{"id":374520,"date":"2024-10-20T02:39:01","date_gmt":"2024-10-20T02:39:01","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-81001-12021\/"},"modified":"2024-10-26T04:36:56","modified_gmt":"2024-10-26T04:36:56","slug":"bs-iso-81001-12021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-81001-12021\/","title":{"rendered":"BS ISO 81001-1:2021"},"content":{"rendered":"

This document provides the principles, concepts, terms and definitions for health software<\/i> and health IT systems, key properties<\/i> of safety<\/i>, effectiveness<\/i> and security,<\/i> across the full life cycle<\/i>, from concept to decommissioning, as represented in Figure 1<\/span>. It also identifies the transition points in the life cycle<\/i> 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<\/i>, effectiveness<\/i>, and security<\/i> (including privacy<\/i>) of health software<\/i> and health IT systems<\/i>.<\/p>\n

This document is applicable to all parties involved in the health software<\/i> and health IT systems<\/i> life cycle<\/i> including the following:<\/p>\n

    \n
  1. \n

    Organizations<\/i>, health informatics professionals and clinical leaders designing, developing, integrating, implementing and operating health software<\/i> and health IT systems<\/i> \u2013 for example health software<\/i> developers<\/i> and medical device<\/i> manufacturers<\/i>, system<\/i> integrators<\/i>, system<\/i> administrators<\/i> (including cloud and other IT service providers);<\/p>\n<\/li>\n

  2. \n

    Healthcare service delivery organizations<\/i>, healthcare providers and others who use health software<\/i> and health IT systems<\/i> in providing health services;<\/p>\n<\/li>\n

  3. \n

    Governments, health system funders, monitoring agencies, professional organizations<\/i> and customers<\/i> seeking confidence in an organization\u2019s<\/i> ability to consistently provide safe, effective and secure health software<\/i>, health IT systems<\/i> and services;<\/p>\n<\/li>\n

  4. \n

    Organizations<\/i> and interested parties seeking to improve communication in managing safety<\/i>, effectiveness<\/i> and security<\/i> risks<\/i> through a common understanding of the concepts and terminology used in safety<\/i>, effectiveness<\/i> and security<\/i> management;<\/p>\n<\/li>\n

  5. \n

    Providers of training, assessment or advice in safety<\/i>, effectiveness<\/i> and security<\/i> risk management<\/i> for health software<\/i> and health IT systems<\/i>;<\/p>\n<\/li>\n

  6. \n

    Developers<\/i> of related safety<\/i>, effectiveness<\/i> and security<\/i> standards.<\/p>\n<\/li>\n<\/ol>\n

    PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
    PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
    2<\/td>\nundefined <\/td>\n<\/tr>\n
    6<\/td>\nForeword <\/td>\n<\/tr>\n
    7<\/td>\nIntroduction <\/td>\n<\/tr>\n
    9<\/td>\n1 Scope
    2 Normative references
    3 Terms and definitions <\/td>\n<\/tr>\n
    10<\/td>\n3.1 Organizations, people, and roles <\/td>\n<\/tr>\n
    11<\/td>\n3.2 Key properties and processes <\/td>\n<\/tr>\n
    13<\/td>\n3.3 Health information and technology <\/td>\n<\/tr>\n
    16<\/td>\n3.4 Risk management <\/td>\n<\/tr>\n
    19<\/td>\n4 Core themes
    4.1 General <\/td>\n<\/tr>\n
    20<\/td>\n4.2 Sociotechnical ecosystem <\/td>\n<\/tr>\n
    21<\/td>\n4.3 System of systems <\/td>\n<\/tr>\n
    22<\/td>\n4.4 Life cycle of health software and health IT systems <\/td>\n<\/tr>\n
    25<\/td>\n4.5 Roles and responsibilities <\/td>\n<\/tr>\n
    26<\/td>\n4.6 Communication <\/td>\n<\/tr>\n
    28<\/td>\n4.7 Interdependence of safety, effectiveness and security <\/td>\n<\/tr>\n
    29<\/td>\n5 Foundational elements
    5.1 General <\/td>\n<\/tr>\n
    30<\/td>\n5.2 Governance (intra organization focus)
    5.2.1 General
    5.2.2 Organization culture, roles and competencies <\/td>\n<\/tr>\n
    32<\/td>\n5.2.3 Quality management <\/td>\n<\/tr>\n
    33<\/td>\n5.2.4 Information management <\/td>\n<\/tr>\n
    34<\/td>\n5.2.5 Human factors and usability <\/td>\n<\/tr>\n
    36<\/td>\n5.3 Knowledge transfer (inter- and intra- organization collaboration)
    5.3.1 General
    5.3.2 Risk management <\/td>\n<\/tr>\n
    38<\/td>\n5.3.3 Safety management <\/td>\n<\/tr>\n
    41<\/td>\n5.3.4 Security management <\/td>\n<\/tr>\n
    44<\/td>\n5.3.5 Privacy management <\/td>\n<\/tr>\n
    47<\/td>\nAnnex A (informative) Rationale <\/td>\n<\/tr>\n
    51<\/td>\nAnnex B (informative) Concept diagrams <\/td>\n<\/tr>\n
    56<\/td>\nAnnex C (informative) Use of assurance cases for knowledge transfer <\/td>\n<\/tr>\n
    67<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    Health software and health IT systems safety, effectiveness and security – Principles and concepts<\/b><\/p>\n\n\n\n\n
    Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
    BSI<\/b><\/a><\/td>\n2021<\/td>\n70<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":374525,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[704,2641],"product_tag":[],"class_list":{"0":"post-374520","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-35-240-80","7":"product_cat-bsi","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\/374520","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\/374525"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=374520"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=374520"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=374520"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}