ISO and CEN Standards for Health Informatics – Synergy or Competition

The European standardisation of health informatics in CEN/TC 251 started in 1990 with the now twenty national standards bodies as members and a political mandate from the European Union and EFTA. The start of the international work in ISO/TC 215 has been welcomed by Europe and there is a lot of co-operation where European pre-standards have often been the basis for the start of international standards work, particularly in the area of medical device communication and for health cards. CEN and ISO also collaborate with other bodies in the field such as DICOM for imaging, IEEE for devices and the US based HL7 organisation for message development. It is important to find the right level of standards work for different aspects. The European CEN work will be maintained for issues like the electronic health record, some security aspects and medication related communication where there are common views and legislation makes European consensus necessary and achievable. The device market on the other hand requires global standards. In addition to multinational co-operation, it is important with a national strategy for the use of standards and adaptation and promotion of specific profiles to achieve interoperability in the still mainly national health systems.