BETTER4U_Deliverable_D2.1.First BETTER4U Legal and Ethical Framework Report

This deliverable presents the initial Legal and Ethical Framework for the EU-funded project BETTER4U. The project operates under Grant Agreement 101080117. The aim of this deliverable is to provide an overview of the legal and ethical considerations and requirements of the research activities conducted in the BETTER4U project. It also covers the development of the causal AI model and the BETTER4U intervention platform. 1 This report addresses the key legal and ethical challenges relevant to the BETTER4U project, specifically in the context of EU Fundamental Rights and Data Protection law. The deliverable focuses on the processing of personal data and the steps implemented in the project to ensure compliance with the GDPR. A key feature of this deliverable is the processing of retrospective data from national registries and biobanks, the collection and processing of prospective personal data from sensors and the pilot study in WP6, the development of the causal AI model, and informed consent processes. The data protection roles and responsibilities within the project are outlined in this document, and the corresponding Joint Controllership Arrangement will be integrated in the Data Sharing Agreement. Furthermore, the European Commission’s Guidelines for Trustworthy AI (and related policy) along with the EC proposal for the Artificial Intelligence Act will be considered to guide the ethical development of the BETTER4U causal AI model and the assessment of the applicable legal framework.2 The ethical framework outlines the ethical principles of developing a human-centric AI as envisioned by the European Parliament3, provides a summary of the ethical considerations in conducting randomized clinical trials with human-patient involvement, and addresses the socio-ethical aspects of obesity treatment studies.