Mandate M-403: eHealth Interoperability

Karl Øyri

Intervensjonseteret,

Rikshospitalet HF

M-403:

Mandate to the European Standardisation Organisations CEN, CENELEC and ETSI in the field of Information and Communication Technologies, applied to the domain of eHealth

•CEN, the European Committee for Standardization, was founded in 1961 by the national standards bodies in the European Economic Community and EFTA countries.

•Now CEN is contributing to the objectives of the European Union and European Economic Area with voluntary technical standards which promote free trade, the safety of workers and consumers, interoperability of networks, environmental protection, exploitation of research and development programmes, and public procurement.

•CEN is a non-profit making technical organization set up under Belgian law.

CENELEC, the European Committee for Electrotechnical Standardization, was created in 1973 as a result of the merger of two previous European organizations: CENELCOM and CENEL. Nowadays, CENELEC is a non-profit technical organization set up under Belgian law and composed of the National Electro technical Committees of 30 European countries. In addition, 8 National Committees from neighboring countries are participating in CENELEC work with an Affiliate status.

CENELEC members have been working together in the interests of European harmonization since the 1950s, creating both standards requested by the market and harmonized standards in support of European legislation and which have helped to shape the European Internal Market. CENELEC works with 15,000 technical experts from 30 European countries. Its work directly increases market potential, encourages technological development and guarantees the safety and health of consumers and workers.

CENELEC’s mission is to prepare voluntary electro technical standards that help develop the Single European Market/European Economic Area for electrical and electronic goods and services removing barriers to trade, creating new markets and cutting compliance costs.

ETSI:The European Telecommunications Standards Institute (ETSI) produces globally-applicable standards for Information and Communications Technologies (ICT), including fixed, mobile, radio, converged, broadcast and internet technologies.

M-403 Objectives (end 2015) -for cross-border interoperability of EHR•To outline & agree the principles

•To enable interoperability between health information shared among different healthcare systems

•To resolve the various challenges of achieving cross-border interoperability of electronic health record systems in the Community

•To assess not only benfits, but also the barriers, hurdles, and potential threats to achieving eHealth interoperability, and to identify the necessary preconditions and relevant incentives to overcoming these

M-403 Action levels

1. Overall political level

2. Organisational level

3. Technical level

4. Semantic level

5. Education and awareness raising

-> EC i2011innitiative-> eHealth is part

BackgroundFor a relatively large number of years standardization of eHealth in Europe and globally was building a number of very important framework standards that could not directly be implemented. These have been refined and finally reached maturity being published as full European standards in the last couple of years. Key standards that could be mentioned are for the communication of the Electronic Health Record, for the Enterprise Service Architecture and for Pont of Care Medical Devices communication.

Information security, terminology and identification of patients and healthcare professionals etc etc. G Klein

Organisational mattersHow and by whom should the standards be developed?

It is important to concentrate the work on CEN/TC 251 and avoida split of resources to ETSI and CENELEC except wherenecessary and the nature of the items relate to the other business of these bodies.

The preferred route for new eHealth standards should be via the TC process and formal European Standards rather than CEN workshops

However, there is also a need for advisory guidelines on standards to apply for specific European applications where otherforms may be considered.

And ..

G Klein

Organisational mattersHow and by whom should the standards be developed?

•International co-operation via primarily ISO but also as relevant other standards bodies such as, IEEE, ITU, DICOM, GS1, HL7, OASIS, IHTSDO and WHO shouldbe a strategy to achieve certain European goals.

•Consider financial support to ISO work in some cases

G Klein

CEN-TC 251 WG IV

-ISO/IEEE 11073 standards

-Personal Health Devices Group

•11073

•profile

M Gallaraga, 2007:

M Gallaraga, 2007:

http://www.ehealthhttp://www.ehealth--interop.nen.nl/publicaties/2860interop.nen.nl/publicaties/2860