Standardization in Health and Medical Informatics
Authors: Kern Josipa 
Published: May 2010

When things go well then often it is because they conform to standards (ISO, 2005). According to the Oxford Dictionary of Modern English, there is a lot of explanation of what standard means, but, in context of the first sentence, the best meaning is «standard is a thing or quality or specification by which something may be tested or measured». Personal computer is a standardized computer. It means that any of its components is made according to strictly defined specification. Consequently, it does not matter who produces components and where they are produced. Industry put the first demand for standards. Especially standardization is extremely important for electronics, for information and communication technology (ICT), and its application in different areas. Nowadays developing of standards is organized on global, international level, but it exists also on national level, well harmonized with international one. Developers of standards are organizations and groups working on this matter. The leading standard developer in the world is International Standards Organization (ISO). ISO is a nongovernmental organization established on 23 February 1947. Its mission is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity (ISO, 2005). ISO collaborates with its partners in international standardization, the International Electrotechnical Commission (IEC), a non-governmental body, whose scope of activities complements ISO’s. The ISO and the IEC cooperate on a joint basis with the International Telecommunication Union (ITU), part of the United Nations Organization and its members are governments. The ISO standard can be recognized by the ISO logo, ISO prefix and the designation, “International Standard”. European developer of standards is the European Committee for Standardisation (Comité Européen de Normalisation – CEN). It was founded in 1961 by the national standards bodies in the European Economic Community and EFTA countries. CEN promotes voluntary technical harmonization in Europe in conjunction with worldwide bodies and its partners in Europe and the conformity assessment of products and their certification (CEN, 2005). CEN cooperates with the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI). Product of this cooperation is the European standard which can be recognized by the prefix EN. Any added prefix to the existing one, for both ISO and CEN standard, means that this standard is result of cooperation with other standardization group or organization. The prefix ENV in European standardization means that this standard is not yet a full standard (it is under development by CEN). ISO and CEN have Technical Committees working in the specific areas. ISO/TC215, established in 1998, and CEN/TC251, established in 1991, are corresponding technical committees working on standardization in health and medical informatics in ISO and CEN. Both standardization bodies, the ISO and CEN cooperate, and they mutually exchange their standards. There are also a variety of organizations and groups developing standards, cooperating with ISO and CEN or acting as administer and coordinator in standardization. For example, there are Health Level 7 (HL7), Digital Imaging and Communications in Medicine (DICOM), American National Standards Institute (ANSI), non-profit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system, etc.