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Connected objects today present a range of opportunities in medicine. We live in a new digital era where the monitoring and analysis of one's own health information no longer belongs solely to the realm of science fiction.The success of these new devices resides in their usage, which integrates seamlessly into the daily life of the user in order to continually collect the maximum amount of data. These medical connected devices therefore constitute a new hope in transforming user experience as well as the care pathway. They offer a better level of support and a better quality of life for those suffering from chronic illnesses or mental, sensorial or physical disabilities. However, these solutions also pose systematic problems, especially regarding the risks linked to their usage.This book presents a cartography which clearly details all the potential risk scenarios linked to the usage of connected devices as well as the actions which should be undertaken to promote balanced governance and guarantee the development of high-quality medical devices.
- Aims to help the reader understand the difference between a connected object and a medical connected device- Identifies and evaluates all the potential risks and perspectives associated with the use of connected medical devices- Shows how to make a comprehensive risk analysis with standards like ISO 31000 and 14971
Laure Beyala is a Biomedical Engineer who worked in numerous biotechnological industries before submitting her thesis to the Ecole Centrale Paris in 2015.
Part 1. Basic Concepts1. Connected Objects.2. The Digitization of Health.Part 2. Analysis and Cartography of the Risks Linked to Connected Object Usage3. Project Management.4. Comprehensive Risk Analysis Process.5. Results of the Scenario and Dangerous Situation Analysis.6. Comprehensive Risk Analysis by Subfunction and by Danger.7. The Scales of Loss and Effort.8. Comprehensive Approach.Part 3. Connected Objects, a New Era for Scientific Revolution9. Prospects in Health.10. A Step Towards the Augmented Human.Part 4. Methodological Approach11. Functional Need Analysis.12. Comprehensive Risk ScenarioAnalysis Cartography.13. Risk-Rreduction Action Forms.
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