Standard
Track updates
AS ISO 81001.1:2022
[Current]Health software and health IT systems safety, effectiveness and security, Part 1: Principles and concepts
AS ISO 81001.1:2022 identically adopts ISO 81001 1:2021, which provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning
Published: 29/07/2022
Pages: 61
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.1 Organizations, people, and roles
3.2 Key properties and processes
3.3 Health information and technology
3.4 Risk management
4 Core themes
4.1 General
4.2 Sociotechnical ecosystem
4.3 System of systems
4.4 Life cycle of health software and health IT systems
4.5 Roles and responsibilities
4.6 Communication
4.7 Interdependence of safety, effectiveness and security
5 Foundational elements
5.1 General
5.2 Governance (intra organization focus)
5.2.1 General
5.2.2 Organization culture, roles and competencies
5.2.2.1 Statement
5.2.2.2 Rationale
5.2.2.3 Key concepts and principles
5.2.2.4 Approach
5.2.3 Quality management
5.2.3.1 Statement
5.2.3.2 Rationale
5.2.3.3 Key concepts and principles
5.2.3.4 Approach
5.2.4 Information management
5.2.4.1 Statement
5.2.4.2 Rationale
5.2.4.3 Key concepts and principles
5.2.4.4 Approach
5.2.5 Human factors and usability
5.2.5.1 Statement
5.2.5.2 Rationale
5.2.5.3 Key concepts and principles
5.2.5.4 Approach
5.3 Knowledge transfer (inter- and intra- organization collaboration)
5.3.1 General
5.3.2 Risk management
5.3.2.1 Statement
5.3.2.2 Rationale
5.3.2.3 Key concepts
5.3.2.4 Approach
5.3.2.5 Communication
5.3.2.6 Information sharing at major transition points (pre-implementation)
5.3.2.7 Ongoing cross-functional information sharing
5.3.3 Safety management
5.3.3.1 Statement
5.3.3.2 Rationale
5.3.3.3 Key concepts
5.3.3.4 Approach
5.3.3.5 Communication
5.3.3.6 Information sharing at major transition points (pre-implementation)
5.3.3.7 Ongoing cross-functional information sharing
5.3.4 Security management
5.3.4.1 Statement
5.3.4.2 Rationale
5.3.4.3 Key concepts
5.3.4.4 Approach
5.3.4.5 Communication
5.3.4.6 Information sharing at major transition points (pre-implementation)
5.3.4.7 Ongoing cross-functional information sharing
5.3.5 Privacy management
5.3.5.1 Statement
5.3.5.2 Rationale
5.3.5.3 Key concepts and principles
5.3.5.4 Approach
5.3.5.5 Communication
5.3.5.6 Information sharing at major transition points (pre-implementation)
5.3.5.7 Ongoing cross-functional information sharing
Annex A
A.1 General
A.2 Rationale
Annex B
B.1 Overview of concept diagrams
B.2 Concept diagrams
Annex C
C.1 Overview
C.2 Structuring the assurance case claim and argument
C.3 Guidance on developing assurance cases
Bibliography
Cited references in this standard
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