Report from workshop 31 january 2014. selected papers

in Lyngby-Taarbæk municipality, Denmark. The encounter between vision and
reality. Status and perspectives
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Selected papers from workshop Friday 31 January 2014:
Health and the Internet of Things
• Jesper Thestrup, In-Jet: Telemonitoring and IoT
• JacoB Nielsen, Cortrium: A Vital Sign Monitoring System
Program
10:00 Arrival, registration, coffee, networking
10:30 Leif Bloch Rasmussen, CBS: Ethical aspects of welfare technology,
specifically health technology. What social sciences are currently occupied
with.
11:30 Jesper Thestrup, In-jet: Telemonitoring, self-discovery and semantic
interoperationability. Technical aspects.
12:30 Lunch
13:15 Thomas Sørensen: Klinisk fokuseret udvikling®. New legislation makes it
possible to introduce a new practice with regard to the authorities’ approval
of medical equipment. The idea is to move the heavy costs from the start of
product development to a later phase. Hence, investors do not need to focus
on risk, but on return of investment, which would be attractive for all
14:15 Jacob Nielsen, Cortrium: IoT Startup. Introduction: Kim Balle, Drobe
15:00 Coffee
15:20 Klaus Phanareth, the Epital: Experience with an ongoing telemedicine project
16:20 Wrap-up and finish
www.iotpeople.eu - contact@iotpeople.eu

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IoTPeople
Workshop: Friday 31 January 2014, CBS Porcelænshaven nr. 407
In co-operation with CBS Competitiveness Platform
Health and Internet of Things
Presentation by Jesper Thestrup, In-Jet:
Telemonitoring, self-discovery and semantic interoperability.
Technical aspects.
Outline of presentation:
1. Introduction – societal challenges and intelligent solutions
2. Can technology help us overcome the challenges?
3. Practical implementation of Telemonitoring
4. Internet of Things technologies
5. Sustainable Business Models
6. Ethical issues and protection of rights
7. Q&A session
In-JeT ApS is a private research and innovation company and a provider of Internet Based Services
and Products in healthcare under the name LinkWatch:
• eHealth: Internet based healthcare services such as telemedicine solutions offering device
interoperability, integrated care models and sustainable business models. Markets LinkWatch
Telemedicine.
• eDemocracy: Products and services for internet based citizen engagement solutions such as
webcasting, citizen centric engagement portals and integration with social media.
• Smart Society: Internet based smart society information infrastructures, such as energy
efficient buildings, cloud-enabling technologies for physical devices and subsystems,
interoperable machine-to-machine business systems, life-cycle traceability solutions, etc.
The presentation will focus on technical aspects of Telemonitoring, self-discovery and semantic
interoperability.
24 February 2014

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4
Content of the presentation
1. Introduction – societal challenges and intelligent solutions ..................................................... 6
1.1. Healthcare challenges .................................................................................................... 6
1.2. Healthcare economics .................................................................................................... 6
2. Can technology help us overcome the challenges? ............................................................... 8
2.1. Disease management using technology ......................................................................... 8
2.2. Challenges in eHealth ..................................................................................................... 9
2.3. Best of breeds .............................................................................................................. 11
3. Practical implementation of Telemonitoring ......................................................................... 12
3.1. The LinkWatch solution by In-JeT ................................................................................. 12
3.2. The REACTION project ................................................................................................ 13
4. Internet of Things technologies ........................................................................................... 16
4.1. IoT technologies ........................................................................................................... 16
4.2. The LinkSmart middleware ........................................................................................... 17
4.3. Sustainable Business Models ....................................................................................... 19
4.4. A Business Case .......................................................................................................... 19
5. Ethical issues and protection of rights ................................................................................. 21
5.1. Ethical Policy ................................................................................................................ 22
5.2. Ethical Guidelines ......................................................................................................... 22
6. Questions to Group Work ................................................................................................... 24

In-JeT ApS makes no warranty of any kind with regard to this document, including, but not limited to,
the implied warranties of merchantability and fitness for a particular purpose. In-JeT ApS shall not be
held liable for errors contained herein or direct, indirect, special, incidental or consequential damages
in connection with the furnishing, performance, or use of this material.
All information in this document can be freely used for academic and private purposes, with due
reference given to In-JeT ApS. All figures in this document are © of the respective sources or, if no
sources are provided, of In-JeT ApS.
For further information, please contact Jesper Thestrup at jth@in-jet.dk or the following web sites:
www.in-jet.dk, www.linkwatch.dk, www.reaction-project.eu, www.ebbits-project.eu
22 February 2014
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Table of figures
Figure 1: Demographic development - Source: Population Reference Bureau ........................... 6
Figure 2: Forecasts of healthcare costs in Europe – Source EC 2009 ........................................ 8
Figure 3: Definition of eHealth terms - Source: Telemedicine Toolkit, COCIR 2011 .................... 9
Figure 4 Use of various eHealth services – Source: emperica .................................................. 10
Figure 5: LinkWatch overview – Source: The REACTION project ............................................. 13
Figure 6: The REACTION platform concept – Source: The REACTION project ........................ 14
Figure 7: IoT Technology Maturity Chasm – Source: Gartner ................................................... 16
Figure 8: Reference IoT architecture developed in ebbits – Source: The ebbits project ............ 17
Figure 9: LinkSmart Architecture – Source: The HYDRA project .............................................. 18
Figure 10: A value proposition ................................................................................................. 19
Figure 11: Diabetes Home Management System Business Case ............................................ 20
Disclaimer

1.1. Healthcare challenges
The emerging demographic situation in Europe and the challenge of delivering quality healthcare to all its
citizens necessitate changes in the way healthcare is delivered and the way medical knowledge is managed and
transferred to clinical practice.
The world population is growing in the developing world and the population is getting rapidly older!
Normally we base forecasts of healthcare needs on the assumption that 65 year olds of today are like
65 year olds of yesteryear. But this isn’t the case. Europeans, particularly in Western Europe, are
healthier nowadays, are living longer and working longer. With these different metrics the problem
changes.
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1. Introduction – societal challenges and intelligent solutions
This part of the presentation raised the questions: What is happening? What are we doing about it?
Figure 1: Demographic development - Source: Population Reference Bureau
1.2. Healthcare economics
Healthcare services across Europe face massive challenges in the future as the European population
is growing older, more and more people have chronic diseases, and the general needs and
expectations for efficient and effective healthcare services increase. These challenges concern both
the quality of healthcare and the availability of human as well as economic resources to deliver

healthcare services. Most European Member States are likely to face a severe shortage of healthcare
staff to care for the growing number of patients.
From the economic perspective, a smaller working population means less tax revenue to finance the
public healthcare system, thus placing additional strain on the resources within public healthcare
delivery. Public healthcare systems face serious challenges in controlling and managing healthcare
costs while at the same time meeting healthcare needs. Similarly, the general public is expected to
have higher demands requiring an efficient healthcare system. Public demand for high-quality care,
easy access and fast and reliable treatment will become even more firm and influential in the future.
So how are these increases in healthcare costs justified? The question of whether healthcare costs
are justified cannot be easily answered. And the answer is different if provided by a medical
practitioner or an economist. In 2012 the US spent $2,500,000 million on healthcare, corresponding
to 17% of GDP! Is the US healthcare system worth its cost?
From a medical point of view the answer may be: NO! The US population is younger, has fewer visits
to the doctor and hospital and spends less on intervention. However, the US life expectancy is much
shorter than in the EU, Americans die more frequently in hospitals and have many more lifestyle
diseases.
From an economic point of view the answer may be: YES! The increase in longevity of the US
population since 1950 has been as valuable as all other economical growth combined. Medical
advances producing 10% reduction in mortality from cancer and heart disease would add some
$10,000,000 million to GDP, i.e., +68%!
Forecasts of healthcare costs in Europe show staggering and alarming increases, unless serious
changes in the way healthcare is delivered and consumed are introduced. Figure 2 shows forecasts
provided by the European Commission and the Economic Policy Committee in 2009. The green curve
shows that pure demographic changes will increase healthcare costs from 6.8% of GDP to 8.8%, an
increase in volume of almost 30%. But if other factors such as improved medical technologies are
taken into account, the healthcare costs can double to some 13% of GDP in just 50 years.
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2.1. Disease management using technology
Via eHealth solutions new opportunities in health and disease management arise, offering improved
illness prevention and facilitating chronic disease management through active participation of patients
and personalisation of care contributing to improvements in healthcare provisioning. eHealth services
and the development of sophisticated personal wearable and portable medical devices can improve
the management of chronic conditions such as diabetes considerably.
It is important, however, that sophisticated and intelligent medical devices, which can be used by
people at home or on the road, are developed according to the needs and demands of both patients
and healthcare professionals. Intelligent devices must be interoperable allowing them to interact with
other devices and services.
When these basic requirements are fulfilled, eHealth and medical devices will allow patients and
healthcare professionals to become more mobile, as well as enabling a more efficient monitoring and
management of diseases.
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Figure 2: Forecasts of healthcare costs in Europe – Source EC 2009
The figures clearly show that some kinds of innovations are needed to bail out the healthcare system
in the coming years.
2. Can technology help us overcome the challenges?
This part of the presentation raised the question: Why is telemonitoring interesting? and describe
telemonitoring as a tool for patient empowerment.

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Figure 3: Definition of eHealth terms - Source: Telemedicine Toolkit, COCIR 2011
2.2. Challenges in eHealth
Telemonitoring is not as widespread as one could expect, despite the obvious advantages in solving
our societal issues.

– Lack of definitive evidence for cost-effectiveness when applied wide-scale (Whitten et
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Figure 4 Use of various eHealth services – Source: emperica
The barriers for widespread uptake most often found in relation to Telemonitoring are:
• Clinical issues
– Lack of definitive evidence for clinical effectiveness (Wootton, 2001)
• Organisational and human issues
al., 2002)
– Lack of funding to establish services (Hopp et al., 2006)
– Lack of experience (Richards et al., 2005)
• Technical issues
– Technical issues, especially with the early equipment (Hopp et al., 2006)
– Absence of a well-established industry (Craft, 2003)
– Uncertainty due to the lack of
• standards (Loane & Wootton, 2002)
• guidelines (Stanberry, 2006)
• service models (Barlow et al, 2006)

Evidence of improvements in medical outcome from eHealth exist in the literature (from COCIR) where
27 meta and RCT studies were analysed shows important results:
2.3.Best of breeds
An increasing number of cases shows successful deployment of eHealth services. Among the present
Best-of-Breed cases are:
– Development, testing, dissemination and quality assurance of telemedicine systems, 6
– Bosch’s Health Buddy System uses telehealth to help patients manage a broad range
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• CHF (17) e.g. from Inglis et al. 2011 (meta analysis n=9805):
o CHF-related hospitalisations RR 0.79 (95% CI 0.67 to 0.94, P = 0.008)
o all-cause mortality RR 0.66 (95% CI 0.54 to 0.81, P < 0.0001)
• COPD (5) e.g. from Koff et.al. (2009) RTC monocentric n=38 1/1)
o Quality of life (SGRQ): intervention: 10.3 points improved (19%), control: 0.6 points
improved (1%), p=0.018
o Detection of exacerbations (9 vs. 2 patients)
• Diabetes (2) e.g. Chumbler et al. 2009 (retro. comp. n=774 1/1) :
o Mean survival time: intervention 1348 days versus 1278 days, p=0.015
o 4-year all-cause mortality: RR 0.69 (95% CI 0.50–0.92, p=0.013)
• Multimorbidity (3) e.g. Darkins et al. 2008 (NC post eval. N=17025)
o 25% reduction in numbers of bed days of care
o 19% reduction in numbers of hospital admissions
• Denmark: MedCom (1995)
mio. EDI messages per month, 100% GPs and Pharmacies
• USA: Health Buddy (~2000)
of chronic illnesses, started by VA
• Austria: NÖMED WAN (2005)
– Master patient index, patient history integrates all 27 hospitals of the region, XDS
standard, to be integrated with national EPR ELGA
• USA: Kaiser Permanente (2011)
– Implemented over 50 telehealth/telemedicine projects that provided 250,000+
visits/encounters
• Finland: KanTa (2011)
– Nationwide system for professionals and patients. Prescriptions, patient data,
pharmaceuticals, etc.
• France: Le Dossier Médical Personnel (DMP) (2011)
– National web-based EHR programme, prescriptions, medication, etc. Now available
with 378 healthcare providers (2013)
New cases are constantly emerging and will soon joint the Best-of-Breed cases
• The Netherlands: VitaPorta (2012)
– Web-based Disease Management System for 65.000 chronic patients offering
monitoring of INR, Diabetes T1 and T2, Asthma/COPD, CVRM and Elderly Care.

smartphones. 12 000 individuals monitored since 2012 to be extended with 148 000
patients subject to more than ten different treatments
3.1. The LinkWatch solution by In-JeT
In-JeT markets the LinkWatch© Telemedicine platform for easy and secure collection of medical data
from patients’ location. LinkWatch Telemedicine solutions are intelligent and user-friendly applications
adapted to both the clinicians’ and the patient's needs and designed for flexibility and ease of use.
The solutions support patients in managing their diseases efficiently and help healthcare professionals
provide better care with more frequent, reliable and relevant data about patients’ health status.
The LinkWatch solution implements the client part of the Continua© Health Alliance Reference
Architecture for interoperable end-to-end healthcare systems. It supports Continua and IHE network
interfaces and all ISO/IEEE 11073 data format standards. In addition, LinkWatch also supports a
range of non-Continua interfaces and data formats, which may be converted to appropriate ISO/IEEE
11073 data formats, in the case of applications using non-Continua devices.
The LinkWatch Application Hosting Device (AHD) is a home gateway that allows for seamless
connectivity to patients’ devices via wireless and wired transport protocols. Auto discovery and self
configuration of devices ensures ease of operation, flexibility and expandability, and enables vendor
independent applications. LinkWatch can also perform local monitoring functions, such as patient
guidance and feedback functions with audio and/or visual means, reminders and compliance
monitoring, intelligent data fusion, as well as data analysis and alarm handling, including self-monitoring
The LinkWatch application runs on the gateway and performs data management, storage and transfer
from the devices to the server. It uses the LinkSmart middleware for device communication, for data
storage, for security implementation and for communication with the server.
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• Italy: Chronic Related Group (CReG) ‘Buongiorno CReG’ (2013)
– Large-scale initiative with cloud-based remote monitoring for over 300 general
practitioners and 37 000 patients with chronic diseases
• Sweden: Digital Personal Health Records (2014+)
– Empower the patient and improve and rationalise national health and caregiving with
Microsoft HealthVault
• Denmark: NSI, RSI, KL (2014+)
– National strategy for telemedicine, architecture, standards (HL7, XDS, Continua)
• Switzerland: eHealth (2015)
– An electronic patient’s file and a health portal with quality-assured online information
and access to one’s own patient file
• Spain: Valcrònic in Valencia autonomous region (2015)
– Biomedical information is transferred to healthcare professionals via tablets or
3. Practical implementation of Telemonitoring
This part of the presentation took a closer look at LinkWatch Care Platform and the REACTION
platforms and demonstrated how these platforms can help patients.
of system behaviour.

Data can be send to any backend Health Information System such as KMD or IBM. Or it can be send
to the LinkWatch / REACTION Patient Portal. The Patient Portal allows the carers to collect patient
input data (including life-style data (activity, diet) and medication data. It also allows for life-style and
compliance questionnaires and manual entry of data extracted from the EPR to create a
comprehensive care management system. The patient portal is designed to enable sharing of
information between clinicians and patient, and supports the patients and informal carers in the self-management
3.2. The REACTION project
In-JeT participates in the REACTION project - a 4-year research project funded by the European
Commission as part of the 7th Framework Programme’s objective on Personal Health Systems. The
project aims at improving long-term management of diabetes by providing a professional service
platform for healthcare professionals, patients and caregivers.
The ambition of the REACTION project is to develop an intelligent ICT (Information & Communication
Technology) platform with monitoring and feedback services that can assist healthcare professionals,
informal carers and patients in managing diabetes insulin treatment, help patients understand their
disease, support self-management and offer a safe environment by monitoring potentially life-threatening
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Figure 5: LinkWatch overview – Source: The REACTION project
of chronic diseases.
situations. The platform will incorporate wearable, continuous blood glucose monitoring
sensors, and for insulin-dependent patients, automated closed-loop delivery of insulin. The platform
will provide integrated management and therapy services, including self-management support, to
diabetes patients in different healthcare regimes across Europe.

The REACTION platform consists of subsets of production servers for data management, security,
application execution and communication. All servers interoperate on the basis of web services and
are thus completely platform agnostic and scalable.
The REACTION platform connects to sensors and devices in the Patients’ Sphere and to healthcare
professionals and informal carers as well as emergency and crisis management teams in the Carers’
Sphere. It also connects to Health Information Systems (HIS) and external medical knowledge
repositories (e.g. biomedical models) and security providers as visualised in Figure 6.
diabetes patients algorithms for estimating the insulin dose needed to adjust for short-term
variations in activity, diet and stress level is implemented. As a result, glycaemic management will be
substantially improved and the risk of complications correspondingly reduced.
The platform utilises a service orchestration mechanism combining clinical workflows and resource
scheduling to control the monitoring process, including event handling.
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Figure 6: The REACTION platform concept – Source: The REACTION project
In primary care, patients’ blood glucose levels can be checked by remote patient monitoring and in
case of problems, alerts can be generated for the patients themselves and/or their carers and
healthcare professionals. Another feature is the monitoring of therapy compliance. For insulin-dependent

Developers of applications for health and wellness monitoring are facing a diversity of protocols,
standards and communication mechanisms for collecting data from heterogeneous sensors, devices
and services, as well as when exporting data to various health and wellness services and systems.
The REACTION platform addresses this using the LinkSmart middleware approach which leverages
the development tasks to a service-oriented level allowing developers to use open standard
technologies like web services. The REACTION SOA (Service-Oriented Architecture) approach offers
a scalable and interoperable platform for use in different healthcare settings.
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• Setup of an architectural reference model for the interoperability of Internet-of-Things
• Establishing corresponding mechanism for its efficient integration into the service layer of the
• Providing a protocol based on open standards
• Defining a novel resolution infrastructure, allowing scalable look up and discovery of Internet-of-
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4. Internet of Things technologies
In this section we will discuss how telemonitoring relates to IoT and the LinkSmart middleware for
interoperability will be presented.
4.1. IoT technologies
The IoT technologies are still in the Technology Trigger region of the Technology Life-cycle.
Figure 7: IoT Technology Maturity Chasm – Source: Gartner
However attempts have been made to facilitate the uptake by various means, one of which being a
standardised IoT Architecture developed in a project called IoT-A with the following aims:
Future Internet
Things resources
• Building novel device platform components
• Implementing real-life use cases
With an IoT architecture it is possible to provide a common framework to support interactions
between any “physical world” device and the backend platform as can be seen on the following
figure:

4.2. The LinkSmart middleware
The REACTION platform addresses this heterogeneity by applying an “Internet of Things” perspective
on medical device connectivity. It uses a middleware approach which leverages the developers’ tasks
to a service-oriented level allowing developers to use open standard technologies like web services.
The middleware approach also makes the applications independent of the underlying device and
service protocol level and ensures interoperability as well as re-usability, since new devices can be
deployed and/or old ones replaced without the applications have to be re-built.
The LinkSmart middleware builds on results from the integrated EU project Hydra which researched
Open Source middleware for Internet of Things. The LinkSmart middleware incorporates support for
ontology-driven discovery of devices, P2P (Peer-to-Peer) communications, use of semantic
technologies for code generation. The REACTION project extends and adapts the middleware to
device connectivity in the health and wellness sectors. This allows developers to rapidly create health
and wellness applications as collections of services which can be orchestrated to perform desired
workflows supported through the platform spheres in Figure 6 which improves development efficiency
while delivering trusted and reliable patient-oriented services.
LinkSmart provides the following features for the developers:
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Figure 8: Reference IoT architecture developed in ebbits – Source: The ebbits project
• A middleware for networked embedded systems based on a Service-oriented Architecture
including:
– Support for distributed as well as centralised intelligent architectures

• Provide a generic semantic model-based architecture supporting model-driven development
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– Support for reflective properties of components of the middleware
– Support for security and trust enabling components
• SoA (Service Oriented Architecture)
– Each device is represented as a web service
– Each middleware component is a web service in itself (centralised or distributed
intelligence architecture)
of intelligent applications.
• Semantic Model Driven Architecture
– Device Ontology
– Security Ontology
– Software Components Ontology
• LinkSmart features offered to applications
– Automatic device discovery (multi vendor programme)
– Self configuration of devices
– Interoperability of physical devices and proxies of devices
– Security and privacy
An overview of all the components in the LinkSmart middleware is provided in Figure 9:
Figure 9: LinkSmart Architecture – Source: The HYDRA project

4.3. Sustainable Business Models
This section will focus on Business Modelling framework and identification of value propositions
When developing Sustainable Business Models in telemonitoring domains, a value modelling
approach is preferable over process modelling because of its suitability for identifying new business
opportunities and engineering radical strategic changes, whereas process modelling is more suited for
implementation of business strategies in established infrastructures.
In the REACTION project we adopted an ontological perspective on the exploration of innovative
service concepts and for quantifying value creation (Thestrup, 2008). The chosen approach, called
e3value, is based on the methodology for analysis of economic value creation (Gordijn, 2002).
The purpose of the value model is to describe who exchanges objects of value with whom, while a
process model describes the way a value model is put into operation: the activities needed, as well as
their sequence, to create, distribute, and consume value. The concepts in a value model are thus
centred around the notion of value, while in process modelling concepts focus on operational aspects
of a process:
• A value model captures decisions regarding who is offering and exchanging what with whom
and who expects what in return whereas a process model focuses on how processes should
be carried out, and by whom.
• A value model predicts to which extent actors are profitable, and whether actors are willing to
Finally, value modelling uses decomposition of value activities as a way to discover new profitable
activities, where decomposition of activities in process modelling serves the goal of clarity, or studying
various resource allocations (e.g. operational actors) to activities.
A value proposition is a promise of value to be delivered…
… and a belief from the
customer that value will be
experienced.
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• A value model shows the essentials (the strategic intent) of the way of doing business in
terms of actors creating and exchanging objects of value with each other, while a process
model shows decisions regarding the way a business is put into operation.
exchange objects of value with each other. A process models states which activities should
performed, in which order, and which objects (in which order) flow between activities.
Customer
group
Value
proposition
Value
configuration
Revenue
Cost
Partnership
Core capability
Dist. Channel
Relationship
Operation and delivery
Collaboration
Key competencies
HOW?
WHAT?
WHO?
Customers
Distribution
Retention
4.4. A Business Case
Based on the value modelling
approach, a business case
can be developed.
In the business case
presented here, the business
Figure 10: A value proposition

LEGEND
Value Activity
The Municipality benefits from the Homecare diabetes management services and can realise a
potential annual savings of €9,000 in activity-based payments for hospitalisation and GP consultations
for diabetic patients. With an investment of only €15,000 the payback time for the Homecare diabetes
management system is less than 2 years.
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model is developed for a REACTION Homecare diabetes management system that has been
instantiated in a Municipality in Denmark. The business model for the Homecare diabetes
management system is developed using the e3value modelling tool as visualised in Figure 11.
The value model is used to identify all relevant stakeholders and the value objects they exchange as
part of the business process. The business model takes the viewpoint from the Municipal actor and
models the interaction between the following actors
The main driver is better diabetes management and the economic driver is reduced hospitalisation,
shorter stays and fewer visits to the General Practitioners.
Figure 11: Diabetes Home Management System Business Case
Actor
Market Segment
Start/End Stimuli
Value Interface

5. Ethical issues and protection of rights
In this part of the presentation will include some of the work we have been doing on analysing ethical
issues of telemonitoring.
Telemonitoring services needs to consider the ethical issues, the philosophy, and the vision against
the background of the European Charter of Fundamental Human Rights and other important
instruments. Special focus must be put on medical surveillance, the meaning of human dignity and
threats to people’s autonomy. The European Convention on Human Rights and Fundamental
Freedoms states that the individual has the right to enjoy the private and family life. There is
consensus among scholars that this principle should be extended to digital types of personal space
such as the PAN (Personal Area Network), which will need to be defended against any invasion as
fervently as we now defend our homes. In addition to privacy, the analysis must focus on important
ethical aspects such as stigmatisation, inclusion and the need to allow self-determination for patients.
5.1. The Existing Legal Framework
The following EU directives are relevant for the governance of telemonitoring services and the ethical
analysis:
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• European Convention of Human Rights (ECHR
• International Covenant on Economic, Social and Cultural Rights
• Directive 95/46 Data Protection
• Directive 98/34 Technical standards and regulations
• Directive 2002/58 privacy in the telecommunications sec
• Directive 2000/31 e-commerce
• Directive 2007/47 MDD
• Directive 1997/7 distance contracts…
• Directive 2011/24 patients‘ righrs
• Rome I and Rome II regulations
• Directive 85/374/EEC
Other topics that should be included in the analysis are:
• Data protection
o Informed consent
o Freedom of choice
o Individual participation principle
o Data minimization
o Purpose Limitation
o Security of data
o Right to access
o Profiles or decisions based on inadequate criteria
o Compensation
o Function creep
o Inter-operability
• Product liability
• Intellectual property rights and DRM

5.1. Ethical Policy
An Ethical Policy should be established to set standards regarding the way partners should operate in
ethical matters, particularly in relation to the execution of the telemonitoring services.
The Ethical Policy shall be implemented in a set of Ethical Guidelines which directs the practical work
and sets out how partners shall address the ethical issues and which questions should be asked
before and during pilot execution. The Ethical Policy helps define the project’s commitment to ensure
a working culture based on trust, integrity and transparency and to carry out all project activities with
the highest standards of ethical conduct.
A main objective of the Ethical Policy is to protect the rights of the patients and residents that will
participate in the telemonitoring services and the Ethical Policy should be reviewed on a yearly basis.
The Ethical Policy can contains 10 principles that will ensure that the consortium conducts ethically
responsible services:
5.2. Ethical Guidelines
Each telemonitoring service needs to establish an ethical guideline to be followed by its users. The
Ethical Guideline takes the form of a series of questions, a check list, which will make the assessment
of whether the Ethical Guideline is followed more simple and straightforward. The Ethical Guideline is
a tool for all involved partner to use, and an Ethical Board should be created with the responsibility for
overseeing that the Ethical Guideline is adhered to.
The following elements should be dealt with in the guideline:
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• Respect the right to privacy and protection of data of all participants in the telemonitoring
service.
• Respect the right to autonomy of all participants in the telemonitoring service.
• Respect the right to dignity of all participants in the telemonitoring service.
• Be committed to transparency and integrity when ethical issues arise.
• Respect and abide by international, European, national and local legal and ethical
requirements.
• Obtain ethical approval from national or regional ethical committees as required in relation to
the execution of the service.
• Obtain written informed consent from all participants in the service.
• Adhere to the Ethical Guidelines.
• Report all ethical issues encountered before and during the service execution to the Ethical
Board for further consideration, without any delay.
• Address all questions related to ethical issues raised by the Ethical Board without any delay.
• Privacy and data protection
– Privacy of the person/body, e.g. sensors monitoring behaviour/habits
– Data security and confidentiality, incl. technical provisions i.e. built into the system)
– User’s right to control data, i.e. regarding access, accuracy and use
• Surveillance

– Technologies must be assistive, i.e. not taking control of user’s life
– Technological paternalism replacing medical paternalism: decrease agency, liberty and
– Right to life and the integrity of the person, incl. right to free and informed consent
– User need and requirements à Individualised technological solutions
– The technological solutions should not be stigmatizing, i.e. not clearly mark patients as
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– The service will / will not use surveillance cameras;
– The surveillance in form of sensors transmitting habitual data will be included;
– Constant/periodic monitoring at home; risk of feeling that privacy is invaded and/or
exercising self-censorship
– The realities of being monitored may be different than first imagined.
• Autonomy
autonomy e.g. if non-compliance isn’t an option because of technology
– Educated patients à Self-determined use of the technology
• Dignity
incapable and/or disabled.
• Informed consent
– Crucial and vital to avoid the ethical issues described above
– Must concisely and in a lay language aimed at the user group describe the
technologies and the implications of its use, incl. potential risks
– Does not place liability and reliability responsibilities onto the patient.

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6. Questions to Group Work
The following questions were posed for discussion…
• Group 1: Drivers for Telemonitoring
• Describe the societal need for telehealth and telecare and how this technology can
support new healthcare paradigms (ref challenges)
• Group 2: IoT solutions for health
• Identify and new and innovative solutions in health, wellness and assisted living that
can benefit from real IoT architecture (ref PWAL)
• Group 3: Business Models for IoT services
• Identify value objects and value exchanges in an IoT service like health, energy
efficiency, traffic.
• Group 4: Internet of Things and People
• Explain how the people dimension can be applied to the IoT; where are the humans
and how do we avoid stigmatization and provide useful and safe tools for personal
interaction.

Jacob Nielsen, Cortrium
Cortrium is a technology based start-up company founded in 2013 as a spin-off from the Nokia R&D
department in Copenhagen, Denmark. Our vision is to develop high-end tailor made solutions for the
medical sector and professional athletes. We have been developing for 1½ years and will launch our
first products in 2014.
Team
We are 8 dedicated individuals (most of which are former Nokia R&D employees) all triggered by the
vast potential our mobile health technology offers.
Our Product
We are working on a A Vital Sign Monitoring System. We have developed a C3-device that is C3 is
worn on the body chest. The C3-device uses standard electrodes and communicates via Bluetooth
live health data to our application on a Smartphone or Tablet. The C3-device is transmitting scientific
biometrics about your body - This will empower you and health care staff to monitor your health
condition. The Cortrium cloud service allows your doctor or physician to remotely track your vital signs
parameters and take appropriate action.
25
C3-‐device
with
iPad
C3 Metrics: Key Features:
Electrocardiography (ECG) Weight: 24 grams
Heart Rate (Pulse) Battery: Up to 36 hours
Respiratory Rate Seamless monitoring via Bluetooth Smart
Skin Surface Temperature Automatic Synchronization with smart device
Heart Rate Recovery Memory: 1GB for 6 days consecutive recording
Sleep Analysis Data stored on C3 (Memory card), Smartphone/Tablet and/or
Cortrium Cloud service
Heart Rate Variability

At Cortrium we are working on including Saturation (SPO2) and Blood Pressure on our C3-device.
This will be launched in 2015. We consider also integrating a microphone on our C3-device for further
scrutinizing cardiovascular diseases and breathe analysis.
User opportunities
We see great potential for our Vital Sign Monitoring System in the health care sector. The C3-device
can seamless monitor all patients at hospital early signs of critical values of vital life signs parameters.
Today health care staff at hospitals is spending valuable time of these relatively trivial monitoring
procedures. The C3-device offers automated monitoring of vital sign parameters.
The C3-device can be used as helping tool in rehabilitation programs. Breathe analysis together with
heart rate variability and recovery are here important parameters for the physiotherapists as planning
and performance tools for a better suited personalized training programme.
26
Physical Activity Level
Body Position & Motion
Also the C3 is able to detect Chronic Obstructive Pulmonary Disease (COPD), Sleep Apnea and
various heart arrhythmias such as Atrial Fibrillation (A-Fib). These diagnosis are made today with
expensive equipment where patients have to be hospitalized. The C3-device can offer an at-your-home
solution where doctors can follow the patient remote from his Smartphone or Tablet.

Report from workshop 31 january 2014. selected papers

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