A Futures Framework for Clinical AI Governance: Anticipating Emerging Risks, Shifting Roles, and Regulatory Challenges.

This viewpoint develops the futures framework for clinical artificial intelligence governance (FF-CAIG), a conceptual and anticipatory framework for organizing emerging governance challenges in clinical artificial intelligence (AI). Although life cycle-oriented oversight is increasingly reflected in clinical AI regulation and institutional governance, existing approaches remain more developed for near-term validation, current-state assurance, and retrospective risk detection than for longer-horizon sociotechnical change. This gap is increasingly relevant, as AI systems become more complex, adaptive, and autonomous, and as they become more deeply embedded in care relationships and accountability structures. FF-CAIG is grounded in 3 futures methodologies: the 3 horizons model, scenario planning, and causal layered analysis. It is operationalized through an emerging clinical AI risk taxonomy that links these methods to governance domains. Its practical outputs include horizon classification, risk-domain mapping, scenario stress-testing findings, accountability-chain mapping, and horizon-scaled minimum governance actions for deployment or continued use. Applied across near-term, transitional, and longer-term horizons, the framework proposes cross-horizon priorities, including stronger predeployment equity evaluation, clearer life cycle accountability, clinician AI oversight competencies, and safeguards for increasingly autonomous or AI-mediated care systems. We illustrate FF-CAIG through 3 representative clinical AI deployment patterns and discuss its limitations, including differential compliance burdens, risks of overdocumentation, variable feasibility across jurisdictions, and the need for empirical validation. FF-CAIG is intended not as a prescriptive policy instrument or validated assessment tool, but as a structured analytic approach for regulators, health system leaders, developers, and researchers seeking prospective and systems-oriented approaches to clinical AI governance.