Italy - GDPR Requirements for Biobanking Activities Across Europe

The aim of this chapter is to present an overview of the Italian regulatory landscape on research involving biobanks. As there is no specific law that is applicable, several regulatory texts interact. The data protection law is particularly relevant, as it provides specific rules for the processing of genetic and health-related categories of data as well as for the collection of personal data for medical, biomedical and epidemiological research. The special treatment of research is demonstrated by the exceptions to the consent rule and the principle of the limitation of storage. The Italian Superior Council of Health has adopted guidelines (which have not yet been implemented) on the traceability, collection, storage and archiving of tissues for diagnostic investigations in pathological anatomy. After the period for which human specimens must be maintained in historical archives, the reuse of tissues for biobanking would be allowed.