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BSI 19/30381225 DC:2019 Edition

BSI 19/30381225 DC:2019 Edition

$13.70

BS ISO 81001-1. Health software and health IT systems safety, effectiveness and security. Foundational principles, concepts, and terms

Published By Publication Date Number of Pages
BSI 2019 61
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PDF Catalog

PDF Pages PDF Title
11 1 Scope
2 Normative references
12 3 Terms and definitions
23 4 Symbols (and abbreviated terms)
5 Core themes
5.1 General
24 5.2 Socio-Technical Ecosystem
25 5.3 System of systems
26 5.4 Life cycle of a health IT system
28 5.5 Roles and responsibilities
29 5.6 Communication
31 5.7 Interdependence of safety, effectiveness and security
6 Foundational elements
6.1 General
33 6.2 Governance (intra organization focus)
6.2.1 Organization leadership, culture and competence
6.2.1.1 Statement
6.2.1.2 Rationale
6.2.1.3 Key concepts and principles
34 6.2.1.4 Approach
6.2.2 Quality management
6.2.2.1 Statement
35 6.2.2.2 Rationale
6.2.2.3 Key concepts and Principles
6.2.2.4 Approach
36 6.2.3 Information Management
6.2.3.1 Statement
6.2.3.2 Rationale
6.2.3.3 Key concepts and Principles
37 6.2.3.4 Approach
6.2.4 Human factors and Usability
6.2.4.1 Statement
6.2.4.2 Rationale
6.2.4.3 Key concepts and Principles
38 6.2.4.4 Approach
39 6.3 Knowledge transfer (inter and intra organization collaboration)
6.3.1 Risk management
6.3.1.1 Statement
6.3.1.2 Rationale
6.3.1.3 Key concepts
40 6.3.1.4 Approach
41 6.3.1.5 Knowledge transfer (communication)
6.3.1.6 Information sharing at major transition points (pre-implementation)
6.3.1.7 Ongoing cross-functional information sharing
42 6.3.2 Safety management
6.3.2.1 Statement
6.3.2.2 Rationale
6.3.2.3 Key concepts
43 6.3.2.4 Approach
6.3.2.5 Knowledge Transfer
44 6.3.2.6 Information sharing at major transition points (pre-implementation)
6.3.2.7 Ongoing Cross-Functional Information sharing
45 6.3.3 Security management
6.3.3.1 Statement
6.3.3.2 Rationale
6.3.3.3 Key concepts
46 6.3.3.4 Approach
6.3.3.5 Knowledge transfer
47 6.3.3.6 Information sharing at major transition points (pre-implementation)
6.3.3.7 Ongoing cross-functional information sharing
6.3.4 Privacy management
6.3.4.1 Statement
6.3.4.2 Rationale
48 6.3.4.3 Key concepts and principles
49 6.3.4.4 Approach
6.3.4.5 Knowledge transfer (Communication)
6.3.4.6 Information sharing at major transition points (pre-implementation)
6.3.4.7 Ongoing cross-functional information sharing
50 Annex A (informative) Particular guidance and rationale
53 Annex B (informative) Concept diagrams
55 Annex C (informative) Use of assurance cases for knowledge transfer
59 NOTE TO REVIEWERS: This section is a placeholder for an example assurance case
60 (1) IEC 60027 (all parts), Letter symbols to be used in electrical technology
(2) IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities and activities
(3) IEC/TR 80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
(4) IEC/TR 80001-2-3:2012, Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
(5) IEC 60601 Technical standards for the safety and essential performance of medical electrical equipment
(6) ISO/IEC Guide 51:2014, Safety aspects — Guidelines for their inclusion in standards
(7) ISO/IEC Guide 63:2018, Guide to the development and inclusion of aspects of safety in International Standards for medical devices
(8) ISO 31 (all parts), Quantities and units
(9) ISO 690, Documentation — Bibliographic references — Content, form and structure
(10) ISO 690-2, Information and documentation — Bibliographic references — Part 2: Electronic documents or parts thereof
(11) ISO 128-30, Technical drawings — General principles of presentation — Part 30: Basic conventions for views
(12) ISO 128-34, Technical drawings — General principles of presentation — Part 34: Views on mechanical engineering drawings
(13) ISO 128-40, Technical drawings — General principles of presentation — Part 40: Basic conventions for cuts and sections
(14) ISO 128-44, Technical drawings — General principles of presentation — Part 44: Sections on mechanical engineering drawings
(15) ISO 1000, SI units and recommendations for the use of their multiples and of certain other units
(16) ISO 10241, International terminology standards — Preparation and layout
(17) ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
(18) ISO/IEC TR 10000-1, Information technology — Framework and taxonomy of International Standardized Profiles — Part 1: General principles and documentation framework
(19) ISO 14971:2007, Medical devices — Application of risk management to medical devices
(20) ISO/IEC 20000-1:2005, Information technology — Service management — Part 1: Specification
61 (21) ISO 27799:2016, Health informatics — Information security management in health using ISO/IEC 27002
(22) ISO 31000,2018, Risk management
(23) ISB 0160, F. Brindley, J. Fox, S. White, Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems – Implementation Guidance, UK National Health Service: 2013 (Available at: http://webarchive.nationalarchives.gov.u…
(24) ISO TS 20405:2018, Health informatics – Framework of event data and reporting definitions for the safety of health software
(25) Neily J, Mills PD, Young-Xu Y, et al. Association between implementation of a medical team training program and surgical mortality. JAMA. 2010;304:1693-1700

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