It has long been recognized that eHealth has the potential to improve the quality and effectiveness of healthcare services. This view has been endorsed by the Council for Employment, Social Policy, Health and Consumer Affairs, which "recognises that electronic health cards, electronic health dedicated national and regional networks and the use of other information technology tools can achieve significant improvements in the quality and safety of the health care that is delivered to patients in an environment of increasing pressure on healthcare systems, while contributing to cost savings in the longer term."

Many countries of Europe are focusing their attention on the use of ICT in the health domain. Services and work practices to which ICT is being directed involve many diverse, organisational entities sometimes located in different countries. Successful application of ICT in these circumstances can only be achieved if all the organisations concerned agree on a set of common standards. Where the services extend between countries, those agreements will need to be international.

Health informatics standards are essential to achieve the goals of eHealth in Europe for:

• interoperability between systems and patient information exchange between health organisations;
• market efficiency by providing increased understanding between all players in that market through a common technical framework and terminology for eHealth application development, procurement and implementation;
• meeting non-functional requirements to ensure safety, security and legal requirements e.g. protecting the privacy of the citizens;
• establishing a representative set of multinational interoperable, coordinated and open eHealth services based on a common business and service architecture;
• managing eHealth services.

Many health informatics standards from CEN, ISO and other bodies such as DICOM, HL7 and IEEE exist, or are being finalised, to meet many of the requirements. However, they face serious problems:

• Standards are often not well known (this statement applies particularly to formal standards).
• Standards are not used enough.
• The interoperability of standards is usually not proven.
• Some standards even contradict each other.

If adequate standards exist, they:

• allow suppliers to market their products or services internationally without designing for each country;
• assist buyers in specifying exact requirements with assurance;
• facilitate cross-national communications and applications;
• meet the obligations of EU Directives and World Trade Organisation (WTO) objectives.

There is a lack of guidance on where and how to use standards. Commitment to European as well as to global standards is generally weak in the health domain and there is an increasing tendency for Member States to create national standards. This development seems to contradict:

• EU Directives and Commission Communications which emphasise the advantages of using European or global standards;
• obligations on EU Member States to use such standards in national applications and procurements;
• obligations on EU Member States not to create national standards where European or global standards exist.

Existing standards should be widely adopted and applied, according to suitable local implementation guidelines. Standards developed by diverse organisations should be harmonised according to a common vision, and additional standards should be agreed upon, in order to complete the fulfilment of the increasingly demanding requirements.

The focus of this section is to address these issues in standardization efforts and to provide recommendations and proposals for actions and initiatives in the area of standardization to enable health policies and strategies to be efficiently realised at local, regional, national and international levels. In particular, we investigate which extensions in the existing standardization efforts should be recommended to Standards Development Organisations (SDOs), such as CEN TC 251, CEN/ISSS, HL7, ISO or IEEE.

It is not possible to investigate all relevant gaps in standardization work. We focus on those areas in which we see the most urgent need for action and for which we are able to issue a well-grounded recommendation in such a way that there are predictable benefits to be gained from its realisation. In this process, we do not distinguish clearly between mandated standards and other as this difference does not seem to be a mark for the relevance and importance of a standardization effort in the present state of the biomedical and eHealth domain. However, we make a proposal regarding the direction of further developments so as to change this situation in the foreseeable future.