Presentation (CTI)

OBJECTIVES: The Canadian Drug Agency (CDA) has aligned its AI principles with NICE and committed to leveraging AI for evidence synthesis and trial design. However, whether these commitments translate into operational AI governance readiness for HTA processes remains unexamined. This study aimed to map CDA's current AI governance posture against emerging international standards and identify priority gaps.
METHODS: A rapid scoping review of CDA's publicly available guidance documents, strategic plans, and policy statements was conducted alongside a comparative analysis of AI governance frameworks from NICE (UK), HAS (France), and CMS (USA), published between 2023 and 2026. International benchmarks were drawn from the ISPOR Working Group Report on Generative AI (2025), ELEVATE-GenAI guidelines (2025), and the HTAi Global Policy Forum report (2026). Governance domains assessed included: formal AI policy, transparency standards, validation requirements, staff capacity, stakeholder engagement, and enforcement mechanisms.
RESULTS: CDA's publicly available documentation confirmed alignment with NICE principles and commitment to AI for evidence synthesis, but no operational AI governance framework specific to HTA review was identified. Comparative analysis revealed that no benchmarked agency, including NICE, HAS, or CMS, had fully operationalized AI governance across all assessed domains. Transparency and strategic intent were consistently documented, while enforcement mechanisms and validation standards remained absent across all jurisdictions, including Canada. Canada-specific gaps included absence of guidance on AI use in Common Drug Review submissions and no published position on AI-generated clinical or economic evidence.
CONCLUSIONS: Despite stated alignment with international AI principles, CDA has not yet operationalized AI governance requirements for HTA processes. As peer agencies face the same challenge, Canada has an opportunity to position itself as a leader by developing the first submission-specific AI governance framework in HTA. These findings provide a baseline for future policy development and underscore the need for coordinated national guidance on AI in Canadian health technology assessment.