Informed Consent for AI in Healthcare: Widely Endorsed but Lacking Formal Protocols, Scoping Review Finds

In a scoping review of 70 sources (2015-2026), informed consent for AI was endorsed in 95.7% (67/70) but formal protocols were proposed in only 8.6% (6/70). Most evidence was conceptual, with dynamic consent uncommon (8.6%), underscoring the need for practical, risk-adapted AI c…

• Design: PRISMA-ScR-guided scoping review of 70 sources (mostly conceptual analyses and reviews); medicine-only sources predominated (85.7%).
• Secondary finding: Explainability/transparency was addressed in 92.9% (65/70), but formal protocols for AI-specific consent were rare (8.6%).
• Limitation: Evidence base remains largely non-empirical and conceptual, lacking validation with stakeholders or real-world implementation data.

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