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<p>This document provides the principles, concepts, terms and definitions for <em>health software</em> and <em>health IT systems, key properties</em> of <em>safety</em>, <em>effectiveness</em> and <em>security,</em> across the full <em>life cycle</em>, from concept to decommissioning, as represented in Figure 1. It also identifies the transition points in the <em>life cycle</em> 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 <em>safety</em>, <em>effectiveness</em>, and <em>security</em> (including <em>privacy</em>) of <em>health software </em>and<em> health IT systems</em>.</p>
<p>This document is applicable to all parties involved in the <em>health software</em> and <em>health IT systems</em> <em>life cycle</em> including the following:</p>
<p>a) <em>Organizations</em>, health informatics professionals and clinical leaders designing, developing, integrating, implementing and operating <em>health software </em>and<em> health IT systems</em> – for example <em>health software</em> <em>developers</em> and <em>medical device</em> <em>manufacturers</em>, <em>system</em> <em>integrators</em>, <em>system</em> <em>administrators</em> (including cloud and other IT service providers);</p>
<p>b) Healthcare service delivery <em>organizations</em>, healthcare providers and others who use <em>health software </em>and<em> health IT systems</em> in providing health services;</p>
<p>c) Governments, health system funders, monitoring agencies, professional <em>organizations</em> and <em>customers</em> seeking confidence in an<em> organization’s </em>ability<em> </em>to<em> </em>consistently provide safe, effective and secure<em> health software</em>, <em>health IT systems</em> and services;</p>
<p>d) <em>Organizations</em> and interested parties seeking to improve communication in managing <em>safety</em>, <em>effectiveness</em> and <em>security</em> <em>risks</em> through a common understanding of the concepts and terminology used in <em>safety</em>, <em>effectiveness</em> and <em>security</em> management;</p>
<p>e) Providers of training, assessment or advice in <em>safety</em>, <em>effectiveness</em> and <em>security</em> <em>risk management</em> for <em>health software </em>and<em> health IT systems</em>;</p>
<p>f) <em>Developers</em> of related <em>safety</em>, <em>effectiveness</em> and <em>security </em>standards<em>.</em></p>
Reģistrācijas numurs (WIID)
91523
Darbības sfēra
<p>This document provides the principles, concepts, terms and definitions for <em>health software</em> and <em>health IT systems, key properties</em> of <em>safety</em>, <em>effectiveness</em> and <em>security,</em> across the full <em>life cycle</em>, from concept to decommissioning, as represented in Figure 1. It also identifies the transition points in the <em>life cycle</em> 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 <em>safety</em>, <em>effectiveness</em>, and <em>security</em> (including <em>privacy</em>) of <em>health software </em>and<em> health IT systems</em>.</p>
<p>This document is applicable to all parties involved in the <em>health software</em> and <em>health IT systems</em> <em>life cycle</em> including the following:</p>
<p>a) <em>Organizations</em>, health informatics professionals and clinical leaders designing, developing, integrating, implementing and operating <em>health software </em>and<em> health IT systems</em> – for example <em>health software</em> <em>developers</em> and <em>medical device</em> <em>manufacturers</em>, <em>system</em> <em>integrators</em>, <em>system</em> <em>administrators</em> (including cloud and other IT service providers);</p>
<p>b) Healthcare service delivery <em>organizations</em>, healthcare providers and others who use <em>health software </em>and<em> health IT systems</em> in providing health services;</p>
<p>c) Governments, health system funders, monitoring agencies, professional <em>organizations</em> and <em>customers</em> seeking confidence in an<em> organization’s </em>ability<em> </em>to<em> </em>consistently provide safe, effective and secure<em> health software</em>, <em>health IT systems</em> and services;</p>
<p>d) <em>Organizations</em> and interested parties seeking to improve communication in managing <em>safety</em>, <em>effectiveness</em> and <em>security</em> <em>risks</em> through a common understanding of the concepts and terminology used in <em>safety</em>, <em>effectiveness</em> and <em>security</em> management;</p>
<p>e) Providers of training, assessment or advice in <em>safety</em>, <em>effectiveness</em> and <em>security</em> <em>risk management</em> for <em>health software </em>and<em> health IT systems</em>;</p>
<p>f) <em>Developers</em> of related <em>safety</em>, <em>effectiveness</em> and <em>security </em>standards<em>.</em></p>
