Summary
Establishes principles for using artificial intelligence to prepare evidence for EU Joint Clinical Assessment dossiers. Preserves health technology developers’ accountability for dossier content and methods, requires appropriate human oversight, and calls for transparent documentation of AI-assisted activities, including the tools, versions, purposes, steps, and outputs involved.
Healthcare Implications
Pharmaceutical, biotechnology, and medical-device developers using AI to prepare EU health technology assessment submissions should maintain human control, validate AI-assisted evidence work, document how and where AI was used, preserve methodological rigor, and comply with applicable data-protection, copyright, AI Act, and health technology assessment requirements.