Giulia Mele

Jul 10, 2023 | uk.practicallaw.thomsonreuters.com | Giulia Mele |Max Jerman |Candido Garcia Molyneux

The Italian Medicines Agency has published updated guidance on negotiating the price and reimbursement status of medicinal products following a marketing authorisation variation.

Jun 30, 2023 | uk.practicallaw.thomsonreuters.com | Giulia Mele |Max Jerman |Candido Garcia Molyneux

A Ministry of Health Decree establishes requirements for sites to be deemed suitable for clinical investigations of medical devices.

Jun 29, 2023 | uk.practicallaw.thomsonreuters.com | Giulia Mele |Candido Garcia Molyneux |Max Jerman

The Italian government has proposed amendments to Law Decree 51/2023 which include the introduction of a new legislative framework for managing public expenditure on medical devices by 2026.

Jun 1, 2023 | uk.practicallaw.thomsonreuters.com | Giulia Mele |Candido Garcia Molyneux

The Italian Medicines Agency has published a Q&A on the promotion of medicinal products to healthcare professionals.

Feb 23, 2023 | lexblog.com | Kristof Van Quathem |Giulia Mele |Allan Topol

On 24 January 2023, the Italian Supervisory Authority (“Garante”) announced it fined three hospitals in the amount of 55,000 EUR each for their unlawful use an artificial intelligence (“AI”) system for risk stratification purposes, i.e., to systematically categorize patients based on their health status. The Garante also ordered the hospitals to erase all the data they obtained as a consequence of that unlawful processing.