eHealth 

Key to the safety and integrity of the patient and of his health data is the interoperability of health information systems between all the actors and devices who handle and process health data. As the exchange of data is nowadays global rather than limited to Europe, CEN/TC 251 is committed to developing and delivering European Standards in close cooperation with ISO (International Standardization Organization) and with most of the Standards Development Organizations (SDOs) active in the field of eHealth.

CEN and CENELEC contact person: Jennifer Ogbonna

News and events

No News and events available at the moment.

Technical bodies and activities

CEN/TC 251 ‘Health informatics’ develops eHealth European Standards that are harmonized and consistent with the existing international framework. Its scope, ranging from Electronic Health Records (HER) architecture and Health Informatics Service Architecture, to Detailed Clinical Modelling (DCM), is reflected in its very broad work programme accessible via the workprogramme (soon to come).

Sector forum

A Sector Forum is a platform aiming at facilitating the exchange of information between the various stakeholders impacted by, involved in or interested in the European standardization activities in a particular domain. It also constitutes a convenient means of coordinating the standardization activities and identifying new standardization needs.
 
In the field of healthcare – which includes medical equipment and eHealth –, the Sector Forum is a joint one between CEN and CENELEC. The Terms of Reference of this 'CEN-CENELEC Advisory Board for Healthcare Standards' (ABHS) (pdf format) were revised in 2012.

European legislation and mandates

Following specific requests – called 'standardization requests' or 'mandates' – from the European Commission, CEN and CENELEC develop European Standards that support the European legislation – mainly Directives – in a number of domains, among which Healthcare.
 
EU Directives
The EU Directive 93/42/EEC on Medical Devices does not explicitly cover standalone health software, although  their regulation at EU level has been considered for some time. Therefore, CEN/TC 251 formed a European group of experts under the banner ‘Software as a medical device’ (SAMD), which contributed to the development of the EU guideline document MDDEV 2.1/6 ‘Guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of Medical Devices’ (pdf format, issued in January 2012).
 
Mandates
The following mandate from the European Commission to CEN and CENELEC in the field of eHealth was completed:
The response to M/403 was in the form of the ‘eHealth-INTEROP report’ giving a set of recommendations related to interoperability in the Health informatics domain.

Useful links and documents

European Standards in the field of eHealth are developed with, inter alia, the contribution of COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry).
 
Daily contacts are also maintained with the European Commission's DG GROW (Unit D.4 'Health technology and Cosmetics') as regards to link with the EU regulatory context.