UNIversal solutions in TElemedicine Deployment for ... - United4Health

ICT CIP – Competitive and Innovation Programme

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

Document D5.1 IAT Workshop Version 1.0 Work Package:

WP5

Version & Date:

v1.0 / 2nd November 2013

Deliverable type:

Report

Distribution Status:

Public

Author:

Michael Strübin

Reviewed by:

John Oates

Approved by:

Janne Rasmussen

Filename:

D5.1 v1.0 United4Health IAT workshop

Abstract This contains a short summary of the Workshop for regions delivered on 18 th June 2013 in Ljubljana, Slovenia. Presenters included Bridget Moorman on interoperability and Nicole Denjoy on regulatory issues. Michael Strübin facilitated. Key Word List COCIR, Continua Heath Alliance, GSMA, Industry advisory team, interoperability, procurement, technology, telehealth, telemedicine, regulatory issues.

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.

D5.1 IAT Workshop

Executive Summary The "Workshop for regions: Procuring interoperable solutions" took place as part of the second United4Health Project Assembly on 18th June 2013 in Ljubljana, Slovenia, and was delivered to a plenary meeting in the morning over 90 minutes. The IAT workshop provided additional information and analysis of the featured services in terms of their compliance with interoperability and regulatory requirements, and thus served as an initial education tool for regions to assess vendors of telemedicine solutions. The Industry Advisory Team (IAT) also organised a Product Showcase at the same venue with ten vendors of telemedicine solutions presenting their services and products. This report includes in the Appendix B a procurement checklist that the IAT prepared in response to the project's request following the IAT workshop; this was delivered to the project in October 2013.

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Change History Version History: 0.1 25th October 2013 1.0 2nd November 2013

Initial Version Final Version

Version Changes 0.1 Initial version 0.2 Minor changes prior to issue Outstanding Issues None

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Table of Contents EXECUTIVE SUMMARY

2

CHANGE HISTORY

3

TABLE OF CONTENTS

4

1.

INTRODUCTION

5

1.1

Purpose of this document

5

1.2

Glossary

5

INTRODUCTION

6

2.1

Background

6

2.2

Preparations for the workshop

6

2.3

Product showcase

6

WORKSHOP

7

3.1

Dealing with vendors

7

3.2

Interoperability

8

3.3

Regulatory compliance

9

3.4

Reactions and next steps

10

VENDOR SHOWCASE

11

4.1

Showcase preparations

11

4.2

Quick reference guides

12

4.3

Implementation

12

4.4

Reaction to product showcase

13

2.

3.

4.

APPENDIX A – QUICK REFERENCE GUIDE - DIABETES

14

APPENDIX B – PROCUREMENT CHECKLIST

17

APPENDIX C – UNITED4HEALTH PRODUCT SHOWCASE PARTICIPATION GUIDE

21

ANNEX 1 - PRESENTATIONS Figure 1 – Description of Work ............................................................................................... 7 Figure 2 – Suggestion for procurers...................................................................................... 9 Figure 3 – Telehealth scenario with software as medical device ..................................... 10 Figure 4 – Three quick reference guides (excerpt from presentation) ............................ 12

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1.

Introduction

1.1

Purpose of this document This document is a written record of the first deliverable of the Industry Advisory Team: the workshop for regions due in project Month 6. It contains background information and the presentations delivered at the workshop.

1.2

Public

Glossary CHA

Continua Health Alliance, member of the IAT

COCIR

European Coordination Committee of the Radiological Electromedical and Healthcare IT Industry, member of the IAT

CVD

Cardio Vascular Disease

GSMA

GSM Association, member of the IAT

IAT

Industry Advisory Team

IHE

Integrating the Healthcare Enterprise

MDD

Medical Device Directive

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2.

Introduction

2.1

Background The United4Health project is a large scale pilot to trial telemedicine solutions with more than 13,000 patients in 15 regions in Europe, focusing on patients with cardiovascular disease, chronic lung disease and diabetes. The project runs from 2013 to 2015 and is led by NHS Scotland. To solicit and secure advice and support from industry, an Industry Advisory Team (IAT) was formed comprising representatives from the industry associations COCIR, the Continua Health Alliance and GSMA. The IAT will support the project and the participating regions with advice on technology, interoperability and regulatory compliance, and with support on communication and outreach.

2.2

Preparations for the workshop The purpose of the first deliverable, D5.1 "Workshop for regions: Procuring interoperable solutions", was set out in the Description of Work to focus on interoperable solutions. The IAT's intent was to educate and orient representatives from participating regions about the benefits of interoperable solutions, the questions to ask potential vendors, and the options available on the market. Advice would be vendor neutral and unbiased, and delivered by association staff rather than member companies. In the project plan, the workshop was set early in the project to provide this orientation before regions would finish their procurement of telemedicine equipment. In the first meetings of the IAT in February 2013, the IAT determined that the scope of the workshop should be expanded to also provide advice on regulatory compliance, based on the observation that many regions (and even vendors) were not always aware of issues related to clinical liability, privacy and security concerns. The IAT agreed with project leadership on the enlarged scope as well as on making the workshop part of the second Project Assembly scheduled for June 2013 (project Month 6), rather than scheduling the workshop as a stand-alone or virtual event. The workshop is discussed in detail in section 3.

2.3

Product showcase The project leadership agreed with the IAT also on the usefulness of organising a small industry exhibition to further provide examples from the marketplace about state of the art equipment. The IAT designed a "product showcase" (also sometimes referred to as "vendor showcase") with an open invitation to vendors of telemedicine equipment to participate. A few simple rules applied: no big stands, just tables, chairs and rollups; maximum two company staff, a submission to some screening by the IAT. The participation was free of charge for participating companies, while the additional costs were covered by sponsorship. The vendor showcase is discussed in detail in section 4.

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3.

Workshop The workshop took place as part of the 2nd United4Health Project Assembly on 18 June 2013. It followed the opening session and welcomes in the morning, and began with a 30 minute session titled " Industry Advisory Team workshop I: Dealing with vendors " that provided an overview of the Industry Advisory Team and the product showcase. An additional hour was then allocated to the second part of the workshop "Industry Advisory Team workshop II: Interoperability and regulatory compliance". In total the workshop lasted 90 minutes. It took place before a plenary meeting of the Project Assembly, ensuring maximum visibility before the Consortium.

3.1

Dealing with vendors Michael Strübin, European Programme Manager of the Continua Health Alliance and manager of the Industry Advisory Team, gave an overview of the IAT's purpose, members and objectives. He discussed the description of work as well as the internal organisation and division of labour and responsibilities among Continua, COCIR and GSMA.

Figure 1 – Description of Work The IAT includes both the member staff of these industry associations, and selected company representatives that lead the telemedicine or health work groups in their associations. The IAT had convened in monthly phone calls in the preparation for the workshop. Other consultations and preparations had taken place via email. In a second part of his presentation, Michael described the purpose, rationale and organisation of the vendor showcase. A total of ten vendors had set up stands at the beginning of the day in another room of the venue, separated from the assembly meeting, but where all breaks were held. Project Assembly participants were invited to come to the product showcase for the morning coffee break, lunch break, afternoon coffee break as well as for a reception at the end of the day.

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To facilitate interactions with the vendors and to provide some guidance about the products on offer, the IAT had developed three "quick reference guides". A full discussion of these guides can be found in section 4.2. An example of the quick reference guides for diabetes can be found in Appendix A. With this type of guidance, each member in the audience was equipped with a hard copy of the three reference guides before the meeting broke for the coffee break, and to join the vendors for the first time.

3.2

Interoperability After the break, Bridget Moorman, Continua Technical Manager, delivered an overview of interoperability issues and focused on the following elements:  Definition of Interoperability.  Interoperability – Why?.  Interoperability at Interfaces.  Sample HL7 messages with and without data standards.  Continua Architecture.  Acronym definitions.  IHE. She proposed as a definition of interoperability: Interoperability - the ability of a system or a product to work with other systems or products without special effort on the part of the customer. The goal of interoperability is to lower long term cost, including the cost of replacing equipment components. Bridget gave an overview of examples where lack of interoperability created problems, and discussed potential interoperability issues in hardware and software. Buyers that were interested in procuring interoperable equipment had a number of ways to insert such requirements into their procurement documents without running the risk of legal challenges. If there were few or no interoperable solutions in the market, buyers could still use their procurement documents to send a message to the market (see Figure 2).

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Figure 2 – Suggestion for procurers After this discussion of the technical aspects of interoperability, Michael addressed some of the practical issues and the market situation, which suffered from the problem of market adoption: lack of demand for interoperable product led to a scarcity of available products, which then further weakened market demand. He illustrated this dynamic with the story of the USB adoption, which had suffered from a similar stall before the appearance of the iMac created a rush of demand for USB compliant products and the emergence of an open, vendor agnostic eco system. He acknowledged that the eHealth field was currently stuck in a pre-iMac stall, and exhorted the regions in United4Health to use their buying power and behaviour to contribute to standards adoption. The full presentation is available in Annex 1.

3.3

Regulatory compliance Nicole Denjoy, Secretary General of COCIR, discussed a number of regulatory issues affecting telemedicine. She walked the Consortium through a short history of the European regulatory framework, especially related to the medical device directive (MDD) . This was currently being updated, with discussions held at the Committee level of the European Parliament. Other ongoing developments were a green paper on wellness apps being developed by EC's DG CNECT, expected to be presented after the summer 2013; and an international push for the harmonisation of regulations for medical software. How did the MDD apply to telehealth? Nicole clarified that a telehealth solution as a whole did not constitute a medical device, but that individual components might. Similarly, stand alone software could be considered an active medical device. These considerations might present problems for healthcare providers that were seeking to integrate various individual devices that build new functionalities and may present new risks. Nicole urged healthcare providers in the United4Health project to ensure that their chosen systems had elements in compliance with regulations where appropriate.

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Figure 3 – Telehealth scenario with software as medical device Nicole finally discussed the data protection regulation, and highlighted the activities of the healthcare coalition on data protection that, under COCIR's leadership, had voiced common concerns among a number of stakeholder organisations with some of the elements that were being considered. Her full presentation is available in Annex 1.

3.4

Reactions and next steps In the Q&A session, it was noted that if regulations on medical devices included software; this would impose a responsibility on United4Health partners to demand good software development methodology. If regulations required end-to-end certification of telehealth systems, this might pose problems. It was suggested that United4Health pilots might monitor regulatory developments with a view to potentially intervene with the European institutions. Following the workshop and discussions, the project requested that the IAT prepare a checklist for procurers to assist the United4Health regions in producing equipment in lined with the IAT's recommendations. The IAT agrees to this request. Because of the summer and the intense and consultative process, the development and delivery of the checklist was delayed until October 2013. The full checklist can be found in Appendix B.

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4.

Vendor Showcase The Vendor Showcase was not part of the workshop, nor was it a formal deliverable. It was, however, an example of the contribution that the Industry Advisory Team could bring to the project, by bringing some of the latest available telemedicine products to the project's attention, while providing added information and guidance regarding these solutions’ compliance with interoperability and regulatory requirements.

4.1

Showcase preparations The proposal for the showcase came from the project management, which invited the IAT to deliver an industry exhibition in February. Bridget Moorman, who was engaged in a research effort to map the regions’ intentions, inquired also about the intention of regions to procure telemedicine equipment. Few were planning to do so. Nevertheless, the IAT decided in their 22 nd March 2013 meeting to proceed with organising an industry exhibition. A "save the date" notice was disseminated among Continua, COCIR and GSMA membership in mid-April. The IAT developed a showcase guide that laid down the rationale, the timelines and the conditions for participation in the showcase. Because of the uncertain commitment of regions to buy, the IAT was careful to manage expectations and be transparent in written and oral communications that this showcase might not lead to contracts, but was an opportunity to interact with a key target group and to build relationships that might pay off later. The showcase guide included a questionnaire that participating organisations were asked to complete: the results served as the basis of the quick reference guides (see below section 4.2). To cover the additional expense of the showcase (extra room, extra food and beverages, additional internet passes), the IAT briefly considered charging a fee for participation, but in the end determined to seek financial contributions through a sponsorship package. Two levels of sponsorship, gold (€ 1,000) and silver (€ 500) entitled companies to additional recognition, visibility and access including logos on slides and participation in the informal project dinner on the evening of 18th June in the Ljubljana castle. The full product showcase guide is in Appendix C. In the end, ten companies participated in the showcase:  Intel-GE Care Innovations (Gold sponsor).  T-Systems (Gold sponsor).  Health Insight Solutions (Silver sponsor).  Acute Technology/Brunel University.  AIT Austrian Institute of Technology.  BodyTel Europe GmbH.  Bosch.  Medvivo.  Modz.  S3 Group. There was a good diversity of some well known market leaders as well as small and medium sized enterprises and equipment developed as part of academic research initiatives. Most vendors had affiliations with one or more IAT member associations, though a few did not.

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4.2

Quick reference guides In the Showcase guide, participating vendors were asked to complete a questionnaire discussing technical and regulatory elements of the equipment they were intending to show. Bridget Moorman analysed this information and developed three quick reference guides. Each reference guide, one each for of CVD, COPD and diabetes, lists vendors' products and solutions and discusses the type of telemonitoring devices, the data gateway, the different website views for clinicians/social workers/family, and an assessment of their compliance with standards and regulations. An example of the guides is provided in Appendix A.

Figure 4 – Three quick reference guides (excerpt from presentation) As part of the IAT workshop on 18 th June, each participant received a printed copy of the reference guides. The intent was to educate participants to properly assess the equipment in the showcase in terms of their meeting interoperability and regulatory requirements. Bridget discussed the structure and format of the guides immediately preceding the first coffee break when they would enter the showcase for the first time.

4.3

Implementation The showcase took place in a separate room of the meeting venue. Participating vendors were not allowed to access the project meeting, but all food and drinks were served in showcase room. Thus the principal opportunities for interactions on 19th June 2013 were:  The morning coffee break (30 minutes).  The lunch break (60 minutes).  The afternoon coffee break (30 minutes).  The (sponsored) evening reception. The IAT managers (Michael and Bridget) met all vendors in the morning of the exhibition and allocated the spaces. They also periodically liaised with vendors, posed questions, occasionally made introductions, and solved problems liaising with the hotel staff.

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The Showcase ended around 19:00 with the end of the reception and with consortium members getting ready for the Consortium dinner in Ljubljana castle. Gold and silver sponsors were invited to join. While gold sponsors had been promised a speaking opportunity at the dinner, it was agreed on site that the acoustic conditions were not conducive, and all parties agreed to not exercise this opportunity. The sponsorship fees were invoiced by the Grand Hotel Union and served to defray the meeting cost to the project. No funds went through the IAT or its member associations.

4.4

Reaction to product showcase All participants – Consortium and vendors – were queried for feedback: an email was sent to all vendors, and the Consortium was queried both onsite and after the event. The vendor feedback was mixed but overall positive. Some complained that the Consortium members did not show much interest in their products. Others said they had excellent interactions. It did appear that those vendors who engaged with Consortium members and approached individuals seemed more successful than those that stayed behind their tables waiting for Consortium members to approach them. Feedback from the Consortium was overall positive. George Crooks, project coordinator, called it a "useful exercise" and others echoed that sentiment. The separation between vendors and the Consortium meeting was appreciated, although it was also observed that some vendors could have brought substantial expertise in chronic disease management to the discussions about clinical protocols.

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Appendix A – Quick reference guide - Diabetes Clinical architecture for diabetes

Vendor showcase supported by:

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Diabetes Quick Reference Guide to U4H Vendor Showcase All Vendors have applications and/or web based portals at the server and regional health centre which aggregate/filter and analyse the data. Vendor

Telemonitoring Devices

Gateway

Clinicians/Social Workers/Family

Standards/Regulatory

ACUTE TECHNOLOGY/BRUNEL UNIVERSITY www.acutetechnology.com Hydra remote monitoring platform

No – will interoperate with Continua compliant devices, specifically Philips and A&D scales (weight)-glucometer (glucose) from Lifescan

Hydra Gateway; ZigBee networking protocol in home; GSM/GPRS WAN telecommunications to server

Separate clinician, patient and carer web portals available

Devices- IEEE 11073, Continua and ZigBee certified; Gateway- Continua and ZigBee certified and IHE-PCD01 compliant/in process of receiving CE marking/27 EU countries

AIT AUSTRIAN INSTITUTE OF TECHNOLOGY Diabmemory: www.diabmemory.at

Partner with A&D for scale (weight), Lifescan (One Touch Ultra II) for Glucometer; also partner with TAGnology

Smartphones with Android OS (2.3 or higher ) and NFC for networking interface to medical devices; GSM/GPRS for interface to server

Separate clinician, patient and carer web portal views available

NFC for medical device/mobile phone interface; will migrate to Continua Guidelines using NFC and REST; communicate with third party systems (health information systems, professional software for doctor offices) by means of HL7 messages/Medical Devices are MDD 93/42/EEC and IVD 98/79/EC for glucometer/available as a product on the market but as a customized solution being used in a proof-of-concept in Austria–willing to work with other EU countries.

BODYTEL BodyTel Mobile App: https://secure.bodytel.com/en/ products/bodytel-system/bodytelmobile-android.html BodyTel Center: https://secure.bodytel.com/ en/products/bodytelsystem/bodytel-center.html

GlucoTel (glucometer with Bluetooth); WeightTel (body weight)

Bluetooth for devices interface to Android OS Phone (Mobile App); GSM/GPRS/Wi-Fi for Android Phone to Server

Accessible by whomever patient designates

Continua Certification in process-IHE between BodyTel Center and Third Party backend/CE Medical - MDD 93/42/EEC also IVD 98/79/EC for glucometer/Medical Devices-Germany, Netherlands, Turkey, Italy/ BodyTel Center 27 EU countries

BOSCH HEALTHCARE Telehealth – Health Buddy/Telehealth Plus http://www.boschtelehealth.co.uk/en/uk/products_2/ health_buddy_2/health_buddy.ht ml

Scales (WS 3000 BT) (weight), partners with various glucometers manufacturers (USB, serial and Infrared)

Configured patient interface box which uses physical (USB, serial) and Bluetooth and infrared connected medical devices for home; POTS, ISDN, GSM/GPRS, Ethernet for internet access

Primarily for clinicians

Scale is Continua compliant with Bluetooth– other devices to follow; devices rely upon IEEE 11073 data standard/optional xml-based interface to hospital information systems/ MDD 93/42/EEC class IIa/Germany, UK, Netherlands

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Vendor

Telemonitoring Devices

Gateway

Clinicians/Social Workers/Family

Standards/Regulatory

HEALTH INSIGHT SOLUTIONS HIS Santigo Call, Care and Portal

Cignus Glucometer; IEM Scale

Mobile Android OS Device (2.3 or higher) with Bluetooth (3.0 or higher); GSM/GPRS/WiFi to server; UMTS for video chat


xML messaging standard for all interfaces/ Medical Devices are MDD 93/42/EEC/27 EU Countries

INTEL-GE CARE INNOVATIONS Guide; Guide Client; Guide Virtual Care Suite; Guide Data Bridge http://www.careinnovations.com/u k/products/guide-diseasemanagement

Patient needs to provide from approved list: Wired glucometer; wired or Bluetooth scale (weight)

Software loaded Intel-GE tablet device; POTS, GSM or WiFi

Separate clinician, patient and carer views of Guide application

HL7 2.5 ORU and HL7 3.0 CCD/ MDD 93/42/EEC/UK, Ireland, Italy and the Netherlands

MEDVIVO HomePod

A&D Bluetooth scale (weight); patient enters by hand glucometer information (no current glucometer integration listed)

Software loaded on tablet device; 3G, GPRS; also mobile version requires Android OS device


MDD 93/42/EEC, Class I/UK

MODZ www.modz.fi

Mobile glucometer with embedded GSM 2G radio

Glucometer also functions as gateway


IVD 98/79/EC for glucometer/in product development phase; will launch later this year

S3 GROUPHealthy Citizen, www.healthycitizen.co.uk

No – must integrate with sensor and gateway vendors

No – must integrate with sensor and gateway vendors


No/No/27 EU countries

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Appendix B – Procurement checklist A.

Standards and Interoperability

1.

Networks/Connectivity: How do your sensors connect with the data hub? Tick all that apply. Physical connectivity ☐ USB ☐ DB9 ☐ DB22 ☐ Other (proprietary): Wireless connectivity ☐ IrDa (which version): ☐ NFC (which version): ☐ Bluetooth (which version and profile implemented): ☐ Zigbee (which version): ☐ Wifi (which version): ☐ Mobile eg GSM (which version/generation): Other connectivity ☐ Publicly Switched Telephone Network ☐ Other (proprietary network protocol) Comments

2.

Data/Messaging Standards Does your device comply/use the following standards? Tick all that apply. IEEE 11073 ☐ Yes

☐ No

☐ N/A

If yes: which standards? (ex: 20601, PHD (please list all)

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HL7 (Health Level 7) ☐ Yes

☐No

☐N/A

If yes: which version (2.x, 3.0)? Which document (CDA, CCD)? Other standard nomenclature ☐ LOINC ☐ SNOMED ☐Other (please identify) Comments

3.

Guidelines/Profiles Have your devices been certified or issued conformance to the following: Continua Guidelines ☐ Yes

☐No

☐N/A

☐No

☐N/A

If yes: which guidelines version? Which interface? (PAN/ LAN/ AHD/ WAN/ HRN) Which device (weight scale, blood pressure cuff, etc.)? IHE profiles ☐ Yes If yes: which profiles?

B.

Regulatory, Legal, Information Integrity, Security and Privacy

4.

Does your system (or modules of your system, or software component) qualify as a medical device1? ☐ Yes

☐No

☐N/A

If yes: which elements and which class of those elements? 1

Please refer either to MDD 93/42/EEC; MEDDEV 2.1/6 Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices. Go to http://bit.ly/1g3SZU1

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If yes: provide declaration of conformity with essential principles of safety & performance.

5.

Patient Data Security: How does your system and service comply with the European and local legislation on data privacy concerning patient information?

6.

Has your organisation performed a risk assessment of your system as part of the development cycle (e.g. compliance to ISO 14971)? ☐ Yes

☐No

☐N/A

If no, provide a rationale:

7.

Do you have a process in place to monitor and track anomalies or incidents generated by your system ☐ Yes

☐No

☐N/A

If no, provide a rationale:

C.

Additional Questions (Optional)

8.

Is your organisation certified according to Information Security Standards, for example ISO / IEC 27001? ☐ Yes

☐ No

If yes: provide certificate of compliance:

9.

Is your organisation certified according to QM Standards, for example ISO 13485? ☐ Yes

☐ No

If yes: provide certificate of compliance:

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10.

Who takes over system responsibility (ensuring all components work together)? Tick all that apply. ☐ Your organisation

☐ Healthcare providers

☐ Original manufacturer(s)

☐ User

☐ Yes ☐ Other (explain)

11.

Who carries liability for the individual components? ☐ Your organisation

☐ Healthcare providers

☐ Original manufacturer(s)

☐ User

☐ Yes ☐ Other (explain)

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Appendix C – United4Health Product showcase Participation guide 18 June 2013, Grand Hotel Union Business, Ljubljana, Slovenia United4Health (U4H) is a partially EC-funded large scale pilot to support and test the deployment of telemedicine (aka telehealth) services. Between 2013 and 2015 the project will trial and deploy telemonitoring solutions for diabetes, COPD and CHF in 15 regions with 13,000 patients. The consortium will meet for the second time on 18/19 June 2013 in Ljubljana, Slovenia, and has asked the Industry Advisory Team to invite interested companies to present relevant technical solutions at this meeting in a one day U4H Product Showcase on Tuesday, 18 June 2013. The showcase is a good opportunity for vendors of telemedicine products and services to meet clinical and policy representatives of a number of regions that have a documented interest in implementing these solutions. Two caveats should be noted:  It is not clear whether, or which, U4H regions will actually procure telemonitoring solutions. Rather, this is an opportunity to educate potential buyers about your products and develop contacts and relationships.  The U4H consortium meeting is devoted to internal project management and is closed to participants in the product showcase. Interactions with members of the consortium will be possible in the breaks and after the end of the meeting. Your participation will help educate the consortium about market offerings in the field of telemedicine and telehealth, and contribute to showing the industry’s vital interest in, and significant contribution to, the success of United4Health. The following pages contain:  Information about the product showcase (conditions, practicalities, sponsorship, contact).  Project details (background, consortium, trials and service architectures, and compliance).  The Showcase product questionnaire (and explanations).

Timelines By 20 May 2013 confirm your participation by contacting [email protected] with (1) name of company and of individuals (max 2 per company) who will come and (2) and your interest in sponsoring (sponsorship opportunities will be allocated on a first come, first serve basis). By 31 May 2013 send your completed product questionnaire (in annex of this document) for each product(s)/service(s) that you would like to showcase to [email protected].

Conditions The IAT would like to invite interested companies to participate in this product showcase. The conditions:  The product showcase will run for one day, on Tuesday, 18 June 2013, in parallel to the U4H consortium meeting. The consortium meeting will not be open to vendors, Public

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however, vendors can meet consortium members in two half hour coffee breaks, a one hour lunch break, and after the end of the meeting foreseen at 17.30. (Coffee and lunch breaks will be held near the stands.)  Participation will be limited to fifteen (15) vendors. If there are more interested companies, preference will be given to companies that are members of one of the IAT member associations (Continua, COCIR, GSMA) and/or are compliant with interoperability and regulatory requirements. Remaining companies will be waitlisted.  There will be no costs or fees, although the IAT has created sponsorship opportunities to support the breaks and consortium dinner (see below).  Participation will be limited to companies that offer relevant product and services in Europe.  Companies should send no more than two representatives.  Spaces will be allocated onsite on 18 June 2013 at 8.00. Sponsors will have first choice (gold, then silver), then first come first serve.  Each participating company will receive a table, two chairs and room for a rollup or two. They are encouraged to bring merchandise, collateral and possible demos. Electricity will be provided. Internet may have to be contracted with the hotel.  IAT representatives Michael Strübin and Bridget Moorman are the principal agents of the Showcase. Please follow their instructions onsite. For questions or any special technical needs (including internet) please contact Michael (contact details below.) The project cannot provide financial support for participants in the product showcase.

Practicalities The consortium meeting and the product showcase will take place in the GRAND HOTEL UNION Miklošičeva 3 1000 Ljubljana Slovenija T: +386 1 308 1899 F: +386 1 308 1914 W: http://www.gh-union.si Participants are invited and encouraged to book rooms in the Grand Hotel Union at the rate of € 84/night at the following link: http://booking.ihotelier.com/istay/istay.jsp?groupID=1026377&hotelID=76847

Sponsorship To defray the additional cost of the product showcase and to fund the meeting breaks that drive the consortium to the showcase and encourage interaction, the IAT offers a few sponsorship packages to showcase participants.

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Name Amount Gold

Silver

Number

Practical details

Benefits

€ 1,000 Up to three

Covers rent of the hotel meeting room, and partially funds coffee and lunch breaks and consortium dinner

Acknowledgement (“supported by”) in all showcase-related communications. Participation for up to two company representatives in the consortium dinner. Opportunity to address the consortium dinner for up to 5 minutes per company.

€ 500 Up to five

Pays for own dinner and subsidises consortium dinner

Participation for up to two company representatives in the consortium dinner.

The consortium has asked the IAT to limit vendor participation in the consortium dinner, therefore no more sponsorships will be allocated. Allocation of sponsorships will be strictly on a first come, first serve basis: send your email to Michael Strübin. The IAT will not become involved with the financial transaction but will facilitate direct payment to either the hotel or the caterer. All payments have to be completed one week before the showcase. Non-payment may result in exclusion from the showcase or dinner.

IAT Contact The U4H Industry Advisory Team (“IAT”) is composed of Continua Health Alliance, COCIR and the GSMA, and is led by the Continua. The principal contact people are;  Michael Strübin, Programme Manager Europe, [email protected] or +32 498 520044.  Bridget Moorman, Technical Manager Europe, [email protected]. Michael and Bridget will also be onsite in Ljubljana, beginning on Monday, 17 June 2013 at 18.00. At COCIR and GSMA your points of contact are:  Anna Campbell, [email protected]  Marie-Astrid Libert, [email protected]

The United4Health Project Introduction The United4Health telemedicine large scale pilot is led by NHS24 (Scotland) and will last until December 2015. It is organised into three multicentre trials with common inclusion and exclusion criteria for participants within each of them, plus one monocentre (France) for hypertension screening and monitoring. (The showcase will focus only on the multicentre trials).

The consortium The consortium includes the following organisations:  National/Regional Authorities with the budgetary responsibility for healthcare. Public

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– – – – – – – –

NHS24 (Scotland - UK) Basque country (ES) NHS Wales (Wales - UK) Regione Campania (IT - without EU funding) Regione Calabria (IT - without EU funding) Regione Sicilia (IT - as an observer) Galicia (ES - without EU funding) Hellenic Ministry of Administration Reform and E-Governance (GR)

 Regional Authorities belonging to the RENEWING HEALTH Consortium – Regione del Veneto (IT) – Region Syddanmark (DK) – South Karelia Social and Health Care District (FI) – Thessaly & Stereas (GR)  Healthcare providers – General Hospital Slovenj Gradec (SI) – Health Centre of Ravne na Koroskem (SI) – Palacky University, Olomouc (CZ) – Jean-Paul II Hospital (PL) – Sørlandet sykehus Helseforetak (NO) – Vigisanté (FR) – Pflegewerk (DE – RENEWING HEALTH partner) – Ministère des affaires sociales et de la santé (FR)

The trials The trials will include more than 13,000 patients in fifteen trials, per the following table:

Not all regions have expressed an interest in purchasing new equipment; however all have expressed interest in learning more about what is on the market.

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What is needed? Each of the clinical data workflow depictions below will be mandatory for the pilots. For each of the chronic diseases being monitored, there will a baseline set of physiological measurements required from the patients as well as communication between the patients and clinicians. The method for data transmission can be that which is most reliable and appropriate in that pilot’s region for the patient home, regional telecenter and healthcare system, and could be WiFi, GSM (mobile phone telecommunications) or other means (phone service). Diabetes In the case of Diabetes, the basic requirement for monitoring will be to measure a patient’s glucose with a glucometer at the specified intervals as per the clinical protocol. This information will then need to be transmitted via a gateway device to a regional telecenter. The telecenter will act as an aggregator and communicator between the patient and healthcare system. In addition to the glucose information, an alarm indicator will be given to the patient for the management and communication (bi-directional) of an alarm situation for any situation which warrants an immediate response.

Service architecture for diabetes Chronic Obstructive Pulmonary Disease In the case of Chronic Obstructive Pulmonary Disease (COPD), the basic requirement for monitoring will be to measure a patient’s pulse oximetry as well as their airflow characteristics with a spirometer. The communication requirement for COPD is different from Diabetes and CHF in that a video-teleconferencing capability will be required into the patient home to ‘coach’ patients when they are using the spirometer. As in Diabetes and CHF, an alarm indicator will also be given to the patient for the management and communication (bi-directional) of an alarm situation. As the clinician will be interacting directly with the patient during coaching, a telecenter aggregation and communication may not be necessary.

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Service architecture for chronic obstructive pulmonary disease (COPD) Congestive Heart Failure In the case of Congestive Heart Failure (CHF), the basic requirement for monitoring will be to measure a patient’s heart rate, pulse-oximetry, blood pressure, weight and 1-lead electrocardiograph at specified intervals as per the clinical protocol. As in the case of Diabetes, an alarm indicator will also be given to the patient for the management and communication (bi-directional) of an alarm situation. Again, a telecenter will act as an aggregator and communicator between the patient and the healthcare system.

Service architecture for congestive heart failure

Compliance The Industry Advisory Team (IAT) advises the consortium to give preference to those products and services that are compliant with relevant technical interoperability standards and guidelines, and that meet relevant legal and regulatory requirements.

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To allow the IAT to make these determinations, vendors are asked to discuss their products in the questionnaire in the appendix to this document. At the consortium meeting in Ljubljana, the IAT will educate the consortium about the principles of interoperability and regulatory compliance, and help the consortium identify those products and services that meet these criteria. Interoperability It is in the interest of the pilot sites to use standards-based equipment as much as possible. While some vendors may wish to provide an end-to-end solution, some pilot sites will require that at least the final interface to their healthcare systems adhere to Continua and IHE guidelines regarding data, messaging and security/privacy requirements. Moreover, some of the pilot sites may prefer medical devices, gateways and aggregation services to adhere to standards cited in the Continua and IHE guidelines. Specific information regarding the Continua and IHE guidelines can be accessed at:  Continua: http://www.continuaalliance.org/products/design-guidelines  IHE: http://www.ihe-europe.net/ (for specific European information) and http://www.ihe.net/profiles/index.cfm (listing of profiles which identify standards used at interfaces) Additionally, you may contact the Industry Advisory Board Technical Manager, Bridget Moorman, [email protected] for more information.

Regulatory Components of TeleHealth solutions are a Medical Device (Article 1 of Directive 93/42/EEC) when they meet the definition of a Medical Device (e.g. blood pressure monitor or software if performing an action on data different from storage, archival, lossless compression, communication or simple search but treating data such as creating or modifying information). Definition “Medical Device” means any instrument, apparatus, application, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human being for the purpose of:  Diagnosis, prevention, monitoring, treatment or alleviation of disease  Diagnosis, monitoring, treatment, alleviation of or compensation for any injury or handicap  Investigation, replacement or modification of the anatomy or of a physiological process,  Control or conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. Other relevant Guidelines EC Guidelines on standalone software. MEDDEV 2.1/6 of January 2012.

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Introduction: recital 6 of Directive 2007/47/EC. Software in its own right, when specifically intended by the manufacturer to be used for one or more medical purposes set out in the definition of a medical device, is a medical device. The manufacturer is responsible for defining:  Intended use  Specifications and boundaries of the device The manufacturer shall ensure:  That adequate functionality and performance supporting the claim of intended (medical) purpose  That patient safety is considered in the risk management process The Manufacturer shall present:  An evaluation showing that the performance of the product actually meets the medical purpose. When several products (medical and non-medical) form an interconnected system (e.g. a TeleHealth solution), they may create new functionality (intended or not intended), and new risks may occur. A manufacturer can define to only market separate medical and non-medical modules, by defining the module limits and dependencies. The question however will be - how to describe overall clinical performance and risks in combined systems. Alternatively manufacturers (system integrators or customers) can take a system approach and CE-mark medical and non-medical modules together. For more information on regulatory compliance please contact Marie-Astrid Libert at [email protected].

Product Questionnaire The trials section lists the service architecture models required for each clinical use case. In order to better prepare the consortium for the showcase, we ask all showcase participants to answer the following set of questions for each product. 1)

What’s the name of your product? (Please include a website link if applicable.)

2)

For what clinical use case does your product provide service (Diabetes, COPD, CHF)?

3)

Where does it fit within the geographical and functional areas in the use case architecture?

4)

Over what portions of the use case is your product integrated?

5)

For each of your products, what data standards or certification have you obtained?

6)

What are the hardware and software requirements?

7)

What are the infrastructure requirements?

8)

Are there any specific power requirements?

9)

What is the “Intended Use” of your TeleHealth product or module?

10) Is your module / software component registered as a Medical Device, in accord with MDD 93/42/EEC? Public

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11) Have you elected to take overall system responsibility for your TeleHealth offering? 12) If you are providing individual components of a TeleHealth solution, who will take responsibility for the “Interconnected Solution”? 13) In which country/region in Europe is your product on the market?

Questionnaire Explanations Each of the questions refers to specifics regarding the product. If the product spans several of the geographical and functional areas depicted in the use cases, please answer the question for each of those geographical and functional areas. The example statements are usually one specific instance of the question. For 3) Where does it fit within the geographical and functional areas in the architecture? For example, you may offer a blood pressure measurement device for use in the patient home; or you may offer the database/aggregation capability at a regional eHealth Centre; or you may offer the gateway product for the home. For 4) Over what portions of the use case is your product integrated? For example, you may offer an integrated product which provides physiological monitoring for CHF to the home gateway Regional eHealth Centre interface; or you may offer an integrated product which provides physiological monitoring, alarm monitoring, a regional aggregation along with clinical personnel intervention as well as message filtering to the Healthcare enterprise interface. For 5) For each of your products, what data standards or certification have you obtained? For example, your medical device may be Continua certified; or your Regional eHealth Centre product may output the information adhering to an IHE protocol for interface to the Healthcare enterprise; please show at each interface where the standards are applied. For 6) What are the hardware and software requirements? For example, what type of handset or computer is required in the Home or regional eHealth Centre environment? What type of software is required on the hardware? For 7) What are the infrastructure requirements? For one example, what type of telecommunications presence is required in the patient home (GSM, WI-FI, POTS, other); is there a minimum bandwidth requirement for use of your product? (for example for the COPD use case, since video-teleconferencing is desired, the bandwidth for effective communication would be more than that for a simple medical device data transfer) Also, for an alarm signal, is a communication prioritisation schema or dedicated communication presence required and what type do you require? For 13) In which country/region in Europe is your product on the market? Feel free to say here “all EU 27” or specify the countries. Of specific relevance of course will be the countries in the United4Health (see section “about the trials).

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