• contextual harmonization
• data governance
• ethical compliance
• health data sharing
• international health research
• pandemic preparedness

The rapid expansion of digital health technologies and the intensification of global health challenges such as pandemics and zoonotic outbreaks have transformed medical research into a transnational enterprise reliant on the large-scale exchange of data. The COVID-19 pandemic in particular underscored the urgency of cross-border health data sharing for timely disease surveillance, diagnosis, and preparedness. Yet, while the scientific imperative for data sharing is widely acknowledged, its implementation remains constrained by fragmented legal regimes, divergent ethical standards, and unequal technical capacities across jurisdictions. This dissertation addresses these tensions by examining the International Atomic Energy Agency’s (IAEA) Zoonotic Disease Integrated Action (ZODIAC) initiative, launched in 2020 as a flagship program to strengthen global diagnostic resilience and pandemic preparedness. ZODIAC offers a paradigmatic case study through which to explore the design of responsible data governance frameworks, given its reliance on the coordination of diagnostic data across Member States and its integration of nuclear-derived diagnostic techniques with advanced, data-driven infrastructures.
The central research question guiding this study is how a responsible data governance framework can be conceptualized to support ethical and legally compliant health data sharing in international health research, with specific application to the ZODIAC initiative. To answer this question, the dissertation pursues three interrelated objectives: first, to analyse existing international frameworks, legal instruments, and ethical guidelines in order to map the current state of health data governance and identify areas of convergence and divergence; second, to examine the governance gaps and challenges evident within the ZODIAC initiative, particularly those relating to retrospective data use, ethical clearance processes, and technical disparities; and third, to propose a conceptual governance framework that balances scientific utility with ethical responsibility, privacy protection, and cross-border collaboration, while remaining feasible within the institutional context of the IAEA.
The research employs a qualitative case study methodology. It draws on primary sources, including official IAEA documentation, confidential materials, and non-structured interviews with personnel from the IAEA’s Nuclear Medicine and Diagnostic Imaging (NMDI) Section, supplemented by secondary sources such as academic literature, comparative analyses of governance models, and international policy reports. This approach allows for both an in-depth examination of ZODIAC’s institutional arrangements and a broader situating of the initiative within the global health data governance landscape. Despite extensive literature on data governance, limited research has examined how international organizations can operationalize responsible governance frameworks across diverse regulatory environments
The findings highlight several governance challenges that hinder ZODIAC’s full realization. These include the reliance on retrospective data, which complicates the ethical and legal grounds for data sharing in the absence of prospective consent; the coexistence of structured imaging data, which is more amenable to standardization, and unstructured clinical data, which presents persistent challenges for anonymization and interoperability; and the institutional reliance on the IAEA’s Coordinated Research Projects, which were designed for time-limited research collaborations rather than continuous big data stewardship. Additionally, the diversity of national legal frameworks and uneven institutional capacities among participating laboratories exacerbate fragmentation and reduce interoperability, creating barriers to coherent governance across borders.
The contributions of this dissertation are threefold. Empirically, it demonstrates how ZODIAC exemplifies the governance tensions faced by international health research initiatives in transitioning from project-based collaboration to sustained big data ecosystems. Theoretically, it advances the notion of contextual harmonization as an alternative to both rigid legal harmonization and purely voluntary standards, offering an approach that establishes minimum protections while allowing for contextualized implementation. It also contributes to the literature on multi-level governance and responsible innovation by showing how law, ethics, and technology can be integrated as mutually constitutive dimensions of governance. Practically, it provides the IAEA with a conceptual framework that can guide ZODIAC’s future development.
At the same time, the study acknowledges its limitations, including its reliance on a single case study, the contextual specificity of ZODIAC, and the untested nature of the proposed framework. Nevertheless, the research underscores the importance of responsible data governance as a dynamic and iterative process that balances scientific innovation with the protection of individual and community rights.