Abstract Currently, data collection processes in healthcare institutions across Europe remain exclusively geared towards the needs of primary use. Neither medical professionals’ clinical workflows, nor the data infrastructures and data management processes established within different organisations allow for the kind of highly standardised and structured data collection, processing and segregation from operational systems that secondary use requires. The development of a European Health Data Space offers large possibilities for research and innovation. High quality or primary data and secure pathways are required for the secondary use of data. Closing the loop and making relevant information from secondary use of data available to clinicians and health care professionals is a crucial step to build trust and enable a cultural shift that will enable health innovations and targeted treatments reach all those who could benefit from them without delay. Closing the loop between primary and secondary use of data will accelerate the shift from treatment of illness to prediction and prevention in the way healthcare is delivered - a shift that will need to be accompanied by an overhaul of European health systems’ current funding and reimbursement models. Establishing trustworthy sources of information and guidance for the use of novel health technologies, as well as involving patients and their caregivers early in the development of concrete applications, could help to foster better understanding and build trust in this area. To ensure acceptance, it will be particularly important for these developments to be driven by identified problems and defined needs in healthcare. Efforts should be made to address and include all parts of the population, not just the highly engaged and usually highly educated patients who typically participate in collaborative initiatives. The workshop will provide a holistic understanding of the interconnectedness between primary data and secondary use of health data. High quality of data and secure pathways are required for the secondary use of data. The workshop will explore paths for the evaluation of data-driven innovation and its introduction into clinical pathways that need to be further developed and standardised across the EU and the role that different actors in the health data system must play to meet the needs for secure and high-quality of data for research and policy development. The importance of actors like healthcare professionals, patients and citizens as well as the role of industry, public-private partnerships and relevance of health data innovative solutions will be addressed by each of the panellists and collaboration pathways for closing the loop will be further explored. The discussion will use and build on the findings and solutions identified in the EIT Health Think Tank report ‘Implementing the EHDS across Europe’. Key messages • In order to move to a data sharing environment, a cultural shift is needed to foster an environment of equality and openness to share data. • Healthcare professionals, patients and citizens are active participants and public-private partnerships could be instrumental to foster novel solutions and trust in this cultural transformation. Speakers/Panelists Nienke Schutte Sciensano, Brussels, Belgium Milana Trucl European Patient Forum, Etterbeek, Belgium Sinead O’Connor Trinity College Dublin, Dublin, Ireland Aneta Tyszkiewicz EFPIA, Brussels, Belgium Elina Drakvik Sitra, Helsinki, Finland
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