DRAFT for WDC WS on Nov. 12, 2010 This project is funded by the European Union within the framework of the Pilot Project on Transatlantic Methods for Handling Global Challenges in the European Union and the United States. The general objective of the Pilot Project, created through a European Parliament initiative, is to promote mutual understanding and learning among EU and US policy researchers and policymakers on a number of challenges with a global dimension. ARGOS PB Benefits, 19 October 2010 1 of 27 DRAFT for WDC WS on Nov. 12, 2010 “Transatlantic Methods for Handling Global Challenges in the European Union and the United States” Transatlantic Observatory for Meeting Global Health Policy Challenges through ICT-Enabled Solutions 1 ARGOS eHealth Draft Policy Brief on Policy needs and options for a common approach towards measuring Adoption, usage and benefits of eHealth Gesellschaft für Kommunikations- und Technologieforschung mbH, Bonn, Germany American Medical Informatics Association (AMIA), Washington, DC, USA Partners Healthcare System, Harvard Medical School Boston, MA, USA Bonn/Washington, DC/Boston, MA ARGOS is funded by the European Union. This is one of the seven projects under the Pilot Project ‘Transatlantic Methods for Handling Global Challenges in the European Union and the United States’. In Greek mythology, Argus Panoptes (Ἄργος Πανόπτης) or Argos was guardian of the heifer-nymph Io and son of Arestor. He was a primordial giant whose epithet "Panoptes" (i.e. "all-seeing") led to him being described as having multiple (often a hundred) eyes. The name therefore fits with such kind of transatlantic eHealth observatory. 1 ARGOS PB Benefits, 19 October 2010 2 of 27 DRAFT for WDC WS on Nov. 12, 2010 Preface: What is ARGOS about: ... Purpose of this paper: A key output of ARGOS will be three Policy Briefs. They will concisely analyse and summarise project results on the three topics of the project on policy needs and options regarding • Interoperability in eHealth and Certification of Electronic Health Record systems (EHRs); • Measuring adoption, usage and benefits of eHealth solutions; • Modelling and simulation of human physiology and diseases - Virtual Physiological Human (VPH) and provide recommendations for developing together and aligning trans-Atlantic eHealth policy strategies and cooperation in these three topical fields, including setting concrete goals, proposing adoption measures and processes to be followed. On measurement and benefits, the ARGOS Proposal formulated these objectives: “Better understanding the benefits (and costs), i.e. their overall clinical and socio-economic impact, identifying challenges and success factors, as well as measuring and globally benchmarking the concrete usage of eHealth solutions are key policy priorities not only of national governments, but also of institutions like WHO or OECD. ...[The objectives will be] to analyse current policy thinking, compare challenges and outcomes and draft a roadmap towards developing advanced global approaches for these issues.” Overall length: 15 - 25 pages, A 5 format or slightly larger Genesis: This draft reflects the initial issues as discussed in Barcelona during the WoHIT Conference in March, the OECD workshop in Barcelona - with contributions from ARGOS - on measuring eHealth, results of the eHealth Strategies workshop in Brussels in September, 2010, and discussions with stakeholder communities (professionals, citizen groups, media, ...), at scientific conferences like the Annual Global Health Technology Assessment international (HTAi) Conference, June 2010, Dublin, Ireland, and with professional and scientific experts in the context of various other meetings and eHealth activities. KAS, EMP, V03, 16 October 2010 ARGOS PB Benefits, 19 October 2010 3 of 27 DRAFT for WDC WS on Nov. 12, 2010 Key (concise) Policy Messages (policy issues and context; policy measures) to be done later Executive Summary to be done later ARGOS PB Benefits, 19 October 2010 4 of 27 DRAFT for WDC WS on Nov. 12, 2010 Policy Brief Contents 1 2 Analysis framework .......................................................................................... 6 What are the issues? ........................................................................................ 6 2.1 2.2 2.3 3 Key issues - a European policy perspective Key issues - a USA perspective European Union evidence 4.1.1 4.1.2 4.1.3 4.2 14 EU evidence at the macro-level: diffusion and usage ...........................................14 EU evidence at the micro-level: benefits assessment ..........................................18 Activities of EU Member States ............................................................................19 United States of America evidence 4.2.1 4.2.2 20 USA evidence at the macro-level: diffusion and usage ........................................20 USA evidence at the micro-level: benefits assessment ........................................20 Research challenges and methodological issues encountered ................. 21 5.1 5.2 6 7 9 11 Past and present realisation activities and results ...................................... 14 4.1 5 6 7 8 Policies, strategies, approaches presently pursued ...................................... 9 3.1 3.2 4 eHealth and the quest for a new model of healthcare Evidence needed at the macro-level: diffusion and usage Evidence needed at the micro-level: benefits assessment Gathering evidence at the macro-level: diffusion and usage Assessing benefits and costs at the micro-level 21 22 Experiences, lessons learned, needs for future actions ............................. 25 Recommendations for transatlantic exchange, policy harmonisation, collaborative initiatives .................................................................................. 26 ARGOS PB Benefits, 19 October 2010 5 of 27 DRAFT for WDC WS on Nov. 12, 2010 1 Analysis framework When analysing the respective national health policy and related eHealth strategy perspectives regarding measuring of adoption, usage and benefits of eHealth solutions, the following analysis framework will be applied. Table 1 depicts a linear policy development and implementation process. Of course, in reality such processes are complex, recursive, disruptive and multi-level in character. Nevertheless, for analytical purposes and as sketched in Figure 1 below, it is useful to regard them as a linear process involving usually these basic steps: TABLE 1: BASIC STEPS OF THE POLICY LIFE CYCLE: 1) Identification of the issues guiding high level policy goals and objectives (Problem definition) 2) Mustering support for the policy (Agenda setting) 3) Drafting and agreeing on a policy document including the identification of a strategy to realise it, the implementation process, measures and resources needed (Adoption) 4) Initiating new or using established organisational structures to implement it and executing the measures foreseen (Implementation) 5) Controlling and evaluating the timely policy realisation, outcomes and performance (Evaluation) 6) Feedback of results into adjusted or new policy development (Feedback). FIGURE 1: THE POLICY LIFE CYCLE Problem Definition Agenda Setting Policy adoption Implementation Evaluation Feedback Source: © empirica 2008, based on Brewer and Jones2 In the framework of this work, it will not be possible to cover in detail all the steps involved in the policy life-cycle. Especially the problem definition and agenda setting part are often hidden from the public and would require knowledge of internal policy processes in ministries and the parliament.3 The most visible parts of this cycle are the policy-adoption and implementation stages. Measurement of outcomes and evaluation of the impact of a policy in the field of Healthcare and eHealth, which is still a rather rare occurrence in most countries, are key concerns of this policy brief. 2 What are the issues? 2.1 eHealth and the quest for a new model of healthcare Health policy-makers are challenged by insufficient human and capital capacity to meet demand for services, and to prioritise finite budgets. Demographic change, rising incidence of chronic 2 Brewer, G. D. and P. DeLeon (1983). The foundations of policy analysis, Dorsey Press Homewood, Illinois. See also Jones, C. O. (1984). An introduction to the study of public policy, Houghton Mifflin Harcourt P. 3 Jann, W. and K. Wegrich (2003). "Phasenmodelle und Politikprozesse: der policy cycle." Lehrbuch der Politikfeldanalyse. München: 71-103. ARGOS PB Benefits, 19 October 2010 6 of 27 DRAFT for WDC WS on Nov. 12, 2010 disease among young and old4, and unmet needs for more personalised care are driving the pressure to introduce a new model of healthcare, a redesigned smart health system. This quest for integrated care close to the home, better involvement of patients and improved efficiency are not new.5 But the context has changed: for the first time the enabling capacities of advanced information and communications technology (ICT) solutions can now enable our health systems to focus indeed on realising this smart health system paradigm.6 ICT systems for clinical decision support7, chronic disease and population management8, shared access to patient data and coordination of clinical pathways9, for public health risk and epidemiological surveillance, for knowledge generation from structured data and better training, and its translation into health service routines are within reach.10 Fostering eHealth systems has been among the earliest research topics supported by the EC’s Framework Programmes.11 eHealth denotes all applications of ICT supporting and interconnecting health service processes and health system actors, both at the local level and remotely. But in spite of a 40 year struggle to mainstream eHealth solutions, their diffusion into many potential application fields is still meagre, and evidence on the various types of benefits forecast and heralded as a new panacea for health policy woes is limited. Despite notable successes in a few settings12, regrettably for all actors involved, be they policy makers and administrators at the European or national/regional level, be they health service providers, taxpaying citizens or other stakeholders, are left wondering whether this expensive and long-term commitment is paying off. 2.2 Evidence needed at the macro-level: diffusion and usage For eHealth to deliver the expected benefits, it requires on the one hand policies to foster actual deployment (including investments, improvement of interoperability, reducing legal barriers and others) and on the other hand measures of deployment and the effectiveness of current and future take-up. To monitor and control the development, implementation and success/impact of eHealth strategies and implementation measures, it is necessary to measure the diffusion and usage of such applications across health service actors and organisations. At the macro-level of the overall health system, this necessitates a clear understanding of the role of measurements / indicators and benchmarking in policy and their use for policy making. A general approach to the use of quantitative indicators and benchmarking for policy is outlined in Figure 2. An indicator system requires as a starting point the definition of the area of activity in broad terms in form of policy challenges. As such, it will be too broad to be directly measured and therefore requires a translation of these challenges into more concrete concerns and policy objectives, which can be used as a basis for the specification of policy actions. Measurable results of policy action, i.e. the specification of policy targets in terms of outputs, outcomes, and impacts are the next step to be conducted. From these, indicators can be derived (through “operationalisation”), which can then be used for a policy evaluation. This typically means comparison of achievements against set targets. These can be referred back to policy objectives and policy challenges. 4 Neal Halfon; Paul Newacheck (2010). Evolving Notions of Childhood Chronic Illness. JAMA 303(7), pp. 665-666. Actually, they have been public health policy desiderata for more than 50 years: Leroy E. Burney (1954). Community OrganizationAn Effective Tool. American Journal of Public Health, Vol. 44 (1954), pp. 1-6 6 Karl Stroetmann et al. eHealth is Worth it - The economic benefits of implemented eHealth solutions at ten European sites. Luxembourg: Office for Official Publications of the European Communities, 2006 7 Bates NEJM 8 DM ref 9 Grant R DM 10 Alexander Dobrev et al. . Interoperable eHealth is Worth it - Securing Benefits from Electronic Health Records and ePrescribing. Luxembourg: Office for Official Publications of the European Communities, 2010 11 Ilias Iakovidis, Octavian Purcarea (2008). eHealth in Europe: from Vision to Reality. In: B. Blobel et al. (eds.). eHealth: Combining Health Telematics, Telemedicine, Biomedical Engineering and Bioinformatics to the Edge. Studies in Health Technology and Informatics Vol.134, pp.:163-8. 12 Chaudry 5 ARGOS PB Benefits, 19 October 2010 7 of 27 DRAFT for WDC WS on Nov. 12, 2010 The resulting indicators can then be defined on different levels:13 • policy outputs, which are comparatively easy to specify using operational indicators; • policy outcomes, which are more difficult to operationalise as they relate to the underlying policy objectives; and • policy impacts, which are most difficult to specify because measurable effects typically only occur in the long-term, and because the relationship between individual effects and causes are often very difficult to disentangle from each other. • FIGURE 2: THE USE OF INDICATORS AND BENCHMARKING FOR POLICY-MAKING Policy challenge • Broad area for activity and investigation • The "mission statement" • Too broad to be directly measured Policy Policy Policy targets targets targets Policy objectives • Translate challenges into more concrete concerns • Basis for specification of policy actions Implementation Policy evaluation Indicators Indicators Indicators • The measurable results of policy actions • Outputs outcomes impacts • Benchmarking: What is the current status? • Benchmarking: Has there been progress towards meeting objectives? • In case of nonachievement, assessment of reasons • Benchlearning: What can be learned from others’ experience? Source: © empirica 2007 Benchmarking diffusion and usage will play a central role in monitoring progress in exploiting opportunities for economic growth and jobs by promoting an open and competitive digital economy. A mix of indicators is needed to measure the different aspects of the objectives that are to be achieved. Policy emphasis now focuses more on complex issues of impact and usage of technologies in the wider economy and benchmarking must become more sophisticated. It is necessary to build on existing work and continue to track some indicators consistently but monitoring of progress now requires indicators that are flexible and timely. 2.3 Evidence needed at the micro-level: effective use and benefits assessment However, availability of such macro-level data covers only one, albeit key, aspect of overall policy monitoring and assessment. The other side is to assess, at the micro-level of individual stakeholders and local/regional health systems, the concrete benefits (and also the costs) associated with investing in and implementing eHealth solutions and systems. These benefits arise directly from effective use of ICT (or as often described in the US policy framework “meaningful use”). Such micro-level socio-economic evaluations of eHealth systems and solutions can offer significant benefits to health policy decision-makers. These include providing evidence-based information to help decision-makers in eHealth to identify the: 13 cite Shortelle S. Program Evaluation in Healthcare ARGOS PB Benefits, 19 October 2010 8 of 27 DRAFT for WDC WS on Nov. 12, 2010 • type and scope of benefits for patients, carers, healthcare professionals, healthcare provider entities, other stakeholders, and any public good to consider when making decisions to invest in e-health applications • de facto beneficiaries and cost bearers of eHealth • number and type of users, their levels of utilisation, and so required and future capacity • impact on meeting healthcare demand • enabling changes to healthcare models and regional networks that become possible • benefits for clinical audit and governance • scale of the critical investments needed in training and change management • potential changes to the costs of providing healthcare and the potential to generate additional income • impact on the future ICT infrastructure needed to support eHealth • impact on third party payers. A major reason for the relatively slow progress in eHealth deployment is the lack of awareness of and empirical evidence on benefits. There is a need to disseminate existing best practices and the associated benefits as well as to examine existing methodologies of assessment and to propose common approaches to proving benefits of interoperable solutions using coherent and quantitative (scientific) methods.”14 Secondarily, healthcare payment models may impede an efficient market for healthcare goods and services supported by ICT. Under certain reimbursement models, the stakeholder investing in ICT may not be the beneficiary if benefits accrue to a different stakeholder.15 A rigorous evaluation framework for identifying and measuring the benefits and costs from eHealth investments and deployment is needed for two reasons: 1) in order to demonstrate the potential, including the points of high-level impact, and 2) in order to analyse incentives structures and thus identify fields of required policy initiatives and action. Success factors and lessons for future initiatives are a valuable by-product of micro-level benefit assessment activities. Rigorous evaluation findings that show the extent to which aspects of eHealth applications have not succeeded are also very valuable to decision-makers, because they will reveal the risks that they are facing. Taken together, these two main types of evaluation findings will help to remove inhibitors, show best practice, support future investment decisions and create enablers for change in eHealth. 3 Policies, strategies, approaches presently pursued 3.1 Key issues - a European policy perspective Measurement of adoption, usage and benefits of eHealth solutions has always been high on the EU agenda. This was clearly stated in the European Commission eHealth Action Plan of 2004. Under Issue 3: Working together and monitoring practice, topic Disseminating best practices, the European Commission recommended that “eHealth should be supported by the widespread dissemination of best practices. These should include ... assessments of cost benefits ...” and asked “to develop a strong evidence basis for the case for e-Health”. Furthermore, with respect to the topic of Benchmarking, it was voiced that “progress also needs to be measured. ...This means assessing and quantifying the added value that eHealth is expected to deliver. ...These measures should be accompanied by proper monitoring of e-Health’s impact on health and 14 Tender specifications: Study on Economic Impact of Interoperable Electronic Health Records and ePrescription in Europe, SMART N°2007/0048 – OJ 2007/S 100-122426, p.5 15 Value of ACPOE, CITL ARGOS PB Benefits, 19 October 2010 9 of 27 DRAFT for WDC WS on Nov. 12, 2010 health care in the Community. All stakeholders should have a role in this process which should feed in to further improvements in e-Health systems and services.” “During the period 2004-2010, every two years, the European Commission will publish a study on the state of the art in deployment, examples of best practices, and the associated benefits of e-Health. By the start of 2005, Member States, in collaboration with the European Commission, should agree on an overall approach to benchmarking in order to assess the quantitative, including economic, and qualitative impacts of e-Health.”16 These recommendations were also recognised recently in the European Council Conclusions on Safe and efficient healthcare through eHealth17 where EU Member states committed to cooperation on eHealth in view of maximising the benefits for their own patients. It also welcomes the collaboration between a number of Member States in the epSOS large scale pilot project18, the €22m initiative jointly funded by the Commission and 12 Member States, which seeks to develop cross-border interoperability of summaries of electronic health records and ePrescriptions, where impact assessment will play a key role. It calls upon Member States to create a high level governance group to address the issue of interoperability. It also calls upon the Commission to “organise an evaluation, at the appropriate intervals, of the health benefits and cost-effectiveness of the use of different eHealth services, building on knowledge accumulated at EU and national levels.” eHealth monitoring and benchmarking need to be seen in the context of the objectives of the i2010 strategic framework19. i2010 was initiated by the European Commission in 2005 to create a European Information Society for growth and employment and formed part of the wider partnership for growth and jobs set out by the European Council in the spring of 2005. In the Extended Impact Assessment of the i2010 Initiative it was already mentioned that “progress with connectivity has been rapid and the policy priority has switched to usage of ICT and their impact on businesses, governments and citizens. In addition, it is important for benchmarking to show market developments ... A core policy aim would be to promote advanced services, and benchmarking should then include a mechanism to identify and monitor market developments.”20 Later on it reads on the i2010 website: “Comparing the development of the information society in the Member States on the basis of certain indicators as well as best practice is an important part of i2010 assessment. Such benchmarking is carried out on the basis of statistical surveys and studies. The results are available in the benchmarking section and every year they are reviewed in the i2010 Annual Report.”21 In the i2010 Benchmarking Framework22, eHealth is only referred to very briefly in the following statement taken directly from the Framework document: “Finally, public services beyond eGovernment (i.e. services of public interest not necessarily provided by public bodies, such as health or education) should also be covered possibly on a case study approach. In the case of eHealth monitoring should be done with indicators developed in consultation with health spe- 16 Commission of the European Communities - COM (2004) 356: Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions: e-Health - making health care better for European citizens: An action plan for a European e-Health Area, Brussels, 2004-04-30. 17 Council conclusions of 1 December 2009 on a safe and efficient healthcare through eHealth. Official Journal of the European Union (2009/C 302/06), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2009:302:0012:0014:EN:PDF (2980th Employment, Social Policy, Health and Consumer Affairs Council meeting, Brussels, 1 December 2009) 18 European Patients Smart Open Services – epSOS, www.epSOS.eu 19 COMMISSION OF THE EUROPEAN COMMUNITIES. COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS: “i2010 – A European Information Society for growth and employment” {SEC(2005) 717}. Brussels, 1.6.2005, COM(2005) 229 final 20 COMMISSION STAFF WORKING PAPER - COMMUNICATION FROM THE COMMISSION “i2010 – A European Information Society for growth and employment”. EXTENDED IMPACT ASSESSMENT {COM(2005) 229 final - Brussels, 01.06.2005, SEC(2005) 717/2, p. 14. 21 http://ec.europa.eu/information_society/eeurope/i2010/measuring_progress/index_en.htm 22 i2010 High Level Group: i2010 Benchmarking Framework, April 2006: http://ec.europa.eu/information_society/eeurope/i2010/benchmarking/index_en.htm ARGOS PB Benefits, 19 October 2010 10 of 27 DRAFT for WDC WS on Nov. 12, 2010 cialists, as agreed at the first workshop. Monitoring of wider public services will contribute to benchmarking of quality of life”. As concerns policy implementation of the above recommendations in practical EU research policy and promotion, measuring and monitoring usage, diffusion, and benefits of eHealth solutions has increasingly become a prerequisite for research proposals of the 7th Framework Programme for EU research (FP7). For generating evidence of scientific, technical, commercial, social, or environmental impacts, recently, assessment and evaluation approaches must be convincingly self-administered to projects. In order to ensure the maximisation of tangible clinical as well health system/societal benefits, quantitative indicators of added value and potential impact are meant to demonstrate and also support the use of foreground, that is, exploitation of project outputs, beyond a project’s life-cycle. Assessment indicators ought to be formatively employed to validate and evaluate eHealth solutions and related research in monetary terms, with respect to individual patients, the overall healthcare organisation, and at the public health level. 3.2 Key issues - a USA perspective Current policy framework overview Assessment activities: Meaningful Use Related concerns: HIE Moving toward Phase 2 and 3 of MU Sustaining HIT (ICT) adoption process and effective use Coordinated US health Information technology policy formulation began with the creation of the Office of the National Coordinator for Health Information Technology (HIT) by an Executive Order from President Bush in 2004.23 Prior to this act, HIT related policy issues arose in a largely uncoordinated process across public and private sectors. In 1998 a milestone occurred when the National Committee on Vital and Health Statistics (NCVHS -- a federal advisory committee composed of private sector experts), reported that the nation’s information infrastructure could be an essential tool for promoting the health of US citizens in its seminal concept paper, “Assuring a Health Dimension for the National Information Infrastructure.”24 Since the time of the NCVHS report, other initiatives have helped to further define the best approach to apply information and communication technologies to the health sector. In 2002, the Markle Foundation (a private US foundation) organized a public-private collaborative, Connecting for Health, which brought together leaders from government, industry, and health care, and consumer advocates to improve patient care by promoting standards for electronic medical information. A year later, the collaboration of more than 100 public and private stakeholders in Connecting for Health achieved consensus on an initial set of health care data standards, and commitment for their adoption from a wide variety of national health care leaders25. Similar activities were underway in the US federal sector. In March 2003, the Consolidated Health Informatics (CHI) initiative involving the US Department of Health and Human Services, the Departments of Defense (DoD), and Veterans Affairs (VA), announced together uniform standards for the electronic exchange of clinical health information to be adopted across the federal health care enterprise. These standards facilitate information exchange, with privacy and security protections, to make it easier for health care providers to share relevant patient information and for public health professionals to identify emerging public health threats.26 23 Executive Order number, date get cite 25 get cite 26 get cite 24 ARGOS PB Benefits, 19 October 2010 11 of 27 DRAFT for WDC WS on Nov. 12, 2010 A very significant related HIT policy initiative resulted from efforts to improve drug safety, coverage, and utilization in the US. At the end of 2003, President Bush signed into law the Medicare Prescription Drug Improvement and Modernization Act (MMA) of 2003. Among other new initiatives, the law includes important provisions for HIT. MMA requires the Centers for Medicare and Medicaid Services (CMS) to develop standards for electronic prescribing, which will be a first step toward the widespread use of electronic health records (EHR). In addition, the MMA required the establishment of a Commission on Systemic Interoperability to provide a road map for interoperability standards.27 In April 2004, President Bush issued Executive Order 13335 calling for widespread adoption of interoperable EHRs within 10 years, and established the position of National Coordinator for Health Information Technology. EO13335 charged the National Coordinator with developing, maintaining, and directing: “ … the implementation of a strategic plan to guide the nationwide implementation of interoperable health information technology in both the public and private health care sectors that will reduce medical errors, improve quality, and produce greater value for health care expenditures.” The first National Coordinator for HIT, Dr. David Brailer, in conjunction with the Secretary of Health and Human Services Mr. Tommy Thopson produced the first strategic framework for HIT: The Decade of Health Information Technology: Delivering Consumer-centric and Information-rich Health Care.28 This framework outlined 4 overarching gals and 3 associated strategies for each (Table XXX). These fundamental goals and strategic objectives serve as a foundation for many of the policy development efforts since that time. Table XXX: The Brailer-Thomson Framework for Strategic Action. (2004) Informing clinical practice Providing incentives for EHR adoption Reducing the risk of EHR investment Promoting EHR diffusion in rural and underserved areas Interconnecting clinicians Enhancing regional collaborations Developing a national health information network Coordinating federal health information systems Personalizing care Encouraging the use of personal health records Enhancing informed consumer choice Promoting the use of telehealth systems Unifying public health surveillance architectures Streamlining quality and health status monitoring Accelerating research and dissemination of evidence Improving population health 27 get cite Brailer DJ, Thompson TG. The Decade of Health Information Technology: Delivering Consumer-centric and Information-rich Health Care. Framework for Strategic Action. July 21, 2004. 28 ARGOS PB Benefits, 19 October 2010 12 of 27 DRAFT for WDC WS on Nov. 12, 2010 With the leadership provided by the Office of the National Coordinator for Health Information Technology, efforts began to coordinate both public sector and private sector policy development activities for HIT. The President’s Information Technology Advisory Committee (PITAC) in June 2004 issued a draft report, “Revolutionizing Health Care Through Information Technology,” which stated that the overall quality and cost-effectiveness of U.S. health care delivery bear directly on three top national priorities of national, homeland, and economic security29. In July 2004, the Markle Foundation Connecting for Health group released a timely report that details specific actions the public and private sectors can take to accelerate the adoption of information technology in health care. Connecting for Health's “Preliminary Roadmap for Achieving Electronic Connectivity in Healthcare” contains recommendations in three categories: creating a technical framework for connectivity, developing incentives to promote improvements in health care quality, and engaging the American public by providing information to promote the benefits of electronic connectivity and to encourage patients and consumers to access their own health information.30 This consensus statement represents a significant alignment of recommended policy and initiatives across a broad coalition of stakeholders. IN June 2008, the Office of the National Coordinator released a significant update to the HIT Strategic Plan.31 The 2008 ONC Strategic Plan has two goals, Patient-focused Health Care and Population Health, and four objectives under each goal (See Table XXX). The themes of privacy and security, interoperability, IT adoption, and collaborative governance recur across the goals, but they apply in very different ways to health care and population health. Achievement of the eight objectives is tied to measurable outcomes. The Plan articulates 43 strategies that describe the work needed to achieve each objective. Each strategy is associated with a milestone against which progress can be assessed, and a set of illustrative actions to implement each strategy. Table XXX. The US ONC Coordinated Strategic Plan for Health IT (2008) Goal 1) Patient-focused health care: Enable Objective 1.1 – Privacy and Security: Facilitate the transformation to higher quality, more cost- electronic exchange, access, and use of elecefficient, patient-focused health care through tronic health information while protecting the electronic health information access and use privacy and security of patients’ health inforby care providers, and by patients and their mation designees. Objective 1.2 – Interoperability: Enable the movement of electronic health information to where and when it is needed to support individual health and care needs Objective 1.3 – Adoption: Promote nationwide deployment of electronic health records and personal health records that put information to use in support of health and care Objective 1.4 – Collaborative Governance: Establish mechanisms for multi-stakeholder 29 30 31 Get cite get cite The ONC-Coordinated Federal Health IT Strategic Plan: 2008-2012. June 3, 2008 ARGOS PB Benefits, 19 October 2010 13 of 27 DRAFT for WDC WS on Nov. 12, 2010 Goal 2) Population health: Enable the appropriate, authorized, and timely access and use of electronic health information to benefit public health, biomedical research, quality improvement, and emergency preparedness. priority-setting and decision-making to guide development of the nation’s health IT infrastructure Objective 2.1 – Privacy and Security: Advance privacy and security policies, principles, procedures, and protections for information access and use in population health Objective 2.2 – Interoperability: Enable the mobility of health information to support population-oriented uses Objective 2.3 – Adoption: Promote nationwide adoption of technologies and technical functions that will improve population and individual health Objective 2.4 – Collaborative Governance: Establish coordinated organizational processes supporting information use for population health The goals, objectives, and strategies of the 2008 Plan portray what must be done, in a coordinated manner distributed across the US public and private sectors, to achieve an interoperable health IT infrastructure in the US in support of patient-focused health care and population health. This Plan is primarily federally focused with many of the strategies proposed in the Plan designed to harmonize activities in the public and private sectors. This approach is designed to ensure that federal resources allocated to health IT, while supporting the individual and distinct missions of the Departments, are also positioned to realize maximum benefit for the nation as a whole. ***Meaningful Use the most significant HIT related policy event in the US, however, is the passage of the ARRA legislation by the US Congress, date (American Recovery and Reinvestment Bill), which contains the HITECH Act (Health IT Economic and Clinical Health Act). This legislation includes a wide array of major policy initiatives directed at stimulating the adoption and “meaningful use” of health IT. ***get my summary 4 Past and present realisation activities and results 4.1 4.1.1 European Union evidence EU evidence at the macro-level: diffusion and usage 4.1.1.1 The policy context and measurement framework The European Union (EU) i2010 Benchmarking Framework of 2006 for measuring the Information Society monitored progress in the 3 pillars of the i2010 Initiative: – Completing the Single European Information Space – Strengthening R&D in ICT and the take up of eBusiness ARGOS PB Benefits, 19 October 2010 14 of 27 DRAFT for WDC WS on Nov. 12, 2010 – Achieving an inclusive European information society Its broad scope concerned both ICT research and various application domains, and it put particular emphasis on the impact of ICT use. eGovernment, including eHealth issues, were covered by the third pillar. As of 2011, it will be followed by the Benchmarking Digital Europe 2011 – 2015 framework which was endorsed by the i2010 High Level Group on 09 November 2009 in Visby, Sweden 32. It proposes a conceptual framework for the collection of statistics on the information society as well as a list of core indicators [EU speak for measures] to be used for benchmarking. It provides a context for measurement and suggests new areas for investigation. For the forthcoming period, a summary list of indicators to be collected routinely has been proposed for the following fields33: A) The ICT sector B) Broadband and connectivity C) ICT usage by households and individuals D) ICT usage by enterprises E) ePublic services eHealth is to be covered partially in the context of these indicators as well as through ad-hoc studies on issues for which official statistics are not available. As concerns the former, consumer data on “seeking health information (on injuries, diseases, nutrition)”, “making an appointment with a practitioner” as well as “consulting a practitioner online” will be collected biannually. The European Commission has been reporting annually on the list of benchmarking indicators through its i2010 annual report that contains detailed country profiles for the EU, Norway, Iceland, and more recently also Croatia.34 With the advent of 2010, the i2010 Strategy has come to an end,35 and is followed by a new initiative – the Digital Agenda36 -, which is one of seven so-called Flagships of the Europe 2020 Strategy37 – the Commission’s proposal on a new economic strategy for the EU. The Europe 2020 Strategy focuses on “three mutually reinforcing priorities: • Smart growth: developing an economy based on knowledge and innovation. • Sustainable growth: promoting a more resource efficient, greener and more competitive economy. • Inclusive growth: fostering a high-employment economy delivering social and territorial cohesion.”38 eHealth does not only feature in the mentioned Digital Agenda Flagship, but will also become a key aspect in the Smart Growth Flagship called “Innovation Union” with various “European Innovation Partnerships” (EIP), where the initial EIP will be on “Active and healthy ageing.”39. 32 i2010 High Level Group: Benchmarking Digital Europe 2011-2015: a conceptual framework, 27 October 2009: http://ec.europa.eu/information_society/eeurope/i2010/docs/benchmarking/benchmarking_digital_europe_2011-2015.pdf 33 Ibidem; for the full list of indicators see pp. 18-21 34 COMMISSION OF THE EUROPEAN COMMUNITIES. Europe’s Digital Competitiveness Report - Main achievements of the i2010 strategy 2005-2009. Brussels, 04.08.2009, COM(2009) 390. Fore more details, see the accompanying COMMISSION STAFF WORKING DOCUMENT. Brussels, 04.08.2009, SEC(2009) 1103 - An overview of all documents can be found at http://ec.europa.eu/information_society/eeurope/i2010/key_documents/index_en.htm 35 For 2010, see the final report: European Commission. Europe’s Digital Competitiveness Report 2010. Commission staff working document, Volume 1, Brussels, 17.5.2010, SEC(2010) 627 36 For details, see http://ec.europa.eu/information_society/digital-agenda/index_en.htm 37 EUROPEAN COMMISSION. EUROPE 2020 - A strategy for smart, sustainable and inclusive growth. Brussels, 3.3.2010, COM(2010) 2020 38 Ibidem, p. 3 39 See European Commission. Europe 2020 Flagship Initiative Innovation Union. Brussels, 6.10.2010, COM(2010) 546 final, ANNEX III European Innovation Partnerships - Aims and scope of a pilot European Innovation Partnership in the field of active and healthy ageing, pp. 40-42 ARGOS PB Benefits, 19 October 2010 15 of 27 DRAFT for WDC WS on Nov. 12, 2010 4.1.1.2 Data sources and surveys Statistical information will continue to be mainly collected through the following sources: • Eurostat surveys on ICT use by households/individuals and enterprises, plus other official statistics; • data on connectivity provided by National Regulatory Authorities; • ad-hoc studies on different issues for which official statistics are not available; • regular annual surveys on the availability of online public services. In the 2011-2015 benchmarking framework, Eurostat - the Statistical Office of the European Communities40 - surveys represent the main source of statistical information, with additional data to be provided by the Communication Committee (COCOM).41 The ICT use surveys will keep the current structure, including core indicators (to be maintained for tracking development over time) and special modules focusing on different topics each year. When specific policy needs cannot be covered by official statistics, ad-hoc surveys/studies will be conducted, with particular attention to the issue of quality and reliability. Member States will be involved in the process of validation of these statistics in the framework of a specific group on measurement. 4.1.1.3 Specific eHealth issues There is a range of relevant policy domains so far only partially covered by Eurostat surveys. These include healthcare and eHealth. Monitoring the use of ICT to support a more efficient and safer delivery of health services is increasingly regarded as highly important. The Eurostat survey on ICT use can provide some evidence on the use of the internet for health related purposes, but for a more exhaustive picture, the analysis has to cover also the use of ICT by various health sector actors, where presently only ad-hoc surveys deliver data.42 Recently, the European Commission has launched a series of studies on measuring usage and diffusion of eHealth. The “eHealth Indicators” (2007-2008)43 study involved a representative European general practitioners survey in all 27 EU Member States as well as Norway and Switzerland, also including 29 Country Briefs reporting on the situation in the respective country compared to the rest of Europe. Almost 7,000 primary care physicians where surveyed on their use of ICT and internet for communication with patients, and between primary and secondary care and other health system actors. A Commission study on eHealth benchmarking (2008-2009) provided additional input in terms of a comprehensive measurement framework and on potentially useful, related measures44. The study identified and collected quantitative and qualitative evidence of eHealth deployment and use in the European Union, Norway, Iceland, Canada and the United States - with a particular focus on measurements specified in the European Union's 2004 eHealth Action Plan.45 Sources covered include healthcare associations and bodies, international organisations such as OECD and WHO, IT industry, national statistical institutes and authorities at regional and national level. The outputs of the study include an online knowledge base with almost 100 eHealth Benchmarking data sources in 31 countries with a total number of around 4,500 eHealth indicators46. Late in 2009, the EC has launched a third study in this series, this time on the use of ICT and eHealth solutions by medical staff in hospitals, both for administrative and clinical processes. The overriding aim is to obtain a better understanding of the current level of digitalisation, the actual usage (compared to availability as surveyed in other studies), and the perceived benefits 40 http://epp.eurostat.ec.europa.eu/portal/page/portal/eurostat/home/ Through the COCOM - Communications Committee - National Regulatory Authorities collect data to supplement Eurostat activities, e.g. in the field of broadband penetration . 42 http://ec.europa.eu/information_society/eeurope/i2010/docs/benchmarking/gp_survey_final_report.pdf 43 http://ehealth-indicators.eu/ 44 http://ec.europa.eu/information_society/eeurope/i2010/docs/benchmarking/ehealth_ii_bench_final_report.pdf 45 Commission of the European Communities: e-Health - making health care better for European citizens: An action plan for a European e-Health Area. COM (2004) 356, Brussels, 2004-04-30 46 see http://kb.ehealth-benchmarking.eu/search.do# 41 ARGOS PB Benefits, 19 October 2010 16 of 27 DRAFT for WDC WS on Nov. 12, 2010 from and effectiveness of eHealth solutions.47 Results should become available at the beginning of 2011. 4.1.1.4 OECD activities48 On July 6-7, 2009, at their 5th Session, OECD Health Committee delegates had already expressed their support for further work on the application of ICT solutions in two areas: • Option 1: development of a standardized survey for international comparison of adoption and use of ICTs in the Health Sector • Option 2: review the use of EHRs for data collection for population-based quality indicators These projects had not been anticipated in the 2009/2010 OECD Programme of Work and Budget, but they were being put forward because of strong demand from experts in two subgroups (the National Experts on ICTs in Health Systems, and the OECD Health Care Quality Indicator (HCQI) group). To avoid double work and, on the other hand, take advantage of potential synergies, OECD and the ARGOS Initiative discussed their respective briefs and plans, and agreed to cooperate on option 1 mentioned above, with the lead to be allocated to OECD. Involvement of WHO was highly welcomed. An initial common workshop was the OECD special session towards international cooperation in measuring the adoption and usage of IT in the health sector. It took place on March 16, 2010, at the World of Health IT Conference in Barcelona, Spain. The meeting was devoted to further scoping a proposal for international work to measure adoption and use of ICTs in the health sector (OECD paper DELSA/HEA(2009)7) and, specifically, to discuss, also in light of the ARGOS brief, • shared needs; • key lessons from work to date; • a strategy to employ common measures while preserving continuity of each nation’s measurements; and an action plan to develop shared measures and approaches to meet highpriority policy needs. Delegates from Member States confirmed their countries’ interest in an international benchmarking initiative and welcomed the attempts to develop a set of common indicators and definitions. It was noted that the impacts of ICT implementation in the health sector are still very much an open question and reliable and credible measurements of adoption and use would be a useful starting point. On this issue, the following observations were made: • Comparable reliable measurements can be a powerful motivating tool (what you do not measure will not get done) and are necessary to understand the value of programmes and initiatives. • Benchmarking provides a useful means to identify countries which may be facing similar implementation challenges, compare and understand possible success factors, and understand where improvements are most significant (we need to measure not just what we are doing but how we are doing it). • A joint international effort can help countries identify what can be measured, how to develop meaningful comparators and the ways to collect data (there is already value added in agreeing on what to compare). • Measurement can help address resource allocation and impacts questions. (Have we well invested our money? Are our healthcare professionals using ICT tools? For what purpose? Are we improving the quality and efficiency of our health systems? ) 47 http://ec.europa.eu/information_society/eeurope/i2010/studies/ The following is based on the OECD DRAFT SUMMARY OF MAIN POINTS paper about the OECD SPECIAL SESSION TOWARDS INTERNATIONAL COOPERATION IN MEASURING ADOPTION AND USE OF INFORMATION TECHNOLOGIES IN THE HEALTH SECTOR, on MARCH 16, 2010, at the WORLD OF HEALTH IT Conference in BARCELONA, Spain, compiled by Elettra Ronchi and Niek Klazinga. 48 ARGOS PB Benefits, 19 October 2010 17 of 27 DRAFT for WDC WS on Nov. 12, 2010 • International comparisons should not be used to rank countries but should be seen as a means to enhance collaboration across countries. 4.1.2 EU evidence at the micro-level: benefits assessment Measuring the benefits and costs and assessing the socio-economic impact of eHealth solutions has been a key policy concern at the EU level since the start of this century. Commissioned by the EC, the eHealth IMPACT study (2005-2006)49 developed a generic methodology for the socio-economic evaluation of eHealth applications. It is a context adaptive model, so it can be applied to a wide diversity of applications, from clinical settings to supply chain solutions, in the respective health system context. The model is based on the concept of benefit-cost analysis. Benefits concern a great variety of detailed measures related to better quality of care, greater efficiency and/or improved access to health services. Benefits for all potential stakeholders can be analysed, be they individual persons, organisations, or the health system as a whole/society. Special attention has been paid to identifying the benefits to, and impact on, citizens. The concept of cost-avoidance is important in identifying benefits. These are the costs estimated for achieving the ICT-based performance without ICT, which may prove prohibitive. Cost measures include the initial and continuous eHealth investments, such as those in ICT and change management, as well as the running costs of eHealth systems and solutions. Whereas typical publications on benefits (and sometimes also costs) of eHealth are either based on very limited, subsidised experiments and pilot experience, or concern potential benefits heroically extrapolated from limited, often atypical experience, the eHealth IMPACT study for the first time looked at a diversity of longer term, routine eHealth (systems) solutions integrated into standard health service provision. They were, albeit, also atypical in the sense that they were purposefully selected on the assumption to provide exemplar case studies of how to do it successfully. For the first time, the empirical ex-post results of the study showed that for a wider health system context that, given the right approach, context and implementation process, benefits from effective eHealth investments are indeed better quality and improved productivity, which in turn liberate capacity and enable greater access. But the results also showed that eHealth system investments are usually longer-term endeavours not delivering net cash savings. The EHR IMPACT50 study (2008-2009), building on the foundations laid in the eHealth IMPACT study, investigated the socio-economic impact of interoperable electronic health record (EHR) and ePrescribing systems in Europe and beyond. Core to the project was a detailed qualitative analysis of eleven good practice cases in Europe, USA and Israel. Nine of these also underwent a quantitative assessment of their socio-economic impacts. Each case studied represents a sustained solution in routine operation. The goals of the EHR IMPACT study required an inductive and adaptive empirical approach. Two perspectives were applied, the socio-economic, and a narrower, financial one within the socio-economic. This dual perspective in the EHR IMPACT methodology provides a rigorous evaluation of the long-term impacts of interoperable EHR and ePrescribing systems. The case studies provide empirical insights that underpin findings on the socio-economic impact of interoperable EHR and ePrescribing systems and the factors that need to be in place to accelerate their successful deployment. The cases show that there is no single, ‘right’ strategy for implementing interoperable EHR and ePrescribing systems. Decisions to invest in such solutions must devise and adopt strategies that fit their local or regional setting, and be designed to succeed by meeting clearly identified, measurable needs. Transferability of some technology and tools to other contexts is more viable 49 eHealth is Worth it - The economic benefits of implemented eHealth solutions at ten European sites. Luxembourg: Office for Official Publications of the European Communities, 2006 (56 pp. - ISBN 92-79-02762-X). Electronic file: http://europa.eu.int/information_society/activities/health/docs/publications/ehealthimpactsept2006.pdf 50 www.ehr-impact.eu; publication upcoming ARGOS PB Benefits, 19 October 2010 18 of 27 DRAFT for WDC WS on Nov. 12, 2010 than transferring specific functionalities and organisational features. The specific roles and priorities of healthcare professionals and HPOs differ between jurisdictions and healthcare systems, limiting transferability of success stories mainly to principles, tools and techniques rather than specific EHR and ePrescribing systems. The most transferable features are the experiences and capabilities gained, and requirements for success identified. By taking the socio-economic perspective, the cases illustrate that initiatives can achieve returns of close to 200% on their total investment, and an average of about 80% over some nine years. These represent excellent returns from a wide range of benefits, but must be seen as longer-term investment to support a longer-term strategy for improving clinical performance. The EHR IMPACT study provides evidence on concrete implementations at the local and regional level. The gains from EHR and ePrescribing systems rely on access to information regardless of place and time, and from re-using information for multiple purposes. Without meaningful sharing and exchange of information, the gains would be marginal and not justify the cost of investments. The other is to ensure continuous engagement and a productive dialogue between clinical and administrative users on the one hand, and ICT experts on the other. Healthcare professionals, who are essential users of eHealth systems, are too often not sufficiently involved. It follows upon earlier research and adds well-founded empirical evidence to the pool of knowledge about the potential of “eHealth in the context of healthcare reform programmes”51. Further micro-level evidence has been collected in the context of the Good eHealth project (2006-2008)52, now followed up by the ePractice portal53. Good eHealth project sought to promote examples of good practices in eHealth which have not yet been so widely publicised. The goal was to make them available for use as good models and experiences. The objectives of this study were to identify good practices and their associated benefits, develop and implement proven approaches to wider dissemination and transfer real-life experiences, and stimulate and foster accelerated take-up of eHealth by addressing the common challenges of eHealth and lessons learned. Another currently running study is developing an evaluation methodology for telemedicine applications.54 4.1.3 Activities of EU Member States The topic of ex-ante impact assessment as well as of formative and ex-post summative evaluation has gained considerable momentum across Europe. The scope and procedures used are very diverse however, and a systematic comparison of approaches, techniques/tools applied and specific applications or processes evaluated is not possible. Countries with well advanced eHealth infrastructures and services have often carried out assessments of the benefits of their eHealth investments. A recent study55 on eHealth strategies in Member States has generated more knowledge on the topic at this point in time. Around one-half of the surveyed 33 countries (including the four home countries of the UK) mention a specific body of one form or another as being responsible for evaluation activities. These include: national eHealth-platform (Belgium), Estonia State Audit Office, Centro Nazionale per Informatica nella Pubblica Amministrazione (CNIPA, Italy), Department of IT of Ministry of Health (Lithuania), Centre for Health Economics (Latvia), National Institute for Health and Welfare - THL/Ministry of Health (Finland). Some mention a diversity of entities/agencies, two the involvement of research institutes. In decentralised healthcare systems such as Italy and Spain, regional evaluations prevail over systematic national level assessments. Some of these bodies have only recently taken up responsibility for the evaluation role and – from the evidence offered – have not yet finalised any particular evaluation. 51 Council Conclusions 1 December 2009, p. 2 http://www.good-ehealth.org/about/introducing.php 53 http://www.epractice.eu/ 54 MethoTelemed: http://www.telemed.no/methotelemed.4567567-51256.html 55 http://www.ehealth-strategies.eu/ 52 ARGOS PB Benefits, 19 October 2010 19 of 27 DRAFT for WDC WS on Nov. 12, 2010 Past Member State activities include: • A detailed German report focusing on the (additional) costs of the planned advanced electronic health insurance card and some of its planned applications, largely neglecting benefit aspects. • Selected Spanish activities like an evaluation undertaken within the framework of cooperation provided by the Quality Plan for the National Health System, within the context of an collaboration agreement signed by the Carlos III Health Institute, an autonomous agency of the Ministry of Health and Consumer Affairs, and the Department of Health of the Basque Country Government (OSTEBA). • During its recent EU presidency, the Swedish government commissioned a study on the benefits from eHealth56, which focused on rough estimates of the potential for benefits from eHealth implementations based on singular experiences being extrapolated to several countries and neglecting costs. Seven countries report on actual (Ireland, England, Switzerlan) or planned (France, Slovenia, Slovakia, Bulgaria) assessments of the impact of investments in the eHealth domain. As such analyses are expected to lead to an optimisation of resource allocations not only with respect to planned investments, but also for already running activities, one can expect more attention to be paid to such socio-economic and change management aspects in future.57 So far only a single country, Switzerland, has officially subscribed to undertaking an initial ‘rough’ and later a detailed Regulatory Impact Analysis (RIA) of specific eHealth legislation under discussion at the parliamentary level right now. RIA is a systemic approach to critically assessing the positive and negative effects of proposed and existing regulations and nonregulatory alternatives. As employed in OECD countries since 1974, it encompasses a range of methods. At its core it is an important element of an evidence-based approach to policy making. The United Kingdom is another exam-ple of almost continuous evaluations of the National Programme for IT (NPfIT) of the Na-tional Health Service in England by a wide variety of actors. A few Member States also mention EC co-financed studies which have provided them with some insights into the socio-economic impacts of eHealth solutions (Denmark, Malta, Sweden). The two studies cited were the Institute for Prospective Technological Studies (IPTS) commissioned study of state-of-play vis-à-vis eGovernment and eHealth in ten New Member States (2005-2008) and the EC-commissioned eHealth Impact study analysing 10 routine applications across Europe (Denmark, Sweden) (2005-2006). 4.2 United States of America evidence 4.2.1 USA evidence at the macro-level: diffusion and usage AMIA/Blackford please add a short summary 4.2.2 USA evidence at the micro-level: benefits assessment AMIA/Blackford please add a short summary 56 Cf. Ministry of Health and Social Affairs in Sweden (2009): eHealth for a Healthier Europe. Opportunities for a better use of healthcare resources. 57 Stand 2007: http://www.ehealth-era.org/documents/2007ehealth-era-countries.pdf ARGOS PB Benefits, 19 October 2010 20 of 27 DRAFT for WDC WS on Nov. 12, 2010 5 Research challenges and methodological issues encountered 5.1 Introduction Frame the issues 5.2 Gathering evidence at the macro-level: diffusion and usage From the OECD paper: At the OECD/ARGOS Barcelona meeting in March, the following concerns were raised over possible country-specific interpretations of the various indicators discussed: Possible Measures to Benchmark Adoption and Use of ICTs in the Ambulatory Sector Notes: The Table is adapted from the OECD‟s compilation of most common indicators to measure adoption and use of Health ICTs (from the report: “Achieving Efficiency Improvement in the Health Sector through ICTs”). The table does not list all of the variations in the data collections or the measurement units for the available indicators. The OECD „s study included the following countries: Australia, Canada, the Czech Republic, Finland, France, Norway, New Zealand, Spain, Sweden, the United States. It also included surveys from the European Commission and the Commonwealth Fund Participants are invited to consider: • • what are the potential "core" measures for all nations to track which of these measures may add value in surveys to measure ICT adoption ARGOS PB Benefits, 19 October 2010 21 of 27 DRAFT for WDC WS on Nov. 12, 2010 • whether a joint effort to standardize the definitions of these concepts is required The three individual countries that are listed were selected to provide a cross-national comparison. Canada, Australia, and the United States are three non-EU nations where ICT adoption has been measured at both the local and national levels through various surveys. Source: OECD Paper on Barcelona meeting, ANNEX III. However, it was noted that this would be resolved if the group could first agree on the meaning of the terms used. Participants agreed that a most promising approach today is to characterize ICT applications by the features and functions they offer. This approach provides a framework on which to base international agreement on definitions. Countries may have been surveying ICT adoption by health service providers for several years by now. This raises the question what such countries would gain from participating in an international exercise if benchmarking would primarily focus only on a first cluster of indicators (adoption). It would be more interesting to compare the adoption curve/rate of adoption of specific kinds of ICT applications with countries where there is scope to learn from other countries. The use of a “modular survey” approach may therefore be to be recommended. On next steps, the following was contemplated: • A feasible way forward would be to establish three/four small expert sub-groups tasked to create spanning definitions for the fifteen indicators. • The sub-groups should work primarily on-line and through an electronic discussion group. • Provided the groups could make some progress, the OECD could organise a follow-up meeting at OECD headquarters in Paris. 5.3 Assessing benefits and costs at the micro-level There are several limitations of presently undertaken individual eHealth evaluations, such as: • Benefits are not based on or measured with data from high quality (random) surveys, validated tools and survey instruments, or (in the extreme, randomised controlled) clinical trials (RCTs). • Data and attributes of cause and effect are not precisely aligned, and rely on assumptions and estimates • Only one, or too few, dimensions of eHealth are included in the evaluation • Limited account is taken of prerequisites and enabling investments, such as ubiquitous (broadband) communication networks • Economic evaluations do not deal with financing implications for healthcare entities like credit rating, affordability in the public sector • The characteristics of the healthcare setting and the idiosyncrasies of national health service systems are not properly dealt with • The impact on other entities, both within and outside healthcare, are excluded from evaluation, but are often very critical and may impact results considerably • Findings and conclusions cannot be validly transferred to other settings. For evaluations to be useful in advancing viable eHealth investment, it is essential that some of these factors are addressed. This will also allow a look "behind the scene", to attempt to identify and understand the reasons why at one site an eHealth investment indeed triggered a positive increase in efficiency, and why this did not materialise in another, perhaps very similar context. Citation from the report of the USA CBO58: 58 Congressional Budget Office (CBO): Evidence on the Costs and Benefits of Health Information Technology. The Congress of the United States - Congressional Budget Office, Washington,. DC, May 2008 ARGOS PB Benefits, 19 October 2010 22 of 27 DRAFT for WDC WS on Nov. 12, 2010 "The RAND researchers attempted to measure the potential impact of widespread adoption of health IT—assuming the occurrence of “appropriate changes in health care”—rather than the likely impact, which would take account of factors that might impede its effective use. For example, health care financing and delivery are now organized in such a way that the payment methods of many private and public health insurers do not reward providers for reducing costs— and may even penalize them for doing so. B The RAND study was based solely on empirical studies from the literature that found positive effects for the implementation of health IT systems; it excluded the studies of health IT, even those published in peer reviewed journals, that failed to find favorable results. The decision to ignore evidence of zero or negative net savings clearly biases any estimate of the actual impact of health IT on spending. B The RAND study was not intended to be an estimate of savings measured against the rates of adoption that would occur under current law, but rather against the level of adoption in 2004. That is, the researchers did not allow for growth in adoption rates that would occur without any changes in policy, as CBO would do in a cost estimate for a legislative proposal." "The potential of health IT to reduce spending for health care depends in large part on its ability to make care more efficient by cutting the cost of delivering services, avoiding redundant services, and improving providers’ productivity. Evidence from the literature on health IT, however, does not uniformly support the possibility of such savings. The potential for savings appears to depend heavily on their source and whether that source is in a hospital or in an ambulatory care setting (such as a clinic or a physician’s office). In addition, savings are difficult to assess because the trimming of costs in one area of a physician’s practice, for example, may be offset by increased costs or reduced efficiency in another area. Estimating the impact of some potential sources of savings, especially those arising from greater exchange of information among providers, insurers, and patients, is especially difficult because health IT networks are in an early stage of development. Furthermore, health care providers and hospitals that were early adopters of health IT may have been motivated by particular characteristics of their organizations or operations that made them more likely than nonadopters to achieve benefits from health IT—in which case the outcomes they have seen might not be generalizable. Evidence of savings in the health care sector as a whole from adopting health IT is also limited." "As discussed earlier with regard to the RAND study, reductions in the average length of hospital stays are unlikely to result in cost savings of a similar proportion to the reduction in average length of stay, such as that found by the Mekhjian research team (that is, of 5 percent or more). In particular, reductions in stays that stem from performing various hospital functions more quickly are not likely to cut costs as much as will reductions that result from improving care—for example, by diminishing the number of adverse drug reactions. Reducing the length of time required to process a lab test or diagnostic image from the time it is ordered to the moment the results are delivered only speeds up the delivery of care; it does not necessarily reduce the amount of care provided or its associated cost." Note on Gartner study for Sweden Presidency 200959: Study results are largely based on speculation ("could be avoided", "could be freed", "an opportunity for"), not on convincing evidence. For each "benefit" (p. 17) they mention only one source (p. 72 ff) - probably one can find many other sources with quite different or even negative values as well. Also - such studies are usually pilots etc., i.e. their extrapolation to the overall system is more than questionable (for 40 years we have now seen probably more than 10,000 of such reports on pilots, experiments etc. etc. (and, in small, shorter term studies you will usually find positive reactions - the Hawthorne effect is well known in methodology). Another aspect is that the good, intelligent, curious doctors engage in such studies, not the "average" ones. Cf. "The benefits presented in this chapter are projections based on evidence of benefits reported on individual [!] case studies." p. 19 [!!! - how can you generalise???] Gartner (prepared for the Swedish Presidency of the European Union): eHealth for a Healthier Europe! – opportunities for a better use of healthcare resources. 2009 59 ARGOS PB Benefits, 19 October 2010 23 of 27 DRAFT for WDC WS on Nov. 12, 2010 - you simply cannot directly compare the Dutch with the English, the French with the Swedish health system and apply data from one to the other (seems many extrapolations are based on NHS England data). Often even hospitals in neighbouring cities are very different and will, with the same technology, generate different outcomes. Note on present status and applicability of conventional HTA approaches to eHealth issues: Health Technology Assessments (HTA) are usually carried out in order to provide a particular competent health authority or stakeholder with information about accurate judgments on technologies, but limited by the respective idiosyncrasies of their health system. Even though some of the principles that inspire HTA should remain valid when assessing benefits and costs, eHealth solutions put ICT technology in a whole different context, also in terms of assessment. Virtually all of the detailed frameworks for HTA have been developed with more conventional technologies in mind: the term “technology” in HTA commonly refers to drug testing or medical devices, but not to health information technology based systems and solutions. HTA programmes, moreover, predominantly use integrative (meta-level) approaches, with particular attention to formulating findings that are based on distinguishing between stronger and weaker evidence drawn from already available multiple, primary data studies. Yet the very research challenge behind benefits assessment of health ICT solutions is to develop frameworks that are at all capable of producing primary data, as the lack of robust data and evidence, and the tools to arrive at, is the major deficiency that prohibits deployment, awareness and diffusion. 5.4 Assessing the anticipated clinical and socio-economic benefits from RTD initiatives More and more, even in the case of basic research initiatives and projects, like the European VPH initiative, RTD endeavours are being marked from the very beginning by a strong interest in early applications of their expected final results and outcomes to clinical practice, and a demand for measurable evidence that such complex technology is actually worth to society the cost and the complexity it involves. E.g., as the first wave of VPH projects is unravelling, and as the first batch of VPH technologies is getting closer to the time when they will enter first clinical trials, there is a growing attention within the VPH community to the issue of how to quantitatively assess these technologies in term of safety, efficacy, clinical and socio-economic impact. A first, apparently trivial answer to this question is “Health Technology Assessment” (HTA). In many contexts, it has become the preferred approach for policymakers to base decisions on health technology investments and reimbursement policies on factual evidence, gained as independently as possible from the many biases that tend to revolve around the introduction of a new health technology. HTA embraces a diverse group of methods that can be grouped into two broad categories. Primary data methods involve collection of original data, ranging from more scientifically rigorous approaches such as randomized controlled trials to less rigorous ones such as case studies. Integrative methods (also known as "secondary" or "synthesis" methods) involve combining data or information from existing sources, including from primary data studies. These can range from quantitative, structured approaches such as meta-analyses or systematic literature reviews to informal, unstructured literature reviews (Goodmann, 2004). However, VPH technology is so radically different from anything else used in hospitals that a systematic assessment is required already in the phase where specific tentative clinical indications are being searched. Due to its very innovative nature, medical professionals have no general understanding of the potential of VPH technology, and thus have difficulties in driving the process that associates the output of such basic technological research to the solution of a concrete clinical problem. Whereas 99% of diagnostic medical technology measures one specific variable, VPH technology does something radically different: it predicts. It generates new knowledge from a set of individual patient and cohort data. Different to clinical decision-support systems, this knowledge is not already available somewhere, it is new and original, and not in ARGOS PB Benefits, 19 October 2010 24 of 27 DRAFT for WDC WS on Nov. 12, 2010 possession of the medical professional (although to be clinical useful, this knowledge needs to be integrated and combined with that of the medical professional). In addition, the integrative nature of most VPH technology implies that the knowledge that emerges cannot be linearly derived from the available data, but it results form complex non-linear interaction between various sets of information. This means also that no clinician can assess the validity of such a prediction just by looking at it. All of this implies totally new challenges for benefits assessment and requires new approaches and methods to be defined and identified in some detail. There is need for a more dynamic approach to impact assessment of medical technologies, and in particular of VPH-based health technology. The purpose of many impact assessments involving clinical assessment of medical technologies is to measure the change of cost-benefit ratio during the development and during the early phases of innovation, often for each stage of development and prototype, and dynamically per each year. Therefore we need an approach that also takes into account the technology dynamics by emphasizing socio-dynamic processes. Similar to the so called constructive technology assessment (CTA) (Douma, Karsenberg, Hummel, Bueno-de-Mesquita, & van Harten, 2007), first described in the 1980s, a comprehensive assessment can be combined with an intentional influence in a favourable direction to improve quality (related to so-called formative evaluation). Early assessments (including feedback into ongoing developments -- “action‐oriented assessments”) occur, but choices will be primarily about promises: the role of expectations and promises (and concerns), and the need to understand their role in ongoing developments. Using VPH here only as an example, we expect that future eHealth technologies will need a whole new assessment framework, significantly different from those currently available, and deeply entangled with the design and development phases of these eHealth solutions. 6 Experiences, lessons learned, needs for future actions to be done later Question: Use an integrated approach mingling EU and USA perspectives and lessons learned, or report separately on this here? 6.1 Macro-measures: OECD suggests to use its model survey framework which takes a staged approach in moving international measurement work forward. To be useful in all contexts, a „model survey‟ is composed of separate, self-contained modules that ensure flexibility and adaptability to a rapidly changing environment. The use of core modules (as an add-on to existing country surveys or as a stand alone survey) allows measurement on an internationally comparable basis. Additional modules and new indicators can be added to respond to evolving or country-specific policy needs in this area. At the OECD/ARGOS Barcelona meeting, it was suggested to organise macro measures according to the following four categories or steps: 1. Adoption 2. Modes of Use/Purpose of Use 3. Critical Success Factors 4. Outcomes/Impacts 6.2 Micro measures ARGOS PB Benefits, 19 October 2010 25 of 27 DRAFT for WDC WS on Nov. 12, 2010 6.3 Measures related to RTD activities in eHealth 7 Recommendations for transatlantic exchange, policy harmonisation, collaborative initiatives to be done later ARGOS PB Benefits, 19 October 2010 26 of 27 DRAFT for WDC WS on Nov. 12, 2010 References ARGOS PB Benefits, 19 October 2010 27 of 27