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ISO 18308:2011 Health Informatics - Requirements for an Electronic Health Record Architecture


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.

For the purposes of this International Standard, the EHR is defined as:

"one or more repositories, physically or virtually integrated, of information in computer processable form, relevant to the wellness, health and healthcare of an individual, capable of being stored and communicated securely and of being accessible by multiple authorized users, represented according to a standardized or commonly agreed logical information model. Its primary purpose is the support of life-long, effective, high quality and safe integrated healthcare."

To complement this definition, the ideal vision of health (and consequently health information) according to WHO definition is:

"Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity."


The scope of the EHR is broader than the mere documentation of health information

In addition to the conventional clinical systems within healthcare provider organizations; systems capturing complementary therapy, wellness, and home care information are deemed potential contributors to an EHR.

The standard elaborates on the business objectives and architectural requirements of an EHR.

Purpose of ISO 18308 Standard

Purpose of ISO 18308 Standard

Information to Get Electronic Health Record (EHR) Standards for India is available at the Get Standard