Enabling and Safeguarding Personalized Medicine by Casarosa, Federica; Gennari, Francesca; Rossi, Arianna;

Long description:

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.

Table of Contents:

Introduction.- Part I: Facilitating and protecting personalized medicine.- Defining Scientific Research under the EU Politics of Data: The Impact on Personalized Smart Medicine.- Data altruism consent: A move forward towards the creation of a European health data sharing space?.- One Form to Rule them All – Towards a Personalized, but Standardized, European Data Altruism Consent Form.- Redefining anonymization: legal challenges and emerging threats in the era of EHDS.- Cybersecurity of internet of health things.- Part II: Scoping challenges through the players of the personalized medicine ecosystem.- A medical perspective on personalized medicine.- Navigating Increasing Complexity in Health Technology Assessment in the Digital Health Era: how to support a value-based personalized healthcare?.- Health technology assessment and personalized medicine: a necessary marriage.- New perspectives in R&D for patients and caregivers: the challenges on health digital competences in Europe for personalized medicine.-Motivating Corporations: Compliance and Responses in the Medical Devices Sector.- The Role of Artificial Intelligence and Machine Learning in Personalizing the Control of Robotic Lower-Limb Prostheses.- Bridging the Gap: Overcoming Barriers for the Integration of Robotics in Rehabilitation.- Part III: Challenges of personalized medicine to liability.- AI-powered medical devices for personalized medicine in the EU: between regulation and civil liability.- “Opacity of AI-based systems and liability.- (Product) Liability in the Medical Internet of Things. What now?.