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

Projektinformationen

REALM

ID Finanzhilfevereinbarung: 101095435

DOI

10.3030/101095435

EK-Unterschriftsdatum 24 November 2022

Startdatum 1 Januar 2023

Enddatum 31 Dezember 2026

Finanziert unter

• Health

Gesamtkosten

€ 6 659 650,00

EU-Beitrag

€ 6 659 650,00

Koordiniert durch

UNIVERSITEIT MAASTRICHT
Netherlands

CORDIS bietet Links zu öffentlichen Ergebnissen und Veröffentlichungen von HORIZONT-Projekten.

Links zu Ergebnissen und Veröffentlichungen von RP7-Projekten sowie Links zu einigen Typen spezifischer Ergebnisse wie Datensätzen und Software werden dynamisch von OpenAIRE abgerufen.

Leistungen

Websites, patent fillings, videos etc. (1)

Public project website

The website will inform the public about the project’s aims, updates and results. The website will be continuously updated throughout the project’s lifetime. Links to social media will be implemented as well.

Documents, reports (2)

Authorized access agreements with European Medical Data Pools and DT

In this deliverable we aim to bridge REALM’s data infrastructure with ongoing (and completed) European projects with standardized medical data component, Digital Twins Platforms, In-Silico trial technologies and restricted access biobanks.

Data Management Plan

The DMP describes the data management life cycle for the data to be collected, processed and/or generated. As part of making research data findable, accessible, interoperable and re-usable (FAIR), the DMP will include information on:- the handling of research data during & after the end of the project- what data will be collected, processed and/or generated- which methodology & standards will be applied- whether data will be shared/made open access and how data will be curated & preserved (including after the end of the project).

Veröffentlichungen

Peer reviewed articles (14)

Generating unseen diseases patient data using ontology enhanced generative adversarial networks

Autoren: Chang Sun 0001; Michel Dumontier
Veröffentlicht in: npj Digital Medicine, 2025, ISSN 2398-6352
Herausgeber: 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

Autoren: Babu C. S., Holsinger F.C., Zuchowski L/, Ratti E., Rameau A.
Veröffentlicht in: American Academy of Otolaryngology—Head and Neck Surgery Foundation, 2023, ISSN 2644-1276
Herausgeber: 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

Autoren: Mahmoud Ibrahim, Yasmina Al Khalil, Sina Amirrajab, Chang Sun, Marcel Breeuwer, Josien Pluim, Bart Elen, Gokhan Ertaylan, Michel Dumontier
Veröffentlicht in: arXiv, 2024, ISSN 2644-1276
Herausgeber: arXiv
DOI: 10.48550/arXiv.2407.00116

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

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

Science and values: a two-way direction

Autoren: Emanuele Ratti, Federica Russo
Veröffentlicht in: European Journal for Philosophy of Science, 2024, ISSN 2644-1276
Herausgeber: 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

Autoren: Mahmoud K. Ibrahim; Yasmina Al Khalil; Sina Amirrajab; Chang Sun 0001; Marcel Breeuwer; Josien P. W. Pluim; Bart Elen; Gökhan Ertaylan; Michel Dumontier
Veröffentlicht in: Computers in Biology and Medicine, 2025, ISSN 1879-0534
Herausgeber: 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

Autoren: Marie Seret, Vincent Uyttendaele, J. Geoffrey Chase, Geoffrey M Shaw, Thomas Desaive
Veröffentlicht in: Journal of Diabetes Science and Technology, ISSN 1932-2976
Herausgeber: Sage
DOI: 10.1177/193229682514128

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

Autoren: Avigail Ferdman & Emanuele Ratti
Veröffentlicht in: Science and Engineering Ethics, 2024, ISSN 2644-1276
Herausgeber: 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

Autoren: Nikolaos Ntampakis, Konstantinos Diamantaras, Ioanna Chouvarda, Vasileios Argyriou, Panagiotis Sarigiannidis
Veröffentlicht in: Biomedical Signal Processing and Control, Ausgabe 113, 2025, ISSN 1746-8094
Herausgeber: 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

Autoren: Nikolaos Ntampakis, Vasileios Argyriou, Konstantinos Diamantaras, Konstantinos Goulianas, Panagiotis Sarigiannidis, Ilias Siniosoglou
Veröffentlicht in: IEEE Open Journal of Engineering in Medicine and Biology, 2024, ISSN 2644-1276
Herausgeber: IEEE
DOI: 10.1109/OJEMB.2024.3426910

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

Autoren: Mahmoud Ibrahim, Yasmina Al Khalil, Sina Amirrajab, Chang Sun, Marcel Breeuwer, Josien Pluim, Bart Elen, Gökhan Ertaylan, Michel Dumontier
Veröffentlicht in: Computers in Biology and Medicine, Ausgabe 189, 2026, ISSN 0010-4825
Herausgeber: Elsevier BV
DOI: 10.1016/J.COMPBIOMED.2025.109834

BMC Medical Ethics

Autoren: Ratti, E; Morrison, M; Jakab, I
Veröffentlicht in: BMC Medical Ethics, 2025, ISSN 1472-6939
Herausgeber: BioMed Central
DOI: 10.1186/S12910-025-01198-1

User acceptability of blockchain technology for enabling electronic health record exchange

Autoren: Lilly Marie Baltruschat, Vikas Jaiman, Visara Urovi
Veröffentlicht in: Journal of Systems and Information Technology, Ausgabe 25, 2025, ISSN 1328-7265
Herausgeber: Emerald
DOI: 10.1108/JSIT-09-2022-0225

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

Autoren: Jionghui Gu, Xian Zhong, Chengyu Fang, Wenjing Lou, Peifen Fu, Henry C Woodruff, Baohua Wang, Tianan Jiang, Philippe Lambin
Veröffentlicht in: The Oncologist, Ausgabe 29, 2024, ISSN 1083-7159
Herausgeber: 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

Autoren: Kakkamani, S., JUNG, F., Verbiest, J., & PEETERS, L.
Veröffentlicht in: European OHDSI Symposium 2025
Herausgeber: 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

Autoren: 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
Veröffentlicht in: CoRR, 2024
Herausgeber: arXiv (Cornell University Library)
DOI: 10.48550/ARXIV.2408.03771

Enhancing transparency in AI for healthcare with OMOP Model Card reporting

Autoren: JUNG, F., Lohachab, A., Madureira Sanches Ribeiro, G., Rommes, S., Urovi, V., Sun, C., & Ertaylan, G.
Veröffentlicht in: European OHDSI Symposium 2025
Herausgeber: OHDSI Europe
DOI: 10.5281/ZENODO.18788825

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

Autoren: JUNG, F., Madureira Sanches Ribeiro, G., Lohachab, A., Rommes, S., Urovi, V., Sun, C., Ertaylan, G., & Attipoe, A.
Veröffentlicht in: European OHDSI Symposium 2025
Herausgeber: OHDSI Europe
DOI: 10.5281/ZENODO.18788892

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

Autoren: JUNG, F., Sun, C., Ibrahim, M., & Ertaylan, G.
Veröffentlicht in: European OHDSI Symposium 2024 , Rotterdam
Herausgeber: 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

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

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

Autoren: Ankur Lohachab, Visara Urovi
Veröffentlicht in: Lecture Notes in Business Information Processing, Advanced Information Systems Engineering Workshops, 2024
Herausgeber: 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

Autoren: Nikolaos Ntampakis, Konstantinos Diamantaras, Konstantinos Goulianas, Ioanna Chouvarda, Vasileios Argyriou, Panagiotis Sarigiannidis
Veröffentlicht in: Lecture Notes in Computer Science, Medical Image Understanding and Analysis, 2024
Herausgeber: 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

Autoren: Tomasz Braun, Dominika Ewa Harasimiuk
Veröffentlicht in: 2023 IEEE Conference on Computational Intelligence in Bioinformatics and Computational Biology (CIBCB), 2023
Herausgeber: IEEE
DOI: 10.1109/CIBCB56990.2023.10264892

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

Autoren: JUNG, F., Sakkalis, V., Sun, C., Ibrahim, M., & Ertaylan, G.
Veröffentlicht in: European OHDSI Symposium 2024, Rotterdam
Herausgeber: OHDSI Europe
DOI: 10.5281/ZENODO.18783801

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

Autoren: Georgios Tsoumplekas, Ilias Siniosoglou, Vasileios Argyriou, Ioannis D. Moscholios, Panagiotis Sarigiannidis
Veröffentlicht in: Lecture Notes in Computer Science, Artificial Intelligence in Healthcare, 2024
Herausgeber: 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

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