Real-world-data Enabled Assessment for heaLth regulatory decision-Making

Project Information

REALM

Grant agreement ID: 101095435

DOI

10.3030/101095435

EC signature date 24 November 2022

Start date 1 January 2023

End date 31 December 2026

Funded under

• Health

Total cost

€ 6 659 650,00

EU contribution

€ 6 659 650,00

Coordinated by

UNIVERSITEIT MAASTRICHT
Netherlands

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Publications

Peer reviewed articles (14)

Generating unseen diseases patient data using ontology enhanced generative adversarial networks

Author(s): Chang Sun 0001; Michel Dumontier
Published in: npj Digital Medicine, 2025, ISSN 2398-6352
Publisher: Springer Nature (Nature Portfolio)
DOI: 10.1038/S41746-024-01421-0

Epistemological Challenges of Artificial Intelligence Clinical Decision Support Tools in Otolaryngology: The Black Box Problem

Author(s): Babu C. S., Holsinger F.C., Zuchowski L/, Ratti E., Rameau A.
Published in: American Academy of Otolaryngology—Head and Neck Surgery Foundation, 2023, ISSN 2644-1276
Publisher: American Academy of Otolaryngology—Head and Neck Surgery Foundation
DOI: 10.1002/ohn.410

Generative AI for Synthetic Data Across Multiple Medical Modalities: A Systematic Review of Recent Developments and Challenges

Author(s): Mahmoud Ibrahim, Yasmina Al Khalil, Sina Amirrajab, Chang Sun, Marcel Breeuwer, Josien Pluim, Bart Elen, Gokhan Ertaylan, Michel Dumontier
Published in: arXiv, 2024, ISSN 2644-1276
Publisher: arXiv
DOI: 10.48550/arXiv.2407.00116

Using Generative Artificial Intelligence in the Production and Dissemination of Innovation in Otolaryngology—Ethical Considerations

Author(s): Carolyn Jane Khoury BA, Necati Enver MD, FEBORL-HNS, Alberto Paderno MD, PhD, Emanuele Ratti PhD, Anaïs Rameau MD, MPhil, MS FACS
Published in: American Academy of Otolaryngology—Head and Neck Surgery Foundation, 2023, ISSN 2644-1276
Publisher: American Academy of Otolaryngology—Head and Neck Surgery Foundation
DOI: 10.1002/ohn.601

Science and values: a two-way direction

Author(s): Emanuele Ratti, Federica Russo
Published in: European Journal for Philosophy of Science, 2024, ISSN 2644-1276
Publisher: Springer
DOI: 10.1007/s13194-024-00567-8

Generative AI for synthetic data across multiple medical modalities: A systematic review of recent developments and challenges

Author(s): Mahmoud K. Ibrahim; Yasmina Al Khalil; Sina Amirrajab; Chang Sun 0001; Marcel Breeuwer; Josien P. W. Pluim; Bart Elen; Gökhan Ertaylan; Michel Dumontier
Published in: Computers in Biology and Medicine, 2025, ISSN 1879-0534
Publisher: Elsevier
DOI: 10.48550/ARXIV.2407.00116

Tight Glycemic Control Can Be Achieved in Adult ICU Patients Safely: Results From a 5-Year Single-Center Observational Study Using the STAR Glycemic Control Framework

Author(s): Marie Seret, Vincent Uyttendaele, J. Geoffrey Chase, Geoffrey M Shaw, Thomas Desaive
Published in: Journal of Diabetes Science and Technology, ISSN 1932-2976
Publisher: Sage
DOI: 10.1177/193229682514128

What Do We Teach to Engineering Students: Embedded Ethics, Morality, and Politics

Author(s): Avigail Ferdman & Emanuele Ratti
Published in: Science and Engineering Ethics, 2024, ISSN 2644-1276
Publisher: Springer
DOI: 10.1007/s11948-024-00469-1

Introducing DEFORMISE: A deep learning framework for dementia diagnosis in the elderly using optimized MRI slice selection

Author(s): Nikolaos Ntampakis, Konstantinos Diamantaras, Ioanna Chouvarda, Vasileios Argyriou, Panagiotis Sarigiannidis
Published in: Biomedical Signal Processing and Control, Issue 113, 2025, ISSN 1746-8094
Publisher: Elsevier BV
DOI: 10.1016/J.BSPC.2025.109151

Introducing SPINE: A Holistic Approach to Synthetic Pulmonary Imaging Evaluation through End-to-End Data and Model Management

Author(s): Nikolaos Ntampakis, Vasileios Argyriou, Konstantinos Diamantaras, Konstantinos Goulianas, Panagiotis Sarigiannidis, Ilias Siniosoglou
Published in: IEEE Open Journal of Engineering in Medicine and Biology, 2024, ISSN 2644-1276
Publisher: IEEE
DOI: 10.1109/OJEMB.2024.3426910

Generative AI for synthetic data across multiple medical modalities: A systematic review of recent developments and challenges

Author(s): Mahmoud Ibrahim, Yasmina Al Khalil, Sina Amirrajab, Chang Sun, Marcel Breeuwer, Josien Pluim, Bart Elen, Gökhan Ertaylan, Michel Dumontier
Published in: Computers in Biology and Medicine, Issue 189, 2026, ISSN 0010-4825
Publisher: Elsevier BV
DOI: 10.1016/J.COMPBIOMED.2025.109834

BMC Medical Ethics

Author(s): Ratti, E; Morrison, M; Jakab, I
Published in: BMC Medical Ethics, 2025, ISSN 1472-6939
Publisher: BioMed Central
DOI: 10.1186/S12910-025-01198-1

User acceptability of blockchain technology for enabling electronic health record exchange

Author(s): Lilly Marie Baltruschat, Vikas Jaiman, Visara Urovi
Published in: Journal of Systems and Information Technology, Issue 25, 2025, ISSN 1328-7265
Publisher: Emerald
DOI: 10.1108/JSIT-09-2022-0225

Deep Learning of Multimodal Ultrasound: Stratifying the Response to Neoadjuvant Chemotherapy in Breast Cancer Before Treatment

Author(s): Jionghui Gu, Xian Zhong, Chengyu Fang, Wenjing Lou, Peifen Fu, Henry C Woodruff, Baohua Wang, Tianan Jiang, Philippe Lambin
Published in: The Oncologist, Issue 29, 2024, ISSN 1083-7159
Publisher: Oxford University Press (OUP)
DOI: 10.1093/ONCOLO/OYAD227

Other (5)

RAG-Enhanced LLM Pipeline for Semantic Mapping of Context-based Features to OMOP Vocabulary

Author(s): Kakkamani, S., JUNG, F., Verbiest, J., & PEETERS, L.
Published in: European OHDSI Symposium 2025
Publisher: OHDSI Europe
DOI: 10.5281/ZENODO.18789039

Methodological Explainability Evaluation of an Interpretable Deep Learning Model for Post-Hepatectomy Liver Failure Prediction Incorporating Counterfactual Explanations and Layerwise Relevance Propagation: A Prospective In Silico Trial

Author(s): Xian Zhong; Zohaib Salahuddin; Yi Chen; Henry C. Woodruff; Haiyi Long; Jianyun Peng; Nuwan Udawatte; Roberto Casale; Ayoub Mokhtari; Xiaoer Zhang; Jiayao Huang; Qingyu Wu; Li Tan; Lili Chen; Dongming Li; Xiaoyan Xie; Manxia Lin; Philippe Lambin
Published in: CoRR, 2024
Publisher: arXiv (Cornell University Library)
DOI: 10.48550/ARXIV.2408.03771

Enhancing transparency in AI for healthcare with OMOP Model Card reporting

Author(s): JUNG, F., Lohachab, A., Madureira Sanches Ribeiro, G., Rommes, S., Urovi, V., Sun, C., & Ertaylan, G.
Published in: European OHDSI Symposium 2025
Publisher: OHDSI Europe
DOI: 10.5281/ZENODO.18788825

RIANA Dashboard: A Blockchain-Enabled Approach for Representing AI Model Intent in OMOP with Atlas-Like Functionality

Author(s): JUNG, F., Madureira Sanches Ribeiro, G., Lohachab, A., Rommes, S., Urovi, V., Sun, C., Ertaylan, G., & Attipoe, A.
Published in: European OHDSI Symposium 2025
Publisher: OHDSI Europe
DOI: 10.5281/ZENODO.18788892

REALM – innovative solutions for the creation and evaluation of AI medical device software

Author(s): JUNG, F., Sun, C., Ibrahim, M., & Ertaylan, G.
Published in: European OHDSI Symposium 2024 , Rotterdam
Publisher: OHDSI Europe
DOI: 10.5281/ZENODO.18788473

Book chapters (3)

Enhancing Performance for Highly Imbalanced Medical Data via Data Regularization in a Federated Learning Setting

Author(s): Georgios Tsoumplekas; Ilias Siniosoglou; Vasileios Argyriou; Ioannis D. Moscholios; Panagiotis G. Sarigiannidis
Published in: Lecture Notes in Computer Science ISBN: 9783031672842, 2024
Publisher: Springer Nature (Springer)
DOI: 10.48550/ARXIV.2405.20430

A Blockchain-Based Approach for Model Card Accountability and Regulatory Compliance

Author(s): Ankur Lohachab, Visara Urovi
Published in: Lecture Notes in Business Information Processing, Advanced Information Systems Engineering Workshops, 2024
Publisher: Springer Nature Switzerland
DOI: 10.1007/978-3-031-61003-5_4

Optimizing Melanoma Prognosis Through Synergistic Preprocessing and Deep Learning Architecture for Dermoscopic Thickness Prediction

Author(s): Nikolaos Ntampakis, Konstantinos Diamantaras, Konstantinos Goulianas, Ioanna Chouvarda, Vasileios Argyriou, Panagiotis Sarigiannidis
Published in: Lecture Notes in Computer Science, Medical Image Understanding and Analysis, 2024
Publisher: Springer Nature Switzerland
DOI: 10.1007/978-3-031-66958-3_24

Conference proceedings (4)

AI Deployment in Medical Devices-Ethical and Regulaltory Reflections, Beyond Data Protection and Bias – EU perspective

Author(s): Tomasz Braun, Dominika Ewa Harasimiuk
Published in: 2023 IEEE Conference on Computational Intelligence in Bioinformatics and Computational Biology (CIBCB), 2023
Publisher: IEEE
DOI: 10.1109/CIBCB56990.2023.10264892

Open research datasets harmonized to the OMOP CDM can be used to evaluate COPD AI models

Author(s): JUNG, F., Sakkalis, V., Sun, C., Ibrahim, M., & Ertaylan, G.
Published in: European OHDSI Symposium 2024, Rotterdam
Publisher: OHDSI Europe
DOI: 10.5281/ZENODO.18783801

Enhancing Performance for Highly Imbalanced Medical Data via Data Regularization in a Federated Learning Setting

Author(s): Georgios Tsoumplekas, Ilias Siniosoglou, Vasileios Argyriou, Ioannis D. Moscholios, Panagiotis Sarigiannidis
Published in: Lecture Notes in Computer Science, Artificial Intelligence in Healthcare, 2024
Publisher: Springer Nature Switzerland
DOI: 10.1007/978-3-031-67285-9_22

Predicting the Onset of Dementia in Initially Healthy Individuals Using Demographic and Clinical Data

Author(s): Nikolaos Ntampakis, Konstantinos Diamantaras, Konstantinos Goulianas, Ioanna Chouvarda
Published in: 2023 IEEE 23rd International Conference on Bioinformatics and Bioengineering (BIBE), 2024
Publisher: IEEE
DOI: 10.1109/BIBE60311.2023.00066