Report from workshop 31 january 2014. selected papers

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www.iotpeople.eu - [email protected]

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

in Lyngby-Taarbæk municipality, Denmark. The encounter between vision and reality. Status and perspectives

16:20 Wrap-up and finish

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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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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

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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

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 [email protected] 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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1. Introduction – societal challenges and intelligent solutions

This part of the presentation raised the questions: What is happening? What are we doing about it?

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!

Figure 1: Demographic development - Source: Population Reference Bureau

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.

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

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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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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.

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 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.

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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

– Lack of definitive evidence for cost-effectiveness when applied wide-scale (Whitten et 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)

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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:

• 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

2.3.Best of breeds

An increasing number of cases shows successful deployment of eHealth services. Among the present Best-of-Breed cases are:

• Denmark: MedCom (1995)

– Development, testing, dissemination and quality assurance of telemedicine systems, 6 mio. EDI messages per month, 100% GPs and Pharmacies

• USA: Health Buddy (~2000)

– Bosch’s Health Buddy System uses telehealth to help patients manage a broad range 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.

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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 smartphones. 12 000 individuals monitored since 2012 to be extended with 148 000 patients subject to more than ten different treatments

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.

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 of system behaviour.

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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Figure 5: LinkWatch overview – Source: The REACTION project

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 of chronic diseases.

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 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.

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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.

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 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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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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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:

• 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 Future Internet

• Providing a protocol based on open standards

• Defining a novel resolution infrastructure, allowing scalable look up and discovery of Internet-of-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:

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Figure 8: Reference IoT architecture developed in ebbits – Source: The ebbits project

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:

• A middleware for networked embedded systems based on a Service-oriented Architecture including:

– Support for distributed as well as centralised intelligent architectures

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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)

• Provide a generic semantic model-based architecture supporting model-driven development 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

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Customer group

Value proposition

Value configuration

RevenueCost

PartnershipCore capability

Dist. ChannelRelationship

Operation and deliveryCollaboration

Key competencies

HOW?

WHAT?

WHO?

CustomersDistributionRetention

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 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.

• A value model predicts to which extent actors are profitable, and whether actors are willing to 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.

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.

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

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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

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.

Actor

Market Segment

LEGEND

Start/End Stimuli

Value Interface

Value Activity

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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:

• 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

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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:

• 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.

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:

• 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

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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

– Technologies must be assistive, i.e. not taking control of user’s life

– Technological paternalism replacing medical paternalism: decrease agency, liberty and autonomy e.g. if non-compliance isn’t an option because of technology

– Educated patients à Self-determined use of the technology

• Dignity

– 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 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.

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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.

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

C3-‐device with iPad

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Physical Activity Level Body Position & Motion 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. 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. 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.

Report from workshop 31 january 2014. selected papers

Business

internet of thingspresentation

healthcare challenges

telemedicine solutions

citizen engagement solutions

health technology

healthcare economics

machine business systems

iot jacob nielsen