Silvia Stefanelli

Silvia Stefanelli is a lawyer, founder and co-owner of the Studio legale Stefanelli&Stefanelli. She is an expert in healthcare law, with extensive expertise in digital health, medical devices, healthcare advertising, PA contracts, and data protection.
In 2016 she obtained the qualification of "Privacy Officer and Privacy Consultant" and in 2017 she received the certificate "Course on European Data Protection Law" issued by the Academy of European Law in Brussels.

In 2022, she has joined the team of Individual Experts to implement a pool to support the EDPB - European Data Protection Board in the groups "Technical expertise in new technology and information security" and "Legal expertise in new technologies."

She participates in several innovative projects related to the use of technology in healthcare. Some examples are her collaboration with the Smith Kline Foundation on national projects in the field of Digital Therapeutics, her contribution as Team Leader in Clusit Artificial Intelligence projects and as a member of the Scientific Committee of the Telemedicine Observatory of Altems-Unicatt.

She teaches at the Master in DPO held by the University of Roma Tre and at the Master in Healthcare at Il Sole 24 Ore Sanità. She gives courses at national level for several training institutions, including IQVIA, and collaborates with the CIRSFID Interdisciplinary Center of the University of Bologna.

Since 2005 she is a registered publicist at the Association of Journalists of Bologna. She collaborates with several magazines, including AboutPharma, Il Sole 24 Ore Sanità and Quotidiano Sanità. She is co-author of several publications and contributions, most recently "La Privacy in sanità" - Giuffrè 2020.

Recent Publications

12/06/2024

New amendments to the MDR and IVDR regulations

New amendments on the - somewhat rocky - road of the medical device (MDR) and in-vitro diagnosEcs (IVDR) regulaEons. Last 23 January 2024 the Commission presented an amendment proposal (COM 2024 – 43 final) which was fast tracked through and approved by the EU Council on 24 May. It will shortly be published in the Official Journal (Guce).
22/11/2023

Data sharing in healthcare: new techniques for sharing health-related data

In healthcare, data sharing is important not only for the purpose of care, but also for various public interest reasons. For data sharing to reach its full potential, regulatory barriers must be overcome and data quality and security must be ensured.