ISO 18308:2011 PDF

Scope: This International Standard 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. This International Standard 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 this International Standard do contribute to the governance of EHR information within such systems.

ISO 18308:2011 history

2011 ISO 18308:2011 Health informatics - Requirements for an electronic health record architecture