ICT CIP – Competitive and Innovation Programme

UNIversal solutions in TElemedicine Deployment for European HEALTH care (Grant Agreement No 325215)

Document D4.3 Annex 3 UPAB meeting Brussels, 9th April 2015 Version 1

United4Health User Policy Advisory Board meeting: “Cardiac conditions: provisional policy messages”

Report from meeting Monday, 9th April, 2015 Rue de Trèves 49-51, B-1040 Brussels, Belgium

This board meeting was hosted thanks to the European Respiratory Society office in Brussels, Belgium. Vitor TEIXEIRA was present on behalf of the Society.

Work Package: WP4 Version & Date: v1 / 9th April 2015 Distribution Status: Confidential Authors: Julie Bjerregaerd (EWMA) Filename: 07113e10fcd606a1e7f84c9b1e65e0fb.doc

The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user thereof uses the information at its sole risk and liability. D4.3 Annex 3 UPAB meeting Brussels, 9th April 2015

Table of Contents

TABLE OF CONTENTS 2

1. OVERVIEW 3

2. INTRODUCTION TO THE PURPOSE OF THE BOARD AND THE PROJECT 4

3. EVIDENCE GATHERING ON DIFFERENT BUSINESS PERSPECTIVES (SESSION 1) 5 3.1 CORDIVA - A large-scale eHealth programme with evidence of benefits by Christian KLOSS (Gesellschaft für Patientenhilfe, Germany), presented on his behalf by Stephan SCHUG, EHTEL 5 3.2 Implantable Cardiac Devices by Jannis RADELOFF, Manager Reimbursement (St. Jude Medical EMEA Headquarters, Brussels) 6 3.3 Evidence from Renewing Health on telemonitoring of chronic heart failure by Silvia MANCIN (Arsenal IT, Italy) 6 3.4 First steps in monitoring the various chronic conditions in U4H by Panos STAFYLOS (HIM SA) 7

4. EXPLORING A CASE THROUGH THE BUSINESS MODEL CANVAS (SESSION 2) 9

5. TRANSFORMING EVIDENCE INTO POLICY MESSAGES (SESSION 3) 10

6. PLANNING NEXT STEPS (SESSION 4) 11 6.1 EWMA 11 6.2 European Respiratory Society 11 6.3 United4Health Project Assembly and the project’s annual technical review 12 6.4 Next U4H UPAB meeting and next steps 12

APPENDIX A: TRANSFORMING EVIDENCE INTO POLICY MESSAGES 13

APPENDIX B: OBSERVATIONS, IDEAS AND QUESTIONS POSED ON SPECIFIC TOPICS BY ATTENDEES 17

APPENDIX C: AGENDA 19

APPENDIX D: ATTENDEES AND APOLOGIES 21

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1. Overview

The meeting was divided into four sessions during which presentations were made on:  Evidence gathering on different business perspectives (Session 1).  Exploring a case through the business model canvas (Session 2).  Transforming evidence into policy messages (Session 3).  Planning next steps (Session 4).

Each presentation is written up in three ways: by, first, by highlighting its main findings; second, identifying any main lessons learned (these details are included in Appendix 1 to this document) which can be considered as potential policy messages; and, third, listing the main United4Health user policy advisory board questions or observations (these details are included in Appendix 2).

A preliminary effort has been made to transform the “lessons learned” concepts into tentative recommendations. The Board’s second deliverable, entitled D4.3 User policy advisory board: Final feedback, to be produced by the Board members, will work in more detail on the transformation of messages into recommendations.

All the relevant presenters’ PowerPoints have been made available to the board members, with one exception.1

The four action points arising from the meeting were:  The European Respiratory Society could be asked to look at the United4Health toolkit for clinicians and see how far it could advantage of it. Any observations on the toolkit could be included in a lessons learned section of United4Health’s work.  Other societies, such as CPME or UEMS, could be approached to see if they are interested in giving their input to/on the toolkit.  The next United4Health user policy advisory board meeting will be held on Monday 6 July, 2015.  The board management team should develop a “to do” list of actions that the board needs to undertake to reach its goal of an acceptable final deliverable by end November 2015. These activities will be discussed provisionally at the next board meeting.

1 See the presentation of Dr Jannis RADELOFF, St Jude’s Medical.

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2. Introduction to the purpose of the board and the project

The aim of the United4Health user policy advisory board is to feed the wider community with policy-oriented messages. To facilitate this, the board intends – in future – to examine a set of lessons learned produced by the project.

The overall aim of this workshop was to explore what could potentially be formulated as some main policy messages, to be highlighted – where possible – from a user-oriented perspective, related to cardiac conditions. The messages were extracted not only from the work done so far in United4Health, but also from other initiatives and projects. The user representatives involved in giving their feedback included health professionals, patients, and other client groups.

Particular effort is to be made by the board to highlight tools and methods that can be helpful in bridging any gaps in service re-design. In the case of this meeting, the focus was on the business model canvas produced by Alex Osterwalder and colleagues: https://strategyzer.com/canvas.

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3. Evidence gathering on different business perspectives (Session 1)

This session consisted of five presentations.

The presentations focused on findings on cardiac condition applications that had been tested previously in the Renewing Health project http://www.renewinghealth.eu, and in three other cardiac-related initiatives that involved technologies. In contrast to the order in which the presentations were made in the actual meeting, in this report they are ordered in priority of: the two external sites presented, the Renewing Health presentation, and the United4Health presentation.

The board members were given an update on the status of the United4Health project http://united4health.eu, specifically vis-à-vis patient recruitment (see section 3.4).

The presentations illustrated a number of key messages. For example: It is feasible for pilots to produce evidence about a variety of benefits (such as clinical, organisational and cost-related benefits) of using telehealth with cardiac condition patients. As a result, that evidence can be used to introduce routine care applications in real-life settings with large numbers of patients (i.e., in some cases, up to 30,000 people). The underpinning health systems, and their legal/regulatory systems can, however, on occasions in particular countries be problematic in terms of the difficulties with the wider deployment of telehealth. In the specific case of cardiac conditions, the context of statutory insurance schemes may have an effect on how easy telehealth is to apply in certain countries/regions. In research terms, there are advantages and disadvantages to conducting telehealth randomised controlled trials. Patient recruitment into studies can also be a challenging process. The United4Health project is itself currently facing a number of challenges specific to patient recruitment.

3.1 CORDIVA - A large-scale eHealth programme with evidence of benefits by Christian KLOSS (Gesellschaft für Patientenhilfe, Germany), presented on his behalf by Stephan SCHUG, EHT EL

This presentation focused on an overview of chronic heart failure in Europe, and the fact that the CORDIVA system is used in routine care with around 30,000 patients. It also looked at a number of important issues. These included the way in which: the CORDIVA system was tested, and showed positive results, during the 2011-2013 time-period; and the fact that an external evaluation was undertaken on the study findings by academics from the University of Greifswald in Germany. A large and sophisticated matched-control study took place (that won a prize in Germany) and showed huge benefits to the programme. However, criticism exists since no full randomised controlled trials took place. Hence, the case also demonstrates some of the hurdles that exist in relation to the provision of public evidence to support policy- making with regard to telehealth in Europe.

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Concluding discussions indicated that:  There are benefits to establishing a commonly agreed methodology that can help evaluate complex eHealth interventions.  There could be benefits to easing the administrative/regulatory processes that payers must comply with when they run/use eHealth technologies.

3.2 Implantable Cardiac Devices by Jannis RADELOFF, Manager R eimbursement (St. Jude Medical EMEA Headquarters, Bruss els)

This presentation described an implantable device intended for phase 3 chronic health failure patients, that automatically provides measurements of the health status of the patients. Some of the test results of the use of this implantable device have already been published. The studies conducted on the device show that it is important to identify where the use of telehealth is most important in the treatment/care process, i.e., at what stage of the care pathway.

A number of the questions posed to Jannis RADELOFF were clarificatory in character, particularly with regard to: the evidence provided; the reactions of patients and healthcare professionals; the way in which business cases are approached in St. Jude Medical; and expectations with regard to the final study results. The discussion highlighted the international, European, national and regional questions surrounding telehealth; the organisational and legal aspects of telehealth; difficulties related to incentivisation; and the implications of introducing technologies in countries where statutory health insurance funds operate.

Concluding discussions indicated that:  Potentially, the description of the process of researching/investigating this device could provide a good example for of how a study of incentivisation is needed with regard to the encouragement of the use of telehealth devices by different groups of stakeholders.

3.3 Evidence from Renewing Health on telemonitoring of chronic heart failure by Silvia MANCIN (Arsenal IT, Italy)

Silvia MANCIN first highlighted the main outcomes of the Renewing Health pilot in relation to cardiac conditions. She did so in terms of financing; patient satisfaction; and the effects of the application on caregivers. She included in this exploration the main technology directions taken by the Veneto Region and other general outcomes.2 Later, she explained how the Veneto Region of Italy had used Alex OSTERWALDER’s business model canvas3 during the course of the Renewing Health project.

Concluding discussions showed that:  This presentation provided a useful introduction to this meeting’s coverage of business models (explained in Section 3 of these notes).

2 These findings have been captured in the final report of Renewing Health and in D4.1 of the United4Health user policy advisory board. 3 https://strategyzer.com/canvas.

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3.4 First steps in monitoring the various chronic conditions in U4 H by Panos STAFYLOS (HIM SA)

The main focus of this presentation was on the process of patient recruitment in United4Health, and the lessons learned about this process.

The United4Health study has been designed to enable the stratification of patients in different ways according to e.g., their co-morbidities and their age. By the time the project is completed, it should be possible to evaluate whether the services that have been tested are cost-effective for some groups of patients, and not for others. (This issue, reported in the United4Health D4.1 Initial User Feedback, is considered to be particularly important by the United4health user policy advisory board members.)

In United4Health, there is no comparison group. Instead, the results from the patients can be compared with past data. It is anticipated that this data will be valuable for regions that are making decisions about whether to move forward on implementing the services tested. By December 2015, United4Health should be able – in the project’s final report – to present the relevant economic and organisational results. (The user policy advisory board members look forward to reading these results, even in draft.)

United4Health is, however, experiencing difficulties in attracting patients to be recruited into the studies that it is conducting.

Patient recruitment challenges: The recruitment of patients started 6-12 months late in many of the regions participating in the project.

As a result, the specific challenges that have affected patient recruitment have also involved time delays in:  Procuring technological devices (with prices that are too high for the pilot sites).  Arranging contracts with the healthcare facilities to recruit patients.

Counterbalancing activities: Specific actions to resolve these recruitment problems, and the delays on the sites, and hence in the project, have been taken:  The United4Health research protocols were made more open (by extending the patient inclusion criteria).  One-on-one assistance was given to pilot sites with low recruitment.  Patients were offered flyers with relevant information (so as to communicate to them more effectively the benefits of the United4Health studies).  The pilot sites were recommended to engage additional healthcare organisations, and not simply the original ones.

Guidance for the management of heart failure: In conclusion, it was noted that the European Society of Cardiology will publish a revised version of its guidelines for the management of heart failure in 2016. Based on the currently available evidence, it seems that the messages on telemonitoring will be made stronger than they were previously written up: http://www.escardio.org/Guidelines-&-Education/Clinical- Practice-Guidelines/Acute-and-Chronic-Heart-Failure

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Concluding discussions indicated that:  Much of the focus of the United4Health project is now on lessons learned. These lessons will be shared among the project partners, and eventually others. These lessons could be transformed into recommendations (see, the examples that have arisen simply from this meeting’s board discussion).

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4. Exploring a case through the business model canvas (Session 2)

There is a clear relationship between this presentation and presentation 2.3 by Silvia MANCIN on the use of business canvas modelling by the Veneto Region in Renewing Health.

Tino MARTI presented in theory and practice the business canvas model explored by Alex Osterwalder and colleagues in their two books Business model generation and Value proposition design: https://strategyzer.com/books.

The arguments for using the business model canvas in the eHealth/telehealth field are that it provides a structured approach and tool/method that:  Introduces stakeholders to the actors, organisational elements, types of costs involved in making a business case (e.g., for telehealth).  Enables people to learn to speak the same (business) “language”.  Enables stakeholders to experiment (“play”) with business-related ideas.  Identifies what “problems” customers have that need to be resolved, and how a service provider can offer its customers specific added-value.  Includes all the necessary details about the business value chain. To talk about reimbursement, as an example, is not enough. Instead, one must specify the reimbursement of particular items or activities, and identify whether the proposed business model supports the items/actions that need to be reimbursed.

Specifically, using the model provides evidence that:  Diverse stakeholders have different ways of reasoning in terms of e.g., what brings them value.  There can be different business models.  The choice to be made is ultimately about which particular business model to select, and for whom.  The different services proposed, based on different business models, can be both beneficial or innovative.

Concluding discussions showed that:  The potential use of the business model canvas was well received by the Board members. They could see the tool’s utility. Additional observations/ideas on the canvas are captured in Appendix B.4.

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5. Transforming evidence into policy messages (Session 3)

Initial feedback from the United4Health user policy advisory board members was gathered about the main policy messages they foresaw as deriving from the project. Wherever possible, the suggestions made have been modified so that they no longer have the status simply of observations, but could be used as tentative recommendations.

The current list is located in Appendix 1 of this document. The items contained in those notes concentrate on potential recommendations related to: recommendations for policy-makers; macro level recommendations; cultural readiness; local settings; older people’s concerns; patients and patient stratification; technology concerns; and the use of such tools as the business model canvas.

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6. Planning next steps (Session 4)

Four specific items were discussed: wound care management; respiratory diseases; the May 6/7, 2015 United4Health project assembly; and the next steps for the user policy advisory board. These items are reported on directly below.

6.1 EWMA

As part of its work in United4Health, the European Wound Management Association (EWMA) has developed a framework that targets “non-believing” clinicians: see http://ewma.org/english/ewma-activities/ehealth-in-wound-care.html and http://ewma.org/fileadmin/user_upload/EWMA/images/logos/Projects/D2.4_v1.0_Uni ted4Health_Dissemination_tool_kit_targeting_clinicians.pdf.

A conference symposium, dedicated to eHealth in wound care, has been designed for wound care healthcare professionals. It was held on May 14/15th 2015 in the framework of the conference programme of a traditional scientific society. See the eHealth symposium programme at: http://www.ewma2015.org/scientific/ehealth- symposium.html.4

By trialling such an approach, it is hoped that the method could act as an example framework that could be adopted by other healthcare professional societies.

Concluding discussions implied that:  The European Respiratory Society could be asked to look at the toolkit and see how far it could advantage of it. Any observations on the toolkit could be included in a lessons learned section of United4Health’s work.  Other societies, such as CPME or UEMS, could be approached to see if they are interested in giving their input to/on the toolkit.

6.2 European Respiratory Society

The European Respiratory Society is the leading medical society in its field. It has 20,000 members. It is deeply involved in education, science and advocacy in the field of respiratory conditions. The society has recently signed a Memorandum of Understanding with the World Health Organization on eHealth/mHealth and the use of these technologies with tuberculosis and tobacco. More specifically, the agreement targets the development of various apps to deal with tobacco smoking cessation and care of tuberculosis patients.

Similarly to EWMA, the subject of eHealth was included in the European Respiratory Society presidential summit on Personalising Respiratory Care in Europe in Brussels on June 16/17, 2015: http://www.ersnet.org/congresses/research- seminars/item/4953-ers-summit-2015.html. Up to 100 attendees attended.

4 An attendee feedback survey was conducted after the event. The general audience feedback appears to have been very positive.

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6.3 United4Health Project Assembly and the project’s annual tech nical review

The project assembly was held in Santiago de Compostela, Galicia, Spain on May 6/7th, 2015. Much of this meeting focused on lessons learned, care pathways, and appropriate legal and regulatory conditions for the introduction of eHealth/telehealth.

For much of June 2015, the United4Health consortium has been in the process of assessing the feedback it received from the European Commission/reviewers at its March 2015 annual technical review.

6.4 Next U4H UPAB meeting and next steps

The group discussed briefly various longer-term means of making these Board meetings more self-sustaining and more continuous, i.e., a group that can develop healthcare recommendations. This challenge will be discussed in other board meetings later in 2015.

Members present felt that the board could benefit from being even more multi- stakeholder-oriented. They found that having both non-governmental organisation policy advisors and actual doers (people involved in the telehealth field) present in meetings is very useful.

Concluding discussions agreed that:  The next United4Health user policy advisory board meeting would be held towards end June/beginning July 2015. The date was set for Monday 6th July, 2015.  The board management team should develop a “to do” list of actions that the board needs to undertake to reach its goal of an acceptable final deliverable by end November 2015. These activities will be discussed provisionally at the next board meeting.

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Appendix A: Transforming evidence into policy messages

The user policy advisory board members made some very specific observations about the objectives of any policy messages.

When developing recommendations/outcomes (e.g., in reports) of the United4Health project for policy-makers  Be clear about who needs the study results of United4Health as a basis for their decision making, and what findings they need precisely.  More generally, consider this aspect of who needs what also when designing telehealth initiatives, studies or projects. Specifically, as an example, from the perspective of a region, how does that region deal with the complex situation of large-scale deployment?

The initial feedback on potential policy messages emerging from United4Health – listed below – was extracted from a plenary round table that sought the main messages/observations made by the board members themselves. These individual messages have later been classified into categories. (Some of these categories are not restricted to the United4Health project and its study sites, but are about eHealth/telehealth in general.)

Specific questions posed by the board members with regard to cardiac conditions are included in Appendix B.

The eight categories of potential policy messages are: 1. Mainstreaming and scaling-up. 2. The macro (or systems) level. 3. Cultural readiness. 4. Local settings. 5. Older people’s concerns. 6. Patients and patient stratification. 7. Technology concerns. 8. Tools that can be helpful in bridging gaps on service re-design (e.g., the business model canvas).

A.1 Mainstreaming and scaling-up  Pay attention to mainstreaming (i.e., service redesign and change management) when preparing any policy action on eHealth and/or telehealth.  Bear in mind messages like: “Mainstreaming eHealth into routine care has proven to be more challenging than expected. ... People are still discussing the same (old) things, i.e. there is still too much focus on technology.”  Collect lessons learned throughout the development of any project (and specifically, in the United4Health initiative).

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 Improve the way in which all studies are conducted so as to increase the value of their results.  Match together the “healthcare mind set” and the “business case mind set”.

A.2 Macro (i.e., systems) level  Consider the wide variety of healthcare systems, and adapt the specific process to the particular healthcare system (examples that were suggested to be explored included Belgium, Netherlands, and the various national health services in the United Kingdom).  Develop a complete system around the proposed eHealth solution, and consider bringing the “whole system” forward.5  Take into consideration, when studies are developed, that patients are changing, technologies are changing, and the whole target is moving.6  Create cross-sectoral collaboration around the integration of services and devices.  Focus on the fact that telehealth provides a big step forward in terms of the personalisation of care: it enables healthcare professionals to check their patients’ status more easily and regularly.  Identify why certain services and products succeed. (For example, answer the question: Why is telehealth challenging, when teleradiology is not? Is it because the business model for teleradiology was more effective or more obvious i.e., companies earn an income by providing scans?)  Avoid a “one size fits all” approach.  Avoid situations in which an “old organisation + new technology = costly organisation”.

A.3 Cultural readiness7

Observation: While people want to change, their cultural readiness varies. In some countries people do not have the technological basis and background to use eHealth easily (see also section 7 on Technology Concerns).  Study the culture of the setting before trying to set up a new (health or care) system (i.e., adapting the system to the existing structure will facilitate large-scale deployment).  Elaborate more recommendations on the need for cultural change and individual adaption.  Develop, and use, tools for identifying the perspectives/needs of the different stakeholders.

5 The CALLIOPE model, developed in collaboration with stakeholders in 2008-2010, could be useful here: http://ec.europa.eu/information_society/apps/projects/factsheet/index.cfm?project_ref=224986. 6 E.g., No specific evidence for this was cited, but it was commented that people aged under 40 are probably more inclined to use smart technologies and mobile technologies than those who are above e.g., 70. 7 Here, it was mentioned that such tools as MOMENTUM, TREAT and the business model canvas devised by Alex Osterwalder can be of particular use.

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 Show that initiatives/projects are beneficial and cost-effective in the long run, also once a pilot project’s funding has ended.  Apply all the aspects to telemedicine that are usually applied to medicine.  Focus on data protection as well as data exchange. (Given the expected changes in the General Data Protection Regulation in 2015/2016: http://ec.europa.eu/justice/data-protection/, there may be more harmonisation of data protection systems in Europe in the future.)8

A.4 Local settings  Identify local benefits as well as local problems. Think not only at the national level, but also at the (local) organisational level.  Do not always think too big! The telemedicine domain could be “more humble”. I.e., Making “small steps” towards improving healthcare systems can also be a good, relevant approach.  Remember that hospitals are complex environments, and each hospital department is a complicated environment too.9 (For example, while the Veneto Region showed its willingness to invest in telehealth, there were other open issues that – as a region – it needed to resolve in order to scale up the system.)  Pilots, e.g., United4Health pilot sites, have only offered preliminary answers to questions so far. The picture eventually needs to be placed in an even more complex situation (e.g., integrated care).  Choose appropriate technology that is well proven.  Do not underestimate the time needed for technology procurement (i.e., commissioning) or for the deployment process itself.

A.5 Older people’s concerns

Observation: Take into account older people’s responses and patient responses earlier in the design process of the initiative/project. More specifically:  Focus on independent care and independent living.  Focus on integrated care.  Take users’ voices into account.  Consider that patients are end-users/customers, and must be central to any study design.  Involve patients in the study/research from the initial planning phase.  Take into account the fact that older people often appreciate face-to- face care.

8 See also recent work by CPME on data protection. 9 E.g., There may even be conflicts between university hospital departments (e.g., radiology and information technology).

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A.6 Patients and patient stratification  Identify the lessons learned on the need for patient stratification, and the link between the targeted population and the service offered. (I.e., With regard to chronic heart failure, some services are relevant for just a small proportion of the patient population.)  Remember that patient stratification is needed to provide each patient group with the best care in the most efficient way.  Include the evaluation of patient stratification as a standard part of studies. (It is important to identify exactly what patient groups will benefit from which treatment/technology, and which will not.)

A.7 Technology concerns

Observation: Technology concerns still remain e.g., about broadband and infrastructure. Therefore, readiness generally can be about what infrastructure and technologies are available (nationally; locally).  Develop certain technologies further e.g., fibre connectivity, broadband and infrastructure. (There are enormous differences between availability in particular countries e.g., between Portugal and Sweden. The amounts invested in connectivity are noticeably different in the various countries in Europe.)  Choose appropriate technology solutions. Examples cited included: a pulsometer finger-clip for people with COPD may set off lots of false alarms; Wifi does not necessarily work in hospitals.  It is not just about technology availability, it is also about the perceptions of individuals.

A.8 Tools that can be helpful in bridging gaps on service re-design (e.g., the Business Model Canvas)

Advantages: Advantages of the business model canvas tool perceived by the workshop attendees included that:  Using the business model canvas10 can be a useful technique for opening up wider organisational and financial questions to stakeholders.  Users can work through the model before they start to use it.  The tool can help highlight the gaps between episodic care and continuous care i.e., patients will not feel alone; they will be accompanied at any time; they will be monitored for a given period (e.g., one year); they will be supported in their health-related learning.  The tool can enable a healthcare service to develop a response (to its customers/clients) that is continuous in character e.g., is based on improved adherence and compliance.  The tool can be used at the hospital level.

Challenges: Challenges implicit in the tool involve:

10 https://strategyzer.com/canvas

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 Working out the cost structure of the service.  The customer concept is complex, especially because patients are very often not the direct payers for the services that they receive.

Other observations about the business model canvas are located in Appendix B.5.

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Appendix B: Observations, ideas and questions posed on specific topics by attendees

Specific observations with regard to the United4Health project cardiac conditions’ sites, and the project in general, are included in this Appendix.

B.1 Questions on implantable devices (St. Jude’s)  What was the resulting evidence with regard to improved quality of life on the part of patients?  Did patient compliance prove to be a challenge?  Which (healthcare) professionals chose the particular device e.g., was it cardiologists or pharmacists?  When will the study/project results be available?  Can a two-year comparison of the case be made e.g., as in the U4H project?  At what level of assessment (e.g., international, national, regional or on the basis of specific stakeholders) does St. Jude make its business case(s))?

B.2 Possible eventual observations and/or recommendations (St. Jude’s)  A more comprehensive (“global”) organisational picture is needed of the devices used in this trial and in other pilots.  Telehealth implementation in Europe remains at the level of the Member State(s).  The implications of new eHealth legislation and (professional) codes in Germany need a more in-depth examination.  Many professional associations (e.g., representing doctors) continue to be involved in protection of their members’ rights.  The organisational and management issues around the devices introduced are important (e.g., more/less staff may be needed when robots are introduced).  The types of incentives that are needed to encourage use of the devices at the level of both the region and stakeholders need investigation.  Statutory health insurance funds need to see the perceived benefits of the technologies (i.e., in this particular case, the payers do not yet see the benefits to the hospitals or to the clinicians).

B.3 Questions on the Renewing Health project

All the questions posed by user policy advisory board members were clarificatory in nature. They focused on healthcare staff training; patient enrolment; the status of current assessment of the Renewing Health project results; and methodological issues. Specific questions included:

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 Did the pilot focus on integrated care or some other form of health or care?  Did the pilot take into account the measure of reduced (or increased) mortality of the patients as a result of the technology introduction?  How was training provided to healthcare staff? Which types of devices were used with the patients?  What types of patients were enrolled in the pilot?  When will the Renewing Health randomised control trials' results be published?  Is the application tested by the Veneto Region now being applied in practice as a result of the pilot exercise?

B.4 Discussion and possible eventual recommendations on/to Uni ted4Health / cardiac conditions  Identify healthcare members of staff who are good at engaging with patients.  Bear in mind that patients may trust some types of healthcare professionals more than others.  Identify early potential proposals for solving typical patient recruitment difficulties e.g., related to engaging healthcare facilities as well as patients.  Do not underestimate the time needed for procurement of the technologies.  Adopt lessons learned on patient recruitment and absorb them into the United4Health project and into future initiatives and projects.  Involve patient organisations in the development of the services and studies/projects.  Involve local patient groups and healthcare groups in United4Health.

B.5 Discussion and possible eventual recommendations on the bu siness model canvas  Should we stop talking about business models (which may “give the wrong idea”)? Or should we instead talk about economic models or care models?  Should we eventually try to build a business model for three stakeholder types e.g., for patients, for clinicians and for healthcare providers? Then, see how these three models can be matched with each other.  Should we focus on e.g., the levels of patient benefits and workforce benefits?

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Appendix C: Agenda

United4Health User Policy Advisory Board: “Cardiac conditions: provisional policy messages.” ARRIVALS: 9:30 - 9:45 CET AGENDA: 9:45 CET - 16:30 CET Hosted thanks to the European Respiratory Society, Rue de Trèves 49-51, B-1040 Brussels, Belgium, Elevator A, 4th floor, Metro station: Maelbeck. In case of difficulties: Diane WHITEHOUSE (00 32 496 29 59 32) 9 30 - 9 45: Arrivals.

9 45 - 9 50 Welcome - Diane WHITEHOUSE (EHTEL, Belgium) and Vitor TEIXEIRA (European Respiratory Society, Switzerland).

9 50 - 10 05 A "re-introduction" to United4Health. Marc LANGE, U4H user policy advisory board management team (EHTEL, Belgium).

10 10 - 13 00 EVIDENCE-GATHERING ON DIFFERENT BUSINESS PERSPECTIVES Chair: Stephan SCHUG (EHTEL, Belgium) Each presentation will be followed by a 15-minute discussion session. The purpose is to help us transform what we hear/learn from the presenters on business perspectives (including business models and modelling) so as to be able to transform them, later in the day, into the beginnings of potential policy messages.

10 05 - 10 25 Evidence from Renewing Health on telemonitoring of chronic heart failure: Silvia MANCIN (Arsenal IT, Italy).

10 40 - 11 00 First steps in monitoring the various chronic conditions in United4Health - an overview: Panos STAFYLAS (HIM SA, Brussels).

11 15 - 11 35 Evidence regarding chronic heart failure telemonitoring in Germany: Dr Neeltje VAN DEN BERG (Greifswald/Community Medicine). 11 50 - 12 10 Implantable Cardiac Devices. Jannis RADELOFF, Manager Reimbursement - Market Access & Public Affairs (St. Jude Medical EMEA Headquarters, Brussels). 12 25 - 12 45 Current practice of Chronic Heart Failure telemonitoring from Ithaca/Badalona. Tino MARTI (TicSalut, Spain).

13 00 - 13 30 BRIEF SANDWICH LUNCH

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13 30 - 14 15 AN EXERCISE: EXPLORING A BUSINESS CASE THROUGH BUSINESS CANVAS MODELLING Chair: Diane WHITEHOUSE (EHTEL, Belgium) Everyone gets to explore how the business canvas model can help people to look in more detail at business models in the field of telemonitoring of cardiac conditions. A facilitated exercise using Alex Osterwalder's Business Canvas Model led by Tino MARTI (TicSalut, Spain).

14 15 - 14 30 BREAK

14 30 - 15 30 TRANSFORMING EVIDENCE INTO POLICY MESSAGES Chair: Diane WHITEHOUSE (EHTEL, Belgium) A round table discussion – and collation – of all the relevant main policy messages derived from business models/modelling in the field of telemonitoring of cardiac conditions (All - patients, clinicians and other end-users).

15 30 - 16 30 "BRIDGING THE GAPS" Chair: Marc LANGE (EHTEL, Belgium) This final session of the day will enable us to capture some quick snapshots of efforts being made to bridge gaps that exist inside and outside the United4Health project. Examples include the U4H project assembly, the Industry Advisory Team, and various end-user groups (e.g., health professionals especially involved with respiratory conditions and with wound care).

15 30 - 15 40 (including discussion) The role of the United4Health Project Assembly. Marc LANGE (EHTEL, Belgium). 15 40 - 15 50 (including discussion) Respiratory conditions and eHealth. Vitor TEIXEIRA (European Respiratory Society, Switzerland). 15 50 - 16 00 (including discussion) European Wound Management Association: a toolkit for clinicians. Julie BJERREGAERD (EWMA, Denmark). 16 00 - 16 10 (including discussion) Next steps: United4Health user policy advisory board meetings in 2015. Diane WHITEHOUSE (EHTEL, Belgium). 16 10 - 16 30 Wrap-up and conclusions - Marc LANGE and Diane WHITEHOUSE (EHTEL, Belgium).

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Appendix D: Attendees and apologies

S.1 Attendees:  Borja ARRUE ASTRAIN, AGE Platform Europe, Belgium  Walter ATZIORI, European Patients Forum, Belgium  Silvia BOTTARO, HOPE, Belgium  Julie BJERREGAERD, European Wound Management Association, Denmark  Giuseppe DI CARLO, European Federation of Allergy and Airways Diseases Patients' Associations, Belgium  Marc LANGE, EHTEL, Belgium  Jessica CARRENO LAURO, AIM, Belgium  Laurent LOUETTE, European Heart Network, Belgium (morning only)  Bernard MAILLET (Dr), CPME, Belgium  Stephan SCHUG, EHTEL, Belgium (from Germany)  Vitor TEIXEIRA, European Respiratory Society, Switzerland (Brussels office)  Diane WHITEHOUSE, EHTEL, Belgium (from the UK).

D.2 Speakers:  Silvia MANCIN, Arsenal, Italy  Tino MARTI, Barcelona, Spain  Jannis RADELOFF, St. Jude Medical EMEA Headquarters, Brussels, Belgium (from Germany)  Panos STAFYLAS, HIM SA, Belgium (GoToMeeting, from Greece).

D.3 Apologies:  Maeve BARRY, European Respiratory Society, Switzerland  Lise CARRATALA, UEMS, Belgium (UEMS Council, 9-11 April)  Bertrand DUVAL, UEMS, Belgium (UEMS Council, 9-11 April)  Catherine HARTMANN, European COPD Coalition (ECC), Belgium  Rachelle KAYE, AIM, Belgium  Christian KLOSS (Gesellschaft für Patientenhilfe, Germany)  Anna KOTSEVA, AQuAS, Spain  Line BASSE LAURSEN, RSD, Denmark  Myriam LEGOFF PRONOST, France  Magdalena MACHALSKA, AEIP - The European Association of Paritarian Institutions, Belgium  Sascha MARSCHANG, EPHA, Belgium  Johanna PACEVIUS - AER, France  Janne RASMUSSEN, NHS 24, Scotland  Michael STRUEBIN, Industry Advisory Team, Belgium  [Speaker] Dr Neeltje VAN DEN BERG, Greifswald/Community Medicine

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 Christina WANSCHER, Renewing Health, RSD, Denmark  Barry WOOD, European Respiratory Society, Switzerland.

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