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Techniques for generating synthetic data from real datasets are highly advanced and continually evolving. This paper aims to present the INSAFEDARE project\u2019s ambition regarding medical devices\u2019 regulation and how real and synthetic data can be used to check if devices are safe and effective. The project will consist of three pillars: a) assurance of new state-of-the-art technologies and approaches (such as synthetic data), which will support the validation methods as part of regulatory decision-making; b) technical and scientific, focusing on data-based safety assurance, as well as discovery, integration and use of datasets, and use of machine learning approaches; and c) delivery to practice, through co-production involving relevant stakeholders, dissemination and sustainability of the project\u2019s outputs. Finally, INSAFEDARE will develop an open syllabus and training certification for health professionals focused on quality assurance.<\/jats:p>","DOI":"10.3233\/shti240624","type":"book-chapter","created":{"date-parts":[[2024,8,23]],"date-time":"2024-08-23T10:09:59Z","timestamp":1724407799000},"source":"Crossref","is-referenced-by-count":0,"title":["INSAFEDARE Project: Innovative Applications of Assessment and Assurance of Data and Synthetic Data for Regulatory Decision Support"],"prefix":"10.3233","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8630-7200","authenticated-orcid":false,"given":"Parisis","family":"Gallos","sequence":"first","affiliation":[{"name":"European Federation for Medical Informatics, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8594-1912","authenticated-orcid":false,"given":"Nicholas","family":"Matragkas","sequence":"additional","affiliation":[{"name":"CEA, List, Universit\u00e9 Paris-Saclay, 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