Governing Patient-Facing AI-Generated Video in Digital Health: A Risk-and-Ethics Matrix for Deployment, Monitoring, and Change Control.

Abstract

In this Viewpoint, we argue that patient-facing high-fidelity artificial intelligence (AI)-generated video requires governance that is operational, life cycle based, and embedded in existing institutional review pathways rather than limited to predeployment checks alone. Patient-facing high-fidelity AI-generated video-synthetic or substantially AI-mediated video that presents realistic human likeness, voices, or clinical communication cues-is rapidly entering patient education and clinical communication. We propose a risk-and-ethics matrix that combines residual clinical risk (likelihood × severity after mitigations) with an ethical alignment score that operationalizes autonomy, beneficence, nonmaleficence, and justice to yield actionable dispositions (encourage, permit with oversight, restrict or redesign, or prohibit). The framework links each disposition to dossier-based review, minimum controls, and postdeployment monitoring triggers-focused on measurable outcomes (eg, comprehension, content-attributable follow-up burden, incidents and complaints, and equity gaps) as well as provenance and change control-to support auditable, revisitable decisions over the system life cycle.