A Risk Analysis has been done within the framework of the PICCOLO project to guarantee the correct anonymization of the clinical data being used in the project according to the new General Data Protection Regulation.

BIOEF, as responsible for the compliance of the ethical aspects of the consortium, has overseen the generation of the Risk Analysis Report, which is a great achievement for the PICCOLO project.

One of the objectives of the PICCOLO project is the generation of a database of colorectal lesions (human and animal origin) that will contain images from different diagnosis modalities and their associated clinical data and will be available to the scientific community. The approval for the generation of the PICCOLO Project database has been obtained by the local ethics committees of the clinical partners of the consortium.

In order to properly store, centralize and share the extensive amount of data that will be generated within the project, a Network-Attached Storage (NAS) has been selected as the best commercially available data storage device, exploitable for PICCOLO database generation.

Regarding the human data, the new General Data Protection Regulation (EU) 2016/679 (GDPR) states that, for the rights and freedoms of the patients, it is necessary to make a Risk Analysis of the data that is being used in the study and review the security measures that are being applied and, where appropriate, completing them in light of the results.

In the PICCOLO project, all data will be collected after the patients participating in the study sign the informed consent. Furthermore, in compliance with the new GDPR, a Risk Analysis has been carried out to guarantee the correct anonymization of the data under study. The report states the clinical data that is being used can be considered anonymous, which means the data does not need to go through a second layer of anonymization. This Risk Analysis report supports the possibility of making the PICCOLO database open-access once created.