Download or read book Application de l analyse des risques un dispositif m dical actif et un dispositif implantable written by Frédéric Gourlay and published by . This book was released on 2004 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: L'ensemble des dispositifs médicaux présents sur le marché européen sont soumis depuis le 14 juin 1998 à l'obligation d'obtenir le marquage CE. Celui-ci matérialise le respect des " Exigences Essentielles " de santé et de sécurité, qui couvrent à la fois les conditions de conception, de fabrication et d'information des utilisateurs. Ainsi, il est obligatoire, en tant que fabricant d'un dispositif médical, de réaliser une analyse de risque permettant de démontrer que l'ensemble des risques potentiels associés au dispositif ont été identifiés, estimés et évalués, mais aussi, que des moyens de gestion de ces risques ont été mis en oeuvre afin d'éradiquer ou de réduire ces risques au niveau la plus bas possible. Ce travail apporte des clarifications sur la mise en place d'une analyse des risques suivant la norme NF EN 1441 et plus récemment l'ISO 14971. Il est abordé les différents concepts et outils de l'analyse des risques illustrés par des exemples décrivant l'apport de cette analyse lors de la conception du dispositif et son caractère itératif.

Download or read book Gestion des risques des dispositifs m dicaux written by Syndicat national de l'industrie des technologies médicales (France) and published by . This book was released on 2018 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book La gestion des risques written by Madely Roux and published by . This book was released on 2013 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: Qu'il soit administré ou seulement manipulé, chaque produit de santé présente des risques potentiels pour ses utilisateurs (patients, professionnels de santé ...). Il est important d'identifier ces risques dès le développement du produit de santé et tout au long de son cycle de vie. La notion de risque est omniprésente dans la réglementation relative aux dispositifs médicaux. Afin de minimiser les risques pour la santé leur étant liés, des dynamiques d'identification, d'analyse et de maîtrise des risques sont mises en oeuvre. Ce sont les démarches de gestion des risques. Deux grandes phases de gestion des risques se différencient au cours du cycle de vie d'un dispositif médical, la gestion des risques a priori et la gestion des risques a posteriori. Ces processus font intervenir différents acteurs mais l'objectif principal est commun: la protection de la santé. La gestion des risques a priori consiste à prévoir et prévenir les risques pouvant survenir lors de l'utilisation des dispositifs médicaux. Par ailleurs, la gestion des risques a posteriori englobe toutes les mesures mises en place pour identifier et maîtriser les risques apparaissant lors de l'utilisation du dispositif médical en conditions réelles une fois que celui-ci est mis sur le marché. De plus, la gestion des risques concerne aujourd'hui tous les produits de santé. Elle pose également différentes problématiques comme celle de son adaptation à certains produits comme les produits frontières qui sont à cheval entre deux réglementations. Cette démarche de gestion des risques en Santé évolue pour se renforcer afin de répondre notamment à l'évolution des exigences de la société

Download or read book Gestion des risques et application au dispositif m dical written by Christophe Duflot and published by . This book was released on 2006 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Data Protection by Design in the E Health Care Sector written by Giorgia Bincoletto and published by . This book was released on 2021-12-30 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the digital age, e-health technologies play a pivotal role in the processing of medical information. As personal health data represent sensitive information concerning a data subject, enhancing data protection and security of systems and practices has become a primary concern. This book explores how an e-health system could be developed and how data processing activities could be carried out to apply data protection principles and requirements from the design stage. There is currently a lack of clarity and knowledge on the topic among developers, data controllers and stakeholders. The research attempts to bridge the gap between the legal and technical disciplines on DPbD by providing a set of guidelines for the implementation of the principle in the e-health care sector.

Download or read book Privacy Confidentiality and Health Research written by William W. Lowrance and published by Cambridge University Press. This book was released on 2012-06-21 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines how privacy, confidentiality, consent, identifiability, safeguards and data sharing affect the pursuit of health research for the common good.

Download or read book HealthTech written by Jelena Madir and published by Edward Elgar Publishing. This book was released on 2020-10-30 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive book provides a detailed survey and practical examination of a wide range of legal and regulatory topics in HealthTech. Key features include: • Analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers • Examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges • Guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market • Discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.

Download or read book Under Observation The Interplay Between eHealth and Surveillance written by Samantha Adams and published by Springer. This book was released on 2016-12-31 with total page 215 pages. Available in PDF, EPUB and Kindle. Book excerpt: The essays in this book clarify the technical, legal, ethical, and social aspects of the interaction between eHealth technologies and surveillance practices. The book starts out by presenting a theoretical framework on eHealth and surveillance, followed by an introduction to the various ideas on eHealth and surveillance explored in the subsequent chapters. Issues addressed in the chapters include privacy and data protection, social acceptance of eHealth, cost-effective and innovative healthcare, as well as the privacy aspects of employee wellness programs using eHealth, the use of mobile health app data by insurance companies, advertising industry and law enforcement, and the ethics of Big Data use in healthcare. A closing chapter draws on the previous content to explore the notion that people are ‘under observation’, bringing together two hitherto unrelated streams of scholarship interested in observation: eHealth and surveillance studies. In short, the book represents a first essential step towards cross-fertilization and offers new insights into the legal, ethical and social significance of being ‘under observation’.

Download or read book How s Life in the Digital Age Opportunities and Risks of the Digital Transformation for People s Well being written by OECD and published by OECD Publishing. This book was released on 2019-02-26 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report documents how the ongoing digital transformation is affecting people’s lives across the 11 key dimensions that make up the How’s Life? Well-being Framework (Income and wealth, Jobs and earnings, Housing, Health status, Education and skills, Work-life balance, Civic engagement and ...

Download or read book Computational Power written by Massimo Durante and published by Routledge. This book was released on 2021-03-11 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: We delegate more and more decisions and tasks to artificial agents, machine-learning mechanisms, and algorithmic procedures or, in other words, to computational systems. Not that we are driven by powerful ambitions of colonizing the Moon, replacing humans with legions of androids, creating sci-fi scenarios à la Matrix or masterminding some sort of Person of Interest-like Machine. No, the current digital revolution based on computational power is chiefly an everyday revolution. It is therefore that much more profound, unnoticed and widespread, for it affects our customary habits and routines and alters the very texture of our day-to-day lives. This opens a precise line of inquiry, which constitutes the basic thesis of the present text: our computational power is exercised by trying to adapt not just the world but also our representation of reality to how computationally based ICTs work. The impact of this technology is such that it does not leave things as they are: it changes the nature of agents, habits, objects and institutions and hence it subverts the existing order, without necessarily generating a new one. I argue that this power is often not distributed in an egalitarian manner but, on the contrary, is likely to result in concentrations of wealth, in dominant positions or in unjust competitive advantages. This opens up a struggle, with respect to which the task of reaffirming the fundamental values, the guiding principles, the priorities and the rules of the game, which can transform, or attempt to transform, a fierce confrontation between enemies in a fair competition between opponents rests on us.

Download or read book The General Data Protection Regulation in Plain Language written by Bart van der Sloot and published by . This book was released on 2020 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The General Data Protection Regulation in Plain Language is a guide for anyone interested in the much-discussed rules of the GDPR. In this legislation, which came into force in 2018, the European Union meticulously describes what you can and cannot do with data about other people. Violating these rules can lead to a fine of up to 20 million euros. This book sets out the most important obligations of individuals and organisations that process data about others. These include taking technical security measures, carrying out an impact assessment and registering all data-processing procedures within an organisation. It also discusses the rights of citizens whose data are processed, such as the right to be forgotten, the right to information and the right to data portability.

Download or read book Data Science for Healthcare written by Sergio Consoli and published by Springer. This book was released on 2019-02-23 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book seeks to promote the exploitation of data science in healthcare systems. The focus is on advancing the automated analytical methods used to extract new knowledge from data for healthcare applications. To do so, the book draws on several interrelated disciplines, including machine learning, big data analytics, statistics, pattern recognition, computer vision, and Semantic Web technologies, and focuses on their direct application to healthcare. Building on three tutorial-like chapters on data science in healthcare, the following eleven chapters highlight success stories on the application of data science in healthcare, where data science and artificial intelligence technologies have proven to be very promising. This book is primarily intended for data scientists involved in the healthcare or medical sector. By reading this book, they will gain essential insights into the modern data science technologies needed to advance innovation for both healthcare businesses and patients. A basic grasp of data science is recommended in order to fully benefit from this book.

Download or read book Privacy Rights in the Digital Age written by Christopher Anglim and published by Grey House Publishing. This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new encyclopedia discusses the practical, political, psychological, and philosphical challenges we face as technological advances have changed the landscape of traditional notions of privacy.