Enabling and Safeguarding Personalized Medicine (Data Science, Machine Intelligence, and Law, 7)

This open-access volume provides a comprehensive guide to the most pressing challenges arising from the technologies that enable personalized medicine. It brings together theoretical, empirical, and case study-based contributions that span across disciplinary boundaries to examine related problems and propose solutions critically.

Personalized medicine is the next frontier in scientific, public health, and commercial advancements. By recognizing the uniqueness of each human body, data-driven treatments and digital, robotic devices are being increasingly developed to enable patients and medical personnel to benefit from highly accurate and personalized diagnoses and therapies. Healthcare customization is based on predictive, preventive, personalized, and participatory elements – each of which requires an interplay between healthcare systems, medical personnel, patients, as well as bioengineers, economists, regulators, lawyers, and business owners. If the goal of more proactive patient inclusion is to enhance the efficacy of personalized medical interventions, it is also paramount to evaluate whether the adoption of customized solutions is sustainable from both economic and organizational perspectives. Legal norms provide the framework in which the development of new medical devices, the sharing of data for the public good, and the provision of healthcare may occur.

This area of research and practice is regulated by a complex mix of norms concerning personal and non-personal data, AI governance, cybersecurity, health law, and liability regimes. In ever-evolving domains where some regulations still need to be defined, approved, or implemented, researchers and practitioners need guidance to enable the safe-by-design development of medical technologies.

The book is organized in three sections: I) “Facilitating and Protecting Personalized Medicine,” which revolves around the mechanisms that enable the sharing and reuse of health data within the Common European Data Spaces, seeks to address the cybersecurity challenges posed by medical technologies, and critically discusses the definition of scientific research in recent legislative efforts; II) “Scoping Challenges Through the Players in the Personalized Medicine Ecosystem,” which gathers varied interdisciplinary insights from scholars and practitioners in the fields of medicine, economics, engineering, education and compliance; and III) “Challenges of Personalized Medicine for Liability,” which focuses on the challenges that personalized data-driven medicine poses for traditional and novel liability regimes.

Federica Casarosa is a Research Associate at the Scuola Superiore Sant'Anna (Pisa) and a part-time professor at the European University Institute. Since her degree in Private Law (University of Pisa, 2001) and her subsequent PhD in Law (European University Institute, 2008), Federica Casarosa has directed her interests towards the intersection of law and technology, analysing the role of information in consumer contracting, the protection of consumer data and internet users, private regulation in the protection of freedom of expression, and the impact of cybersecurity legislation in private law. She has carried out both teaching and research activities on these topics.

Francesca Gennari is a research affiliate of the LIDER-Lab at Sant’Anna School of Advanced Studies (Pisa, Italy), where she manages research activities and projects at the intersection of law, medicine, and bioengineering. After completing her joint law degree between the University of Trento and the Université Sorbonne Paris Nord, she pursued an LLM in EU law at the College of Europe (Bruges Campus) and she worked as a trainee lawyer at the EU Ombudsman. Initially interested in EU consumer private law, she developed an interest in the challenges posed by new technologies to law and obtained a PhD in March 2023 in Law, Science, and Technology (a joint Doctoral Degree between Mykolas Romeris University of Vilnius and the University of Bologna). Her current research interests encompass a range of topics, including liability rules, regulatory aspects of the digital single market, and medical devices.

Arianna Rossi is a research affiliate of the LIDER Lab at Sant’Anna School of Advanced Studies (Pisa, Italy), where she coordinates the legal and compliance research activities related to bioengineering studies. She is an expert in usable privacy, digital manipulation, and legal design, topics on which she has published extensively in international venues. Arianna has a mixed background, with a joint international Doctoral Degree in Law, Science and Technology (University of Bologna) and a Ph.D. degree in Computer Science (University of Luxembourg). She has been an invited speaker at international conferences and regularly teaches courses on law, design, and technology to academic students and practitioners.