Health

This article compares the digitalization process of healthcare in Italy and Germany focusing on two main tools: the electronic health record and the mHealth regulation. Despite structural differences, the two countries present similar levels of digitization and, whereas Germany has recently introduced cutting-edge legislation on digital care, Italy has a more advanced level of EHR implementation. The analysis therefore focuses on the issues that have emerged in the two jurisdictions and the complementarity of the solutions adopted.

The paper analyses the relationship between public and private actors in the context of the Italian National Health Service. This relationship not only characterizes and conditions the structure and organisation of the NHS, but also affects the right to health of citizens-users.

Health data are sensitive data and must therefore be protected from unauthorised access. However, exchanging individual patient information is crucial for coordinating treatment between different medical professions and for the statutory health insurance schemes. Digitalisation of health data will facilitate all these processes. To promote EU-wide mobility of patients, the European Commission has proposed the establishment of a European Health Data Space. It is intended to trigger technological development in the member states, given that to date digitalisation has been used to different extents throughout the union. It is not guaranteed that patients in all member states will have access to their health data and thus be able to receive treatment or fill prescriptions within the single market. At the same time, the common experiences in the SARS-CoV2-pandemic made clear that there is a vital need for using patient data as a tool for monitoring health threats and for improving the coordination of both preparedness and response measures in times of health crisis.

With the decision n. 261/2021 of the 10th September 2021, the Administrative court of Friuli Venezia Giulia has ruled on relevant aspects related to the compulsory vaccination for healthcare personnel established by art. 4 D.L. 44/2021. The court has clarified that it is incorrect to claim that the vaccines used in the current vaccine campaign are still on trial, since they have been authorized by the Commission with a conditional marketing authorization, after EMA recommendation.

The article outlines the exemptions made by d. 18/2020 (Measures to strengthen the National Health Service and economic support for families, workers and businesses related to the epidemiological emergency by COVID-19) to the legal architecture of the responsibilities of principal actors behind clinical trials of drugs for compassionate use in the wake of the establishment of a Unique National Ethics Committee and the devising of new expertise in charge of AIFA. While waiting for the vaccine, the compassionate use of drugs, as we will see, is at present almost the only viable path of health activities around the world against SARS-Cov-2 which can be credited with creating an unprecedented 'scientific relevance' by the world scientific community.

This paper sets out the legal framework adopted in Italy for performing diagnostic tests for SARS-CoV-2 and for containing SARS-CoV-2 contagion, by analysing the consequences of their application and reviewing the decisions taken on this point by the Regional Administrative Courts in the framework of monocratic precautionary procedures.