Developing national eHealth infrastructures – results and lessons from Europe

Abstract

The European eHealth Strategies study analyzed policy development and strategy planning, implementation measures as well as progress achieved with respect to national and regional eHealth solutions in 34 European countries, with emphasis on barriers and enablers beyond technology. The focus was on infrastructure elements and selected solutions emphasized in the European Union eHealth Action Plan of 2004. At the governance level, issues around administrative responsibility and competence centers, stakeholder engagement, legal and regulatory facilitators, financing and reimbursement, and evaluation activities were surveyed. Solutions analyzed included patient summaries and electronic health records, ePrescription, telehealth, electronic identifiers, eCards as well standardization aspects. Results indicate that across Europe eHealth has matured from a policy debate to a very tangible, implementation oriented endeavor.

Introduction

Following the Communication of the European Commission (EC) on “eHealth – making healthcare better for European citizens: An action plan for a European eHealth Area”,¹ Member States of the European Union (EU) have committed themselves to develop and issue national eHealth strategies and implementation roadmaps – plans for the deployment of eHealth applications addressing policy goals identified in this eHealth Action Plan. Various non-Union European countries also followed this vision. Whereas some years ago, Union Member States had published only mostly high level official policy documents or statements of intent (roadmaps) on their eHealth implementation strategies, by 2010 almost all countries had drafted detailed documents outlining concrete eHealth goals, implementation measures and past achievements.

The 2004 eHealth Action Plan directed the European Commission to also regularly monitor the state of the art in deployment of eHealth, the progress made in agreeing on and updating national eHealth roadmaps, and to facilitate the exchange of good practices. Furthermore, in December 2006 the EU Competitiveness Council agreed to launch the Lead Market Initiative² as a new policy approach aimed at creating markets with high economic and social value, in which European companies could develop a globally leading role. Following this impetus, a European roadmap for implementation of the “eHealth Task Force Lead Market Initiative” identified better coordination and exchange of good practices in eHealth as a way to reduce market fragmentation and lack of interoperability.³

On the more specific aspects of electronic health record (EHR) systems, the recent EC Recommendation on cross-border interoperability of electronic health record systems⁴ noted under “Monitoring and Evaluation”, that “in order to ensure monitoring and evaluation of cross-border interoperability of electronic health record systems, Member States should consider the possibilities for setting up a monitoring observatory for interoperability of electronic health record systems in the Community to monitor, benchmark and assess progress on technical and semantic interoperability for successful implementation of electronic health record systems.”

The eHealth Strategies study, on which this paper is based, provided a contribution to monitoring the progress made in establishing national/regional EHR systems in EU Member States and other European countries. It provided not only an assessment of progress made towards realising key objectives of the eHealth Action Plan across Europe, but presented also a wide variety of good practice examples and lessons learned from national eHealth programmes and related planning and implementation efforts.

Methods

The research covered the 27 Member States of the European Union, including the United Kingdom with its four home countries England, Northern Ireland, Scotland and Wales and their respective national health services, plus Iceland, Norway, Switzerland and Turkey.

The methodological approach conceptualizes the health(care) system as a value system of a wide variety of cooperating health service providers, each of which has to manage its own health value chain. “Gaining and sustaining competitive advantage depends on understanding not only a firm’s value chain but how the firm fits in the overall value system... Competitive advantage is increasingly a function of how well a company [here: a healthcare provider] can manage this entire system. Linkages not only connect activities inside a company but also create interdependencies between a firm and its suppliers and channels.”⁵ At the core lies the generic health service delivery system, which consists of interrelated value chains of individual health service providers. Together they ‘produce’ and sustain health by promoting good health and well-being, supporting disease prevention, undertaking diagnostic and therapeutic interventions, providing healthcare, rehabilitation and long-term care services. To enable health delivery, supporting processes as well as facilitating tools and services are necessary, connected to and interconnecting these core processes. Only as a complex, dynamic ecosystem of interrelated processes all of these effectively lead to health for all citizens.

For purposes of this research, the supporting information and communications technologies (ICT) infrastructure, tools and services were of key relevance. As an initial step, key objectives, applications and challenges as outlined in the European eHealth Action Plan of 2004 were identified and, with the support of the conceptual model, defined and grouped.

Next, national level information was collected through a Europe-wide network of national correspondents. The key tool used to collect this information was an online survey template, consisting of six sections:

1. National eHealth strategy

2. eHealth implementations

3. Legal and regulatory facilitators

4. Administrative and process support

5. Financing and reimbursement issues

6. Evaluation

Under each of these six sections, a range of questions was formulated and drop-down menus provided for specified answer options. Free text fields allowed for further qualified input.

The drop-down menus were designed for two purposes: to capture dates and stages of development (planning/implementation/routine operation), and to focus the number of possible answering options on key topics, for example with regard to issues included in a strategy document or specific types of telemedicine services. This limit on the number of options also allowed for a more uniform comparison across countries.

Concerning eHealth implementations, questions regarding the following applications were formulated: existence and deployment of electronic patient and healthcare provider identifiers and the usage of eCards, electronic health record (EHR)-like systems and/or patient summaries, ePrescription, technical and semantic standards, telemonitoring and telecare.

Data gathering followed a step-wise approach. In order to create a baseline for the assessment of progress, the research team filled in the questionnaire by using data from earlier eHealth ERA reports and various case studies. Most of this information was from 2006. Next, the study team experts and national correspondents filled in the template on post-2006 developments in the health(care) sector of the corresponding country.

All results were checked, revised where necessary and validated. In addition to the internal quality review procedures within the study team, the country reports were validated by national eHealth ministerial representatives of all 34 countries reported on, and/or by respective national experts.

The summary empirical results are based on detailed analyses and integration of data from individual country reports by the study team. This involved a preliminary assembly of structured qualitative and quantitative data into spreadsheets, followed by internal meetings and workshops to arrive at a common interpretation of the data collected. Furthermore, information available in the grey and white literature, feedback received from country representatives and experts as well as the knowledge and experience of the study team all contributed to the final outcome.

In spite of all these efforts to provide balanced results derived from research attempting to adhere to high methodological standards, one needs to be aware that a fundamental problem of the work undertaken is that the results presented will nevertheless be subjective and disputable, both by theoretical necessity and empirical insufficiency, including limited resources to undertake such comprehensive, far reaching research. Unlike in physics the study of social systems will always be prone to subjective measurements and interpretations.

Results

Key activities and progress:

The following overview (Table 1) identifies key fields of national level activities and the considerable increase recorded between 2006 and today:

Table 1:

Key fields of national level eHealth activities in the EU27 countries, 2006 and 2010

Reported eHealth activities	Total 2006 eHealth ERA	Total 2010 eHealth Strategies	Delta
EHR Patient Summary	27	27	0
ePrescription	16	22	6
Telehealth	23	27	4
Patient ID	24	26	2
Professional ID	13	22	9
Citizen card	22	25	3
Professional card	7	18	9
Standards (technical/semantic)	19	27	8
Legal activities	14	22	8
Evaluation	5	21	16

Source: eHealth Strategies study, 2010.

Note: The results of non-EU countries were not integrated due to missing data for 2006. The data of England, Northern Ireland, Scotland and Wales were aggregated into United Kingdom.

Whereas patient summary or electronic health record (EHR)-like systems have been high on the agenda for quite some time, most Member States (+16) now realize the urgent need of evaluation activities to better control policy progress and learn from experience. Further services high on the agenda are the electronic transfer of prescriptions and the provision of telehealth services (e.g. for doctors and patients in remote regions or for chronically ill patients living at home). Both of these are among key activities identified in the EC’s 2004 eHealth Action Plan.

Governance - national leadership and competence centers:

Survey results show that the more advanced countries are characterized by either a more top-down health system structure like in several northern countries, and/or by undertaking a comprehensive eHealth policy dialogue leading to well defined goals specifying where eHealth solutions are expected to substantially contribute to better services. However, experience in most countries has also shown that reaching agreement about eHealth strategies and, even much more so, implementing them has proven to be much more complex and time-consuming than initially anticipated. In addition, the complexity of eHealth as a management challenge has also been vastly underestimated.

An indication of the strong political commitment at the national policy level in many countries is the growing establishment of permanent administrative support structures. National competence centers such as gematik (Society for Telematic Applications of the Health Card) in Germany, ASIP - Agence pour les Systèmes d’ Information de santé Partagés in France, or THL National Institute for Health and Welfare in Finland are increasingly being created, or expanded to also cover eHealth infrastructure requirements.

EHR-like systems:

Touted for 20 or more years as the ‘holy grail’ of eHealth, so-called electronic health record (EHR) systems are a consistent element in all national strategies and roadmaps. But usually they are not well and/or consistently defined, often (implicitly) referring only to a patient summary or similar basic electronic patient record system. Furthermore, whereas EHR-like systems have been implemented or are under development in many healthcare provider organizations, covering patient data from within their own organizational boundaries, and also in various regional healthcare systems, there exist hardly any at the national level. The urgent clinical need for large-scale national systems is being questioned more and more, as a recent English evaluation noted: “Clinicians’ enthusiasm for electronic health records often related to perceived benefits on their immediate surroundings and did not necessarily relate to the NHS Care Records Service goal of geographically widespread sharing of patient data.”⁶ The protracted or initially failed implementation of such systems in countries like England, France or Germany also signal that their complexity has been under- and their necessity overestimated. Of course, within small countries and regions the situation turns out to be different.

This assessment is also reflected by the epSOS (Smart Open Services for European Patients) project undertaken by 23 Member States and other European countries.⁷ It pilots interoperable cross-border services for the exchange of basic patient summary data and electronic prescriptions only - not a complete EHR. Considerable benefits expected for citizens will be the improved quality of health services they receive when abroad and in need of help due to basic information available to the treating professional in her or his own language.

The current stage of implementing patient summary and EHR-like systems in Europe is shown below (Table 2).

Table 2:

Deployment stage of patient summary and EHR-like projects in European countries, 2010

Planning	Implementation	Pilots	Routine	Sum
19	5	2	7	33

Source: eHealth Strategies study, 2010

ePrescription:

This is another key application which the majority of Member States mentions as a part of their national eHealth strategy. ePrescription is used in this case to mean the electronic capture and then transfer of a prescription by a healthcare provider to a pharmacy for retrieval of the medicine by the patient, and the recording of dispensation in the patient’s record. As the following Table 3 illustrates, only a few European countries have implemented a fully operational ePrescription service, and these are mainly in primary care, i.e. exclude medications dispensed in hospitals.

Table 3:

State of ePrescribing in European countries, 2010

	eCapture	eTransfer	eDispensation
Currently available	15	9	7
Planned for near future	5	8	6
Unavailable	12	15	19

Source: eHealth Strategies study, 2010

Up till now, patients rarely a) have access to their own medication profiles and b) are able to re-order certain repeat medications themselves, e.g. via the web. This is expected to increase considerably in the future in those countries where it would be within the constraints of regulatory boundaries.

Stakeholder engagement:

As part of their eHealth governance structure, the majority of countries has by now established advisory or consultative bodies involving, e.g., professional associations, patient representatives, third party payers and/or care providers. It turns out that such bodies in part resolve the challenge of potentially ambiguous or distributed responsibilities for eHealth.

Telehealth:

All countries surveyed report at least small local telehealth or telemedicine pilots. This concerns mostly telemonitoring applications for chronically ill patients, access to care from a distance in scarcely populated areas, sharing of patient data and coordination of services between health and social care providers, and telecare provision as an element of case management for particularly expensive patients. Perhaps the largest, still experimental implementation is reported for England. Its “Whole System Demonstrator (WSD) programme is a two year research project funded by the Department of Health to find out how technology can help people manage their own health while maintaining their independence. The WSD programme is believed to be the largest randomised control trial of telecare and telehealth in the world to date.”⁸ It covers various aspects of support for independent living at home as well as health and social care. However, the wider use of such services at the national level is still the exception in Europe.

Electronic identifiers:

A key component of any national or regional eHealth infrastructure is the ability to uniquely identify electronically citizens/patients, healthcare professionals, healthcare providers, and pharmacies. This is a central requirement to assure patient safety and an unambiguous relation between a patient and her/his data. Whereas a unique patient identifier (ID) was an element of eHealth strategies in most countries (24) in 2006 already, the challenge of professional IDs was neglected till recently (mentioned by 13 only in 2006), but is now an acknowledged topic in 22 countries.

However, virtually all citizen cards issued so far by European countries to be used in an eHealth context are only electronic health insurance cards, not eHealth cards in the proper sense of carrying medical information. They are often based on or equivalent to multipurpose eCards for eGovernment services, including healthcare. - The interest to use eCards as a token for professional ID and as access means to eHealth systems has increased considerably in recent times, from only 7 countries reporting such activities in 2006 to 18 in 2010. In nine European countries, smartcard systems for healthcare professional identification are already in place.⁹ An essential prerequisite for a functioning healthcare professional identifier is a functioning system of healthcare professional registration, which is not always be located at the national, but rather at the regional level.

Standardization:

Almost all countries have some kind of national body directly responsible for eHealth standards development or for overseeing standards development and implementation. The majority of countries require the application of European and international standards. Standards currently in use include: HL7 V2 and V3 (Health Level 7, version 2 and 3) - fifteen countries, CDA R2 (clinical document architecture, release 2, an HL7 V3-based standard) - eight countries, ISO 13606 for electronic health record communication - eight countries, DICOM (Digital Imaging and Communications in Medicine standards) - eight countries, LOINC (Logical Observation Identifiers Names and Codes) - four countries. However, such standards are often not specific enough to assure interoperability, they may not be complementary, or are even contradictory. Therefore, to indeed allow for interoperability at various levels, they need further agreement on more detailed specifications, testing, and certification of solutions. Sometimes countries acknowledge their concern with such challenges, but nation-wide or even trans-European solutions are mostly missing. The above-mentioned European epSOS project is expected to lead to a considerable increase in awareness of and progress in dealing with such issues across Europe.

Legal and regulatory issues:

Whereas in 2006 only half of the 27 EU Member States concerned themselves with specific eHealth legal and regulatory issues, that number increased by 2010 to 22. They are among the most challenging aspects of eHealth in Europe, and unresolved issues led to a slowdown of deployment in several countries. Policy makers had to learn that privacy, confidentiality, liability, and data protection all need to be addressed in order to enable a sustainable implementation and use of eHealth applications. In our survey, virtually no country reported yet on a coherent set of laws specifically designed to address these diverse aspects. Rather, in most of them the use of eHealth is currently regulated only by the general legal framework, in particular by laws on patient rights and data protection, and by regulations on professional conduct. New legislation is often still in the process of being drafted. It was also noted that there exists in many countries a need for greater legal certainty to assure strong trust by all stakeholders into eHealth infrastructures and applications.

Financial resources:

When looking at financing sources for the development and implementation of eHealth infrastructures and applications, a mixed picture emerges. Across Europe, the primary sources of funding are government or quasi-public sources, e.g. the general budget for health, as well as dedicated ICT budgets or special levies on statutory health insurances.

Recurring public budgets dedicated specifically to eHealth are the exception, whereas there is widespread use of projects-based sourcing. Sometimes private and public insurance companies or public technology or innovation agencies are involved in financing. Among the international sources of funding mentioned, EC RTD project co-financing as well as funding from European Union Structural and Regional Funds and the European Investment Bank were mentioned.

Socio-economic impact assessment and evaluation:

Not surprisingly, countries with more advanced eHealth infrastructures and services have a higher propensity to carry out assessments of the benefits of their eHealth investments and the challenges encountered. Around one-half of the countries surveyed (including the four home countries of the UK) mention a specific body of one form or another as being responsible for evaluation activities. In Switzerland, the federal government commissioned a Regulatory Impact Assessment (RIA) of pending eHealth legislation,¹⁰ applying a benefit-cost analysis as promoted by the OECD.¹¹. The United Kingdom undertakes regular evaluations of the National Programme for Information Technology (NPfIT) of the National Health Service in England by a wide variety of actors.¹² Germany regulated the testing, piloting and assessment of acceptance of core elements of its eHealth strategy.¹³

Discussion

In virtually all European countries surveyed, the political as well as stakeholder interest in eHealth policies and the planning and implementation of national or regional infrastructures has gained considerable momentum since 2006. This concerns not so much the number of new priority goals identified, infrastructure components tackled or pilots run, but rather the overall level of awareness, activities and concrete undertakings.

Significant progress on several key dimensions of the eHealth Action Plan of 2004 was achieved. The most noteworthy one has been the strongly increased commitment of national and regional health authorities to provide leadership to eHealth implementation efforts, underlined also by the remarkable growth in assessment and evaluation activities. Whereas in 2006 only 5 Member States reported related intentions, in 2010 already a considerable majority of 21 countries mentions such undertakings - this is the largest increase in attention of all topics surveyed. The scope and procedures used are very diverse, however. Furthermore, by now all countries surveyed have either established specific competence centers or/and have dedicated departments in ministries.

Some kind of national patient summary or electronic health record-type system is a consistent element in all strategies and roadmaps. Some progress can be registered, but the vast majority (19 of 33) of European countries surveyed are still at the planning stage. This is not a surprising result because their full implementation presupposes the availability of various infrastructure components like unique patient and professional IDs, full assurance of data protection and security, etc.

Of course, another perspective is the potential usage of such nation-wide data for public health, medical research or clinical knowledge generation purposes, which however does not seem to be a driver for national systems in Europe.

ePrescription is another key application which the majority of countries mention as a part of their national eHealth strategy. The majority of Member States (16) reported it as an element of their national eHealth strategy and/or implementation plan already in 2006, a number which has further increased to 22 by 2010. However, up till now, only a few countries have indeed implemented a fully operational national system.

With respect to telehealth applications delivering services for patients, all countries surveyed report at least small local pilots, a minor increase (+4) from the already high level of such experimental implementations reported in 2006. But the wider use of such services at the national level is still the exception.

Progress towards establishing a common eHealth infrastructure as a mandatory basis for the further diffusion of eHealth applications is also significant. The ability to uniquely identify electronically citizens/patients is a central requirement to assure an unambiguous relation between a patient and her/his data. Whereas a patient identifier (ID) was an element of eHealth strategies in most Member States (24) in 2006 and increased by two in 2010, the challenge of professional IDs was somewhat neglected till recently (mentioned by 13 only in 2006), but is now an acknowledged topic in 22 countries.

A noteworthy increase in standards-related activities from in 19 Member States in 2007 to 27 in 2010 was reported, i.e. for all Union States. This is witness to the by now wide recognition of the pivotal role of standardization for the wider diffusion of eHealth. Indeed, such issues and related interoperability challenges are not just mentioned or under scrutiny, rather they are key topics in most agendas of national (and regional) eHealth roadmaps and implementation plans.

Legal and regulatory issues remain a very diverse and complex field, but here, too, considerable progress can be noted; an increase of focused attention from in 14 to 22 countries was recorded. With regard to health record systems, nearly all European countries legally enforce a duty to keep a carefully updated and safely stored patient health record, but most keep the option of storing it on paper or electronically open. If opted for an electronic form, additional requirements on content, access and security often apply. It is expected that the obligation to store the records electronically will arise in more and more countries, if only because many are currently rolling out national patient summary or electronic health record-like systems that will be opt-out based.

Conclusions

Synthesizing European experience, some key aspects which seem to strongly support the successful planning and implementation of national eHealth strategies can be identified:

The policy process should assure a comprehensive health policy dialogue leading to well defined goals specifying where eHealth solutions are expected to substantially contribute. The challenges involved in reaching national agreement about eHealth strategies, implementing them, and meeting the related management and organizational tasks have been vastly underestimated. It is here where a European, transatlantic and even global exchange of experience gained, also from failures, and lessons learned may prove particularly beneficial.

Many countries acknowledge the need to assure strong trust by all into eHealth infrastructures and applications. This requires inter alia legal and regulatory certainty, challenges which are among the most demanding aspects of eHealth implementations. Privacy, confidentiality, liability and data protection issues are involved. Closely related is the requirement to better focus on health professional and stakeholder needs and benefits, as evidenced by many countries establishing advisory or consultative bodies involving representatives of relevant stakeholder associations.

The survey results suggest that in large countries the complexity of national EHR systems is very difficult, if not presently impossible to be managed and controlled. Experience so far shows that regions or countries with more than 5 to 10m inhabitants tend to encounter very protracted or even initially failed implementation attempts, particularly when they do not feature a top-down healthcare system.

Infrastructure elements concern items like governance rules and processes, competence centers, secure and unique identification of patients, health professionals and service provider entities, security and data privacy, regulation of technical and semantic standards, and payment/reimbursement issues. They allow for a network effect to kick in, also known as user externality or demand-side economies of scale. Unless a (public) regional or national health institution exists, service providers usually do not have an incentive to establish such an infrastructure, i.e. we face a so-called market failure situation where this ‘public good problem’ can only be solved by government intervention. To compensate for market failure and allow this network effect¹⁴ to kick in, adopting a ‘public good’ perspective of eHealth infrastructure investments seems to be adopted by more and more countries.

Although not a formal topic of the survey undertaken, cursory results indicate that qualified human resources are a key ingredient for success. Education, training and continuous professional development for all, including for those citizens and patients which are capable and motivated to become engaged in their own care, should be strongly promoted. “The most important part of eHealth investment that needs expanding is the eHealth skills and knowledge of healthcare staff and ICT suppliers’ staff. An expanded capability is essential to achieve more success and so help to boost eHealth investment.”¹⁵

It is also noteworthy that interest in socio-economic and regulatory impact assessment has gained very strongly in interest across Europe. This follows the insight that such approaches allow to analyze and select optimal policy measures, help to develop rational business cases, guide implementation processes, and allow to continuously monitor and validate outcomes.

In sum, the impetus of the European Union eHealth Action Plan of 2004 and the clear identification of common challenges there has initiated and by now massively contributed to a heightened degree of activities in European Union Member States and other European countries. Overall, across Europe eHealth has matured from a policy debate to a very tangible, implementation oriented endeavor.