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CORDIS - Wyniki badań wspieranych przez UE
CORDIS

Integration of heterogeneous Data and Evidence towards Regulatory and HTA Acceptance

CORDIS oferuje możliwość skorzystania z odnośników do publicznie dostępnych publikacji i rezultatów projektów realizowanych w ramach programów ramowych HORYZONT.

Odnośniki do rezultatów i publikacji związanych z poszczególnymi projektami 7PR, a także odnośniki do niektórych konkretnych kategorii wyników, takich jak zbiory danych i oprogramowanie, są dynamicznie pobierane z systemu OpenAIRE .

Rezultaty

Data Management Plan (1) (odnośnik otworzy się w nowym oknie)

The Data Management Plan (DMP) will be a living document and evolve during the lifetime of the project in order to describe the data management life cycle for the data that is currently available (retrospective data) and the data to be collected (prospective data), processed and/or generated by IDERHA project and how to provide FAIRfication for research data. It will also cover data flows within consortia, GDPR, data privacy and security and long-term sustainability.

Appraisal of obstacles to data use and reuse case (odnośnik otworzy się w nowym oknie)

Report on the legal and regulatory requirements affecting wide data sharing for reuse of IDERHA data sources including an assessment of their limiting effects

Consensus policy recommendations for data sharing, access and use governance policies (odnośnik otworzy się w nowym oknie)

A report detailing consensus policy recommendations to create clarity on responsible data governance to enable more streamlined multi-stakeholder partnerships for health research. The recommendations will include approaches to address patient privacy, legal, ethical, regulatory and institutional concerns for accessing, sharing and using heterogeneous health data

IDERHA data standards manual (odnośnik otworzy się w nowym oknie)

This deliverable provides a health data standard manual that outlines the state-of-the-art standards and associated technical requirements necessary to qualify IDERHA to exchange FAIR data. It will also recommend and define standards, tools, and processes for federated production and sharing of harmonized, interoperable, semantically rich FAIR data in support of AI-based knowledge discovery

Data and analysis platform architecture (incl. different data sources and data types support) (1) (odnośnik otworzy się w nowym oknie)

Report on the architecture principles, blueprint, governance, standardization, and interfaces that will guide the implementation, adoption, and integration. Describes the architecture for the different platforms and their interconnection in area of care and research

Report on Global Regulatory Best Practices Analysis (odnośnik otworzy się w nowym oknie)

Inventory and analysis of current assessment approaches and policies of evidence generated from heterogeneous health data to identify 1) potential best practices for broader adoption, and 2) current gaps in policies for criteria for regulatory, HTA and payer acceptance of evidence generated using heterogeneous health care data.

AI transparency, data quality and bias documentation framework, per implementation (odnośnik otworzy się w nowym oknie)

Good practices to be adopted regarding AI development and validation, building on D5.4, including risk management, safety, source data quality verification, explicit assessment of bias, explainability and transparency

Recommendations on policies to support the acceptance of heterogeneous health data research in regulatory and HTA decision-making (1) (odnośnik otworzy się w nowym oknie)

A report detailing consensus policy recommendations on assessing the acceptability of evidence generated from heterogeneous data for decision-making by regulators, HTAs and payers. Recommendations will include approaches for assessing data fit-for-purpose to the research question, the rigor of the study methods, as well as transparency best practices throughout the execution and review

General data sharing policy within IDERHA (odnośnik otworzy się w nowym oknie)

General policy describing the practical procedures and guidelines to enable large-scale data sharing between the IDERHA beneficiaries while complying to all ethical and legal requirements

Operational blueprint for regulatory compliance in IDERHA AI developments (odnośnik otworzy się w nowym oknie)

Consolidation of the rules and obligations that the AI development partners in the project should adopt when undertaking AI development and validation in order to conform to the AI Act and other applicable legislation.

Consensus policy recommendations for data sharing, access and use governance policies (2) (odnośnik otworzy się w nowym oknie)

Second report detailing consensus policy recommendations to create clarity on responsible data governance to enable more streamlined multi-stakeholder partnerships for health research. The recommendations will include approaches to address patient privacy, legal, ethical, regulatory and institutional concerns for accessing, sharing and using heterogeneous health data

Updated analysis of current and emerging policies for data access/sharing, research use and transparency requirements (odnośnik otworzy się w nowym oknie)

Updated inventory and comparative analysis of policy and legislative enablers, disablers and gaps impacting on the scale up of health data access for evidence generation. This will consider EU level instruments, selected national and health care center examples, and consider impacts from the perspective of different data stakeholders.

Analysis of current and emerging policies for data access/sharing, research use and transparency requirements (odnośnik otworzy się w nowym oknie)

Inventory and comparative analysis of policy and legislative enablers, disablers and gaps impacting on the scale up of health data access for evidence generation. This will consider EU level instruments, selected national and health care center examples, and consider impacts from the perspective of different data stakeholders.

Evaluated surveillance model; code deployed Open Source on public repository. (odnośnik otworzy się w nowym oknie)

D2.3 is associated to task 2.5 and comprises a description of open source code deposited on GitHub or similar repositories covering tools to evaluate real world data from wearables and smartphone app arising from direct digital patient interactions .

Description of Communication and dissemination tools (odnośnik otworzy się w nowym oknie)

Website, newsletters, social media channels, video, animation, infographic, webinars, press releases, visual identity, template for Word and PowerPoint, style guide etc.

Publikacje

Reality Check: The Aspirations of the European Health Data Space Amidst Challenges in Decentralized Data Analysis (Preprint) (odnośnik otworzy się w nowym oknie)

Autorzy: Holger Fröhlich, Anne Funck Hansen, Mika Hilvo, Gunther Jansen, Sumit Madan, Sobhan Moazemi, Sanziana Negreanu, Venkata Satagopam, Phil Gribbon, Christian Muehlendyck
Opublikowane w: Journal of Medical Internet Research, 2025, ISSN 1438-8871
Wydawca: JMIR Publications Inc.
DOI: 10.2196/76491

Getting ready for the European Health Data Space (EHDS): IDERHA's plan to align with the latest EHDS requirements for the secondary use of health data (odnośnik otworzy się w nowym oknie)

Autorzy: Hussein, Rada; Balaur, Irina; Burmann, Anja; Ćwiek-Kupczyńska, Hanna; Gadiya, Yojana; Ghosh, Soumyabrata; Jayathissa, Prabath; Katsch, Florian; Kremer, Andreas; Lähteenmäki, Jaakko; Meng, Zhaoling; Morasek, Kathrin; C. Rancourt, Rebecca; Satagopam, Venkata; Sauermann, Stefan; Scheider, Simon; Stamm, Tanja; Muehlendyck, Christian; Gribbon, Philip
Opublikowane w: Open Research Europe, 2024, ISSN 2732-5121
Wydawca: European Commission
DOI: 10.12688/OPENRESEUROPE.18179.1

Interoperability Framework of the European Health Data Space for the Secondary Use of Data: Interactive European Interoperability Framework–Based Standards Compliance Toolkit for AI-Driven Projects (odnośnik otworzy się w nowym oknie)

Autorzy: Rada Hussein, Amelie Gyrard, Somayeh Abedian, Philip Gribbon, Sara Alabart Martínez
Opublikowane w: Journal of Medical Internet Research, Numer 27, 2025, ISSN 1438-8871
Wydawca: JMIR Publications Inc.
DOI: 10.2196/69813

BMC Medical Informatics and Decision Making (odnośnik otworzy się w nowym oknie)

Autorzy: Madan, Sumit; Lentzen, Manuel; Brandt, Johannes; Rueckert, Daniel; Hofmann-Apitius, Martin; Fröhlich, Holger
Opublikowane w: BMC Medical Informatics and Decision Making, 2024, ISSN 1472-6947
Wydawca: Springer
DOI: 10.1186/S12911-024-02600-5

Lessons Learned From European Health Data Projects With Cancer Use Cases: Implementation of Health Standards and Internet of Things Semantic Interoperability (odnośnik otworzy się w nowym oknie)

Autorzy: Amelie Gyrard, Somayeh Abedian, Philip Gribbon, George Manias, Rick van Nuland, Kurt Zatloukal, Irina Emilia Nicolae, Gabriel Danciu, Septimiu Nechifor, Luis Marti-Bonmati, Pedro Mallol, Stefano Dalmiani, Serge Autexier, Mario Jendrossek, Ioannis Avramidis, Eva Garcia Alvarez, Petr Holub, Ignacio Blanquer, Anna Boden, Rada Hussein
Opublikowane w: Journal of Medical Internet Research, Numer 27, 2025, ISSN 1438-8871
Wydawca: JMIR Publications Inc.
DOI: 10.2196/66273

Transformer models in biomedicine (odnośnik otworzy się w nowym oknie)

Autorzy: Sumit Madan, Manuel Lentzen, Johannes Brandt, Daniel Rueckert, Martin Hofmann-Apitius, Holger Fröhlich
Opublikowane w: BMC Medical Informatics and Decision Making, Numer 24, 2024, ISSN 1472-6947
Wydawca: Springer Science and Business Media LLC
DOI: 10.1186/S12911-024-02600-5

Exploring Metadata Catalogs in Health Care Data Ecosystems: Taxonomy Development Study (odnośnik otworzy się w nowym oknie)

Autorzy: Simon Scheider; Mostafa Kamal Mallick
Opublikowane w: JMIR Formative Research, 2025
Wydawca: JMIR Publications
DOI: 10.2196/63396

Hygiaso Revolutionizes Patient Discovery Through AI-Powered Real-World Health Data (odnośnik otworzy się w nowym oknie)

Autorzy: Geller, Dominik
Opublikowane w: 2025
Wydawca: Zenodo
DOI: 10.5281/ZENODO.17061411

Towards Semantic Interoperability Health Standardization Recommendation Tool (odnośnik otworzy się w nowym oknie)

Autorzy: Amelie Gyrard, Somayeh Abedian, Philip Gribbon, Stefano Dalmiani, Maria Giuffrida, George Manias, Serge Autexier, Rada Hussein
Opublikowane w: Studies in Health Technology and Informatics, Intelligent Health Systems – From Technology to Data and Knowledge, 2025
Wydawca: IOS Press
DOI: 10.3233/SHTI250562

Synergies Among Health Data Projects with Cancer Use Cases Based on Health Standards (odnośnik otworzy się w nowym oknie)

Autorzy: Amelie Gyrard, Philip Gribbon, Rada Hussein, Somayeh Abedian, Luis Marti Bonmati, Gibi Luisa Cabornero, George Manias, Gabriel Danciu, Stefano Dalmiani, Serge Autexier, Rick van Nuland, Mario Jendrossek, Ioannis Avramidis, Eva Garcia Alvarez
Opublikowane w: Studies in Health Technology and Informatics, Digital Health and Informatics Innovations for Sustainable Health Care Systems, 2024
Wydawca: IOS Press
DOI: 10.3233/SHTI240649

IDERHA Corporate slide deck (odnośnik otworzy się w nowym oknie)

Autorzy: Löwik, Judy
Opublikowane w: 2024
Wydawca: Zenodo
DOI: 10.5281/zenodo.10588707

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