Back

Silvia Stefanelli

Legal Areas

Health Law
Company Law
Medical Devices & Life Sciences
Privacy and Data Protection
New Technologies
Compliance Leg. Decree 231/2001

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

09/07/2026

The AI Act, National Authorities and Penalties: What Changes with the First Implementing Decree of Law No. 132/2025

Silvia Stefanelli
On 10 June 2026, Italy's Council of Ministers gave preliminary approval to two legislative decree schemes implementing Law No. 132 of 23 September 2025 (Legge 132/2025) — Italy's primary domestic law adapting the national legal order to Regulation (EU) 2024/1689 (the AI Act).  More precisely, there are two schemes: the first addresses the powers of the national authorities and the use of artificial intelligence in education and training; the second covers the use of AI systems in policing, and civil and criminal liability. With these texts, the Italian Government begins to build the national institutional framework for AI regulation, in implementation of the AI Act.  The timeline is broad, because the subject matter itself is broad. In this first article, we focus on the first scheme, and specifically on its governance structure and penalty regime.
Read more
Artificial Intelligence
21/04/2026

EDPB Guidelines 1/2026 on the processing of personal data for scientific research purposes: a document that unravels many interpretative knots

Silvia Stefanelli
On 15 April 2026, the European Data Protection Board (EDPB) adopted Guidelines 1/2026 on the processing of personal data for scientific research purposes, which are now open for public consultation until 25 June 2026.  This is the most significant document on data protection for scientific research since 2018. The Guidelines systematically address key challenges that have significantly affected European and Italian scientific research.
Read more
Data Protection