标准编号：ISO 81001-1:2021
中文名称：健康软件和健康IT系统安全、有效性和安全性 第1部分：原则和概念
英文名称：Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts
发布日期：2021-03
标准范围
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.
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