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

HealthHORIZON-RIAID: 101095435
EC Contribution
€66,597
Consortium Size
16 orgs
Start Year
2023
Summary

The overall aim of the REALM project is to create a collaborative framework for regulatory authorities, application developers, healthcare professionals and policy officers to co-create and evaluate software for medical and healthcare use. We propose to create an inclusive platform leading to a transparent ecosystem for evaluation and certification of software in healthcare where both the developers and the regulatory (and Health Technology Assessment) bodies have access to a standardized set of technology stack and data. This will be achieved by first mapping and analyzing regulations, legislative efforts and guidelines from EU, national bodies and around the world on software in healthcare practice. These will guide the roadmap towards building an inclusive, fair and multi-stakeholder ecosystem. The scaffold for an integrated architecture will be developed in collaboration with DARWIN, based on standardized data models and optimized data driven methodologies for the effective use of real-world data (RWD) in healthcare regulatory practice. The architecture will consist of four components: two technological infrastructures, a living lab and a post-marketing surveillance module. i) a federated cloud-based data resources catalog will be established, to bring together currently available RWD data and synthetic data to facilitate the data needs of the platform. ii) Regulatory Toolbox will be established to bring together standardized tools to train, test, evaluate and monitor medical/healthcare software. iii) Living lab environment for piloting medical/healthcare software technology assessment taking into account human-software interactions as part of the system. iv) Post-marketing surveillance with RWD for ensuring quality standards of the certified software in practice. Finally, building on the proposed architecture, five real Medical Device Software (MDSW) projects are going to be implemented across 3 countries (Netherlands, Belgium and Greece).

Consortium (16)

Project Results (30)

Source: CORDIS, the EU research results database.

Publications (26)
Generative AI for synthetic data across multiple medical modalities: A systematic review of recent developments and challenges
Computers in Biology and Medicine· 2026DOI
Mahmoud Ibrahim, Yasmina Al Khalil, Sina Amirrajab, Chang Sun, Marcel Breeuwer, Josien Pluim, Bart Elen, Gökhan Ertaylan, Michel Dumontier
BMC Medical Ethics
BMC Medical Ethics· 2025DOI
Ratti, E; Morrison, M; Jakab, I
Generating unseen diseases patient data using ontology enhanced generative adversarial networks
npj Digital Medicine· 2025DOI
Chang Sun 0001; Michel Dumontier
Generative AI for synthetic data across multiple medical modalities: A systematic review of recent developments and challenges
Computers in Biology and Medicine· 2025DOI
Mahmoud K. Ibrahim; Yasmina Al Khalil; Sina Amirrajab; Chang Sun 0001; Marcel Breeuwer; Josien P. W. Pluim; Bart Elen; Gökhan Ertaylan; Michel Dumontier
Introducing DEFORMISE: A deep learning framework for dementia diagnosis in the elderly using optimized MRI slice selection
Biomedical Signal Processing and Control· 2025DOI
Nikolaos Ntampakis, Konstantinos Diamantaras, Ioanna Chouvarda, Vasileios Argyriou, Panagiotis Sarigiannidis
User acceptability of blockchain technology for enabling electronic health record exchange
Journal of Systems and Information Technology· 2025DOI
Lilly Marie Baltruschat, Vikas Jaiman, Visara Urovi
A Blockchain-Based Approach for Model Card Accountability and Regulatory Compliance
Lecture Notes in Business Information Processing, Advanced Information Systems Engineering Workshops· 2024DOI
Ankur Lohachab, Visara Urovi
Deep Learning of Multimodal Ultrasound: Stratifying the Response to Neoadjuvant Chemotherapy in Breast Cancer Before Treatment
The Oncologist· 2024DOI
Jionghui Gu, Xian Zhong, Chengyu Fang, Wenjing Lou, Peifen Fu, Henry C Woodruff, Baohua Wang, Tianan Jiang, Philippe Lambin
Enhancing Performance for Highly Imbalanced Medical Data via Data Regularization in a Federated Learning Setting
Lecture Notes in Computer Science, Artificial Intelligence in Healthcare· 2024DOI
Georgios Tsoumplekas, Ilias Siniosoglou, Vasileios Argyriou, Ioannis D. Moscholios, Panagiotis Sarigiannidis
Enhancing Performance for Highly Imbalanced Medical Data via Data Regularization in a Federated Learning Setting
Lecture Notes in Computer Science ISBN: 9783031672842· 2024DOI
Georgios Tsoumplekas; Ilias Siniosoglou; Vasileios Argyriou; Ioannis D. Moscholios; Panagiotis G. Sarigiannidis
Generative AI for Synthetic Data Across Multiple Medical Modalities: A Systematic Review of Recent Developments and Challenges
arXiv· 2024DOI
Mahmoud Ibrahim, Yasmina Al Khalil, Sina Amirrajab, Chang Sun, Marcel Breeuwer, Josien Pluim, Bart Elen, Gokhan Ertaylan, Michel Dumontier
Introducing SPINE: A Holistic Approach to Synthetic Pulmonary Imaging Evaluation through End-to-End Data and Model Management
IEEE Open Journal of Engineering in Medicine and Biology· 2024DOI
Nikolaos Ntampakis, Vasileios Argyriou, Konstantinos Diamantaras, Konstantinos Goulianas, Panagiotis Sarigiannidis, Ilias Siniosoglou
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
CoRR· 2024DOI
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
Optimizing Melanoma Prognosis Through Synergistic Preprocessing and Deep Learning Architecture for Dermoscopic Thickness Prediction
Lecture Notes in Computer Science, Medical Image Understanding and Analysis· 2024DOI
Nikolaos Ntampakis, Konstantinos Diamantaras, Konstantinos Goulianas, Ioanna Chouvarda, Vasileios Argyriou, Panagiotis Sarigiannidis
Predicting the Onset of Dementia in Initially Healthy Individuals Using Demographic and Clinical Data
2023 IEEE 23rd International Conference on Bioinformatics and Bioengineering (BIBE)· 2024DOI
Nikolaos Ntampakis, Konstantinos Diamantaras, Konstantinos Goulianas, Ioanna Chouvarda
Science and values: a two-way direction
European Journal for Philosophy of Science· 2024DOI
Emanuele Ratti, Federica Russo
What Do We Teach to Engineering Students: Embedded Ethics, Morality, and Politics
Science and Engineering Ethics· 2024DOI
Avigail Ferdman & Emanuele Ratti
AI Deployment in Medical Devices-Ethical and Regulaltory Reflections, Beyond Data Protection and Bias – EU perspective
2023 IEEE Conference on Computational Intelligence in Bioinformatics and Computational Biology (CIBCB)· 2023DOI
Tomasz Braun, Dominika Ewa Harasimiuk
Epistemological Challenges of Artificial Intelligence Clinical Decision Support Tools in Otolaryngology: The Black Box Problem
American Academy of Otolaryngology—Head and Neck Surgery Foundation· 2023DOI
Babu C. S., Holsinger F.C., Zuchowski L/, Ratti E., Rameau A.
Using Generative Artificial Intelligence in the Production and Dissemination of Innovation in Otolaryngology—Ethical Considerations
American Academy of Otolaryngology—Head and Neck Surgery Foundation· 2023DOI
Carolyn Jane Khoury BA, Necati Enver MD, FEBORL-HNS, Alberto Paderno MD, PhD, Emanuele Ratti PhD, Anaïs Rameau MD, MPhil, MS FACS
Enhancing transparency in AI for healthcare with OMOP Model Card reporting
European OHDSI Symposium 2025DOI
JUNG, F., Lohachab, A., Madureira Sanches Ribeiro, G., Rommes, S., Urovi, V., Sun, C., & Ertaylan, G.
Open research datasets harmonized to the OMOP CDM can be used to evaluate COPD AI models
European OHDSI Symposium 2024, RotterdamDOI
JUNG, F., Sakkalis, V., Sun, C., Ibrahim, M., & Ertaylan, G.
RAG-Enhanced LLM Pipeline for Semantic Mapping of Context-based Features to OMOP Vocabulary
European OHDSI Symposium 2025DOI
Kakkamani, S., JUNG, F., Verbiest, J., & PEETERS, L.
REALM – innovative solutions for the creation and evaluation of AI medical device software
European OHDSI Symposium 2024 , RotterdamDOI
JUNG, F., Sun, C., Ibrahim, M., & Ertaylan, G.
RIANA Dashboard: A Blockchain-Enabled Approach for Representing AI Model Intent in OMOP with Atlas-Like Functionality
European OHDSI Symposium 2025DOI
JUNG, F., Madureira Sanches Ribeiro, G., Lohachab, A., Rommes, S., Urovi, V., Sun, C., Ertaylan, G., & Attipoe, A.
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
Journal of Diabetes Science and TechnologyDOI
Marie Seret, Vincent Uyttendaele, J. Geoffrey Chase, Geoffrey M Shaw, Thomas Desaive
Deliverables (3)
Documents, reports
Websites, patent fillings, videos etc.
Other Results (1)
Periodic Reporting for period 1 - REALM (Real-world-data Enabled Assessment for heaLth regulatory decision-Making)