eHealth & Telemedicine Projects

The recent European Union "Directive on the application of patients' rights in cross-border healthcare" stipulates in Article 11 the "Recognition of prescriptions issued in another Member State" for dispensation in any other Member State. (see: http://eur-lex.europa.eu/) It mandates the adoption of guidelines supporting Member States in developing and implementing the cross-border interoperability of ePrescriptions without prejudice to national rules.

The key goal of the cross-border ePrescription study (commissioned by DG SANCO through its Executive Agency for Health and Consumers ) is to produce a first draft of such guidelines on interoperable ePrescriptions. In the first phase of the study, empirica and its partners will analyse the present status of ePrescription in Member States of the European Union, identify already available guidelines at country level and related good practice, and explore the feasibility of such guidelines as well as the level of detail which may be appropriate to achieve the objective of a single market also for prescriptions on medicines and medical devices for patients. The ePrescription use case underlying the work in the study will be the epSOS (www.epsos.eu) cross-border use case.

Based on this analysis, and with input from European experts on policy, organisational, legal, technical and semantic interoperability challenges, during the second study phase guidelines will be drafted, validated, refined and delivered to the European Commission. Initial results are expected in the second half of 2012. Final results will be presented in the fall of 2013.

The ProeHealth study aims to improve the procurement of ICT solutions for healthcare by providing guidelines for the organisations involved in the procurement process. Both public and private healthcare organisations are included in this. The guidelines will be there to help them from the stage of planning procurement, as it arises that adopting an eHealth solutions is the most suitable approach, following up with instructions for transfer of planning to the procurement specification and finally the procurement process.

The question could be raised as to why such guidelines are necessary. The answer to this is that procuring eHealth solutions is a complex procurement process, quite different to other types of procurement. Experience shows that this complexity can lead to disappointing results. Often, expected benefits are not achieved or value for money is lacking. This leads to the conclusion that support is needed for those carrying out the procurement of eHealth solutions. Further proof for this hypothesis is the lack of any existing procurement guidelines which address eHealth components specifically.

The focus of this Thematic Network is the re-architecting of healthcare services towards a patient centric cooperation of actors and the meaningful integration of information. A roadmap will be developed towards achieving personalised health services and a supportive eHealth infostructure, which would support virtual teams working efficiently and effectively at enabling and empowering patients to play greater roles in their own health and wellness. Special emphasis will be put on chronic disease management for an ageing population. eHealth Innovation will develop consensus among stakeholders and produce a roadmap towards making interoperable eHealth services deployed at large scale in Europe, thereby also supporting patients in managing their health. The resulting requirements for a supportive infostructure and for further innovation measures are further objectives.

In total, five workshops will be organised around thematic areas such as chronic disease management for an ageing population, personal health systems and the requirements for an EU-wide eHealth infostructure. The workshops will each produce validated reports and recommendations on their respective topics. The cumulated results will feed into a final validated roadmap.

Project website: www.ehealth-innovation.eu/

Healthcare is facing increasing quality and resource challenges and telemedicine is often regarded as part of the solution. Numerous pilots are underway, but will these telemedicine services really make healthcare more efficient? Will they increase access, quality, safety of care? And what added value can satellite communication bring to such services? These are questions the ASSIST study aims to address by developing comprehensive methods and easy to use toolkits for telemedicine assessment, which help pilot projects to objectively and rigorously evaluate their solution from an evidence-based multi-stakeholder perspective. ASSIST is funded through the ESA's General Studies Programme (GSP).

More information and project website: http://iap.esa.int/Useful-Resources/ASSIST

The project defines, delivers and pilots a digital infrastructure supporting coordinated cross-sector delivery of timely support to prevent older people from slipping out of safe independent living, maintaining quality of life. The infrastructure enables support services to overcome limitations of sectoral telehealth and telecare and empowers informal carers and the voluntary / third sector to participate in delivery of support, thus radically improving efficiency. The innovative new services are piloted at six sites across the Europe. The project brings together 20 organisations across 6 Member States representing all major stakeholders in the "value chain" of support to older people, from public authorities and social and health service providers to global industry players and specialist SMEs.

More information and project website: http://www.independent-project.eu/

Against the background of the fact that the use of telemedicine services is still limited and the market for devices remains highly fragmented, despite the potential benefits and the technical maturity of many applications, the study explores the European space in terms of the deployment of ICT-enabled care services, to learn from successful examples, and to adapt policies and incentive structures. In an effort to address these needs, the study demonstrates the gains in promoting the de-ployment of home care services using ICT and facilitate the exchange of good practices. The study develops the following key outputs: a consistent, rigorous, and realistic conceptual and methodological design of the study, including clustering of models of long-term care, a choice of 10 national cases, and the structure of a scoreboard on innovation, a scoreboard on the openness to innovation of national models of long-term care in the area of ICT-enabled home care services, set up around a set of macro-categories related to the openness to innovation, a validation workshop of one day, informing relevant stakeholders and experts about, and collecting their views on the interim study findings, as well as more general views, especially on current and future developments in the area of the study and policy implications, a set of analysed good practices in innovative, ICT-enabled of home care services for older people with chronic diseases, covering all six macro-categories of the scoreboard, and several clusters of national long-term care models, a set of relevant, well grounded, and clear policy recommendations, supporting further policy developments at European level to promote the deployment of ICT-enabled home care services, their ongoing monitoring, and the exchange and transferability of good practices across Europe, and adequate promotion of the main findings of the study. The project covers all EU Member States with more intensive activities in 10 countries to be supported by experts and national correspondents from empirica's ENIR network (www.enir.org) in the different countries.

NMS Physiome is a Virtual Physiological Human (VPH) cooperation of the worldwide largest research projects focusing on simulating the musculoskeletal apparatus, the Osteoporotic Virtual Physiological Human (VPHOP) integrated project, with the Center for Physics-based Simulation of Biological Structures (SIMBIOS) at Stanford University, USA.
The Stanford Center for Physics-based Simulation of Biological Structures (SIMBIOS) provides infrastructure, software, and training to help biomedical researchers understand biological form and function as they create novel drugs, synthetic tissues, medical devices, and surgical interventions. The cluster of projects connected to the SIMBIOS Center is investigating a wide scale of biological structures – from molecules to organisms. In particular, the team of one of the two Principal Investigators of SIMBIOS, Scott Delp, based at Stanford University, focuses on the accurate modelling of the neuro-musculoskeletal system. Activities are funded by the USA National Institute of Health.
Empirica is a partner in this project, together with the BioComputing Competence Centre (B3C) of SCS srl in Bologna, Italy, and the Centre for Computer Graphics & Visualisation (CCGV) at the University of Bedfordshire.

The overall goal of the EU-USA ARGOS eHealth Pilot Project is to contribute to establishing a "Transatlantic Observatory for Meeting Global Health Policy Challenges through ICT-Enabled Solutions" in order to develop and promote “Common Methods for Responding to Global eHealth Challenges in the EU and the US”.The Observatory will promote mutual understanding and learning among EU and US policy researchers and policy makers on the following general challenges with global dimension:

1. Improving health and well-being of citizens through accelerating eHealth strategy development and through supporting large scale eHealth infrastructure implementations;
2. Supporting R&D in eHealth to promote the benefits from the pursuit of consistent strategies.

In the ARGOS eHealth project, the following specific target areas will be addressed:

• Interoperability in eHealth and certification of Electronic Health Record systems (EHRs);
• Definition of a common, consistent approach and identification of indicators and tools for measuring the adoption, usage and benefits of eHealth;
• Modelling and simulation of human physiology and diseases with a focus on the Virtual Physiological Human (VPH) and the use of such solutions to support the diagnosis and treatment of rare diseases.

Key outputs for each of the three topics are:

• a comparative analysis of current US and EU approaches;
• workshops in the US and the EU involving the different stakeholder groups;
• interim reports and publications (Policy Briefs: one per target area, three separate brochures) documenting the subprojects’ findings and recommendations (in web- and printed version);
• the “ARGOS project finale” global conference.

empirica leads one of three work packages, concerned with “Definition of a common approach measuring the adoption, usage and benefits-costs of eHealth”. This work will involve the USA Office of the National Coordinator (ONC) for Health IT, the National Institutes of Health (NIH), Harvard University, and the American Medical Informatics Association (AMIA) as coordinator on the USA side.

Smart Personal Health is a European Commission support action to promote awareness about issues and challenges of interoperability among personal health systems (PHS) and to other eHealth systems. The project will substantially assist the drafting of health policy by proposing recommendations for interoperability promotion to the European Commission, regional and national governments, stakeholder groups and industry.
Key activities of SmartPersonalHealth will include three thematically focused stakeholder workshops Barcelona, Belfast, and Berlin and conclude with a pan-European interoperability conference during the Continua Winter Summit 2010. Further networking and dialogue with healthcare providers, patients, industry, insurers, standards development organisations will be carried out.
The workshops and networking will result in a report addressed to the European Commission highlighting the current status, concerns, barriers and incentives to accelerate the development and adoption of interoperable PHS systems. A final report on key interoperability challenges for personal health systems and recommendations for respective policy actions will merge results from the many stakeholder dialogues, integrated with research outcomes from empirica’s experts.
Partners are Continua, the global industry consortium to promote the interoperability of PHS devices and systems, ETSI, the European Telecommunications Standards Institute, responsible for standardization of ICT within Europe, IHE, worldwide reference organisation for the interoperability of healthcare information systems and devices.

The eHealth Strategies study will assess the progress made by EU-Member States in their efforts towards realising the goals of the European Union eHealth Action Plan. This strategy document, published by the European Commission in 2004, identified fields of required action to achieve eHealth interoperability in Europe. Building on the insights of the eHealth ERA project (final results brochure), which was also commissioned to empirica, the study team will describe, measure and assess:

• national eHealth policies, strategies and implementation measures
• progress achieved, focusing on selected eHealth Action Plan priorities
• European and national actions which may support the further realisation of the eHealth Action Plan

At the end of the study, a summary European level progress report will be published. It will include

• main findings and an assessment of progress made by Member States and other European countries towards realising key objectives of the eHealth Action Plan,
• lessons learned in this context and best practices from national eHealth programme planning and implementation,
• recommendations on areas where EC support as well as further coordination and collaboration among Member States may be warranted.

The overall goal of this study by empirica GmbH (Bonn, Germany) and data information intelligence GmbH (Leipzig, Germany), is to provide statistical insights on the current state of deployment of eHealth across Europe and to define an appropriate longer-term procedure for estimating and assessing the eHealth market and its potential, thereby supporting COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry) and industry in their efforts towards developing the European and global market and realising the benefits of eHealth. The specific objectives are to:

• Identify and collect existing market (research) data which can be used to produce an initial market sizing and 5 years forecasts for the overall eHealth or HC ICT market across Europe.
• Provide a segmentation in terms of products/solutions, geographies and customers.
• Design a comprehensive, consistent research and methodology framework as a fundamental step towards a more comprehensive market research and analysis activity as continuation of this market sizing and forecast exercise, which will evolve over the years to come.

The study aims to cover as many of the 27 EU Member States plus Norway and Iceland as feasible and where such data can be obtained within the temporal and budgetary limitations of the study.

This is the second study in a series of three linked studies to develop eHealth benchmarking at European level. The study will cover all 27 EU Member States plus Norway and Iceland as well as Canada and the USA. It will conduct background research and review existing measurement tools and systems for ICT for Health, as well as available eHealth statistics, in order to establish a framework for data compilation and to make progress towards the future establishment of an effective eHealth benchmarking system in Europe, collect the data on an agreed set of eHealth related phenomena from existing sources including professional bodies and regional and national ministries. The study will compile data from existing sources rather than generate original data and – depending on the data availability – provide a measurement for each of the agreed indicators in each country, identify, analyse and report good practice in developing and applying eHealth measurements and benchmarking frameworks for informing policy-making (in all 29+2 countries), and develop and deliver 29(+2) Country Briefs summarising key results for each of the European countries and plus Canada and the USA and make all study results available through a dedicated Online Knowledge Base. Thus this study will significantly enhance the capacity of the i2010 initiative to achieve its goals in relation to monitoring and benchmarking eHealth, a key aspect of information society developments in the old and the New Member States.

In 2004, Europeans made approximately 180 million trips of four nights or more outside their own country. Ensuring their access to seamless and safe healthcare has become a top priority for the European Commission. Information and communication technology plays a key role in this process as it facilitates the transfer of vital medical data across borders. So far, national health IT solutions have coexisted without any interaction. The EC funded Smart Open Services project will for the first time unite key Member States and industry players in a joint effort to get medical data and prescription information to any doctor in the Union - when and where it is needed, and in comprehensible form.

The EC Large Scale Pilot in eHealth aims to develop "Smart Open Services" providing patients travelling across Europe access to the same quality of care as in their home country. As its acronym "S.O.S" suggests, one focus is on getting medical data to doctors urgently when needed, another is on enabling patients travelling in another country of the EU to use a local pharmacy to obtain their prescription medicines ("e-prescription").
The proper consent of patients is crucial to the acceptance of these services. In meeting patient concerns about unauthorised access or loss, the project will build on the now extensive knowledge available and on reliable and safe methods to store and transfer personal data. Building on national initiatives, it is expected that a minimum data set, incorporating emergency and demographic data, can be agreed upon. Limiting the data set facilitates translational work and ensures that the doctor in charge of the treatment fully understands the patient's data - which may be coming from a country with a different language than the doctor's own. Citizens can thereby be sure to receive appropriate medication and care. To achieve the new services, the participating countries will for the first time establish IT links between their healthcare systems.

The Smart Open Services project has the potential to lay the groundwork for a future pan-European eHealth infrastructure which would revolutionise healthcare provision by reducing medical errors and avoiding unnecessary treatment.

This study for the European Commission will make a substantial contribution towards accelerating the implementation of the European eHealth Action Plan. Specifically, the study will actively support ongoing initiatives and implementation work on interoperable EHR and ePrescribing systems by illustrating and widely spreading new knowledge about their socio-economic impact and lessons learned from successful, beneficial applications.

The value added by eHealth will be measured in quantitative terms based on a small number of successful implementations covering a wide variety of types of applications, of healthcare provider organisations and health systems, and of local, regional or even national frameworks. Whereas the individual examples will provide insights on success factors and requirements, the aggregation of results will allow to draw macro level conclusions.
It is foreseen that the study will deliver the following key outputs:

• A methodology for evaluation of the socio-economic impact, tailored to the context of interoperable EHR and ePrescribing systems
• Ten evaluated good practice case studies
• A validation and dissemination workshop in Brussels, at which preliminary results will be presented for in-depth discussions with selected global experts
• Synthesis of outcomes, providing insights on the socio-economic impact of interoperable EHR and ePrescribing systems, on critical success factors in the process of design, development, piloting, implementation, and routine operation, on lessons learned, and finally on implications for European and Member State health policies.

Best results have been obtained when involving local doctors, nurses and other stakeholders, experts and promoters who have a good integrative understanding of medical/clinical, health policy and ICT-related issues and who are aware of new developments and emerging technologies.

EU FP7 Large-scale integrating project: develop a multiscale modelling technology based on conventional diagnostic imaging methods that makes it possible, in a clinical setting, to predict for each patient the strength of his/her bones, how this strength is likely to change over time, and the probability that the he/she will overload his/her bones during daily life. With these three predictions, the evaluation of the absolute risk of bone fracture will be much more accurate than any prediction based on external and indirect determinants, as it is current clinical practice. These predictions will be used to: i) improve the diagnostic accuracy of the current clinical standards; ii) to provide the basis for an evidence-based prognosis with respect to the natural evolution of the disease, to pharmacological treatments, and/or to preventive interventional treatments aimed to selectively strengthen particularly weak regions of the skeleton. For patients at high risk of fracture, and for which the pharmacological treatment appears insufficient, the VPHOP system will also assist the interventional radiologist in planning the augmentation procedure. The various modelling technologies developed during the project will be validated not only in vitro, on animal models, or against retrospective clinical outcomes, but will also be assessed in term of clinical impact and safety on small cohorts of patients enrolled at four different clinical institutions, providing the factual basis for effective clinical and industrial exploitations.

EU FP7 Large-scale integrating project: Based on advanced text, image and structured data mining of about 3m individual patient data from various hospitals new knowledge and decision support will be developed to improve patient safety in antibiotic use, to fight the fast emergence of resistances among pathogens, misuse and overuse of antibiotics.

In half a century of antibiotics use, new challenges have surfaced: the fast emergence of resistances among pathogens and the overuse of antibiotics. Antimicrobial resistance results in escalating healthcare costs, increased morbidity and mortality and the (re-)emergence of potentially untreatable pathogens. For infectious diseases DebugIT will

• Detect patient safety related patterns and trends
• Acquire knowledge
• Invest this knowledge to upgrade quality healthcare.

The DebugIT project, with its innovative approach, is a prime example of how ICT tools can be used to address the emerging challenges in healthcare. This project addresses several of the overriding call topics at once by tackling the problems around antibiotics and of antimicrobial resistance of infectious diseases in an international consortium uniting world class research facilities, SMEs and industry partners.
It is an example of partnering at the European level to keep pace with soaring research costs by making use of complex IT technology technologies. This program addresses the main socio-economic challenges in healthcare, namely to make Europe's healthcare systems safer and sustainable.

EU FP7 Large-scale integrating project: An advanced telemonitoring approach will be developed to close the loop between patients and professionals, giving appropriate access to monitoring, diagnosis and treatment results and reacting immediately, adapting personalized care plans and using automated decision support to derive therapy recommendations.

Each year Cardiovascular Disease (CVD) causes over 1.9 million deaths in the EU, causing direct health costs of €105 billion. Coronary Heart Disease (CHD), half of all CVD deaths, is the single most cause of death in Europe. Heart Failure (HF) – a CHD being the most frequent cause of hospitalization for people over 65 – has 10 million patients in the EU. Current treatment of HF entails recommendations from clinicians on medication, diet and lifestyle. Patients only receive feedback at doctors visits, or when facing symptoms. Daily monitoring, close follow up, and help on treatment routine is lacking. Non-adherence to the treatment regime is a major cause of suboptimal clinical benefit.
HeartCycle will provide a closed-loop disease management solution to serve both HF and CHD patients, including hypertension, diabetes and arrhythmias as possible comorbidities. This will be achieved by multi-parametric monitoring of vital signs, analysing the data and providing automated decision support, to derive therapy recommendations.

European Commission, Directorate General for Public Health-supported project to improve the involvement of patient associations in health-related European studies and research.

Based on the WHO definition:

Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity,

we have in recent years seen a shift in health policy priorities towards considering a broad spectrum of citizen and patient needs. Globally, health system policy makers are now subscribing to the new paradigm of citizen or patient-centred services. If empowering the citizen is to imply more than just generic policy declarations, one needs to provide him with the means and tools to become a well-informed and self-assured patient, to involve him in decision processes in a way best suited to his level of understanding and knowledge, and to provide him with optimal medical services in situations when he does not want to, or is physically or mentally unable to be part of such processes. Value Plus will provide patient organisations with the tools to influence policy-making at EU-level and to participate in EC-funded projects of concern to their constituency. Empirica is supporting these efforts through the statistical analysis of past and ongoing EC-funded projects which show elements of patient involvement to derive insights on barriers and facilitators for greater patient involvement.

Mobility of people is increasing, products and services can be bought in another Member State when the need arises, but obtaining healthcare outside their residence country is still problematic for many Europeans. And this in spite of the legal framework for healthcare provision across Member States having been set up already in 1971 by the EU and its Member States with the so-called E-forms and the later European Health Insurance Card (EHIC). However, knowledge about this is not wide spread, and the administrative processes accompanying cross-Member State provision of healthcare have not developed at the same pace as leisure travel and labour mobility. To alleviate this situation, the TEN4Health project contributes towards improved healthcare provision for mobile European Union citizens. Initiated by leading public health insurance providers, the TEN4Health service package assures access of citizens to healthcare in participating Member States’ hospitals, based on a secure web service and its integration into developing European eHealth infrastructure networks.
The package’s key components include:

• information on local rules, co-payments and other aspects of healthcare for citizens in their respective language at the point and time of treatment abroad
• instantaneous online verification of insurance status for healthcare providers and as-surance of cost coverage
• efficient support for fast electronic post-processing at the national level
• electronification of reimbursement procedures across Member State borders, with special attention to interoperability.

Despite the relatively slow implementation of eHealth in Europe, many eHealth developments have nevertheless been successfully implemented. These implementations constitute a source of valuable experience and of examples of good practices which to date have not yet been properly communicated for emulation and exploitation.
The objectives of this study are thus to:

• Identify good practices and their associated benefits;
• Develop and implement common approaches to wider dissemination and transfer of learning experiences;
• Stimulate and foster accelerated uptake of eHealth by addressing the common challenges of eHealth and common lessons learnt.

ICT can make a vital contribution to improving the safety of European patients by helping to reduce medical errors and other negative incidents, thereby saving lives, and enhancing efficiency, in particular in the field of risk management in healthcare. The eHealth for Safety study has the following overarching goals:

• Identifying key issues, topics and challenges where ICT can have a high impact on patient safety and risk management in healthcare, and which have particular relevance in the European context, as well as on the level of the Member States
• Developing both a ten year vision/strategy and concrete recommendations for RTD measures (within the EU’s 7th framework programme and for longer term research activities)

These goals translate into a three-phase approach, consisting of (1) baseline research, (2) empirical analysis, and the development of (3) a synthesis report as well as a roadmap for further research. Good practice case studies will form part of the study in order to demonstrate concrete applications of ICT tools to enhance patient safety.

The semantic aspects of interoperability have only recently been recognised as the major enabling factor for the safe and sensible communication of patient data. Health language is very large and diverse, and as such not equalled by other professional languages. This SemanticHEALTH SSA develops a European and global roadmap for deployment and research in health-ICT, focusing on semantic interoperability issues of e-Health systems and infrastructures. The roadmap will be based on consensus of the research community, and validated by stakeholders, industry and Member State health authorities. It

• identifies key short-term (2-5 years) and medium-term (4-10 years) needs to achieve semantic interoperability of e-Health systems
• analyses unsolved issues arising in the context of realistic approaches to priority clinical and public health settings
• takes account of the impact of non-technological (health policy, legal, socio-economic)aspects
• reflects and integrates results of related FP6 studies.