Source: Lexpert

Canada's health sciences sector is being reshaped by three converging forces: the adoption of artificial-intelligence tools in clinical practice, regulatory reform for biosimilars and a marked increase in healthcare M&A. AI-powered medical scribes are converting clinical conversations into structured outputs such as summaries, action items and billing codes, and Teresa Reguly of Torys LLP warns these outputs are not mere transcripts but distilled summaries that raise legal questions about consent, downstream access and the need for physician review. Dana Siddle of McCarthy Tétrault LLP cites a 2024 incident at an Ontario hospital where an unauthorized AI tool joined and recorded a virtual clinical meeting, exposing patient information, and she stresses that privacy, algorithmic bias, inaccuracies and cybersecurity must be considered in pre-deployment assessments. With a proposed federal AI law having died on the order paper in 2025, the article says governance responsibilities shift toward provincial guidance and robust vendor contracts as practical frontline protections.

Health Canada’s May 2025 decision to remove routine phase III efficacy trials for biosimilars is described as reducing development costs and accelerating market entry by allowing a biosimilar showing high similarity to a reference product to be approved for all indications without further scientific justification. Jordan Scopa of Goodmans LLP warns brand-side patentees should expect increased regulatory filings and potentially more patent litigation, while Urszula Wojtyra of Smart & Biggar LLP notes the loss of competitive intelligence from previously required phase III trial registrations. On transactions, John Emanoilidis of Torys LLP reports total Canadian healthcare deal value rose from about $4.5 billion in 2023 to over $12 billion in 2025, driven by pharmaceutical and biotech deals; Laurie Turner of Fasken Martineau DuMoulin LLP highlights US and UK buyers targeting Canadian virtual care platforms, and the piece emphasizes that lawyers are advising on governance risks, patent strategies and transaction structures amid uncertainties in valuing AI and data assets.