Innovazione digitale dei sistemi sanitari, eHealth e questioni di data governance, nell’agenda digitale sanitaria nazionale ed europea

«A Europe fit for the digital age» is one of the six political priorities of the EU 2019-2024 agenda: building upon precedent initiatives enhancing the creation of a Digital Single Market, focusing on Health as one of the sectors to be substantially revised to support digital healthcare delivery, but also for health research and health policy making. This essay analizes the set of recent EU initiatives involving the «Digital Services Act package», the «Data Governance Act» and the contemplated creation of a common «European Health Data Space», resulting in a fast and remarkable revision of current regulatory framework of EU Member States Health sectors. This rich interconnected set of regulatory initiatives operating on different registers (international, national, regional), is essentially aimed at enhancing epidemiological surveillance, exchange of information between health authorities, clinical trial process of new medicines and medical devices, and ultimately the entire system of management of the current health emergency. This essay highlights the interaction between these ambitious set of EU initiatives, the evolution of the national healthcare system towards eHealth and Digital Care and some fundamental guidelines to adapt this balance in a manner consistent with the EU pillars of respect for dignity, data protection and human rights in healthcare.