Harnessing the economic and social value of health data in the EU – The European Health Data Space Regulation (the Regulation) as a cornerstone of data-driven healthcare and research – Balancing innovation with fundamental rights and European constitutional values – The Regulation within the broader process of European integration in public health – Contribution of the Regulation to the Digital Single Market and the European Health Union – Limits of member state action in a Union based on the rule of law – Constitutional tensions between strategic policy ambitions and existing EU competences – Critical assessment of the Regulation’s compatibility with the EU constitutional framework – Pathways to address identified shortcomings through constitutional and institutional reforms.