This book is a collection of essays written by keynote speakers who have been part of the event titled "Digitalisation in Health Care between New Technologies, Data and Research", a convenium organised at Ca' Foscari University of Venice in November 2024. The book explores the benefits and challenges of the healthcare system, which has profoundly revolutionised with the advent of the digital age. In the medical field, digitization and datification are much more than technical processes: on the one hand, technologies and algorithms are involved, including AI systems; on the other hand, those tools have a significant impact on health practices and services at an organizational level, on the concrete performance of diagnosis and intervention, on the rights of natural persons, first and foremost the right to health and the right to data protection. The book is an interesting read for researchers, industry personnel, and policymakers.
Health Data Regulation: Normative Innovations and Comparative
Perspectives.- The Legal Basis of Health Data Regulation in the European
Sharing Area.- Health Data and Scientific Research in the Light of the New
European Governance.- Secondary Use of Health Data, Scientific Research and
Experience of the DPA.- Recent Italian Reforms of Health Data Secondary Use
Legislation, in the Name of Accountability.- A Comparison Between Health Data
Sharing Normative Models.- Technological Innovation and Medical Robotics.-
Between Civil Liability and Risk Governance: AI as a Medical Device.- AI and
Medical Liability.- AI, Health and Obligations of Information.- Oncological
Oblivion.- Clinical Trials, Scientific Research and Liability.- Challenges
and Opportunities in the Evolution of the Italian Electronic Health Record
and the Health Data Ecosystem.- Artificial Intelligence, Risk Regulation and
Civil Liability: A Legal Analysis of the EU AI Act.- Closing remarks.
Alessandro Bernes, Ph.D., is an assistant professor of private law. He has substantial experience in legal issues related to data processing for scientific, historical, and statistical research purposes. His studies focus on how to foster research data sharing by implementing technical and organisational measures in order to better ensure the protection of individuals. He has published articles and essays in disparate scientific academic journals on personal data, and he co-authored a book on privacy and data protection in software services for an international publisher. He is the principal investigator of the Italian project of national interest PRIN 2022 PNRR PADS4Health. Shaira Thobani, Ph.D., is an associate professor of private law. She has extensive experience with data protection and management issues addressed from a private law perspective. In this field, her main research areas include the requirements for consent of the data subject to be valid, the market of personal data and the private law remedies (civil liability) in case of violation of the right to personal data protection. She is also an associate principal investigator of the Italian project of national interest PRIN 2022 PNRR PADS4Health.
