Data sharing and health services in the Italian legal framework: case study // SPECIAL MENTION

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Written by Francesca Romana Pesce
Reading Time 5 minutes
Tags Data, Health, Law

Data play a key role in the world economy. This is the reason why regulations should govern such aspect not only restricting and limiting the use of data but also creating opportunities for the re-use of data while removing technical and legislative barriers.
The Data Act fits within the aforementioned scopes. In particular, this paper will focus on the right to share data with third parties (article 5) and provisions related to the interoperability (article 28 ff.). In the data protection field, the health industry is one of the most sensitive and and focused on the public interest. This means that this sector could be one whom benefit the most from an exchange policy of personal data.
Currently, in Italy, all health records issued by a public sanitary structure are made available to the patient within the Fascicolo Sanitario Elettronico (FSE), a digital platform where all health record are stored and accessible by the data subject and health public structure. While public entities are obliged to provide this service and are able to access those data, is not clear if private health structures need to converge within the FSE all the health documentation produced, but certainly are not allowed to access them.
Considering this, this paper will analyze, within the Italian legal framework, opportunities for the right to access (article 15 GDPR) and portability (article 20 GDPR) of health records, requested by an authorized parties in order to be able to secure a private database of health data. Strengths and weaknesses along with risks and opportunities of this project will be analyzed taking into account the legal point of view and some technical aspects.
The aim of this paper is to show how opportunities for the share and re-use of data combined with the removal of technical and legislative barriers provided by new and updated legislation can have a great positive impact not only for the healthcare sector but also for patients.

Francesca Romana Pesce

Ph.D. candidate in Legal Tech at Unimi - LT42 Scholarship


About the author

Graduated in Law in 2020 at "Università Statale degli Studi di Milano" with a thesis on gender disparity perpetuated by artificial intelligence. Winner of the second prize at Premio Valeria Solesin IV edition. Registered with the Milan Bar Association as of October, 2022. PhD candidate in legal tech at Università Statale degli Studi di Milano with an LT42 – the Legal Tech Company scholarship.