Abstract / scope
ISO 18308:2011 defines the set of requirements for the architecture of a system that processes, manages and communicates electronic health record (EHR) information: an EHR architecture. The requirements are formulated to ensure that these EHRs are faithful to the needs of healthcare delivery, are clinically valid and reliable, are ethically sound, meet prevailing legal requirements, support good clinical practice and facilitate data analysis for a multitude of purposes.
ISO 18308:2011 does not specify the full set of requirements that need to be met by an EHR system for direct patient care or for other use cases, but the requirements defined by ISO 18308:2011 do contribute to the governance of EHR information within such systems.