INNOVATIVE APPLICATIONS OF ASSESSMENT AND ASSURANCE OF DATA AND SYNTHETIC DATA FOR REGULATORY DECISION SUPPORTcore
INSAFEDARE · Horizon Europe grant · 2023-11-01–2026-10-31
EC contribution
Total cost
Beneficiaries
About the data
Source: CORDIS (official EU open data), Horizon Europe. Framework HORIZON · call HORIZON-HLTH-2022-TOOL-11 · scheme HORIZON-RIA · topic HORIZON-HLTH-2022-TOOL-11-02. CORDIS record →
Objective
INSAFEDARE aims to provide a toolkit to enable cost-effective and high assurance decision-making in the context of the processes that all stakeholders may follow as part of regulation of medical devices. The toolkit consists of scientific guidance on assurance, tools to retrieve datasets and assist application validation and a publicly available guidance work-group for sustainable support of the discipline. INSAFEDARE will investigate use, challenges, and opportunities real world and synthetic data-driven validation of devices. The project will provide guidance on quality and safety assurance of datasets as a tool for validation, and devices that have validated using data driven approaches. INSAFEDARE will investigate use of synthetic datasets and will identify how they can be used to establish assurance before the formal, established certification process, reducing the risk for developers and waste for regulatory bodies. Furthermore, the project will publish the findings as a public guidance, laying the ground for a standard development working group; and develop training and syllabus that can enhance the skills of stakeholders. Finally, the project will develop a tool for the discovery, integration, and query of multiple datasets, and a tool for supporting the sustainable, dynamic, and through-life surveillance of devices, capturing the impact of new evidence offered by newly published datasets.
Beneficiaries (10)
| Organisation | Country | Role | EC contribution | SME |
|---|---|---|---|---|
| COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES | FR | coordinator | €1,327,750 | |
| ACADEMISCH ZIEKENHUIS LEIDEN | NL | participant | €570,950 | |
| G.F.I. HEALTH TECHNOLOGY CERTIFICATION LIMITED | CY | participant | €343,195 | Yes |
| SYNTHO BV | NL | participant | €320,000 | Yes |
| ISTITUTO ITALIANO PER LA PRIVACY | IT | participant | €293,750 | |
| ASSOCIATION EUROPEAN FEDERATION FORMEDICAL INFORMATICS | CH | associatedPartner | — | |
| THE UNIVERSITY OF BIRMINGHAM | UK | associatedPartner | — | |
| The Open Group Limited | UK | associatedPartner | — | Yes |
| UNIVERSITY OF WARWICK | UK | associatedPartner | — | |
| ETHOS LIMITED | IM | associatedPartner | — | Yes |
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