Fred Prior

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.

Richard Osuala, Grzegorz Skorupko, Noussair Lazrak et al.

Synthetic data generated by generative models can enhance the performance and capabilities of data-hungry deep learning models in medical imaging. However, there is (1) limited availability of (synthetic) datasets and (2) generative models are complex to train, which hinders their adoption in research and clinical applications. To reduce this entry barrier, we propose medigan, a one-stop shop for pretrained generative models implemented as an open-source framework-agnostic Python library. medigan allows researchers and developers to create, increase, and domain-adapt their training data in just a few lines of code. Guided by design decisions based on gathered end-user requirements, we implement medigan based on modular components for generative model (i) execution, (ii) visualisation, (iii) search & ranking, and (iv) contribution. The library's scalability and design is demonstrated by its growing number of integrated and readily-usable pretrained generative models consisting of 21 models utilising 9 different Generative Adversarial Network architectures trained on 11 datasets from 4 domains, namely, mammography, endoscopy, x-ray, and MRI. Furthermore, 3 applications of medigan are analysed in this work, which include (a) enabling community-wide sharing of restricted data, (b) investigating generative model evaluation metrics, and (c) improving clinical downstream tasks. In (b), extending on common medical image synthesis assessment and reporting standards, we show Fréchet Inception Distance variability based on image normalisation and radiology-specific feature extraction.

Betina Idnay, Zihan Xu, William G. Adams et al.

This study reports a comprehensive environmental scan of the generative AI (GenAI) infrastructure in the national network for clinical and translational science across 36 institutions supported by the Clinical and Translational Science Award (CTSA) Program led by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) at the United States. With the rapid advancement of GenAI technologies, including large language models (LLMs), healthcare institutions face unprecedented opportunities and challenges. This research explores the current status of GenAI integration, focusing on stakeholder roles, governance structures, and ethical considerations by administering a survey among leaders of health institutions (i.e., representing academic medical centers and health systems) to assess the institutional readiness and approach towards GenAI adoption. Key findings indicate a diverse range of institutional strategies, with most organizations in the experimental phase of GenAI deployment. The study highlights significant variations in governance models, with a strong preference for centralized decision-making but notable gaps in workforce training and ethical oversight. Moreover, the results underscore the need for a more coordinated approach to GenAI governance, emphasizing collaboration among senior leaders, clinicians, information technology staff, and researchers. Our analysis also reveals concerns regarding GenAI bias, data security, and stakeholder trust, which must be addressed to ensure the ethical and effective implementation of GenAI technologies. This study offers valuable insights into the challenges and opportunities of GenAI integration in healthcare, providing a roadmap for institutions aiming to leverage GenAI for improved quality of care and operational efficiency.

David A. Clunie, Adam Flanders, Adam Taylor et al.

This report addresses the technical aspects of de-identification of medical images of human subjects and biospecimens, such that re-identification risk of ethical, moral, and legal concern is sufficiently reduced to allow unrestricted public sharing for any purpose, regardless of the jurisdiction of the source and distribution sites. All medical images, regardless of the mode of acquisition, are considered, though the primary emphasis is on those with accompanying data elements, especially those encoded in formats in which the data elements are embedded, particularly Digital Imaging and Communications in Medicine (DICOM). These images include image-like objects such as Segmentations, Parametric Maps, and Radiotherapy (RT) Dose objects. The scope also includes related non-image objects, such as RT Structure Sets, Plans and Dose Volume Histograms, Structured Reports, and Presentation States. Only de-identification of publicly released data is considered, and alternative approaches to privacy preservation, such as federated learning for artificial intelligence (AI) model development, are out of scope, as are issues of privacy leakage from AI model sharing. Only technical issues of public sharing are addressed.

Md. Enamul Hoq, Wataru Uegami, Saghir Alfasly et al.

Generative vision-language models can produce fluent medical image captions but remain prone to hallucination, over-specific diagnostic claims, and factual inconsistency-serious issues in pathology. We investigate retrieval-guided generation (RGG) as a safer alternative, where captions are formed by summarizing expert text from visually similar cases rather than generated de novo. On the ARCH histopathology dataset, RGG improves semantic alignment with ground truth, achieving cosine similarity of $\approx$0.60 versus $\approx$0.47 from MedGemma, with non-overlapping confidence intervals indicating a robust gain. A pathologist-led qualitative review shows better preservation of morphology-relevant terminology and fewer unsupported diagnoses, while revealing failure modes such as concept mixing and inherited over-specific labeling. Overall, retrieval-guided captioning offers a more transparent and reliable approach with clearer opportunities for auditing than fully generative methods.

Linmin Pei, Granger Sutton, Michael Rutherford et al.

The de-identification (deID) of protected health information (PHI) and personally identifiable information (PII) is a fundamental requirement for sharing medical images, particularly through public repositories, to ensure compliance with patient privacy laws. In addition, preservation of non-PHI metadata to inform and enable downstream development of imaging artificial intelligence (AI) is an important consideration in biomedical research. The goal of MIDI-B was to provide a standardized platform for benchmarking of DICOM image deID tools based on a set of rules conformant to the HIPAA Safe Harbor regulation, the DICOM Attribute Confidentiality Profiles, and best practices in preservation of research-critical metadata, as defined by The Cancer Imaging Archive (TCIA). The challenge employed a large, diverse, multi-center, and multi-modality set of real de-identified radiology images with synthetic PHI/PII inserted. The MIDI-B Challenge consisted of three phases: training, validation, and test. Eighty individuals registered for the challenge. In the training phase, we encouraged participants to tune their algorithms using their in-house or public data. The validation and test phases utilized the DICOM images containing synthetic identifiers (of 216 and 322 subjects, respectively). Ten teams successfully completed the test phase of the challenge. To measure success of a rule-based approach to image deID, scores were computed as the percentage of correct actions from the total number of required actions. The scores ranged from 97.91% to 99.93%. Participants employed a variety of open-source and proprietary tools with customized configurations, large language models, and optical character recognition (OCR). In this paper we provide a comprehensive report on the MIDI-B Challenge's design, implementation, results, and lessons learned.

Md. Enamul Hoq, Linda Larson-Prior, Fred Prior

Robust preprocessing is rarely quantified in deep-learning pipelines for low-dose CT (LDCT) lung cancer screening. We develop and validate Virtual-Eyes, a clinically motivated 16-bit CT quality-control pipeline, and measure its differential impact on generalist foundation models versus specialist models. Virtual-Eyes enforces strict 512x512 in-plane resolution, rejects short or non-diagnostic series, and extracts a contiguous lung block using Hounsfield-unit filtering and bilateral lung-coverage scoring while preserving the native 16-bit grid. Using 765 NLST patients (182 cancer, 583 non-cancer), we compute slice-level embeddings from RAD-DINO and Merlin with frozen encoders and train leakage-free patient-level MLP heads; we also evaluate Sybil and a 2D ResNet-18 baseline under Raw versus Virtual-Eyes inputs without backbone retraining. Virtual-Eyes improves RAD-DINO slice-level AUC from 0.576 to 0.610 and patient-level AUC from 0.646 to 0.683 (mean pooling) and from 0.619 to 0.735 (max pooling), with improved calibration (Brier score 0.188 to 0.112). In contrast, Sybil and ResNet-18 degrade under Virtual-Eyes (Sybil AUC 0.886 to 0.837; ResNet-18 AUC 0.571 to 0.596) with evidence of context dependence and shortcut learning, and Merlin shows limited transferability (AUC approximately 0.507 to 0.567) regardless of preprocessing. These results demonstrate that anatomically targeted QC can stabilize and improve generalist foundation-model workflows but may disrupt specialist models adapted to raw clinical context.

Michael W. Rutherford, Tracy Nolan, Linmin Pei et al.

Medical imaging research increasingly depends on large-scale data sharing to promote reproducibility and train Artificial Intelligence (AI) models. Ensuring patient privacy remains a significant challenge for open-access data sharing. Digital Imaging and Communications in Medicine (DICOM), the global standard data format for medical imaging, encodes both essential clinical metadata and extensive protected health information (PHI) and personally identifiable information (PII). Effective de-identification must remove identifiers, preserve scientific utility, and maintain DICOM validity. Tools exist to perform de-identification, but few assess its effectiveness, and most rely on subjective reviews, limiting reproducibility and regulatory confidence. To address this gap, we developed an openly accessible DICOM dataset infused with synthetic PHI/PII and an evaluation framework for benchmarking image de-identification workflows. The Medical Image de-identification (MIDI) dataset was built using publicly available de-identified data from The Cancer Imaging Archive (TCIA). It includes 538 subjects (216 for validation, 322 for testing), 605 studies, 708 series, and 53,581 DICOM image instances. These span multiple vendors, imaging modalities, and cancer types. Synthetic PHI and PII were embedded into structured data elements, plain text data elements, and pixel data to simulate real-world identity leaks encountered by TCIA curation teams. Accompanying evaluation tools include a Python script, answer keys (known truth), and mapping files that enable automated comparison of curated data against expected transformations. The framework is aligned with the HIPAA Privacy Rule "Safe Harbor" method, DICOM PS3.15 Confidentiality Profiles, and TCIA best practices. It supports objective, standards-driven evaluation of de-identification workflows, promoting safer and more consistent medical image sharing.

Lidia Garrucho, Kaisar Kushibar, Claire-Anne Reidel et al.

Artificial Intelligence (AI) research in breast cancer Magnetic Resonance Imaging (MRI) faces challenges due to limited expert-labeled segmentations. To address this, we present a multicenter dataset of 1506 pre-treatment T1-weighted dynamic contrast-enhanced MRI cases, including expert annotations of primary tumors and non-mass-enhanced regions. The dataset integrates imaging data from four collections in The Cancer Imaging Archive (TCIA), where only 163 cases with expert segmentations were initially available. To facilitate the annotation process, a deep learning model was trained to produce preliminary segmentations for the remaining cases. These were subsequently corrected and verified by 16 breast cancer experts (averaging 9 years of experience), creating a fully annotated dataset. Additionally, the dataset includes 49 harmonized clinical and demographic variables, as well as pre-trained weights for a baseline nnU-Net model trained on the annotated data. This resource addresses a critical gap in publicly available breast cancer datasets, enabling the development, validation, and benchmarking of advanced deep learning models, thus driving progress in breast cancer diagnostics, treatment response prediction, and personalized care.

Jason L. Causey, Yuanfang Guan, Wei Dong et al.

Lung cancer is the leading cause of cancer deaths. Early detection through low-dose computed tomography (CT) screening has been shown to significantly reduce mortality but suffers from a high false positive rate that leads to unnecessary diagnostic procedures. Quantitative image analysis coupled to deep learning techniques has the potential to reduce this false positive rate. We conducted a computational analysis of 1449 low-dose CT studies drawn from the National Lung Screening Trial (NLST) cohort. We applied to this cohort our newly developed algorithm, DeepScreener, which is based on a novel deep learning approach. The algorithm, after the training process using about 3000 CT studies, does not require lung nodule annotations to conduct cancer prediction. The algorithm uses consecutive slices and multi-task features to determine whether a nodule is likely to be cancer, and a spatial pyramid to detect nodules at different scales. We find that the algorithm can predict a patient's cancer status from a volumetric lung CT image with high accuracy (78.2%, with area under the Receiver Operating Characteristic curve (AUC) of 0.858). Our preliminary framework ranked 16th of 1972 teams (top 1%) in the Data Science Bowl 2017 (DSB2017) competition, based on the challenge datasets. We report here the application of DeepScreener on an independent NLST test set. This study indicates that the deep learning approach has the potential to significantly reduce the false positive rate in lung cancer screening with low-dose CT scans.

Jason Causey, Junyu Zhang, Shiqian Ma et al.

Computed tomography (CT) examinations are commonly used to predict lung nodule malignancy in patients, which are shown to improve noninvasive early diagnosis of lung cancer. It remains challenging for computational approaches to achieve performance comparable to experienced radiologists. Here we present NoduleX, a systematic approach to predict lung nodule malignancy from CT data, based on deep learning convolutional neural networks (CNN). For training and validation, we analyze >1000 lung nodules in images from the LIDC/IDRI cohort. All nodules were identified and classified by four experienced thoracic radiologists who participated in the LIDC project. NoduleX achieves high accuracy for nodule malignancy classification, with an AUC of ~0.99. This is commensurate with the analysis of the dataset by experienced radiologists. Our approach, NoduleX, provides an effective framework for highly accurate nodule malignancy prediction with the model trained on a large patient population. Our results are replicable with software available at http://bioinformatics.astate.edu/NoduleX.