Personale Tecnico Amm.vo
Personale Tecnico Dirpolis
Francesca Gennari
Bio
I am a postdoctoral researcher at the Sant’Anna School of Advanced Studies in Pisa. My research interests range from product and tort liability to regulatory frameworks governing medical devices. At the same time, I closely follow technological and legal developments related to artificial intelligence, robotics, and Internet of Things (IoT) technologies.
Work Experience
06/03/2023 - current: Post-doc researcher at Sant’Anna School of Advanced Studies, Pisa, IT. Management of the BRIEF robotics infrastructure NRRP project and related research publications and of the Fit4Medical Robotics project, NCP funding, for rehabilitation robotics, Activity 4, Law Ethics and Policy Analysis 01/11/2022 - 01/02/2023: Research Consultant at Data Valley S.R.L , Milan, IT. Research in all the regulatory aspects concerning the IoT technologies, and on value extraction from data sharing practices17/07/2019 - 28/03/2023: Joint Doctorate Law Science and Technology, Marie Skłodowska-Curie scholarship, University of Bologna, Mykolas Romeris University of Vilnius, and the University of Turin. The thesis’s title is “Internet of Things: Legal Liability of IoE Devices in the home”. Evaluation: Very Good01/07/2017 - 31/08/2018: Legal trainee at the European Ombudsman, Strasbourg, FR. Research in data protection and transparency law; case-handling in Italian, English and French
Educational background
12/09/2016- 23/06/2017: Master in European Law (LLM), College of Europe, Bruges Campus, BE. Final evaluation: Good. Thesis Title: “Article 5 of the Rome II Regulation: A Possible Recast in the Product Liability Field?” 05/09/2011 - 05/10/2016: Master of Laws University of Trento (IT), double degree Programme with Université Sorbonne Paris Nord (L3). Final Evaluation: 110/110 cum laude. University of Trento Honors Program “Collegio di Merito Bernardo Clesio” recipient. Thesis title: “Obblighi di protezione e obligations de sécurité: fondamento teorico e prassi giurisprudenziale”
Relevant Certifications
Certification ISO 19011/2018 Guidelines for auditing management systems and ISO/IEC 42001:2023 standards (October 2025)
Implementation of Medical Device Regulation (MDR) for CE Marking certificate- BSI ( September 2025)
Certification ISO 14971:2019 Medical Devices - Application of risk management to medical devices (September 2025)
Certification ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for regulatory purposes ( September 2025)
Certification ISO 19011/2018 Guidelines for auditing management systems for ISO/IEC 27001:2022 ( July 2025)
Certification ISO/IEC 27001:2022 - Information security, cybersecurity, and privacy protection - Information security management systems- Requirements ( June 2025)
ISO/IEC 42001:2023 Information Technology - Artificial Intelligence-Management system Requirements ( June 2025)
Expert in Clinical Investigation on Medical Devices, advanced training course, University of La Sapienza, Rome (academic year 2023/2024)
Languages
- Italian (native)
- French: C2
- English: C1
- Lithuanian: A2
- Spanish: A1
Pubblicazioni
Relevant publications (selection)
Gennari, F. (2025). (Product) liability in the medical Internet of Things. What now?. In F. Casarosa, F. Gennari, & A. Rossi (Eds.), Enabling and safeguarding personalized medicine. Data science, machine intelligence, and law (Vol. 7). Springer, Cham. https://doi.org/10.1007/978-3-031-99709-9_16
Fagioli, I., Mazzarini, A., Gennari, F., & Crea, S. (2025). The role of artificial intelligence and machine learning in personalizing the control of robotic lower limb prostheses. In F. Casarosa, F. Gennari, & A. Rossi (Eds.), Enabling and safeguarding personalized medicine. Data science, machine intelligence, and law (Vol. 7). Springer, Cham. https://doi.org/10.1007/978-3-031-99709-9_12
Gennari, F., & Casarosa, F. (2025). La condivisione dei dati nei dispositivi medici connessi (IoMT): tra il Data Act e lo Spazio europeo sui dati sanitari . BioLaw Journal - Rivista Di BioDiritto, (1), 667–704. https://doi.org/10.15168/2284-4503-3504
Casarosa, F., & Gennari, F. (2025). Data Sharing in the Internet of Medical Things: Between the Data Act and the EHDS. European Journal of Risk Regulation, 1–23. doi:10.1017/err.2025.18.
Gennari, F. (2024). O Complementarity, Where Art Thou? Wading through the Medical Device Regulation and the AI Act Compliance: The case of Software as a Medical Device. A Primer. BioLaw Journal - Rivista Di BioDiritto, (3), 411–453. https://doi.org/10.15168/2284-4503-3207
Gennari, F. (2024). Mixed-Functions IoT devices: a Regulatory and Liability Requirements’ Maze. A First Overview. European Journal of Risk Regulation, 15(4), 912–927. doi:10.1017/err.2024.68
Tartaglione, E., Gennari, F., Quétu, V., & Grangetto, M. (2023). Disentangling private classes through regularization. Neurocomputing, 554, 126612. https://doi.org/10.1016/j.neucom.2023.126612
Gennari, F. (2023). A Tale of Two Cities? Fennia v Philips and Article 7 of the Product Liability Directive Update. Journal of European Consumer and Market Law. 12(6), 267- 274.
Gennari, F. (2023). What Liability with the Internet of Things? Insights from the European Case-Law of the PIP Affair. Global Jurist, 23(2), 125-150. https://doi.org/10.1515/gj-2022-0032
Relevant conferences and teaching assignments
20/10/2025: “Artificial Intelligence and Sensitive Data. Challenges, Regulatory solutions and the protection of Fundamental Rights” Conference - University of Parma
25/09/2025 -26/09/2025: “IA, Otras Tecnologías Disruptivas Y El Derecho”- European Law Institute, Spanish Chapter, Madrid
16/06/2025- 18/06/2025: Journées Internationales Sud-Coréennes, Association Henri Capitant, Seoul. Solution of the practical case on the AI tort liability and copyright law - representative for Italy
23/01/2025: “3 minutes challenge” by the Data Protection Scholars Network. Explanation of the then submitted publication “Data sharing in the internet of medical things” (online)
17/09/2024: Class within the Management and Healthcare Master Program at Sant’Anna School of Advanced studies on Data Protection to the NRRP funded class for healthcare structures managers
10/09/2024: Practical Workshop on AI and Software as Medical Device, Oncological Research unit at the Oncological Centre Léon Bérard, Lyon
03/05/2024: EU Product Liability - Platforms, Internet of Things, and Artificial Intelligence conference, University of Turin
09/02/2024: Seminar, Personal Data Processing in Biomedical Research, European University Institute
17/11/2023: Internet of Things (IoT) & Liability. Seminar for the MSc students in Cybersecurity, University of Pisa
15/12/2022 – 16/12/2022: Enforcing EU Consumer and Market Law 10 Years of the Journal of European Consumer and Market Law, online