{"id":625921,"date":"2024-11-06T00:06:23","date_gmt":"2024-11-06T00:06:23","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-81001-12021\/"},"modified":"2024-11-06T00:06:23","modified_gmt":"2024-11-06T00:06:23","slug":"iso-81001-12021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-81001-12021\/","title":{"rendered":"ISO 81001-1:2021"},"content":{"rendered":"<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\u00a01. 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>\n<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>\n<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> \u2013 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>\n<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>\n<p>c) Governments, health system funders, monitoring agencies, professional <em>organizations<\/em> and <em>customers<\/em> seeking confidence in an<em> organization\u2019s <\/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>\n<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>\n<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>\n<p>f) <em>Developers<\/em> of related <em>safety<\/em>, <em>effectiveness<\/em> and <em>security <\/em>standards<em>.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Health software and health IT systems safety, effectiveness and security \u2014 Part 1: Principles and concepts<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/iso\/\"><b>ISO<\/b><\/a><\/td>\n<td>2021-03<\/td>\n<td>68<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":625933,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[704,2634],"product_tag":[],"class_list":{"0":"post-625921","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-35-240-80","7":"product_cat-iso","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/625921","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/625933"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=625921"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=625921"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=625921"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}