6
Jul 22
Clinical trials and pharmacovigilance: Spanish Code of Conduct leads the way in data management
In an effort to expand the regulatory framework with self-regulatory instruments, the Spanish Data Protection Authority recently approved a “Code of conduct for the processing of personal data in the field of clinical trials and other clinical research and of pharmacovigilance” supported by Farmaindustria, the national trade association for the pharmaceutical industry in Spain.
19
Apr 22
The new decree on non-profit studies: Data and results may now be sold
On February 16, 2022, more than two years later than planned, the Ministerial Decree of November 30, 2021, containing measures to facilitate and support the development of nonprofit clinical trials of medicinal products and observational studies, as well as to regulate the transfer of data and results of nonprofit trials for registration purposes, was finally published in the Official Gazette.
11
Jun 21
The role of the DPO in the public sector: New guidance from the Italian Data Protection Authority
On May 24, 2021, the Italian Data Protection Authority published on its website “Guidance on designation, position and tasks of the Data Protection Officer in the public sector”.
7
Jun 21
EU regulations on medical devices and the GDPR: first step forward a necessary coordination
In the wake of application of the European medical device regulation (EU Regulation No. 745 of 2017), occurred on May 26, Italy is taking its first steps toward adjusting its national regulatory framework.
The Italian Data Protection Authority published guidelines on the role of the Data Protection Officer in public entities: important news for hospitals and healthcare facilities
25
Feb 21
Italian Data Protection Authority approved the first code of conduct in the public sector regulating the use of health data for educational and scientific publication purposes
The Italian Data Protection Authority (“Garante”) approved the first code of conduct (Decision No. 7 of January 24, 2021, doc. Web 9535354) on how to use personal data concerning health for educational and scientific publication purposes; the code of conduct was submitted by the Veneto Region (“Code of Conduct”).
