About CEN/TC 251

CEN/TC 251 Health Informatics

Delivering and maintaining health informatics standards for Europe

Health informatics standardization is concerned with the principles of information processing, management and governance of information with the provision of solutions for associated problems in the field of health and care. The health informatics sector is made up of a number of very large software producers, with a great many small and medium enterprises operating primarily either in domain niches or in geographic areas. This disparate global market is reflected within the CEN member states and presents a challenge. It stifles the free flow of knowledge of and experience in the health informatics industry, thus presenting health care organizations with mounting costs and health informatics vendors with limited potential for growth, As a consequence, it makes the work of CEN/TC 251 that much harder, both in terms of standardization and of communication about standards.

CEN/TC 251 delivers and maintains health informatics standards for Europe, preferably by producing them in co-operation with other SDOs at a global level and by adopting standards from other SDOs. CEN/TC 251 will seek to further increase engagement with other standards development organizations, consortia and fora to enhance efforts to coordinate its work with other organizations that have similar goals, such that stakeholder wishes for fewer, but more universal, global standards for health informatics are recognized and delivered in Europe.

Want to join this techinal committee? Contact your National Standardization Body.

Business plan 2023 - 2026

During the plenary meeting on 7 December 2022 in Brussels, the members of CEN/TC 251 unanimously adopted the new business plan that we have been working on collectively since the spring. We recognise the importance of new developments in Europe for our work, in particular the proposed regulation on the European Health Data Space and the proposal for a regulation on Artificial Intelligence (the AI Act). Both stress the role of standards for access to data across the EU and CEN/TC 251 is committed to deliver these standards, in close collaboration with our network of fellow standards development organisations, in the field of Health Informatics. Only with a strong and reliable set of data standards will innovation of new products and services, that make use of these data, be able to flourish across Europe and beyond.

Hence the motto of our new business plan: Standardise – Deliver – Innovate. It is our mission to standardise the personal health data that is crucial for the delivery of safe, high-quality care and to foster both trust and interoperability across the network of creators and users of these data. Rather than carrying out standards development within CEN/TC 251 itself, we aim to deliver global standards developed in close collaboration with our network of partner standards development organisations in the JIC. Using the standards we deliver, we aim to inspire developers to innovate their products and services for patients, healthcare professionals, healthcare organisations and health systems across Europe.

We build upon the successful delivery of standards for the International Patient Summary (EN ISO 27269 and TS 17288) and for the Quality and Reliability of Health and Wellness Apps (CEN/ISO/IEC TS 82304-2).
The combination of active participation in EU projects laying the foundation for standardisation, followed by formal standards development at the global level, has proven to be very effective. We aim to replicate this model of standards development, delivery and innovation in the priority areas indicated by the European Commission, as well as the requirements put forward by our industry partners in COCIR, MedTech Europe and Digital Europe.

Please don’t hesitate to contact us, or your national standards institute, for more information on the standards that support the digital transformation of health and care in Europe!

Download the business plan 2023 – 2026 of CEN/TC 251.