1 Scope
This document provides the principles, concepts, terms and definitions for
health
software and health ITsystems, key properties of
safety, effectiveness and
security, across the full life
cycle, from concept to decommissioning, as represented
in Figure 1. It also identifies the
transition points in the life cycle where
transfers of responsibility occur, and the types of multi-lateral communication that
are necessary at these transition points. This document also establishes a coherent
concepts and terminology for other standards that address specific aspects of the
safety, effectiveness, and
security (including privacy) of health
softwareandhealth ITsystems.
This document is applicable to all parties involved in the health
software and health ITsystemslife cycle including the
following:
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a) Organizations , health informatics professionals and clinical leaders designing, developing, integrating, implementing and operating health softwareandhealth ITsystems – for example health softwaredevelopers and medical devicemanufacturers, systemintegrators, systemadministrators (including cloud and other IT service providers);
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b) Healthcare service delivery organizations, healthcare providers and others who use health softwareandhealth ITsystems in providing health services;
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c) Governments, health system funders, monitoring agencies, professional organizations and customers seeking confidence in anorganization’s abilitytoconsistently provide safe, effective and securehealth software, health ITsystems and services;
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d) Organizations and interested parties seeking to improve communication in managing safety, effectiveness and securityrisks through a common understanding of the concepts and terminology used in safety, effectiveness and security management;
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e) Providers of training, assessment or advice in safety, effectiveness and securityrisk management for health softwareandhealth ITsystems;
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f) Developers of related safety, effectiveness and security standards.