Connected Objects in Health: Risks, Uses and Perspectives

By Laure Beyala

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

• Language: English
• Publisher: Elsevier Science
• Release date: Aug 10, 2017
• ISBN: 9780081023723

Laure Beyala

Laure Beyala is a Biomedical Engineer who worked in numerous biotechnological industries before submitting her thesis to the Ecole Centrale Paris in 2015.

Book preview

Connected Objects in Health

Risks, Uses and Perspectives

Laure Beyala

Health Industrialization Set

coordinated by

Bruno Salgues

Table of Contents

Cover

Title page

Dedication

Copyright

Foreword

Acknowledgements

Introduction

Part 1: Basic Concepts

1: Connected Objects

Abstract

1.1 What is a connected object?

1.2 The different categories of connected objects

1.3 The actors in the ecosystem of a connected medical device

2: The Digitization of Health

Abstract

2.1 Definitions of basic concepts

2.2 Toward a convergence of the connected objects market

Part 2: Analysis and Cartography of the Risks Linked to Connected Object Usage

3: Project Management

Abstract

3.1 Research question

3.2 Goal of the study

3.3 Scope

3.4 Role of the risk manager

4: Comprehensive Risk Analysis Process

Abstract

4.1 Comprehensive risk analysis system

4.2 CRA scenario

5: Results of the Scenario and Dangerous Situation Analysis

Abstract

5.1 Dangerous situation analysis

5.2 Scenario analysis

6: Comprehensive Risk Analysis by Subfunction and by Danger

Abstract

6.1 By subfunction

6.2 By danger

7: The Scales of Loss and Effort

Abstract

7.1 Analysis of the scales loss and effort

7.2 List of major risks

7.3 Risk-reduction action plan and catalogue of security parameters

8: Comprehensive Approach

Abstract

8.1 Contribution from the comprehensive risk analysis process

8.2 New health challenges: risks emerging from the use of connected medical devices

Part 3: Connected Objects, a New Era for Scientific Revolution

9: Prospects in Health

Abstract

9.1 Connected medical devices, participatory contribution to research

9.2 Epidemiological monitoring

9.3 The patient becomes an active member of the healthcare team

9.4 Development of online portals (patient portal) with or without subscriptions

10: A Step Towards the Augmented Human

Abstract

10.1 Transhumanism

10.2 The augmented human

10.3 Some applications of connected health and nanotechnologies to move toward the augmented human

Part 4: Methodological Approach

11: Functional Need Analysis

Abstract

11.1 Functional need analysis

12: Comprehensive Risk Scenario Analysis Cartography

Abstract

12.1 Method

13: Risk-Reduction Action Forms

Abstract

13.1 Risk-reduction actions

13.2 List of the risk-reduction action forms

Conclusion

Glossary

Bibliography

Index

Dedication

For my dear Laura and for David.

For my sister Marie-Louise, who left us too soon.

Copyright

First published 2017 in Great Britain and the United States by ISTE Press Ltd and Elsevier Ltd

Apart from any fair dealing for the purposes of research or private study, or criticism or review, as permitted under the Copyright, Designs and Patents Act 1988, this publication may only be reproduced, stored or transmitted, in any form or by any means, with the prior permission in writing of the publishers, or in the case of reprographic reproduction in accordance with the terms and licenses issued by the CLA. Enquiries concerning reproduction outside these terms should be sent to the publishers at the undermentioned address:

ISTE Press Ltd

27-37 St George’s Road

London SW19 4EU

UK

www.iste.co.uk

Elsevier Ltd

The Boulevard, Langford Lane

Kidlington, Oxford, OX5 1GB

UK

www.elsevier.com

Notices

Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.

Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.

To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.

For information on all our publications visit our website at http://store.elsevier.com/

© ISTE Press Ltd 2017

The rights of Laure Beyala to be identified as the author of this work have been asserted by her in accordance with the Copyright, Designs and Patents Act 1988.

British Library Cataloguing-in-Publication Data

A CIP record for this book is available from the British Library

Library of Congress Cataloging in Publication Data

A catalog record for this book is available from the Library of Congress

ISBN 978-1-78548-259-5

Printed and bound in the UK and US

Foreword

Benjamin Pitrat

The connected health revolution, initiated in the wake of the quantified self movement and the mass distribution of smartphones, is profoundly changing our relationship to the body and disease.

This revolution is stimulated in a singular way by private actors in the domain of new technologies: major actors such as Google, Apple, Microsoft and Samsung, just to mention a few, but also a multitude of start-ups that impose their rhythm on the rest of the world.

Despite the significant expectations that it can bring about concerning the reduction of costs, prevention, and telemedicine, connected health must still show what it can do with regard to its real efficacy as well as its ability to spread without calling into question the ethics of medical care.

The rapid emergence of new technologies, and the new healthcare models that they impose, too often cause legislators and actors from civil society to lag behind in analyzing the technological and human risks of this shift.

In my opinion, it is the purpose of books like this present volume to take the time to analyze the different aspects of this connected revolution with tools adapted to this endeavor.

The rigor of the analysis and the breadth of the subject dealt with make this an indispensible book for all who wish to further reflect on this topic.

Acknowledgements

At the end of this project, I am convinced that publishing a work is far from an individual task. I could never have completed this book without the support of a large number of people whose generosity, good spirits and interest shown on my behalf allowed me to achieve my goals.

I want to thank:

– Dr. Benjamin Pitrat for having accepted to spontaneously write the foreword to my book;

– the whole team from the ISTE Publishing for their trust;

– my parents and my friends, who supported me throughout the entire process;

– Dr. Vincent Leroux, Alain Desroches and Dr. François Teboul for their valuable advice and their human qualities of listening and understanding.

Introduction

A connected object is made up of sensors that transmit information via a mobile application or an online service. This allows personal data to be recovered to better follow its health indicators so as to monitor their evolution. It also constitutes