Intedisciplinary assessment of personal health monitoring

188 Pages·2013·3.82 MB·English

by  Schmidt, Rienhoff, Rienhoff Otto, Silke

INTERDISCIPLINARY ASSESSMENT OF
PERSONAL HEALTH MONITORING
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ISSN 0926-9630 (print)
ISSN 1879-8365 (online)
Interdisciplinary Assessment
of Personal Health Monitoring

Edited by
Silke Schmidt
Department of Health and Prevention, University of Greifswald,
Greifswald, Germany
and
Otto Rienhoff
Institute of Medical Informatics, Göttingen University Medical Center,
Göttingen, Germany
Amsterdam • Berlin • Tokyo • Washington, DC
© 2013 The authors and IOS Press.
All rights reserved. No part of this book may be reproduced, stored in a retrieval system,
or transmitted, in any form or by any means, without prior written permission from the publisher.
ISBN 978-1-61499-255-4 (print)
ISBN 978-1-61499-256-1 (online)
Library of Congress Control Number: 2013941776
Publisher
IOS Press BV
Nieuwe Hemweg 6B
1013 BG Amsterdam
Netherlands
fax: [phone]
e-mail:
Interdisciplinary Assessment of Personal Health Monitoring v
S. Schmidt and O. Rienhoff (Eds.)
IOS Press, 2013
© 2013 The authors and IOS Press. All rights reserved.
Foreword
1
Pēteris ZILGALVIS and Céline DESWARTE
Directorate General, DG Communications Networks,
Content and Technology, European Commission Brussels
Introduction
We welcome this book, which presents selected contributions to the pre-conference
symposium on Personal Health Monitoring (PHM) and Ethics and future areas of Per-
sonal Health Monitoring, held in Rotterdam, prior to the 11th World Congress of Bio-
ethics. The majority of papers present the outcomes of the European PHM-Ethics pro-
ject. In addition, some further invited contributions deal with important issues strongly
related to the project’s primary objectives and outcomes. Therefore, the contributions
in this book cover a broad spectrum, ranging from the technical set-up of PHM systems
to ethical issues raised by PHM applications, and will be of interest to all those con-
cerned with improving the provision of healthcare worldwide.
1. Towards Smart and Sustainable Healthcare in Europe
In Europe we are facing a paradox: while governments try to curb public spending, the
demands on our healthcare systems continue to rise.
The smart use of technologies and innovation can help to address the challenges
healthcare systems are facing today, such as an ageing population, a shortage of
healthcare professionals and a lack of financial resources.
Information and Communication Technologies (ICT) have already made a strong
contribution to these goals, but much more remains to be done. eHealth technologies
such as personal health monitoring devices enable the delivery of higher quality and
more efficient services to European citizens, irrespective of where they are, for the
convenience of both patients and practitioners. This is made possible by granting online
access to personal health information, by supporting personalised therapies and by im-
plementing innovative telemedicine services.
The Digital Agenda for Europe, adopted by the European Commission in 2010,
has defined a number of objectives, including the implementation of interoperable elec-
tronic patient records – which can be safely accessed and exchanged across the EU as
well as the widespread deployment of telemedicine by 2020. To reach these objectives,
the eHealth Network, which is composed of Member States’ representatives, will coop-
erate to ensure wider use of eHealth including EU wide interoperability of electronic
patient summaries.

1 Corresponding Author.
vi
Yet regardless of increasing evidence of the benefits technology can bring, the
healthcare sector has been hesitant to embrace the digital revolution. Instead, it has
stuck to its traditional methods and models.
2. A New eHealth Action Plan
In this context, the Commission launched a new eHealth Action Plan on 6 December
2012, which will provide a roadmap for 2012–2020 and is designed to bring the bene-
fits of digital solutions into healthcare systems and lift the barriers that are preventing
Europe from providing smarter, safer, patient-centred health services. It will also sup-
port Member States in bringing forward interoperable eHealth services within and be-
tween national healthcare systems.
In practical terms the eHealth Action Plan contains actions to give patients and key
healthcare workers in the field, such as nurses, carers and doctors, the skills and confi-
dence to use these new technologies, thus leading to more meaningful time between
doctors and patients and less unnecessary appointments, thanks to the better use,
among others, of ePrescription and telemonitoring. For patients, this means spending
less time, effort and money on unnecessary hospital or GP visits while allowing them
to take a more pro-active role in the management of their health. The plan also focuses
on:
• Linking up the devices and technologies so that they can communicate with
each other and spread the benefits of digital healthcare throughout the system,
thus avoiding waste and repetition;
• Investing in research towards the personalised medicine of the future, so that
future generations can benefit from even more patient-centric care;
• Giving small businesses a helping hand when starting up on this complex
landscape by providing funding opportunities and visibility;
• Providing clarity where there is legal uncertainty: this is particularly the case
for new technologies such as apps where issues such as safety, quality and
transparency remain grey areas.
Health apps could prove to be an enormously important tool to promote consumer
and patient empowerment and self-care. They represent an important technological tool
to help inform and support patients and consumers in the self-management of their
health. They bring valuable health information to our fingertips. The best of these apps
enable us to act swiftly and decisively on self-care issues.
But as more and more citizens start to compile and to take control of their own
health data using apps and other devices it is essential to ensure user confidence in the-
se services and establish appropriate safeguards. Effective data protection is vital for
building trust in eHealth, in particular in respect to the use of cloud computing infra-
structures and services for health and wellbeing data processing.
Ethical issues need to be built into eHealth solutions, ranging from apps to remote
monitoring, utilising a user-centric and user-driven innovation process. The ethical
considerations that should be observed or taken into account in this domain can be de-
duced from binding instruments like the Charter of Fundamental Rights and the Con-
vention on Human Rights and Biomedicine, as well as from opinions such as those of
national ethics committees and the European Group on Ethics. The European Group on
vii
Ethics issued an Opinion in 1999 on the ethics of healthcare in the Information Society,
emphasising the principles of privacy, confidentiality, “legitimate purpose”, consent,
security, transparency, participation, and education. It is one of the points of guidance
that has stood the test of time and is still relevant for those developing or deploying
new technologies today. We intend to discuss issues in ethics, the law, data protection,
and the internal market relevant to eHealth innovation at the eHealth Ministerial and
Week in Dublin in 2013 and hope to engage with stakeholders.
The Action Plan provides a new focus on mobile health (mHealth). Building on the
recommendations of the eHealth Task Force, the Commission will examine a range of
issues, including quality and transparency, in this fast-moving and developing area.
To increase further legal clarity and support the wider deployment of eHealth, the
plan is supported by a legal overview of how current EU legislation applies to cross
border telemedicine. This overview takes the form of a Staff Working Paper, which
provides responses to the main issues a healthcare practitioner would face when seek-
ing to provide telemedicine services across-border:
• Does s/he also need to be licensed/registered in the Member State of the pa-
tient?
• What are the conditions for the legitimate processing of health data?
• Will the telemedicine act be reimbursed?
• What is the liability regime applicable in case damage arises as well as what
are the relevant jurisdiction and law?
This Action Plan marks above all a commitment to change in order to better target
the challenges Europe is increasingly facing. This need to change is already reflected in
the European Innovation Partnership on Active and Healthy Ageing as 3000 stakehold-
ers have committed to improve the quality of life of 4 million European senior citizens
between now and 2015. This includes 20 regions of Europe which will deploy
telemonitoring programmes for chronic disease management and integrated care that
meet the needs of older persons and enhance system efficiency.
To do this, they are learning from the experience of others and adapting it to their
own circumstances. This means that they can save time and money and avoid making
expensive mistakes. As a result, thousands of people with chronic conditions and multi-
morbidity (but also their carers) will not have to travel back and forth between doctors,
hospitals and care institutions and will be able to monitor and self-manage their own
condition and health care choices.
This grass roots approach shows that even in a time of crisis, we can make smart
investments towards a sustainable future. It is our responsibility to take the changes to
the next level for the benefit of today’s citizens and future generations.
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ix

Summary
Helpful technology enters every sector of our private life, our home or even our clothes.
Data streams of our personal behaviour originate from cars and from our gym trainers.
Sensors monitor our body temperature in airports and urine parameters in the toilette.
There are uncountable ways to monitor personal health and hundreds of approaches to
use systems and data for this purpose.
This book is addressing the ethical aspects of personal health monitoring from an
interdisciplinary perspective. It is based on the European project “PHM-Ethics”, a pro-
ject conducting interdisciplinary analyses of emerging Personal Health Monitoring
(PHM) applications. Thus, the primary intention of this volume is to present the out-
comes of the PHM-Ethics project. Moreover, several invited contributions had been
added to broaden the scope on PHM, covering aspects of PHM that are strongly related
to those questions investigated within the PHM-Ethics project.
As Pēteris Zilgalvis and Céline Deswarte point out in their foreword to this volume,
the outcomes of the PHM-Ethics project are strongly associated with a new eHealth
Action Plan currently launched by the European Commission in December 2012,
“which will provide a roadmap for 2012–2020 and is designed to bring the benefits of
digital solutions into healthcare systems”.
The Project “PHM-Ethics”
The aim of the collaborative PHM-Ethics research project has been to conduct scien-
tific interdisciplinary research to analyse the dependencies between ethical, legal and
psychosocial aspects of Personal Health Monitoring (PHM) in relation to the major
types and steps of this very dynamic part of IT-development from a European perspec-
tive. An integrated European approach to the assessment of ethical, legal and psycho-
social issues in PHM applications has been developed.
The coordinating centre of the PHM-Ethics Consortium was located on the Uni-
versity of Greifswald in Germany and had its project partners at the Centre for Applied
Ethics at the Linköping University in Sweden, the Centre for Computing and Social
Responsibility at the De Montfort University in Great Britain, Callens Law Firm in
Brussels in Belgium as well as the Institute of Medical Informatics at the University
Medical Center of Göttingen in Germany and the International Ethics Office (IN-
SERM) in France as well as the Institute of Ethics of the University of Utrecht in the
Netherlands.
Introduction to PHM
The first chapter of the book provides an introduction to Personal Health Monitoring as
well as an overview on the PHM-Ethics project and its outcomes.
Otto Rienhoff from the University Medical Center Göttingen (Germany), partner
of the international PHM-Ethics project, describes the historical roots of monitoring in
x
health care in his contribution “From Intensive Care Monitoring to Personal Health
Monitoring to Ambient Intelligence”. It shows that since the 1970ies monitoring has
been spreading in more and more domains of health and even public health. Today one
can observe a ubiquitous monitoring of persons in many environments and regarding
widely different questions. It also emphasises why ethical and data protection questions
are an absolute must in most monitoring activities today.
Following that, Silke Schmidt from the University of Greifswald (Germany) as
well as Marcel Verweij from the University of Utrecht (Netherlands) briefly introduce
the PHM-Ethics project and the PHM methodology. Within the PHM-Ethics project, a
set of tools and modules had been developed that may assist in the assessment and
evaluation of new technologies for personal health monitoring, referred to as “PHM
methodology” or “PHM toolbox”. An overview on this interdisciplinary methodology
and its comprising modules is provided, areas of application and intended target groups
are indicated.
Perspectives on PHM
In their “Technical Literature Review” Gunnar Nußbeck and Murat Gök from the Uni-
versity Medical Center Göttingen (Germany) give a comprehensive overview on the
technical perspective of PHM. The increasing number of publications that are pub-
lished per year shows that the field of PHM is of growing interest in the research com-
munity. Most publications deal with telemonitoring, thus forming the core technologi-
cal application in this field. It also provides an outlook on information and communica-
tion technology that foster the integration possibilities of PHM into decision making
and remote monitoring of individual people’s health.
Holger Muehlan and Silke Schmidt from the Department of Health and Prevention
at the University of Greifswald (Germany) coordinated the international PHM-Ethics
project. They provide a descriptive literature review of psycho-social aspects of PHM.
Both core questions addressed within this review are: What is the impact of PHM on
intended psycho-social and health-related outcomes? And which psycho-social issues
affected by or related to PHM have already been investigated?
Stefaan Callens and Adrien Galot from Callens Law Firm (Belgium) as well as
Eugenia Lamas from the French National Institute of Health and Medical Research
(INSERM) located in Paris (France) give an insight into legal aspects of PHM in their
contribution. Firstly, it analyses the short term actions that are needed at the European
level to allow PHM in respect of the interests and rights of patients such as the need to
have more harmonised medical liability rules at the level of the European Union. Intro-
ducing PHM also implies legal actions at the level of the European Union on the long
run, which are related to e.g. the way in which hospitals are organised in their relation
with healthcare professionals and with other hospitals or healthcare actors. Finally,
health monitoring projects may change the traditional (non-)relationship between pa-
tients and pharmaceutical/medical device industry and may require new legal rules.
Assessment of PHM
PHM-Ethics project partners Murat Gök, Xia Teng, Gunnar Nußbeck and Otto Rien-
hoff from the University Medical Center Göttingen (Germany) present a taxonomy of