biochimica clinica

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DOCUMENTI - Documents

Volume:

Biochimica Clinica, 2024; 48(1) 67-76

Pubblicato on-line:

January 8, 2024

DOI:

10.19186/BC_2023.094

Scarica in PDF:
Autenticazione richiesta

Adempimenti per l’avvio di studi osservazionali retrospettivi in medicina di laboratorio

AUTORI

Fabio Del Ben1, Alice Pisapia2, Andrea Padoan3, Roberta Rolla4, Tommaso Trenti5, Giuseppe Banfi6,7, Anna Carobene8, Rossella Tomaiuolo6,7
1IRCCS Centro di Riferimento Oncologico di Aviano (Pordenone)
2Università degli Studi dell’Insubria (Varese)
3Università di Padova
4Università del Piemonte Orientale (Novara)
5Ospedale Civile Sant’Agostino-Estense (Baggiovara, Modena)
6Università Vita-Salute San Raffaele (Milano)
7IRCCS Ospedale Galeazzi-Sant’Ambrogio (Milano)
8IRCCS Ospedale San Raffaele (Milano)

ABSTRACT

Requirements for Initiating Retrospective Observational Studies in Laboratory Medicine

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.

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