Silvia Stefanelli is a lawyer who has the right of representing clients in the highest Italian Court and founder of the Stefanelli&Stefanelli law firm. She is an expert in healthcare law, with particular expertise in digital health, medical devices, healthcare advertising, contracts with public administration authorities, and data protection. In 2016 she obtained the title of "Privacy Officer and Privacy Consultant" and in 2017 the certificate "Course on European Data Protection Law" issued by the Academy of European Law in Brussels. She follows many innovative projects in the healthcare sector related to the use of new technologies.
Since 2022, she joined the team of Individual Experts for the implementation of a pool supporting the EDPB - European Data Protection Board in the groups "Technical expertise in new technology and information security" and "Legal expertise in new technologies". She collaborates with the SmithKline Foundation on several national projects in the field of Digital Therapeutics. She acts as Legal Team Leader in the publications of the Clusit Association. She is a member of the Scientific Committee of the Altems- Unicatt Telemedicine Observatory. She is a lecturer in 2nd level Master courses at Unitelma La Sapienza University; she also collaborates with the University of Roma3 and Altems Cattolica. She holds courses at the national level for numerous training organisations including Il Sole 24 ore and IQVIA.
Since 2005, she has been enrolled in the Register of Publicists of the Order of Journalists of Bologna. She collaborates with several trade magazines, including AboutPharma, Il Sole 24 Ore Sanità and Quotidiano Sanità. She is co-author of publications and numerous collective contributions, most recently "La Privacy in sanità" - Giuffrè 2020. She publishes on AboutPharma in the section "Medical Devices: between legislation and regulation" and on LinkedIn in the group "Medical Devices: legislation and jurisprudence".
She is a founding partner and President of the company between professionals Best in Health, a consultancy company consisting of professionals from different sectors with solid vertical experience in the healthcare sector, whose primary aim is to support investors and operators in the health sector. She is a founding partner of the start-up InsideAI Srl, which carries out consultancy activities in the field of Artificial Intelligence.
Sessions in which Silvia Stefanelli participates
Wednesday 14 May, 2025
Il settore della ricerca è probabilmente quello che oggi è più in fermento. Molte sono le novità normative, sia a livello europeo che a livello nazionale; alcune sono già state pubblicate, altre invece stanno completando il loro iter approvativo. Le Regole Deontologiche per i trattamenti a fini statistici e di ricerca scientifica si trovano davvero in mezzo al guado e potrebbero correre il rischio di “nascere già vecchie”.In questo panel, a...
Sessions in which Silvia Stefanelli attends
Monday 12 May, 2025
Discussions surrounding the interplay of AI and Data Protection Laws will reveal how academics and practitioners from around the world manage the intersectionality of these laws. How do data protection laws and emerging AI intersect, and how do they complement each other? If you’re a privacy professional, legal expert, AI developer, or policymaker, this is your must-attend session, as it will feature professionals from Google, EDRI, DG Justice, a...
L’attuale contesto digitale, segnato da una pervasiva evoluzione tecnologica, solleva alcuni interrogativi sulla tutela dei nostri dati e sul rispetto della dignità umana. Di fronte al rischio di un disallineamento tra progresso tecnologico e principi fondamentali, emerge l’urgenza di sviluppare modelli organizzativi capaci di orientare l’innovazione digitale in modo responsabile, etico e consapevole. In questo scenario, il modello dell’Intelligenza Integrale offre una chiave di lettura strat...
Generative AI development and deployment is exploding, but the recent EDPB Opinion 28/2024 and early enforcement actions (notably the fine against OpenAI by the Garante in Italy) signal that compliance with the GDPR must be taken seriously from the outset. Against this backdrop, our panel will explore how to build trust and avoid pitfalls when developing and deploying LLMs in Europe. We’ll examine the evolving legal landscape—and whether it leaves enough room for meaningful innovation....
Il panel moderato dall’Avv. Cataleta Il panorama normativo cybersecurity e l’impatto sulle organizzazioni copre diversi aspetti relativi alla cybersecurity e non solo. L’obiettivo del panel è attuare delle riflessioni critiche su: scenario della severity degli attacchi cyber e panoramica nel settore manufacturing. Riflessioni sulla corrispondenza tra spesa in cybersecurity e numero degli attacchi e analisi dei rischi derivanti dall’esternalizzazione della ...
The Cyber Resilience Act (CRA) sets obligatory requirements for hardware and software products as well as infrastructure, aiming to guarantee high standards of security for all items connected to the internet. This session brings together experts to explore the CRA’s real-world implications, shedding light on the challenges, opportunities, and urgent questions surrounding cyber resilience.
AI systems are becoming more integrated into critical decision-making processes, which makes questions of liability and accountability more pressing than ever. If an AI-based decision goes wrong, who is responsible? This session will unite experts from Meta, Italian Institute for Privacy and Data Valorisation, AI Law Tech Institute, SGS, and CNPD to explore the evolving frameworks for AI liability and the role of certification in building respons...
Cyber threats are evolving at an unprecedented pace, which makes AI and machine learning essential tools in the fight against cybercrime, by enabling faster threat detection, automated responses, and predictive defense strategies. However, with these advancements come new challenges. The panel of this session will explore the future of AI-driven defense and what it means for privacy, security, and resilience.
Tuesday 13 May, 2025
Modern vehicles are more than just simple transportation; they are data hubs constantly collecting and transmitting information. From GPS tracking and in-car entertainment systems to AI-powered assistance, connected cars are revolutionizing the concept of mobility. The exceptional panel of this session will explore the fine line between convenience and surveillance, geolocation tracking, and how regulations are adapting.
The role of data regulations in enabling economic growth is currently a topic of intense interest in many parts of the world. Attendees of this enriching session will hear discussions on the nature and design of data regulations, and balances to be struck, including the extent to which regulators seek to enable good outcomes as well as prevent bad ones. Key questions
Wednesday 14 May, 2025
This session promises to dive deep into the real-world impact of data anonymization and synthetic data, exploring how these techniques are being used to protect privacy in different industries. Experts of the panel will break down the myths and realities of these privacy-enhancing technologies, tackling their benefits, limitations, and regulatory challenges head-on. Key questions&nbsp...
Aiming to balance a safe and competitive digital space with the right of free expression, the interplay of these two Acts forms a critical discussion when considering the place of freedom of expression in the broader topic of privacy and data regulation. Hearing from representatives from the European Commission and legal experts, attendees of this session will gain an insight into the interplay of the Acts and how they currently sit in relation t...
Europe’s data regulations are very intricate to form the whole picture, which means that each piece is essential, yet constantly shifting. The Data Act, Data Governance Act and GDPR are not isolated frameworks; they are deeply intertwined to shape the way we interact with the digital reality. This session unites esteemed professionals and officials from Euroconsumers, DG Justice, DG Connect, and Lativia DPA, diving beyond the legal aspect to unco...
In un contesto in cui gli agenti AI assumono compiti sempre più sofisticati — dalla rappresentanza nelle interazioni digitali fino alla gestione autonoma di dati personali — si aprono interrogativi cruciali: può un agente artificiale rappresentare legalmente una persona? Quali diritti e doveri si innescano nella delega digitale di sé? Come si tutela la privacy in un contesto dove l’identità può essere “replicata” e “agita” da una macchina? Nel dibattito interverranno i rappresentanti dell’Aut...
Explore the critical issues shaping HR data privacy in the age of AI. This panel of government and legal experts will address the complexities of cross-border data flows, emerging compliance requirements, and the implications of AI for human resources data. Discover strategies for fostering international cooperation and ensuring robust employee data protection in a rapidly evolving regulatory landscape.