The European Commission has recently published a new draft of interoperability guidelines setting out a roadmap to achieve interoperable electronic health records (EHR) across the continent by the middle of the next decade.
In the globalised world where information and communication technologies (ICTs) have broken down borders and reduced distances markedly, one still faces challenges in transferring critical medical data of ones own self, even while travelling within a region that accepts the same currency.
The European Union was established by the Treaty of Maastricht in 1993, with the aim of developing a single market through a standardised system of laws which apply in all member states, guaranteeing the freedom of movement of people, goods, services and capital. The Union also launched the euro as common currency in the region in the year 2002 amidst much protest; however, the region is today seeing great benefit from the strong common currency.
One issue that has, of late, come into the purview of the Union is that the ease of mobility and trade has also raised the necessity of better and stronger healthcare coverage to be provided to the citizens, no matter which Member State they belong to.
Electronic Health Records
Electronic Health (or Patient or Medical) Records have traditionally been understood as being the demographic details of the inpatient flow in hospitals. However, EHRs are more complex and need to be taken more seriously if one needs value return from the capture of data. A good EMR system would capture all data relating to both in/out patient flow and in the long run must be capable of providing Clinical Decision Support (CDS) and disease profiling, helping in developing and implementing solutions faster. Since, the capture of clinical and demographic data is in a pre-determined format, it allows several clinical attributes to the data processing like, clinical decision-making by accessing a rules engine to provide alerts, reminders, clinical protocols, coding assistance etc.
Need for interoperability
Medical Informatics experts world-over have been advocating bringing about standards in the format of data capture, especially using ICD ï¿½ 10 more widely for the greater good of public healthcare, also providing patients more control over their own medical records, and allowing interoperability between hospitals and doctors in different locations where the patient may be travelling. However, the myopic view of most healthcare service providers has kept this idea from becoming a reality.
By interoperability, the EU Recommendation means, “The ability of information and communication technology (ICT) systems and of the business processes they support to exchange data and to enable the sharing of information and knowledge.” Achieving and maintaining cross-border interoperability of EHR systems implies managing a continuous process of change and the adaptation of a multitude of elements and issues within and across electronic infrastructures in Member States. Interoperability of electronic health record systems is claimed to lead to both social and economic benefits, and to be an appropriate means to:
bring about better quality of treatment because of better information about the patient;
improve the cost efficiency of medical treatments, and thus prevent further rapid growth of healthcare budget deficits;
furnish the necessary data for quality control, statistics and planning in the public healthcare sector which should also have a positive effect on public healthcare budgets.
Community eHealth Action Plan (2004)
The high-level eHealth Conference “Empowering the European Citizen through eHealth” was held in Cork between 5th and 6th May 2004 organised by the Irish Presidency and the European Commission. The Conference was an opportunity to demonstrate current eHealth tools and provided a forum in which to take stock of completed, ongoing or planned initiatives at European level. The objective of the Conference was to emphasise the benefits of the empowerment of citizens through eHealth solutions such as information, administration, homecare and telemedicine tools and services. The Conference identified a number of trends and challenges at stake, as echoed in EIPA’s eHealth research report (Mapping the Potential of eHealth: Empowering the citizen through eHealth tools and services).
The European Commission adopted on 30 April 2004 an e-Health Action Plan that aims to improve access to healthcare and boost the quality and effectiveness of health services offered across Europe. The action plan identifies a number of major challenges for wider implementation of eHealth systems and services, including for example the commitment and leadership of health authorities, the interoperability of systems, data protection, high quality and accurate health information, a single market for eHealth allowing equity of access, access for all, improving the effectiveness of healthcare provision, ensuring effective knowledge management. It was suggested that by end 2006, Member States, in collaboration with the European Commission, should identify and outline interoperability standards for health data messages and electronic health records, taking into account best practices and relevant standardisation efforts. And by 2008 health information networks should be commonplace, delivering services over fixed and wireless broadband networks and making the most of networks within so-called “grids” to boost computing power and the interaction between different systems.
The Recommendation proposes a set of guidelines that ought to be attained by individual Member States to ensure the minimum level of compatibility and communication with fellow Member States. The guidelines address the following four objectives:
Â To outline and agree the principles on which there should be broad agreement and engagement in regard to cooperation on shared and interoperable eHealth information.
Â To enable interoperability between health information shared among different healthcare systems,
Â To resolve the various challenges of achieving cross-border interoperability of EHR systems in the Community by building appropriate networked systems and services that cover the entire continuum of care, and that are underpinned by the appropriate legal and regulatory, medical and care requirements.
Â To assess not only the benefits, but also the barriers, hurdles and potential threats to achieving eHealth interoperability, and to identify the necessary preconditions and relevant incentives to overcoming these.
The ultimate goal of the Recommendation is, therefore, to contribute to creating a means whereby authorised health professionals can gain managed access to essential health information about patients, subject to the patients’ consent, and with full regard for data privacy and security requirements. Such information could include the appropriate parts of a patient’s electronic health or medication record, patient summary, and emergency data accessible from any place in the Community.
To achieve this, Member States are invited to undertake actions at several levels, namely:
Overall political level – where the partners need to commit politically and strategically to the implementation at local, regional and national level of EHR systems that are capable also of interoperating with EHR systems in other Member States; engage in active cooperation with other Member States and relevant stakeholders to ensure the adoption and implementation of standards that make this feasible and secure; reserve adequate resources, for example by means of direct incentives, to invest in such systems; accompany implementation of EHR systems by strong involvement of users and other stakeholders in establishing adequate governance, management, public-private partnerships, public procurement, planning, implementation, uation, training, information and education; help raise awareness among relevant stakeholders such as local and regional authorities, health professionals, patients and industry of the benefits and need for interoperability of EHR systems.
The organisational level – It is essential to create an organisational framework and process that will enable cross-border interoperability of EHR. This should be based on a roadmap, developed by Member States, which covers a five-year period and provides details with regard to agreement on a European governance process to establish guidelines for developing, implementing and sustaining cross-border interoperability of EHR covering management for reliable identification of patients and authentication of health professionals as well as other relevant issues; consider policies and incentives to increase demand for procuring eHealth services to enable interoperability of EHR; analyse the factors which render the standardisation processes leading to higher levels of interoperability a long, complex and expensive activity, and devise measures to speed up these processes.
The technical level – Compatibility of EHR systems at the technical level is the essential prerequisite for interoperability, and Member States should undertake a comprehensive survey of existing technical standards and infrastructures that may facilitate the implementation of systems supporting cross-border healthcare and the provision of healthcare services throughout the Community, especially those related to EHRs and exchange of information. Consider standardised information models and standards-based profiles to be part of national or regional specific interoperability specifications; commit to the development of any necessary additional standards, preferably open standards on a global scale.
The action plan identifies a number of major challenges for wider implementation of eHealth systems and services, including for example the commitment and leadership of health authorities, the interoperability of systems, data protection, high quality and accurate health information, a single market for eHealth allowing equity of access, access for all, improving the effectiveness of healthcare provision, ensuring effective knowledge management.
The semantic level – Semantic interoperability is an essential factor in achieving the benefits of EHRs. The Member States should establish an appropriate mechanism in cooperation with the relevant standards development organisations, the Commission and the World Health Organisation, to involve national research centres, relevant industries and stakeholders in the development of health semantics to advance in implementation efforts of interoperable EHR systems; wherever possible, consider the suitability of international medical-clinical terminologies, nomenclatures and classifications of diseases, including those for pharmacovigilance and clinical trials; the establishment of competence centres for multilingual and multicultural adaptation of international classifications and terminologies should also be encouraged; agree on standards for semantic interoperability to represent the relevant health information for a particular application through data structures (such as archetypes and templates), and subsets of terminology systems and ontologies responsive to local user needs; consider the need for a sustainable reference system of concepts (ontology) as a basis for mapping multilingual lexicons that take into account the difference between professional healthcare languages, lay terminologies and traditional coding schemes; support the widespread availability of methodologies and tools for incorporating the semantic content into practical applications, as well as the development of relevant human capacity and skills in this domain.
The level of education and awareness raising – Member States should increase awareness about the benefits of and need for standards in EHR systems and their interoperability among producers and vendors of ICTs, healthcare providers, public health institutions, insurers and other stakeholders; pay particular attention to education, training and dissemination of good practices in electronically recording, storing and processing clinical information as well as in gaining informed consent of the patient and lawfully sharing patient’s personal data; provide parallel information and training, including awareness raising, for all individuals, in particular patients.
Certification of electronic health record systems – There is a need for a mutually recognisable conformity testing procedures that are valid throughout the Community or which serve as a basis for each Member State’s certification mechanism. Therefore, Member States should apply properly the existing eHealth standards and profiles, namely those related to interoperability of EHR systems, in order to enhance the confidence of users in those standards; put into place a joint or mutually recognised mechanism for conformity testing and certification of interoperable EHRs and other eHealth applications, such as the techniques and methodologies offered by various industry consortia; consider the industry self-certification and/or conformity testing activities as a mechanism to reduce delays in bringing interoperable eHealth solutions to the market; take into account national and international practices, including those which exist outside Europe.
Protection of personal data – Member States should ensure that the fundamental right to protection of personal data is fully and effectively protected in interoperable eHealth systems, in particular in EHR systems; Member States should lay down a comprehensive legal framework for interoperable EHR systems. Such a legal framework should recognise and address the sensitive nature of personal data concerning health and provide for specific and suitable safeguards so as to protect the fundamental right to protection of personal data of the individual concerned.
Monitoring and uation – Member States should consider the possibilities of setting up a monitoring observatory for interoperability of EHR systems in the Community to monitor, benchmark and assess progress on technical and semantic interoperability for successful implementation of EHR systems; undertake a number of assessment activities, which may include defining the quantitative and qualitative criteria for measuring the eventual benefits and risks (including economic benefits and cost-effectiveness) of interoperable EHR.
Europe currently has a leading position in the world, with patient data being stored electronically by 80% of all EU-wide primary care physicians. About 70% of European doctors use the Internet and 66% use computers for consultations. Administrative patient data is electronically stored in 80% of general practices: 92% of these also electronically store medical data on diagnoses and medication. Using such eHealth applications, doctors and medical services have already improved healthcare in Europe although progress is still needed, for example to create more efficient administration and reduce waiting times for patients. The benefits could be even more widespread throughout Europe if these systems could work together, making it easier for people to receive treatment even when they are away from their home country.
Source: www.europa.eu, published by the European Union and its institutions