Title: EHEALTH, ELECTRONIC HEALTH RECORDS AND ELECTRONIC HEALTH CARDS

The European Union’s commitment to eHealth started as long ago as 1989 under the label ‘healthcare computing’ (Wilson and Lessens, 2006). The Advanced Informatics in Medicine Program (1989-1991) already stressed the use of computer technologies for medical practice. Whereas its successor (1991-1994) focused (exclusively) on the needs of health care professionals, the following Program ‘Telematics Applications for Health Programme’ focused rather on ‘users’ needs’ in general (Wilson and Lessens, 2006). Since the 5th RTD framework program (1998-2002) the term ‘eHealth’ is coined (Wilson and Lessens, 2006). In 2003 the ministers of the EU member states Acceding and Associated countries, as well as EFTA countries met on 22nd May 2003 in the framework of the eHealth 2003 conference organised jointly by the European Commission and the Greek Presidency of the Council. At that event, eHealth was defined as ‘the use of modern information and communication technologies to meet needs of citizens, patients, healthcare professionals, healthcare providers, as well as policy makers’. The European perspective on eHealth embodies the wish to fundamentally improve health care in Europe. eHealth should support Member States ‘in realizing and sustaining the common values and goals characteristic of Europe’s social infrastructure’ (Stroetmann, 2007). Although health care is a national responsibility in the European Union, the development of a European health services market and thus the cooperation of the Member States with the European Commission, could help to obtain both the specific objectives of the national health care systems as well as the goals of the European Union (for example in relation to the Lisbon Strategy).

The development and use of electronic patient records (EPRs) and cards are crucial elements to eHealth. An electronic patient record can be defined as a ‘comprehensive medical record or similar documentation of the past and present physical and mental state of health of an individual in electronic form and providing for ready availability of these data for medical treatment and other closely related purposes.’ (Art 29, Data Protection Working Party, 2007). There are so many (small and bigger) differences between electronic health/patient files in and between countries. Some of the major differences relate to the (1) Content: e.g. summaries versus ‘full’ records. (2) Role of patient: e.g. patient managed records versus health care professional managed records. (3) Scope: e.g. record on a regional level versus national wide. (4) Use: e.g. for primary care versus records for secondary care levels.

The current activities on electronic health cards actually concentrate mainly on the implementation and use of electronic health insurance cards. It is interesting to differentiate between the two types of cards (although in practice they can be integrated).

Electronic health insurance cards allow ‘access to health care’ and make ‘management and billing easier’ (COM (2004) 356). Electronic health insurance cards are ‘intended to cover care that becomes necessary whilst in temporarily another Member state for other reasons.’ (SEC (2006) 1195/4).

As stipulated by the European Commission, member states should implement the electronic health insurance cards (which replace the E111 files) by 2008.

Electronic health cards ‘may carry emergency data (such as blood types, pathologies, treatments) or medical records, or may allow access to these data over a secure network’(COM (2004) 356 final). In the latter case (this is when the electronic health data is not stored on the electronic health card), the card - coupled to the patient identifier -could provide a key to access electronic health records. (Bourret, 2004, 107). The Article 29 Data Protection Working Party also believes that smart cards are a suitable way to access health data (2007). As a result, there is a close link between the development of electronic health records, patient identifiers and health cards.

EPRs and cards could not have been developed without technological developments. But (socio-technological) conditions defining priorities, strategies and values that are believed to be essential for the future of health care and for the European welfare states in general, have an equally important impact. The development and use of electronic patient records and cards are both affected by and affect the health care systems in the European states. As a result, the EHR and electronic card systems must be seen as specific and sometimes unintended outcomes of social, economical and normative discourses in health care and society in large.

In the following section, we search for crucial narratives / discourses which play a role in the realization of eHealth and the development of EHR and cards. 

eHealth discourses

Four issues have dominated the European debate on eHealth in general and health data in specific. These issues are connected but all have their specificity and backgrounds.  

First of all, the European strive for free movement of citizens and goods has influenced to a large degree the discourse on eHealth. In the context of health care, the free movement refers both to the freedom of citizens to easily and safely seek for health care abroad as well as to the free movement of health data in Europe (under legal-technical restrictions). In several cases at the end of the nineties, the European Court of Justice argued that the internal market should be open for health care provisions. Cross-border health care and patient mobility in specific has become a ‘hot topic’ on the European agenda. Cross-border health care is a perfect catalyst in the realization of an European Health Information Space: ‘In a Europe in which our citizens are increasingly mobile – whether within the borders of their own Member State or among different countries – we need to raise awareness of the pressing need for a more integrated and interoperable European Health Information Space’ (Conclusions of the eHealth Conference, 2005). This requires co-operation on the European level (COM (2004) 301). The European health insurance card and other eHealth related applications to realize this in a safe and efficient way. Such tools can provide the essential information at the right time, at the right place and as such, they help to develop chains in health care beyond national borders. The symbolic value of the card can not be ignored.

A second rationale is found in the consumerist discourse on patient empowerment, a core aspect of Europe’s ambitions for health care. It is the idea ‘to empower patients with a sense of ownership of their own health care, and to improve communication between patients and clinicians…’ (Stroetmann, 2007, 32). Patients have become ‘active consumers of healthcare’ (Stroetmann, 2007). They autonomously inform themselves, pick and choose a healthcare provider (abroad). In line with the idea of patient empowerment, is the idea to make people more responsible for their own health. The shift in responsibilities is very clear in the ‘New NHS’ program in the UK: ‘shifting responsibility to the patients and their families the main basis of a ‘New NHS’ (National Health Service)’ (Bourret, C., 2004, 97).

The third discource is grounded in the emerging problem of the scarcity of resources in health care: policy makers look for ways to (fairly) control or reduce costs. eHealth is assumed to contribute to cost-efficiency, in a context of more expensive health interventions and technologies and the greying of society. Recent projections by the European Commission suggest that age-related public expenditures, such as public pensions and health care spending, will raise by 4% of GDP on average for the European Union in about 45 years from now (see e.g. EPC, 2006). Sustainability of the current welfare provisions as we know them is often linked to cost-effective measures. Typical economical concepts as quality control, budget planning and economical savings are mentioned in relation to the use of electronic health records. (Stroetmann, 2007; Bourret, 2004, 96).

Finally, within the EU discourse eHealth ‘is today’s tool for substantial productivity gains, while providing tomorrow’s instrument for restructured, citizen-centered health systems and, at the same time, respecting the diversity of Europe’s multi-cultural, multi-lingual health care traditions’ (Com (2004) 356). The issue of innovation is considered essential in the realisation of eHealth in Europe. The economic aspirations of the EU are remarkably entangled in the domain of eHealth. The market-oriented approach on health is demonstrated  as eHealth applications use concepts such as ‘B2C’ (for example, the patient can find relevant information regarding a healthcare organization, a treatment or illness on the internet); ‘B2B’ (for example, the ‘simplification and acceleration of data transfers between medial institutions’ and ‘C2C’ (for example, the ‘possibilities to get informed and comminucate with other patients’) (Leys en Potloot, 2004; Scott et al., 2000, 61). This focus on the health care market is striking, as health care in a European tradition has always been linked to the particular traditions of welfare regimes, in which distributive correction mechanisms are core issues in health care market issues to ensure equity, solidarity and fairness.

We briefly sketched some of the narratives currently dominating the EC discourse on eHealth, trying to illustrate that on the European level the debates on technological development is mainly getting form in what could be labelled  as the “Lisbon treaty discourse”: “economic development, technological innovations and free movement of people” are coming to the fore as core values. However, particularly related to health related issues, it could be questioned whether the dominance of this discourse is not blinding for some other welfare related values and ethical considerations in health and health care, that could be of equal importance when discussing the use of health related data.

Furthermore, we are not blind of the existence of (recent) initiatives of the EU on data protection and privacy related issues. However, we have the impression that this debate is a sectorized one, and not necessarily fully integrated in the local policies on eHealth developments.  An explanation for the differences is to a large extent to be sought in the subsidiarity principles of the local member states and Europe in health care related issues. Subsidiarity in health care is the principle that matters ought to be handled by the smaller (or lower) competent authority in the member states. The European treaty literally states: ‘In areas which do not fall within its exclusive competence, the Community shall take action, in accordance with the principle of subsidiarity, only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the proposed action, be better achieved by the Community’. The EU may only act (i.e. make laws) where member states agree that action of individual countries is insufficient. In organisational issues related to health care policy and the organisation of the welfare regimes, this authority is not delegated to the European higher level. However, over time “Europe” has been taking direct responsibility for the selection and implementation of projects and activities related to the European policy level agenda, also in the field of eHealth, but clearly in a different perspective than the one related to the organisation of health care within member states and/or their regions. The division of competencies and the particularities of institution logic are to a large extent explaining the innovation and market-oriented discourse in health related issues on a European level. But it is also clear that the subsidiarity principle in an issue such as health care data within the organisation of health care systems could prohibit a sound discussion on a European level, taking into account the particularities of welfare regimes. Currently, economic principles and issues of technological innovation dominate the debate, but their consequences for health care are hardly taken into account.

Crucial issues in relation to the development of eHealth as reported by the partners

In most countries the debate on eHealth was initiated top-down (e.g. the Netherlands, Switzerland, Belgium, Spain and Germany). Institutions and organizations that deal with health and welfare in specific (e.g. Ministries or governmental departments on Health) are the fore-runners in this debate (e.g. in Netherlands, Belgium, Spain, Germany, UK). The Swiss answer mentions CEST, a Swiss organization which concentrates on science and technology development as the initiator of the debate. In Italy the Department for Innovation and Technologies, alongside with the Minister of Health, appears to play a major role in the development of eHealth initiatives. People from telematics are other important actors (mentioned by Belgium and Italy) In Sweden the debate seems to be initiated from below (from the level of people working in health provision). In Hungary, the debate on the use of eHealth seems mainly to be initiated from pressure groups of doctors and pharmacists. The Norwegian answer explicitly refers to health enterprises, general practitioners and the National Insurance Service as important players in the development of a debate on eHealth.

There was a lot of agreement on what appear to be the most important reasons to implement eHealth (tools). Countries appreciate eHealth because these applications enhance efficiency, quality and security. This ‘trio’ has been mentioned explicitly by almost all countries. For a lot of countries, eHealth appears to be important to guarantee simplified (centralised) communications between health care providers (Netherlands, Hungary, Belgium, Germany, Italy and UK). Several countries state that stakeholders (e.g. policy makers) stress the ability to be cost-efficient or to reduce costs (Spain, Belgium, Germany, Italy and Hungary). The issue of patient-centressness was mentioned by the Belgian and Italian answer. Patient mobility is mentioned as an important catalyst for eHealth in Spain and Italy (countries where health is a regional responsibility). According to the Swiss answer, eHealth should not only facilitate old ways of doing business in health care, it can also bring about some new processes and ways of thinking about the organization of health care.

Questions were asked on the crucial issues in the development and use of eHealth tools. Some interesting (socio-ethical) aspects relate to the position and role of insurance companies in the health information space (mentioned by Germany, Spain and Netherlands). Health insurance companies already know a lot about our medical history. The electronic health record systems and especially the use of unique national identifiers could enable the access and processing of medical data by health insurance companies. A lot of countries wonder how to organize the identification of patient and of health care providers. Should this preferably be done by using national social security identifiers or rather by using health care-specific ID number) (issue on identification is mentioned by Netherlands, Belgium, Hungary and Germany)? In Belgium there seem to be discussion about possible changes in the doctor-patient relation due to the conflict of eHealth tools with healthcare professionals’ duty of medical secrecy. Germany and Hungary explicitly mention the question on how eHealth could organize transparency in health care. Protection of privacy and identity of citizens is a big concern to the questioned countries. When looking at the country answers, it seems that this worry calls for technical and legal measures. Several countries mention the need for technical standards for interoperability and storage of data and the development of secure and effective telematica platforms (e.g. Germany, Belgium, Sweden, Italy, UK and Norway). Access control is an important technical-legal issue. Other legal issues at stake are the issue of consent and the applicability of data protection legislation (e.g. Switzerland, Netherlands, Spain, Belgium, Germany and Italy)

The countries mention various actors involved in the development of eHealth records. Obviously, national or regional governmental bodies and (organizations of) healthcare professionals are mentioned. Other frequently mentioned actors are the social security organizations, insurance companies and product industry. Only a few countries explicitly mention the institutions that deal with data protection and privacy protection (Norway and Belgium). However in most countries, and especially in Germany, the actors in the legal field have to be considered as important actors. Institutions such as the Norwegian KITH and Swiss TARMED are mentioned as important actors in the development of technical standards for eHealth applications (e.g. in the area of the records, resp. medical billing).

According to Newman and Bach (2004), there seems to be a country-specific relationship between the national regulatory system for health matters and the way data protection authorities are organized: ‘unitary governmental systems like the U.K. have a centralized data protection authority while federal governmental systems like Germany rely on a decentralized network of regulators at the federal and state levels.’ Central regulatory authorities seem to be favored for public sectors such as health. However, since public– private cooperation is growing in the health care sector, decentralized networks (‘primarily engaged in advising legislators and the private sector’ (Newman, Bach, 2004) do have an important supportive and co-operative role in the field as well.

State of art of deployment and implementation of eHealth tools