DIGITALISING HEALTHCARE: A COMPARATIVE ANALYSIS OF THE ITALIAN AND GERMAN SYSTEMS

This works adopts a comparative law approach to analyze the process of healthcare digitalisation in two EU countries, Italy and Germany. The selection of the cases and the legal systems object of the comparison was based on several factors, which respectively relate to a (infra-)structural precondition - the level of overall digitalisation in the two countries - and two institutional dimensions - the territorial structure of the state and the model of healthcare protection. The precondition is that Italy and Germany have a comparable level of overall digitalisation: in fact, a large gap between the two countries would have made a comparison in the field of healthcare digitalisation ineffective. However, along the institutional dimension, the constitutional arrangement of the two countries is different, since Italy is a unitary regional state while Germany is a federal republic. Finally, with respect to the second institutional dimension, the Italian and the German healthcare systems differ substantially, the former presenting a Beveridgean model based on a universalistic national healthcare system, whereas the latter is organized in accordance with the Bismarckian model of social insurance. Both similarities and substantial differences allow to assess whether the development of the digitalisation process follows similar trajectories, or whether it is intimately dependent on the chosen healthcare model, as well as the possible role played by the different constitutional arrangements. Within this framework, the study has several objectives: to identify which digital health tools have been introduced in the two jurisdictions; to identify what obstacles have been encountered in the process of legislative introduction and subsequent implementation; to outline future perspectives. Thus, the purpose is to determine whether there is a common matrix with respect to the challenges that have characterized the process of digitalisation of healthcare which - although benefiting from considerable momentum due to the pandemic - has been underway in both countries for more than a decade, and consequently whether the solutions implemented follow a common trajectory or are on the contrary attributable to specific institutional conditions in the two countries. In addition, since Germany has recently introduced “pioneering” legislation in the area of mHealth, the research sought insights into that legislation for possible future development in Italian legislation. The dissertation consists of four chapters. The first is introductory in nature and it aims to outline both the key concepts needed to understand the characteristics of the two health systems analyzed, and the challenges and opportunities related to digitalisation in health. After a brief consideration of the concept of health and its protection at the supranational and international levels, the main features of a universalistic and an insurance-based healthcare models are outlined. The final part of the chapter is then devoted to the definition of digital health in its various declinations and the benefits it can bring, as well as the challenges it poses to legal systems. The two central chapters are dedicated to the two national systems under comparison and follow a similar structure, being divided into three parts: the first is dedicated to the constitutional principles underlying the right to health and the corresponding obligations of protection on the part of the state; the second is aimed at reconstructing the main characteristics of the health systems, centered on the National Healthcare System (NHS) in the Italian case (SSN) and thebGKV in the German case; finally, the third part is dedicated to digitalisation tools and their implementation. This last part is the core of the research, to which the other two are preparatory and functional. Particular attention is paid in both Chapter II and Chapter III to the Electronic Health Record tool, that is the pivot of the digitalisation process in both countries. With regard to the Italian system, interest then shifts to telemedicine guidelines, focusing on their historical evolution and current implementation; differently, the German legislation has also offered the opportunity for an in-depth analysis of mHealth and the prescription and reimbursement mechanism of apps for medical use. The fourth Chapter Four is comparative and it contains the final reflections along the analytical lines followed in the previous chapters. It moves from a comparison of the framework of constitutional principles, which leads to the recognition that although the constitutions of Italy and Germany protect the right to health through different techniques, they establish an equal level of protection. The common goal of protecting this fundamental right is reflected in the different healthcare systems. The final part of the chapter focuses on the main elements of comparison that have emerged in relation to the digitalisation of healthcare, starting with an explicit comparison of the levels of digitalisation in the two states, based on the DESI index, and moving on to a reflection on the points of contact and differences in the legislation and implementation of the Electronic Health Record and telemedicine. A reflection is then devoted to the possible development of an administrative process for the introduction within the Italian SSN of mHealth solutions inspired by the German model . Finally, it is highlighted how the common matrix underlying the obstacles and slowdowns encountered by the two countries in the process of healthcare digitalisation relate to the fragmentation of the legal systems, albeit with different declinations, and how the current development is characterized by a common tendency toward centralization, both at the legislative and administrative levels.