Enabling and Safeguarding Personalized Medicine

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 a...

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言語:英語
出版事項: Springer Nature 2025
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オンライン・アクセス:ONIX_20250918T180551_9783031997099_31
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collection Directory of Open Access Books
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.
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spelling doab-20.500.12854ir-1665952025-09-20T05:05:30Z Enabling and Safeguarding Personalized Medicine Casarosa, Federica Gennari, Francesca Rossi, Arianna Open Access biorobotics engineering personalized medicine internet of health things AI-based medical devices research exception civil liability uman-in-the-loop health technology assessment strict liability scientific research research ethics cybersecurity of health devices human oversight digital health literacy expert patients data altruism data spaces consent data reuse thema EDItEUR::L Law::LN Laws of specific jurisdictions and specific areas of law::LNJ Entertainment and media law thema EDItEUR::L Law::LN Laws of specific jurisdictions and specific areas of law::LNT Social law and Medical law::LNTM Medical and healthcare law thema EDItEUR::M Medicine and Nursing::MB Medicine: general issues::MBN Public health and preventive medicine 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. 2025-09-19T05:02:26Z 2025-09-19T05:02:26Z 2025-09-18T16:13:42Z 2025 book ONIX_20250918T180551_9783031997099_31 https://library.oapen.org/handle/20.500.12657/106061 9783031997099 9783031997082 https://directory.doabooks.org/handle/20.500.12854/166595 eng Data Science, Machine Intelligence, and Law; Law and Criminology; Law and Criminology (R0) open access image/jpeg image/jpeg n/a n/a https://library.oapen.org/bitstream/20.500.12657/106061/1/9783031997099.pdf https://library.oapen.org/bitstream/20.500.12657/106061/1/9783031997099.pdf Springer Nature 10.1007/978-3-031-99709-9 10.1007/978-3-031-99709-9 9fa3421d-f917-4153-b9ab-fc337c396b5a 9783031997099 9783031997082 338 Cham open access
spellingShingle Open Access
biorobotics engineering
personalized medicine
internet of health things
AI-based medical devices
research exception
civil liability
uman-in-the-loop
health technology assessment
strict liability
scientific research
research ethics
cybersecurity of health devices
human oversight
digital health literacy
expert patients
data altruism
data spaces
consent
data reuse
thema EDItEUR::L Law::LN Laws of specific jurisdictions and specific areas of law::LNJ Entertainment and media law
thema EDItEUR::L Law::LN Laws of specific jurisdictions and specific areas of law::LNT Social law and Medical law::LNTM Medical and healthcare law
thema EDItEUR::M Medicine and Nursing::MB Medicine: general issues::MBN Public health and preventive medicine
Enabling and Safeguarding Personalized Medicine
title Enabling and Safeguarding Personalized Medicine
title_full Enabling and Safeguarding Personalized Medicine
title_fullStr Enabling and Safeguarding Personalized Medicine
title_full_unstemmed Enabling and Safeguarding Personalized Medicine
title_short Enabling and Safeguarding Personalized Medicine
title_sort enabling and safeguarding personalized medicine
topic Open Access
biorobotics engineering
personalized medicine
internet of health things
AI-based medical devices
research exception
civil liability
uman-in-the-loop
health technology assessment
strict liability
scientific research
research ethics
cybersecurity of health devices
human oversight
digital health literacy
expert patients
data altruism
data spaces
consent
data reuse
thema EDItEUR::L Law::LN Laws of specific jurisdictions and specific areas of law::LNJ Entertainment and media law
thema EDItEUR::L Law::LN Laws of specific jurisdictions and specific areas of law::LNT Social law and Medical law::LNTM Medical and healthcare law
thema EDItEUR::M Medicine and Nursing::MB Medicine: general issues::MBN Public health and preventive medicine
topic_facet Open Access
biorobotics engineering
personalized medicine
internet of health things
AI-based medical devices
research exception
civil liability
uman-in-the-loop
health technology assessment
strict liability
scientific research
research ethics
cybersecurity of health devices
human oversight
digital health literacy
expert patients
data altruism
data spaces
consent
data reuse
thema EDItEUR::L Law::LN Laws of specific jurisdictions and specific areas of law::LNJ Entertainment and media law
thema EDItEUR::L Law::LN Laws of specific jurisdictions and specific areas of law::LNT Social law and Medical law::LNTM Medical and healthcare law
thema EDItEUR::M Medicine and Nursing::MB Medicine: general issues::MBN Public health and preventive medicine
url ONIX_20250918T180551_9783031997099_31