Vol. 1 No. 2
Contributed by Jeremy Thorp, U.K. Department of Health
A number of European initiatives have published information and proposals in relation to health, standardisation and eHealth standardization, in particular. The Europe 2020 strategy has provided the context for smart, sustainable, and inclusive growth, with support from the Digital Agenda identifying a set of actions. Within the Digital Agenda, the following action points are included:
- Undertake pilot actions to equip Europeans with secure online access to their medical health data by 2015 and achieve by 2020 widespread deployment of telemedicine services.
- Propose a recommendation that defines a minimum common set of patient data for interoperability of patient records to be accessed or exchanged electronically across Member States by 2025.
- Foster EU-wide standards, interoperability testing, and certification of eHealth systems by 2015 through stakeholder dialogue.
CALLIOPE is coordinating an open, stakeholder-driven process to identify key challenges and issues related to interoperability, and define priorities for a European eHealth Roadmap. The Roadmap has been identified as a major policy instrument to support the European eHealth Governance Process. The CALLIOPE Standardisation Task Force has addressed the following objectives:
- to consider European eHealth standardization implications for the roadmap;
- to discuss objectives and requirements for standards for eHealth;
- to propose Europe-wide and national activities to support standardization.
Sustainable health care depends on the ability of patients, service users, and health professionals to work together. This requires interoperability of four types: legal, organisational, semantic, and technical. When developing such standards, different viewpoints need to be reconciled:
- clinical users who need IT support, though it must be understandable, affordable, and adoptable;
- suppliers, who make money by delivering value;
- policy leaders whose main perspective is improvement in health;
- patients and citizens.
Ideally, each of these stakeholder groups will be able to contribute to developments and see their needs fulfilled.
The following are seen as critical success criteria for standardisation activities:
- Relevance: that standardisation activities are seen as relevant to business objectives and current activities;
- Openness: that standardisation is seen as an open and inclusive process which removes rather than presents barriers for progress;
- Engagement: that all parties are able to contribute, from prioritization of business requirements through development, implementation, and maintenance;
- Affordability: that resulting standards are affordable, and demonstrating clear return on investment.
A number of key themes have been identified, summarised below, and for each of these a set of recommendations are included in the CALLIOPE Standardisation Report (in press).
Business objectives: From a health perspective, there are clearly shared drivers, aims and objectives across Member States. These need to be captured and turned into clear requirements, with a process of prioritisation and use-case description that allows all stakeholders to agree on the way forward. Recommendations include proposals for the process of prioritisation of new areas for standardisation, the creation of a framework to support the ways in which innovation can influence standards, market analyses, use-case development and the wider involvement of users.
Priority should be given to building services that are based on standardised, re-usable components (technical examples might include identification and security modules, but the standardisation principles might apply equally well to clinical practice). The necessary investment decisions will only be taken in a timely fashion if evidence is provided on the benefits of eHealth, the sustainability conditions and on the consequences of failing to act. This, therefore, highlights the need for a dialogue and a process in which standards demonstrate value to health care and in which prioritisation depends on value being demonstrated.
Benefits: While evidence is emerging on the benefits of standardisation, the case has not been accepted and more work is needed to collect evidence and to demonstrate the value of participation in development and subsequent use of standards, and to encourage Member States to engage in standards implementation.The CALLIOPE recommendations support the need for a wider dialogue on how standards bring value to health care, with a framework for contribution from participants. It is important that standards are developed in response to well defined user needs, and users (especially professional organisations) need to play a stronger role in providing the use cases and enumerating the potential benefits of the standards they need. These organisations also need to play an active role in the education and promotion of the resulting system features that incorporate those standards. Beyond the application of standards in a public policy context, the benefits of standards should be promoted to the wider community and through the research arena, education system, the place of standards in the economy, and their role in meeting the needs of public authorities and society.
Policy and strategy: There is a need for a standards strategy than can bridge the gap between the policy level use cases and the detailed standards development activity. The EC is proposing a structured set of activities to support standardisation. This needs to be reflected at Member State level. The principles of openness and transparency need to apply, with the coordination of dialogue among all stakeholders. European Standards Organisations have a role in advising policy-makers and providing support on the convergence of technologies. For Member States, there are recommendations for local representation, local standards strategies, and committees eHealth standards, and a recommendation that the European Commission should compile a state-of-the-art overview of national standardisation activities and good practice.
Access: There is still a widely held perception that standardisation is a closed activity for specialists, taking a long time and leading to expensive outputs with difficult license models. The CALLIOPE recommendations include the development of a "talent pool" of experts and the promotion of fora and consortia for progressing specific standards areas. The pathway for stakeholders to interact with standardization organizations needs to be simplified to promote a coherent work programme, where there is ease of access for all interested stakeholders, such as potential end-users and small- to medium-sized enterprises, to standardization work and standards information. There should be adequate incentives to ensure that researchers can be involved in standardization, both to promote continual improvement in the way that standardisation activity takes place and to encourage collaboration in the creation of value through specific instances of standardisation. There is a large issue, still, around access to standards materials and there is a need to assess IPR policies and potential licensing and funding models. There is currently a mixed message of promoting standards and interoperability, making it difficult and costly to get documents (e.g. a cost of €1,000 per 'functional' set of documents).
Supporting the market: an important part of "access" is supporting creation of a viable market for systems and services, with potential to operate not just in Europe but globally. The aim is a default position of global standardisation where possible, with European or national standards only where needs dictate. European Standardisation Organisations should provide thought leadership for Europe-wide standards which might become international. Each Member State should consider the use of standards to support open markets, and together with the European Commission, should consider a European-wide accreditation scheme.
Implementation support: "There remains a perception that standards are complex and hard to implement; at present there is no up-to-date information on how widely standards are used. A number of activities are underway to support adoption, implementation, and use. For many standards, it would be useful to assert what further needs to be done to use a specification, for example through implementation guides. There needs to be life-cycle management of standards, and activities to monitor uptake and use, with sharing of experiences.
CALLIOPE’s 41 recommendations on the above themes are targeted for action by the European Commission, Standards Development Organisations, and European Member States.
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