AI Model Passport: Data and system traceability framework for transparent AI in health

The increasing integration of Artificial Intelligence (AI) into health and biomedical systems necessitates robust frameworks for transparency, accountability, and ethical compliance. Existing frameworks often rely on human-readable, manual documentation which limits scalability, comparability, and machine interpretability across projects and platforms. They also fail to provide a unique, verifiable identity for AI models to ensure their provenance and authenticity across systems and use cases, limiting reproducibility and stakeholder trust. This paper introduces the concept of the <i>AI Model Passport</i>, a structured and standardized documentation framework that acts as a digital identity and verification tool for AI models. It captures essential metadata to uniquely identify, verify, trace and monitor AI models across their lifecycle - from data acquisition and preprocessing to model design, development and deployment. In addition, an implementation of this framework is presented through <i>AIPassport</i>, an MLOps tool developed within the ProCAncer-I EU project for medical imaging applications. AIPassport automates metadata collection, ensures proper versioning, decouples results from source scripts, and integrates with various development environments. Its effectiveness is showcased through a lesion segmentation use case using data from the ProCAncer-I dataset, illustrating how the AI Model Passport enhances transparency, reproducibility, and regulatory readiness while reducing manual effort. This approach aims to set a new standard for fostering trust and accountability in AI-driven healthcare solutions, aspiring to serve as the basis for developing transparent and regulation compliant AI systems across domains.