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 .

Deliverables

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).

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.

Publications

Peer reviewed articles (6)

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

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 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