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19/30381225 DC BS ISO 81001-1. Health software and health IT systems safety, effectiveness and security. Foundational principles, concepts, and terms, 2019
- 62A_1308e_CD.pdf [Go to Page]
- ISO CD2 81001-1_2019-01-04.pdf [Go to Page]
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Symbols (and abbreviated terms)
- 5 Core themes [Go to Page]
- 5.1 General
- 5.2 Socio-Technical Ecosystem
- 5.3 System of systems
- 5.4 Life cycle of a health IT system
- 5.5 Roles and responsibilities
- 5.6 Communication
- 5.7 Interdependence of safety, effectiveness and security
- 6 Foundational elements [Go to Page]
- 6.1 General
- 6.2 Governance (intra organization focus) [Go to Page]
- 6.2.1 Organization leadership, culture and competence [Go to Page]
- 6.2.1.1 Statement
- 6.2.1.2 Rationale
- 6.2.1.3 Key concepts and principles
- 6.2.1.4 Approach
- 6.2.2 Quality management [Go to Page]
- 6.2.2.1 Statement
- 6.2.2.2 Rationale
- 6.2.2.3 Key concepts and Principles
- 6.2.2.4 Approach
- 6.2.3 Information Management [Go to Page]
- 6.2.3.1 Statement
- 6.2.3.2 Rationale
- 6.2.3.3 Key concepts and Principles
- 6.2.3.4 Approach
- 6.2.4 Human factors and Usability [Go to Page]
- 6.2.4.1 Statement
- 6.2.4.2 Rationale
- 6.2.4.3 Key concepts and Principles
- 6.2.4.4 Approach
- 6.3 Knowledge transfer (inter and intra organization collaboration) [Go to Page]
- 6.3.1 Risk management [Go to Page]
- 6.3.1.1 Statement
- 6.3.1.2 Rationale
- 6.3.1.3 Key concepts
- 6.3.1.4 Approach
- 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
- 6.3.2 Safety management [Go to Page]
- 6.3.2.1 Statement
- 6.3.2.2 Rationale
- 6.3.2.3 Key concepts
- 6.3.2.4 Approach
- 6.3.2.5 Knowledge Transfer
- 6.3.2.6 Information sharing at major transition points (pre-implementation)
- 6.3.2.7 Ongoing Cross-Functional Information sharing
- 6.3.3 Security management [Go to Page]
- 6.3.3.1 Statement
- 6.3.3.2 Rationale
- 6.3.3.3 Key concepts
- 6.3.3.4 Approach
- 6.3.3.5 Knowledge transfer
- 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 [Go to Page]
- 6.3.4.1 Statement
- 6.3.4.2 Rationale
- 6.3.4.3 Key concepts and principles
- 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
- Annex A (informative) Particular guidance and rationale
- Annex B (informative) Concept diagrams
- Annex C (informative) Use of assurance cases for knowledge transfer
- NOTE TO REVIEWERS: This section is a placeholder for an example assurance case
- (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
- (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 [Go to Page]
