SCP-ECG and Vital Signs Information Representation--two examples of successful transcontinental cooperation in medical informatics standardization.

During the past 2-3 decades, development work on Medical Devices focused on improving their functionality (device control, signal analysis, pattern recognition and classification). At present, the dominant user requirement is information integration. This requires interconnectivity and interoperability of devices and device systems. Today, due to all major manufacturers operating globally, this requirement can only be met if standards with global relevance are developed. The first standard discussed is the Standard Communications Protocol for Computerized Electrocardiography (SCP ECG). The rapid finalization of the standards document itself was possible due to some of the experts being involved on basic problems for greater than 10 years. Their knowledge and long standing cooperation contributed significantly to a fast consensus finding process as well as quick implementation. The second standard discussed in this paper deals with Vital Signs Information Representation. Before starting to write the document, an International inventory workshop was held to document the state of the technology and of user requirements. This common base of problem understanding makes consensus finding less difficult. Continuous cooperation between the IEEE P1073 group and the CEN/TC251 WG5 project team also ensures early harmonization of the related standards. Finally, early implementation projects in Europe and the US allow verification and modifications based on feed-back from practical experience.