Klein Gunnar O
Dept. of Medicine at KS, Karolinska Institutet & SIS--Swedish Standards Institute, Stockhom, Sweden.
Stud Health Technol Inform. 2003;96:259-65.
The European standardisation of health informatics in CEN/TC 251 started in 1990 with the now twenty national standards bodies as members and a political mandate from the European Union and EFTA. The start of the international work in ISO/TC 215 has been welcomed by Europe and there is a lot of co-operation where European pre-standards have often been the basis for the start of international standards work, particularly in the area of medical device communication and for health cards. CEN and ISO also collaborate with other bodies in the field such as DICOM for imaging, IEEE for devices and the US based HL7 organisation for message development. It is important to find the right level of standards work for different aspects. The European CEN work will be maintained for issues like the electronic health record, some security aspects and medication related communication where there are common views and legislation makes European consensus necessary and achievable. The device market on the other hand requires global standards. In addition to multinational co-operation, it is important with a national strategy for the use of standards and adaptation and promotion of specific profiles to achieve interoperability in the still mainly national health systems.
欧洲标准化委员会/信息技术标准化技术委员会（CEN/TC 251）的健康信息学欧洲标准化工作始于1990年，当时有20个国家标准机构作为成员，并获得了欧盟和欧洲自由贸易联盟的政治授权。ISO/TC 215国际工作的启动受到了欧洲的欢迎，并且在很多方面都有合作，欧洲的预标准常常是国际标准工作启动的基础，特别是在医疗设备通信和健康卡领域。CEN和ISO还与该领域的其他机构合作，如与用于成像的DICOM、用于设备的IEEE以及总部位于美国的用于消息开发的HL7组织合作。为不同方面找到合适的标准工作水平很重要。欧洲CEN的工作将在诸如电子健康记录、一些安全方面以及与用药相关的通信等问题上继续开展，在这些方面存在共同观点，并且立法使得达成欧洲共识既必要又可行。另一方面，设备市场需要全球标准。除了跨国合作外，制定国家层面的标准使用战略以及采用和推广特定配置文件对于在仍主要是国家层面的卫生系统中实现互操作性也很重要。
