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46 www.canadianlawyermag.com advised on the framework in an external working group, he says. "This is a really exciting moment because we're going to get these new regulations," says Da Silva. "But as of this moment … we're at a point where we can't actu- ally benefit from maybe some of the most exciting developments that could come along because adaptive AI could solve a lot of real problems that we have in the Canadian health care system." It could produce more accurate and effi- cient care and address human biases – and to maximize those benefits, Canada will need to permit adaptive machine learning, "and we're not there yet," Da Silva says. Harte says the fear of liability should not halt the progress of AI, which can reduce lawsuits and patient harm in a system that experiences thousands of avoidable injuries every year. "Based on my almost 30 years of experience in medical malpractice, a lot of those errors are amenable to prevention through the use of technology, including artificial intelligence." AI HEALTH CARE APPLICATIONS "[T]here are certain important roles that AI tools play in the actual health care system that aren't being regulated" Michael Da Silva, University of Ottawa's AI + Society Initiative predicting treatment protocols and detecting cancer in radiology images creating, analyzing, and classifying clinical documentation and published research robotic surgical tools diagnosis and disease treatment administrative activities Source: Royal College of Physicians' Future Healthcare Journal Canada's medical device regulations regu- late the sale and importation of medical devices. So, if AI meets the definition of a medical device, he says it will only be regu- lated for its commercial uses or, in rare circumstances, for research purposes. That means doctors could escape regulation if they were to develop an AI medical device and use it in their hospital if they did not sell it to anyone. The regulations currently exclude AI from licensing requirements if the device "is 'not intended to acquire, process, or analyze a medical image or signal,' 'intended to display, analyze, or print medical information,' 'only intended to support' provider decision making, and 'not intended to replace … clin- ical judgment,'" write Da Silva and his co-au- thors in the article. "What this means is that there are certain important roles that AI tools play in the actual health care system that aren't being regulated, either because they don't fit under the definition and its formal version or because Health Canada doesn't understand them as fitting under the definition," says Da Silva. This carve-out captures administrative support, patient management, and when the tool has a "wellness or lifestyle application," he adds. Machine learning, which adapts its operation based on inputs acquired during use, also does not fall under the current regulations, which prevent these tools from being approved for the Canadian market. But Health Canada is developing a new regulatory framework for adap- tive machine-learning tools, and Da Silva MEDICAL LEGAL REPORT