Project introduced at Medical Informatics Europe Conference

The INSAFEDARE project partners have collaborated on a joint paper introducing the project, which has been presented at the 34th Medical Informatics Europe Conference (MIE) held in Athens on 25-29 August with over 1,000 conference participants. The paper titled "INSAFEDARE Project: Innovative Applications of Assessment and Assurance of Data and Synthetic Data for Regulatory Decision Support" provides an overview of the project, the technology innovations targeted and the decision-making support for regulators that will be provided.

Abstract:

Digital health solutions hold promise for enhancing healthcare delivery and patient outcomes, primarily driven by advancements such as machine learning, artificial intelligence, and data science, which enable the development of integrated care systems. Techniques for generating synthetic data from real datasets are highly advanced and continually evolving. This paper aims to present the INSAFEDARE project’s ambition regarding medical devices’ 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’s outputs. Finally, INSAFEDARE will develop an open syllabus and training certification for health professionals focused on quality assurance.

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