Nickolas Papanikolaou

Karim Lekadir, Aasa Feragen, Abdul Joseph Fofanah et al. · eth-zurich

Despite major advances in artificial intelligence (AI) for medicine and healthcare, the deployment and adoption of AI technologies remain limited in real-world clinical practice. In recent years, concerns have been raised about the technical, clinical, ethical and legal risks associated with medical AI. To increase real world adoption, it is essential that medical AI tools are trusted and accepted by patients, clinicians, health organisations and authorities. This work describes the FUTURE-AI guideline as the first international consensus framework for guiding the development and deployment of trustworthy AI tools in healthcare. The FUTURE-AI consortium was founded in 2021 and currently comprises 118 inter-disciplinary experts from 51 countries representing all continents, including AI scientists, clinicians, ethicists, and social scientists. Over a two-year period, the consortium defined guiding principles and best practices for trustworthy AI through an iterative process comprising an in-depth literature review, a modified Delphi survey, and online consensus meetings. The FUTURE-AI framework was established based on 6 guiding principles for trustworthy AI in healthcare, i.e. Fairness, Universality, Traceability, Usability, Robustness and Explainability. Through consensus, a set of 28 best practices were defined, addressing technical, clinical, legal and socio-ethical dimensions. The recommendations cover the entire lifecycle of medical AI, from design, development and validation to regulation, deployment, and monitoring. FUTURE-AI is a risk-informed, assumption-free guideline which provides a structured approach for constructing medical AI tools that will be trusted, deployed and adopted in real-world practice. Researchers are encouraged to take the recommendations into account in proof-of-concept stages to facilitate future translation towards clinical practice of medical AI.

José Guilherme de Almeida, Nuno M. Rodrigues, Sara Silva et al.

Deep learning models trained with large amounts of data have become a recent and effective approach to predictive problem solving -- these have become known as "foundation models" as they can be used as fundamental tools for other applications. While the paramount examples of image classification (earlier) and large language models (more recently) led the way, the Segment Anything Model (SAM) was recently proposed and stands as the first foundation model for image segmentation, trained on over 10 million images and with recourse to over 1 billion masks. However, the question remains -- what are the limits of this foundation? Given that magnetic resonance imaging (MRI) stands as an important method of diagnosis, we sought to understand whether SAM could be used for a few tasks of zero-shot segmentation using MRI data. Particularly, we wanted to know if selecting masks from the pool of SAM predictions could lead to good segmentations. Here, we provide a critical assessment of the performance of SAM on magnetic resonance imaging data. We show that, while acceptable in a very limited set of cases, the overall trend implies that these models are insufficient for MRI segmentation across the whole volume, but can provide good segmentations in a few, specific slices. More importantly, we note that while foundation models trained on natural images are set to become key aspects of predictive modelling, they may prove ineffective when used on other imaging modalities.

Varvara Kalokyri, Nikolaos S. Tachos, Charalampos N. Kalantzopoulos et al.

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 AI Model Passport, 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 AIPassport, 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.

Karim Lekadir, Richard Osuala, Catherine Gallin et al.

The recent advancements in artificial intelligence (AI) combined with the extensive amount of data generated by today's clinical systems, has led to the development of imaging AI solutions across the whole value chain of medical imaging, including image reconstruction, medical image segmentation, image-based diagnosis and treatment planning. Notwithstanding the successes and future potential of AI in medical imaging, many stakeholders are concerned of the potential risks and ethical implications of imaging AI solutions, which are perceived as complex, opaque, and difficult to comprehend, utilise, and trust in critical clinical applications. Addressing these concerns and risks, the FUTURE-AI framework has been proposed, which, sourced from a global multi-domain expert consensus, comprises guiding principles for increased trust, safety, and adoption for AI in healthcare. In this paper, we transform the general FUTURE-AI healthcare principles to a concise and specific AI implementation guide tailored to the needs of the medical imaging community. To this end, we carefully assess each building block of the FUTURE-AI framework consisting of (i) Fairness, (ii) Universality, (iii) Traceability, (iv) Usability, (v) Robustness and (vi) Explainability, and respectively define concrete best practices based on accumulated AI implementation experiences from five large European projects on AI in Health Imaging. We accompany our concrete step-by-step medical imaging development guide with a practical AI solution maturity checklist, thus enabling AI development teams to design, evaluate, maintain, and deploy technically, clinically and ethically trustworthy imaging AI solutions into clinical practice.

Linda Bianchini, Joao Santinha, Nuno Loução et al.

In this study we investigated the repeatability and reproducibility of radiomic features extracted from MRI images and provide a workflow to identify robust features. 2D and 3D T$_2$-weighted images of a pelvic phantom were acquired on three scanners of two manufacturers and two magnetic field strengths. The repeatability and reproducibility of the radiomic features were assessed respectively by intraclass correlation coefficient (ICC) and concordance correlation coefficient (CCC), considering repeated acquisitions with or without phantom repositioning, and with different scanner/acquisition type, and acquisition parameters. The features showing ICC/CCC > 0.9 were selected, and their dependence on shape information (Spearman's $ρ$> 0.8) was analyzed. They were classified for their ability to distinguish textures, after shuffling voxel intensities. From 944 2D features, 79.9% to 96.4% showed excellent repeatability in fixed position across all scanners. Much lower range (11.2% to 85.4%) was obtained after phantom repositioning. 3D extraction did not improve repeatability performance. Excellent reproducibility between scanners was observed in 4.6% to 15.6% of the features, at fixed imaging parameters. 82.4% to 94.9% of features showed excellent agreement when extracted from images acquired with TEs 5 ms apart (values decreased when increasing TE intervals) and 90.7% of the features exhibited excellent reproducibility for changes in TR. 2.0% of non-shape features were identified as providing only shape information. This study demonstrates that radiomic features are affected by specific MRI protocols. The use of our radiomic pelvic phantom allowed to identify unreliable features for radiomic analysis on T$_2$-weighted images. This paper proposes a general workflow to identify repeatable, reproducible, and informative radiomic features, fundamental to ensure robustness of clinical studies.