Seminar with Audrey Dequesnes

Ensure that we get the best of AI in health: liability mechanisms and the application of existing regulation

Abstract

What is often referred to as artificial intelligence covers in fact a variety of techniques and uses, which are now rapidly growing in the medical field. It offers a range of new opportunities to improve health at the individual and societal level, but also raises new questions and increased awareness for the health and safety of individuals, health systems and human rights.

All stakeholders involved in building a health system that benefits from AI need a stable ground to make a responsible development, preserving human rights, as well as patients' interests. This stability inevitably requires an adequate liability mechanism. Liability is the subject of different analyses by lawmakers: for example, in France, it was not modified during the recent reform of civil liability, which did not even mention AI technology; whereas at the European Union level, the tools of soft law are taking shape in a proposal for a regulation, called for by the Parliament as well as by the Commission. Beyond a regulation that explicitly addresses the issue of AI liability, clarifying situations that could lead to litigation requires the adapted application of the existing legal framework, in particular the 2017/745 and 2017/746 regulations on medical devices. However, in order to clarify situations across the range of AI uses in health, there are still issues to be addressed regarding technologies using machine learning and data re-use, including the relevance of clinical trials and their methodology to assess such devices.

Time

9 March 2022, 17:00-18:00 CET

Place

Zoom, link provided upon registration

Registration

Please register no later than the 8 March 2022 at 13:00 (CET) using this registration form

Bio

Audrey Dequesnes is a PhD candidate in law at the University of Lille (France). Her primary field of interest is pharmaceutical science, which she studied at the University of Clermont-Auvergne, before specializing with a MD in European and international regulatory affairs of health products, in Lille. Due to her interest in biomedical technologies, she completed her PharmD thesis on the regulation of nanotechnologies and their biomedical applications. Still with a view to linking health products regulation and innovative digital technologies, she got two university qualifications, in “personal data protection and privacy law”, and in “artificial intelligence in healthcare”, and then started a PhD in 2020 on French and European Union liability law of health products using artificial intelligence. This issue combines those of health product law, defective products, but also data protection, professional confidentiality and cybersecurity.

To stay connected to the clinical field, Audrey collaborates with pharmacists at the Lille University Hospital in the legal aspects of the use of clinical decision support systems, and with the team of Pr. Zoheir Sabeur, Professor of Data Science and Artificial Intelligence at Bournemouth University, on the legal aspects of a device meant to monitor patients at home and detect grave exacerbation of their lung condition. At the University, Audrey teaches the "digital health law" course to law master students, and an introduction to multimedia law to bachelor students in web design. She is involved in two European Union funded projects, mostly in a H2020 project on cybersecurity and the extraction of encrypted evidences from smartphones by law enforcement, and an ERASMUS+ project on biolaw of emerging digital technologies in health.