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BS EN IEC 81001-5-1:2022

BS EN IEC 81001-5-1:2022

$198.66

Health software and health IT systems safety, effectiveness and security – Security. Activities in the product life cycle

Published By Publication Date Number of Pages
BSI 2022 66
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This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1[11] – taking the specific needs for HEALTH SOFTWARE into account. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for secure HEALTH SOFTWARE LIFE CYCLE PROCESSES. An informal overview of activities for HEALTH SOFTWARE is shown in Figure 2. [Figure 2] [derived from IEC 62304:2006[8], Figure 2] Figure 2 – HEALTH SOFTWARE LIFE CYCLE PROCESSES The purpose is to increase the CYBERSECURITY of HEALTH SOFTWARE by establishing certain ACTIVITIES and TASKS in the HEALTH SOFTWARE LIFE CYCLE PROCESSES and also by increasing the SECURITY of SOFTWARE LIFE CYCLE PROCESSES themselves. It is important to maintain an appropriate balance of the key properties SAFETY, effectiveness and SECURITY as discussed in ISO 81001-1[17]. This document excludes specification of ACCOMPANYING DOCUMENTATION contents.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
10 English
CONTENTS
13 FOREWORD
15 INTRODUCTION
0.1 Structure
16 0.2 Field of application
0.3 Conformance
Figure 1 – Health software field of application
18 1 Scope
2 Normative references
Figure 2 – Health software life cycle processes
19 3 Terms and definitions
26 4 General requirements
4.1 Quality management
4.1.1 Quality management system
4.1.2 Identification of responsibilities
4.1.3 Identification of applicability
4.1.4 Security expertise
27 4.1.5 Software items from third-party suppliers
4.1.6 Continuous improvement
4.1.7 Disclosing security-related issues
4.1.8 Periodic review of security defect management
28 4.1.9 Accompanying documentation review
4.2 SECURITY RISK MANAGEMENT
4.3 Software item classification relating to risk transfer
29 5 Software development process
5.1 Software development planning
5.1.1 Activities in the life cycle process
5.1.2 Development environment security
5.1.3 Secure coding standards
5.2 Health software requirements analysis
5.2.1 Health software security requirements
30 5.2.2 Security requirements review
5.2.3 Security risks for required software
5.3 Software architectural design
5.3.1 Defense-in-depth architecture/design
5.3.2 Secure design best practices
31 5.3.3 Security architectural design review
5.4 Software design
5.4.1 Software design best practices
5.4.2 Secure design
5.4.3 Secure health software interfaces
32 5.4.4 Detailed design verification for security
5.5 Software unit implementation and verification
5.5.1 Secure coding standards
5.5.2 Security implementation review
33 5.6 Software integration testing
5.7 Software system testing
5.7.1 Security requirements testing
5.7.2 Threat mitigation testing
5.7.3 Vulnerability testing
34 5.7.4 Penetration testing
5.7.5 Managing conflicts of interest between testers and developers
5.8 Software release
5.8.1 Resolve findings prior to release
35 5.8.2 Release documentation
5.8.3 File integrity
5.8.4 Controls for private keys
5.8.5 Assessing and addressing security-related issues
5.8.6 Activity completion
5.8.7 Secure decommissioning guidelines for health software
36 6 SOFTWARE MAINTENANCE PROCESS
6.1 Establish software maintenance plan
6.1.1 Timely delivery of security updates
6.2 Problem and modification analysis
6.2.1 Monitoring public incident reports
6.2.2 Security update verification
37 6.3 Modification implementation
6.3.1 Supported software security update documentation
6.3.2 Maintained software security update delivery
6.3.3 Maintained software security update integrity
7 SECURITY RISK MANAGEMENT PROCESS
7.1 Risk management context
7.1.1 General
7.1.2 PRODUCT SECURITY CONTEXT
38 7.2 Identification of vulnerabilities, threats and associated adverse impacts
39 7.3 Estimation and evaluation of security risk
7.4 Controlling security risks
7.5 Monitoring the effectiveness of risk controls
40 8 Software configuration management process
9 Software problem resolution process
9.1 Overview
9.2 Receiving notifications about vulnerabilities
9.3 Reviewing vulnerabilities
41 9.4 Analysing vulnerabilities
9.5 Addressing security-related issues
43 Annex A (informative)Rationale
A.1 Relationship to IEC 62443
44 A.2 Relationship to IEC 62304
Table A.1 – Required level of independence of testers from developers
45 A.3 Risk transfer
A.3.1 Overview
A.3.2 MAINTAINED SOFTWARE
A.3.3 SUPPORTED SOFTWARE
A.3.4 REQUIRED SOFTWARE
46 A.4 Secure coding best practices
47 Annex B (informative)Guidance on implementation of security life cycle activities
B.1 Overview
B.2 Related work
48 B.4 Threat and risk management
B.5 Software development planning
B.5.1 Development
49 B.5.2 Health software requirements analysis
B.5.3 Software architectural design
B.5.4 Software unit implementation and verification
50 B.5.5 Secure implementation
B.5.6 Not used
B.5.7 Software system testing
52 Annex C (informative)Threat modelling
C.1 General
C.2 Attack-defense trees
C.3 CAPEC / OWASP / SANS
C.4 CWSS
53 C.6 List known potential vulnerabilities
C.9 Trike
C.10 VAST
54 Annex D (informative)Relation to practices in IEC 62443-4-1:2018
D.1 IEC 81001-5-1 to IEC 62443-4-1:2018
55 D.2 IEC 62443-4-1:2018 to IEC 81001-5-1
56 Annex E (informative)Documents specified in IEC 62443-4-1
E.1 Overview
E.2 Release documentation
E.2.1 Product documentation
57 E.2.2 Health software defense-in-depth documentation
E.2.3 Defense-in-depth measures expected in the environment
E.2.4 Security hardening guidelines
58 E.2.5 Security update information
E.3 Documents for decommissioning health software
59 Annex F (normative)Transitional health software
F.1 Overview
F.2 Development assessment and gap closure activities
60 F.3 Rationale for use of transitional health software
F.4 Post-release activities
61 Annex G (normative)Object identifiers
Table G.1 – Object identifiers for conformance concepts of this document
62 Bibliography

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BS EN IEC 81001-5-1:2022
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