivery. While it may influence future policy discussions in Canada, regulators here continue to take a cautious, safety‑focused approach. AI is increasingly used to support clinical decision‑making, but no province currently allows AI to independently prescribe or refill medications.
Footnotes
1 NEWS RELEASE: Utah and Doctronic Announce Groundbreaking Partnership for AI Prescription Medication Renewals Learn more
2 NEWS RELEASE: Utah and Doctronic Announce Groundbreaking Partnership for AI Prescription Medication Renewals Learn more
3 NEWS RELEASE: Utah and Doctronic Announce Groundbreaking Partnership for AI Prescription Medication Renewals Learn more
4 NEWS RELEASE: Utah and Doctronic Announce Groundbreaking Partnership for AI Prescription Medication Renewals Learn more
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