Strategic Intelligence Monitor on Personal Health Systems (SIMPHS) Market Structure and Innovation Dynamics Authors: Fabienne Abadie, Cristiano Codagnone, Marc van Lieshout, Corina Pascu, Peter Baum, Anssi Hoikkanen, Jose-Antonio Valverde, Ioannis Maghiros EUR 24669 EN - 2011 The mission of the JRC-IPTS is to provide customer-driven support to the EU policy-making process by developing science-based responses to policy challenges that have both a socio-economic as well as a scientific/technological dimension. European Commission Joint Research Centre Institute for Prospective Technological Studies Contact information Address: Edificio Expo. c/ Inca Garcilaso, 3. E-41092 Seville (Spain) E-mail: CONTENTS EXECUTIVE SUMMARY ................................................................................................................................................ 7 PART ONE: EXECUTIVE REPORT ............................................................................................................................ 11 1 INTRODUCTION................................................................................................................................................... 11 1.1 BACKGROUND .................................................................................................................................................. 11 1.2 KEY CONCEPTS ................................................................................................................................................. 12 1.3 SCOPE AND STRUCTURE OF THIS REPORT .......................................................................................................... 15 2 HEALTH CARE CHALLENGES AND NEEDS: HOW CAN RMT CONTRIBUTE? ................................... 17 2.1 THE BIG PICTURE .............................................................................................................................................. 17 2.2 THE RISING CHRONIC DISEASES BURDEN........................................................................................................... 19 2.3 RMT CAN CLEARLY HELP................................................................................................................................. 26 3 RMT DEPLOYMENT: THE OBVIOUS IS NOT YET HAPPENING.............................................................. 29 3.1 WHAT DO MARKET DATA REVEAL?................................................................................................................... 30 3.2 RMT MARKET PLAYERS ................................................................................................................................... 32 3.3 R&D, PILOTS AND PROGRAMMES ..................................................................................................................... 36 3.4 EUROPE VS. US MARKET TRENDS ..................................................................................................................... 39 3.5 SUMMARISING THE EVIDENCE .......................................................................................................................... 41 4 EVIDENCE ON RMT OUTCOMES AND THE POTENTIAL OF HIGHER DEPLOYMENT.................... 43 4.1 THE IMPORTANCE OF EVIDENCE ON OUTCOMES................................................................................................ 43 4.2 EVIDENCE ON CLINICAL AND COST-EFFECTIVENESS OUTCOMES: SELECTED EXAMPLES.................................... 45 4.3 ASSUMING EVIDENCE HAS CONVINCED STAKEHOLDERS: WHAT IF … ............................................................... 48 5 BARRIERS TO INNOVATION AND WAYS TO OVERCOME THEM ......................................................... 57 5.1 BARRIERS: VIEWS FROM THE FIELD................................................................................................................... 57 5.2 INNOVATION DYNAMICS WITHIN A COMPLEX ECOSYSTEM PERSPECTIVE .......................................................... 60 5.3 CONCLUSIVE RECOMMENDATIONS ................................................................................................................... 66 PART TWO: ANNEXES ................................................................................................................................................. 69 6 ANNEX I: INNOVATIVE ACTIVITIES IN RMT.............................................................................................. 69 6.1 SCOPING OF RESEARCH..................................................................................................................................... 69 6.2 ANALYSIS OF EU-FUNDED ACTIVITIES ............................................................................................................. 69 6.3 ANALYSIS OF PILOTS AND PROGRAMMES.......................................................................................................... 73 6.4 LESSONS ON INNOVATIVE ACTIVITIES............................................................................................................... 80 6.5 ROLE OF PILOTS AND PROJECTS IN SPURRING INNOVATION DYNAMICS ............................................................. 81 6.6 OVERVIEW OF RMT RELATED PROJECTS AND PILOTS IN THE EU..................................................................... 85 6.6.1 EU-funded projects ..................................................................................................................................... 85 6.6.2 Overview of pilots in European Member States.......................................................................................... 95 7 ANNEX II: RMT COMPANY ANALYSIS ........................................................................................................ 101 7.1 INTRODUCTION............................................................................................................................................... 101 7.1.1 A two step approach.................................................................................................................................. 101 7.1.2 50+ companies: selection criteria, benefits, and limits of the approach .................................................. 102 7.1.3 General overview of findings .................................................................................................................... 103 7.2 COMPANIES REVIEW: A SNAPSHOT OF THE PHS MARKET ............................................................................... 104 7.3 ANALYSIS OF THE EVIDENCE FROM THE FIELD ON COMPANY STRATEGIES, THE RMT/PHS MARKET CONDITIONS AND THEIR LIKELY IMPACTS.......................................................................................................................................... 110 7.4 50+ COMPANY LIST AND COMPANY PROFILES ................................................................................................ 123 8 ANNEX III: SUMMARY OF COUNTRY REPORTS ...................................................................................... 133 8.1 STUDY DESIGN AND RELIABILITY ................................................................................................................... 133 8.2 CHRONIC CARE MODEL AND DISRUPTIVE INNOVATION.................................................................................. 134 1 8.3 NATIONAL FRAMEWORKS FOR RMT............................................................................................................... 136 8.3.1 Health reforms are the norm – not the exception...................................................................................... 136 8.3.2 Reimbursing health outcomes – incentives for integrated care ................................................................ 136 8.3.3 RMT/PHS market – Innovation dynamics................................................................................................. 137 8.3.4 Embedding RMT into care processes – integrating patient data .............................................................. 138 8.3.5 Creating awareness and evidence............................................................................................................. 139 8.3.6 Standards, innovation cycles and need for integration............................................................................. 140 8.4 SUMMARY OF COUNTRY FINDINGS ................................................................................................................. 141 8.4.1 French RMT market summary .................................................................................................................. 141 8.4.2 German RMT market summary................................................................................................................. 142 8.4.3 Italian RMT market summary ................................................................................................................... 143 8.4.4 Dutch RMT market summary .................................................................................................................... 144 8.4.5 Swedish RMT market summary................................................................................................................. 145 8.4.6 The UK RMT Market ................................................................................................................................ 146 8.5 FINAL CONCLUSIONS ...................................................................................................................................... 148 8.6 INTERVIEW QUESTIONNAIRE........................................................................................................................... 149 8.7 STAKEHOLDERS INTERVIEWED ....................................................................................................................... 150 9 ANNEX IV: HEALTH-RELATED DATA AND SCIENTIFIC EVIDENCE ................................................. 153 9.1 PREVALENCE DATA ........................................................................................................................................ 153 9.1.1 Cardiovascular diseases ........................................................................................................................... 153 9.1.2 Diabetes .................................................................................................................................................... 155 9.1.3 COPD........................................................................................................................................................ 159 9.2 CLINICAL METRICS (COSTS) ............................................................................................................................ 160 9.2.1 Cost of CVD .............................................................................................................................................. 160 9.2.2 Cost for Diabetes ...................................................................................................................................... 164 9.2.3 Cost of COPD ........................................................................................................................................... 166 9.3 SCIENTIFIC EVIDENCE ON RMT FOR HEART CONDITIONS .............................................................................. 167 9.4 SCIENTIFIC EVIDENCE ON RMT FOR DIABETES.............................................................................................. 174 9.5 SCIENTIFIC EVIDENCE ON RMT FOR COPD ................................................................................................... 180 9.6 SCIENTIFIC EVIDENCE ON RMT FOR MULTI-DISEASE CONDITIONS ................................................................ 183 10 ANNEX V: PATENT ANALYSIS ....................................................................................................................... 189 10.1 INTRODUCTION............................................................................................................................................... 189 10.2 METHODOLOGY.............................................................................................................................................. 189 10.3 PATENT ANALYSIS – MAIN FINDINGS .............................................................................................................. 190 10.3.1 Main trends .......................................................................................................................................... 190 10.3.2 Content analysis of the patents............................................................................................................. 191 10.4 LIMITATIONS OF OUR APPROACH .................................................................................................................... 194 10.4.1 Conclusions on content ........................................................................................................................ 194 10.4.2 Conclusions on the methodology.......................................................................................................... 194 10.4.3 Next steps ............................................................................................................................................. 195 10.5 FULL DESCRIPTION OF THE METHODOLOGY USED FOR THE PATENT ANALYSIS ............................................... 195 2 List of Acronyms Acronym/ Term Description ACP American College of Physicians ADAC German Automobile Asociation B2B2C Business to Business to Customer BDOC Bed Days of Care; number of days of hospital stay; measure used to measure the average length of stay BKK Betriebskrankenkasse- German Company Health Insurance Fund CAGR Compound Annual Growth Rate CCHT Care Coordination/Home Telehealth CCM Chronic Care Management or Chronic Care Model CHA Continua Health Alliance. CHF Chronic Heart Failure CKD Chronic Kidney Disease CIS Clinical Information System CIP Competitiveness and Innovation Framework Programme CNR "Comité National Recherche", "Consiglio Nazionale di Ricerca"; French or Italian Research Committee COPD Chronic Obstructive Pulmonary Disease CORDIS The Community Research and Development Information Service CSCI Commission for Social Care Inspection CSO Clinical Systems Organisers CVD Cardiovascular Diseases CVIS Cardiology Information and Image Management Systems DALY Disability-Adjusted Life Year DM Diabetes Melitus DRG Diagnosis Related Group: payment categories that are used to classify patients for the purpose of reimbursing hospital expenses. DHSSPS U.K. Department of Health, Social services and Public Safety ECG Electrocardiogram or Electrocardiography ECCH Northern Ireland's Connected Health and Care strategy EHR Electronic Health Record EMR Electronic Medical Records EPO European Patent Office GDP Gross Domestic Product HBT Home Based Telemanagement HHH Home or Hospital in Heart Failure Study HTA Health Technology Assessment – i.e. the systematic evaluation of properties, effects, and/or impacts of health care technology. ICI information and communication infrastructure ICP Integrated Care Pilots ID International Dolar IDF International Diabetes Federation IGT Impaired Glucose Tolerance IHC Imunohistochemistry IHD Ischemic Heart Disease IHIN Integrated regional/national Health Information networks IPC International Patent Classification 3 IZIT Implementatie-organisatie voor innovatie van de zorg met behulp van ICT - Dutch acronym for Innovation in Healthcare IT KOALA "Kijken op afstand als logisch alternatief" = Dutch Telemedicine/ Telecare large-scale project (http://www.koalaweb.nl/) LFS Labour Force Survey LIS Laboratory Information Systems LMI Lead Market Initiative LTC Long-Term-Care MCU Mobile Care Unit MHC Monitoring Health Conditions MRI Magnetic Resonance Imaging MS Multiple Sclerosis MUD Medical User Devices NAHCH United States National Association for Home Care and Hospice NIC Non-Institutional Care NHS National Health Service (UK) OTN The Ontario Telemedicine Network PACS Picture Archiving and Communications System PDA Personal Digital Assistant PHS Personal Health Systems PPP Purchasing power parity PTSD Posttraumatic Stress Disorder QALY Quality Adjusted Life Years QOF Quality of Outcomes Framework R&D Research and Development RCT Randomised Clinical Trial: clinical trials in which the patient group is at random divided in two, only one given the new treatment. RMT Remote Patient Monitoring and Treatment ROI Return On Investment SI System Integration SCI Spinal Cord Injury SIMPHS Strategic Intelligence Monitoring of Personal Health Systems SME Small and Medium Enterprise TA Tele Assistance TDP Scottish Telecare Development Programme UCDC Ubiquitous Chronic Disease Care USSL Italian Local Socio-Health Unit VHA The Veterans Health Administration VDE Verband der Elektrotechnik, German Association for Electrical, Electronic and Information Technologies VTT Valtion Teknillinen Tutkimuskeskus Technical Research Centre of Finland WIPO World Intellectual Property Organization WSD Whole System Demonstrator WHO World Health Organisation WoHIT08 World of Health IT 2008 conference ZIF Zorg (Health) Innovatie Forum 4 LIST OF FIGURES Figure 1 – Constituent elements of eHealth.........................................................................................13 Figure 2 – Old age dependency, EU25, 2004-2051 (different population scenarios) .........................18 Figure 3 – Map of COPD prevalence in Europe..................................................................................22 Figure 4 – The Health Pyramid and different categories of chronic patients ......................................27 Figure 5 – eHealth adoption in six Member States..............................................................................29 Figure 6 – Orders of magnitude: the “invisible” European RMT market............................................31 Figure 7 – Companies’ offering (200+ companies).............................................................................32 Figure 8 – RMT Companies’ value chain (50 selected companies) ....................................................34 Figure 9 – RMT and telecare activities in three Italian regions...........................................................38 Figure 10 – Home Medical Monitoring market value by segment (world 2008-2013).......................40 Figure 11 – RMT market/expenditure potential growth: CHF segment only......................................50 Figure 12 – RMT potential expenditure and benefits: CHF segment only (four scenarios)................51 Figure 13 – Traditional S-Shaped innovation and diffusion curve......................................................60 Figure 14 – Disruptive innovations of health care professions and institutions ..................................61 Figure 15 – RMT ecosystem: snapshot................................................................................................64 Figure 16 – The vicious circle that needs to be broken .......................................................................65 Figure 17 – Examples of closed loop approaches................................................................................83 Figure 18 – Company size vs. years in business................................................................................104 Figure 19 – RMT companies and technology focus ..........................................................................105 Figure 20 – RMT companies and service focus.................................................................................106 Figure 21 – Company size vs. solution extent ...................................................................................106 Figure 22 – Company size vs. solution type offered .........................................................................107 Figure 23 – Company size vs. health condition addressed ................................................................108 Figure 24 – Years in business vs. solution offered ............................................................................108 Figure 25 – Diversity of activities indicator per health condition .....................................................109 Figure 26 – Diversity of activities indicator vs. company size..........................................................110 Figure 27 – Overview of the Chronic Care Model ............................................................................134 Figure 28 – Age-standardised DALYs rate for CHD, stroke and other CVD ...................................155 Figure 29 – Mortality (SDR) from COPD per 100,000, total in EU-27 in 2003 ...............................160 Figure 30 – Health care costs of CVD, by country, 2006, EU ..........................................................162 Figures 31 and 32– Cost of Cardiovascular diseases.........................................................................163 Figures 33 – Cost for ambulatory care in selected European countries related to Diabetes..............165 Figures 34 – Cost for hospitalisation in selected European countries related to Diabetes ................166 Figure 35 – Distribution of patents over chronic diseases.................................................................191 Figure 36 – Distribution of patents over services and technologies ..................................................192 Figure 37 – Patent applications in RMT technology and RMT services...........................................193 Figure 38 – User interface for patent search at Patentscope..............................................................197 LIST OF TABLES Table 1 – PHS definition......................................................................................................................14 Table 2 – RMT definition ....................................................................................................................14 Table 3 – Diabetes prevalence in the EU27.........................................................................................21 Table 4 – Examples of cost calculations of COPD..............................................................................23 Table 5 – Health care costs of cardiovascular diseases .......................................................................24 Table 6 – Chronic heart failure: UK evidence on prevalence and costs ..............................................25 Table 7 – Telecare a seismic revolution ..............................................................................................28 Table 8 – VHA CCHT success case ....................................................................................................46 5 Table 9 – Data, benchmarks and assumptions used in the extrapolations ...........................................53 Table 10 – Type of incentives adopted to boost adoption of ICT in health care .................................67 Table 11 – Overview of EU-funded activities .....................................................................................70 Table 12 – Multi-site trials and validations (examples).......................................................................72 Table 13 – EU-funded projects ............................................................................................................87 Table 14 – Pilots ..................................................................................................................................96 Table 15 – List of the 50+ companies................................................................................................123 Table 16 – France country study, main findings................................................................................141 Table 17 – Germany country study, main findings............................................................................142 Table 18 – Italy country study, main findings ...................................................................................143 Table 19 – Netherlands country study, main findings .......................................................................144 Table 20 – Sweden country study, main findings..............................................................................145 Table 21 United Kingdom country study, main findings ..................................................................146 Table 22 – List of stakeholders interviewed in the six countries.......................................................150 Table 23 – Scientific evidence on RMT for heart conditions ............................................................168 Table 24 – Scientific evidence on RMT for Diabetes........................................................................175 Table 25 – Scientific evidence on RMT for COPD...........................................................................181 Table 26 – Scientific evidence on RMT for multi-disease conditions...............................................184 Table 27 – Search string for RMT-systems in WIPO database .........................................................189 Table 28 – Distribution of application by firms (> 5 hits).................................................................190 Table 29 – Search string for RMT-systems in WIPO database .........................................................198 6 Executive Summary In an ageing Europe, where more and more citizens live with chronic diseases, telemedicine can help to make the difference in facing the global challenge posed to health systems by an increasingly heavy burden of demand for service. The European Commission realises this potential and intends to exercise leadership in fostering the deployment of telemedicine applications on a large scale. Acting in the structured framework of several policy initiatives started in 2004 with the eHealth Action Plan (COM 356), the Commission addressed in its Communication on Telemedicine (2008, COM 689) the main barriers that need to be overcome in order to facilitate greater deployment, highlighting three key issues: (1) increasing confidence and acceptance of telemedicine services; (2) gaining legal clarity; (3) overcoming unsolved technical issues and supporting market development. This report has been prepared within the study "Strategic Intelligence Monitor on Personal Health Systems" (SIMPHS) conducted by DG JRC IPTS for DG INFSO as a one of the actions devised to 1 address the above issues no. (1) and (3). Focusing on Personal Health Systems (PHS) and, more 2 specifically on Remote Patient Monitoring and Treatment (RMT), this report explores the current status of the RMT market in Europe and addresses the question of how RMT can help face some of the challenges standing in front of the European healthcare delivery systems. By analysing the reasons of the limited deployment and identified barriers, the reports provides ample evidence on the encouraging outcomes of early RMT deployment, while analysing the impact of the outcomes and briefly modelling the potential from EU-wide deployment. The rational of the study is based upon the following considerations: ƒ Fostering a functional, reliable and affordable Health Care system in general and the management of chronic disease in particular has been the key goal of European policies at national and EU level, over a number of years. Health care expenditure as a percentage of GDP 3 has seriously risen from 4.7% in 1970 to about 9% in 2007 in 19 EU countries. In addition, demographics have driven this trend: an aging European population which has doubled the percentage of the population over 65 between 1960 and 2008. Moreover, the ratio between economically inactive elderly and an active person is projected to fall from the current 1:4 to 1:2 in 2050 and beyond, which means that one inactive elderly will eventually be supported by 2 active people from year 2050 onwards. The resulting impact of this situation is two-fold: escalating care cost on the one hand, and shortages in health care delivery caused by the scarcity of professionals and informal carers derived from the increased demand, on the other. An increasing shortage of qualified health care personal is expected by 2020, both in physicians and nurses. This coincides with reduced potential informal carers due to increasing predominance of nuclear families, workforce feminisation, and workforce mobility. ƒ Chronic diseases have become widespread across all age groups causing a large part of the disease burden in Europe and posing a major challenge for health care systems financing and 4 sustainability in Member States. As an example, Cardio Vascular Diseases (CVD) on their own 1 PHS – See the definition given in Table 1 at page 14. 2 RMT – See the definition given in Table 2 at page 14. 3 OECD 2009 Health Data. This set of data did not include: Bulgaria, Cyprus, Estonia, Latvia, Lithuania, Malta, Romania, and Slovenia. These 8 countries amount to less than 9% of the total EU27 population. 4 Type II diabetes affects about 6.6% of the general population and is estimated at costing €29bln per year (Jönsson and B. Jönsson (2002). "Revealing the cost of Type II diabetes in Europe." Diabetologia 45(7): S5-S12) while CVD incure a direct cost of €109 bln and indirect costs of approximately 83 bln in terms of direct lost productivity and that of informal care (see footnote 26) 7 5 carry a high responsibility for mortality causing more than half of all deaths across Europe, and heart disease or stroke represent the leading cause of death across Europe. In terms of resources for instance, in Denmark, it is estimated that 70–80% of health care expenses are allocated to chronic conditions and in the United Kingdom, 8 of the top 11 causes of hospital admissions are chronic conditions such as diabetes, pulmonary conditions and cardiovascular diseases. These prominent chronic conditions are the focal point for applications for Remote Patient Monitoring and Treatment (RMT) and Personal Health Systems (PHS). RMT systems contribute to confronting these challenges in several ways: (a) they improve health care outcomes and simultaneously help control costs; (b) more importantly, they can help extend the reach of the limited –and eventually shrinking– pool of health care professionals; and (c) they are believed to ignite entrepreneurial activities and innovation, which lead to consider this combination of ICT industry and health care services as an engine for job creation and European competitiveness. ƒ There is increasing evidence that such services based on RMT/PHS reduce death rates, and avoid recurring hospitalisation in a cost-effective manner. However, proving beyond doubt their medical effectiveness, safety and reliability is of utmost importance for life critical systems; far more than in other realms of ICT applications. As a result of the need for further evidence, necessary investments are delayed and in general resistance against the use of the technology is reinforced. A vicious cycle is thus created leading to local champions required to provide further evidence, mainstream players not deciding to enter the market, limited market uptake and costs that remain unaffordable. The market itself is fragmented and atomised with the dominance of local initiatives and pilot projects that, with few exceptions, are not sustainable. In short, despite the positive potential for RMT and PHS a stalemate is produced. ƒ A number of barriers have been identified which still hamper full deployment of RMT in Europe. Market players, mainly companies providing the technology, are mentioning constraints to market scale, the lack of reimbursement, unclear Return on Investment and business model choices, fragmentation of purchasers and the difficulties in obtaining approval and certification from health care organisations. Moreover, health care professionals are confronted with an unfavourable structure of incentives for introducing RMT, due to conflicting responsibilities for RMT within health care organisations. This is mirrored by ambiguities in different reimbursement schemes, in particular the allocation between those for primary, secondary, and social care. In addition, the lack of widespread awareness on the positive outcomes which are shown by many studies and meta-reviews, is considered a major bottleneck. Furthermore, the lack of strategic leadership for structural change hampers the natural uptake and diffusion of these technologies. This report fully analyses the above considerations and provides a number of tentative policy options specifically aimed at fostering the take up of RMT, for the consideration of all stakeholders concerned: • Riding the wave of policy consensus, on both sides of the Atlantic, provide governance in eHealth in general and "Telemedicine and Home Care" in particular as was expressed by the ministerial conference in Barcelona (March 2010); • Provide increased and sustained awareness-raising and dissemination activities, especially focussing on spreading the knowledge about local champions, about the increasing positive evidence of RMT with respect to clinical and cost-effectiveness outcomes, as well as through 5 The data of the WHO comprises of more countries than the EU27, yet the tendency remains the same. 8