Norme internationale
Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts
Publié 31 mars 2021
This document provides the principles, concepts, terms and definitions for health software and health IT systems, 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 software and health IT systems . This document is applicable to all parties involved in the health software and health IT systems life cycle including the following: a) Organizations , health informatics professionals and clinical leaders designing, developing, integrating, implementing and operating health software and health IT systems – for example health software developers and medical device manufacturers , system integrators , system administrators (including cloud and other IT service providers); b) Healthcare service delivery organizations , healthcare providers and others who use health software and health IT systems in providing health services; c) Governments, health system funders, monitoring agencies, professional organizations and customers seeking confidence in an organization’s ability to consistently provide safe, effective and secure health software , health IT systems and services; d) Organizations and interested parties seeking to improve communication in managing safety , effectiveness and security risks through a common understanding of the concepts and terminology used in safety , effectiveness and security management; e) Providers of training, assessment or advice in safety , effectiveness and security risk management for health software and health IT systems ; f) Developers of related safety , effectiveness and security standards .
Contains information from ISO Open Data (https://www.iso.org/open-data.html), made available under the ODC Attribution License (ODC-By) v1.0.