This presentation, delivered by Gabriel Hanssen Kiss from the Norwegian University of Science and Technology (NTNU), focuses on risk assessment and multicultural context analysis for clinical data projects. It provides a high-level framework for identifying and mitigating risks associated with handling sensitive Protected Health Information (PHI). A major emphasis is placed on legal compliance, specifically detailing the requirements of the General Data Protection Regulation (GDPR) and HIPAA. The slides also explain critical privacy techniques, distinguishing between reversible pseudonymization and irreversible anonymization to safeguard patient identities. Ethical oversight is highlighted as a core component, referencing the role of ethical committees and the principles of the Belmont Report. Furthermore, the content explores the evolution of data management in a post-AI era, touching upon Large Language Models and federated learning. Finally, the presentation addresses regulatory trends like the EU AI Act and the social necessity of avoiding algorithmic discrimination in diverse contexts
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