Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts
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 â 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 organizationâs 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.
|Publication type||International Standard|
|TC/SC||TC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss|
|ICS||35.240.80 - IT applications in health care technology|
|File size||6256 KB|
The following test report forms are related:
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