References

Regulation (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (link); Legislative Decree No. 196/2003 (Privacy Code) as amended by Legislative Decree No. 101/2018; Regulation (EU) No. 536/2014 on clinical trials; Regulation (EU) No. 745/2017 on medical devices; EDPB Guidelines 3/2020 on the processing of data concerning health for scientific research purposes; General Authorisation No. 9/2016 by the Italian Data Protection Authority (Garante Privacy); Decision of the Italian Data Protection Authority (Garante Privacy) "Code of Conduct for Processing Personal Data for Statistical or Scientific Research Purposes" (Official Gazette No. 11 of 14-1-2019); Ministerial Decree of 15 July 1997 (Transposition of the EU Good Clinical Practice Guidelines).