Health data collected in cohort studies are valuable sources for knowledge generation and the advance of biomedical research. However, the use of these data for research projects beyond the initial purpose raises several ethical, legal, technical, and societal questions. This deliverable addresses these challenges regarding reuse of health/genomic data in CINECA from the ethical, legal, and societal issues (ELSI) perspective and in the light of Open Science and FAIR principles. In responding to the requirements for an appropriate IT and governance framework for CINECA and beyond, the research presented in this document builds on a review of GDPR provisions and their institutional sources of interpretation as well as national laws, the corresponding legal, ethical, and social science literature, as well as stakeholder engagement workshops with patient representatives, African researchers, and co-creative exercises with CINECA technical experts. The core of this deliverable are the ethical and legal recommendations that take societal implications into account for data access to European, Canadian, and African cohorts. The recommendations address four key areas: (1) Engagement and benefit sharing as prerequisites for data sharing, (2) Informed consent and reuse of data, (3) Safeguards and respect for privacy, and (4) Further uses and data-access. The deliverable concludes with an outlook on relevant projects such as the European Health Data Space (EHDS) and upcoming ELSI developments regarding data reuse and artificial intelligence (AI).