CEN is the European Standards body. It produces standards covering all aspects of life and industry, not just medical informatics. 20 countries try to achieve peace, light and harmony through CEN.
CEN's mission is to promote voluntary technical harmonization in Europe in conjunction with worldwide bodies and its partners in Europe. Harmonization diminishes trade barriers, promotes safety, allows interoperability of products, systems and services, and promotes common technical understanding.
In conventional sectors of industry, standards are well known for increasing companies' market opportunities and for lowering the cost of equipment and services to users. The same arguments hold for the field of health care informatics, where European industry currently supplies to a fragmented market, products which have a short life cycle and are over-customised and therefore expensive to develop, to buy, and to maintain. Agreement on common requirements will reduce the cost of healthcare information systems and open up the market.
The annual budget of CEN is 10,640,000 Euro.
If people think a standard is needed in an area, CEN has three methods for getting one:
CEN technical committees, therefore, are convened only when the other two options are not possible. Once started, Technical Committees receive money from CEN to fund their administration activities - web sites, distribution of documents, organisation of meetings etc. This money comes from the European Commission.
When a publicly funded body (=some part of the government) from one of the CEN members seeks to purchase anything, it must ensure that whatever it buys is compliant with all the relevant full CEN standards.
There is no obligation on non-state bodies (i.e. commercial companies) to do the same.
CEN TC251 handles everything to do with medical informatics. The activities in TC251 are further divided between four working groups. These mirror to some extent the working groups of ISO TC215:
Each member country of the European Union will, usually, have its own national standards body, such as the British Standards Institute (BSI). In most cases, these national bodies will set up panels of people in that country who are interested in the particular area of activity covered by a CEN Technical Committee.
These national 'mirror panels' shadow the activities of a CEN technical committee and its working groups. Mirror panels act as a national discussion group for what is going on in the main CEN technical committee. Usually, the mirror panels also nominate one official national expert for each CEN Working Group, and the national government then pays to send these people to the full CEN meetings. These nominated experts function as the official designated country representative at the full meetings. They not only contribute to the discussions, but also eventually vote on behalf of their country to accept ot reject proposals for a standard.
In the UK, for example, the BSI has contracted the NHS to set up IST35 to follow the activities of CEN TC251. The membership of IST35 is controlled - you can ask to join in, but IST35 itself decides whether to allow you in. IST35 also mirrors the activities of ISO, and sends 'PUKEs' (=preferred UK experts) to both, paid for by the Department of Trade and Industry.
The four CEN TC251 working groups meet together for a joint meeting 3 times each year. Each WG generally comprises at least one expert from each member state. These experts decide what work needs to be done to progress the overall process of developing a standard.
TC251 is unusual as a CEN Technical Committee because, in addition to a budget for normal administrative costs, it also has a modest budget to fund new work.
Proposals for possible new work come from within each working group but can also be submitted from outside. Some pieces of work are classed as a 'Short Strategic Study (SSS)'. These are intended as relatively cheap exploratory studies to find out where the real effort should be applied. Other pieces of work might be preparation of a full document which is intended to be voted on to become a standard.
When the working group and TC251 board decide that a piece of new work is sufficiently important to be funded, then a document is prepared indicating what the work should be and roughly how much money is available to fund it. This document forms the basis on which consortia of people are invited to submit a costed proposal, in competition with each other, to carry out the work item.
Once a preferred consortium of people to deliver is chosen, a contract is drawn up and a sum of money agreed. The consortium is then assigned a sequential project team number - e.g. PT102. Once the contract is completed the PT ceases to exist.
When a work Item contract is for the production of a document intended for voting, there are usually several stages in the process that are written into the contract as milestone deliverables. Typically, these are:
The FFV goes for a vote at the full TC251 meeting. Voting is Qualified Majority Voting.
If an FFV is accepted, it usually then gains the status of being a European pre-standard (ENV) and is given a sequential serial number by CEN rather than by the WG itself.
If an FFV is rejected by the full TC251 meeting, then often there will be an attempt to remove all the controversial substance so that the FFV is then accepted at a new vote. This may mean that what is left of the original FFV is of little consequence or meaning, and so although the object has been accepted it is then expected that it will be ignored.
There is no binding obligation on anybody to take any notice of CEN pre-standards. Some ENVs are fairly meaningless and are widely ignored. This is especially true of any ENV that was only accepted after all the meat was taken out.
Those ENVs that do contain meat, however, will usually be looked at fairly seriously by at least some member states. Often there will be national initiatives to take the ENV and validate and test it in real implementations. Sometimes these implementations only involve part of the ENV. This may be because not all of the ENV is relevant to the country or implementing organisation, or because the country does not agree with the whole ENV. The process of picking and choosing what is or is not relevant or desired from a large ENV is called 'profiling' the standard.
Successful ENVs, therefore, will generally be adopted and tested at one or more sites.
Whether or not an ENV is adopted for testing in this way, all ENVs must be reviewed after 3 years to decide what to do with them. Sometimes, during the testing period, it becomes clear that the ENV is not useful - perhaps technology has moved on. Other times people find that it would be better with some clarification or other change. After a consultation phase, a decision will be made whether to vote to turn the pre-standard into a full CEN standard, with or without changes.
If the ENV is voted on by TC251 and accepted as a full standard, then it is referred upwards to a CEN enquiry. This process lasts 6 months, during which time the official standards bodies in all the member countries (e.g. the BSI) are invited to circulate the proposed standard one last time and take their last opportunity to object, before the thing acquires the backing of law and treaty. Assuming the proposal survives this process, then the ENV becomes an EN: a full CEN standard.
CEN TC251 has been operating for 10 years. By October 2004, it had created about 41 ENVs and a further 10 full standards, or EN:
EN 14484:2003 International transfer of personal health data covered by the EU data protection directive - High level security policy EN 14485:2003 Guidance for handling personal health data in international applications in the context of the EU data protection directive EN 1828:2002 Categorial structure for classifications and coding systems of surgical procedures EN ISO 18104:2003 Integration of a reference terminology model for nursing (ISO 18104:2003) EN ISO 18812:2003 Clinical analyser interfaces to laboratry information systems - Use profiles (ISO 18812:2003) EN ISO 21549-1:2004 Patient healthcard data - Part 1: General structure (ISO 21549-1:2004) EN ISO 21549-2:2004 Patient healthcard data - Part 2: Common objects (ISO 21549-2:2004) EN ISO 21549-3:2004 Patient healthcard data - Part 3: Limited clinical data (ISO 21549-3:2004) EN 12251:2004 Secure user identification for healthcare - Identification and authentication by passwords - Management and security EN 12252:2004 Digital imaging - Communication, workflow and data management
(which endorses all of DICOM as a European Standard)