Requirements for Initiating Retrospective Observational Studies in Laboratory Medicine|Adempimenti per l'avvio di studi osservazionali retrospettivi in medicina di laboratorio

In recent years, the increasing digitalization of health technologies and systems for collecting and storing health data has allowed for the creation of value from data and its use. However, this has led to the need to implement risk management regarding the protection and loss of health data. Observational studies, by nature, do not pose direct additional risks to the health of patients. However, the privacy of patients' needs to be preserved. This document, by presenting the obligations introduced by the current Regulation and delving into its impacts on governance, security, and management of health data, aims to provide technical-organizational measures to support the use of health data for research purposes in retrospective observational studies, particularly in laboratory medicine. It should be noted that this document is merely illustrative with reference to the cases analyzed and does not intend in any way to eliminate the evaluations of the Data Protection Officer (DPO) of the involved structures, as well as the necessary and timely risk assessment reserved for the Data Controller (DC). The document therefore aims to support the researcher in the task of providing the DPO and the DC with all the preliminary information regarding the study, in order to simplify and speed up the evaluation process. Accordingly, the document has been structured so that the researcher can benefit not only from information on the current legislation but also from informal tools such as dialogue windows with the lawyer and the analysis of real-world case studies.