IEC TR 80001-2-9:2017
(Main)Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
IEC TR 80001-2-9:2017(E) establishes a security case framework and provides guidance to health care delivery organizations (HDO) and medical device manufacturers (MDM) for identifying, developing, interpreting, updating and maintaining security cases for networked medical devices. Use of this part of 80001 is intended to be one of the possible means to bridge the gap between MDMs and HDOs in providing adequate information to support the HDOs risk management of IT-networks. This document leverages the requirements set out in ISO/IEC 15026-2 for the development of assurance cases. It is not intended that this security case framework will replace a risk management strategy, rather, the intention is to complement risk management and in turn provide a greater level of assurance for a medical device by:
- mapping specific risk management steps to each of the IEC TR 80001-2-2 security capabilities, identifying associated threats and vulnerabilities and presenting them in the format of a security case with the inclusion of a re-useable security pattern;
- providing guidance for the selection of appropriate security controls to establish security capabilities and presenting them as part of the security case pattern (IEC TR 80001-2-8 provides examples of such security controls);
- providing evidence to support the implementation of a security control, hence providing confidence in the establishment of each of the security capabilities.
The purpose of developing the security case is to demonstrate confidence in the establishment of IEC TR 80001-2-2 security capabilities. The quality of artifacts gathered and documented during the development of the security case is agreed and documented as part of a responsibility agreement between the relevant stakeholders. This document provides guidance for one such methodology, through the use of a specific security pattern, to develop and interpret security cases in a systematic manner.
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IEC TR 80001-2-9
Edition 1.0 2017-01
TECHNICAL
REPORT
Application of risk management for it-networks incorporating medical devices –
Part 2-9: Application guidance – Guidance for use of security assurance cases
to demonstrate confidence in IEC TR 80001-2-2 security capabilities
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IEC TR 80001-2-9
Edition 1.0 2017-01
TECHNICAL
REPORT
Application of risk management for it-networks incorporating medical devices –
Part 2-9: Application guidance – Guidance for use of security assurance cases
to demonstrate confidence in IEC TR 80001-2-2 security capabilities
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01, 35.240.80 ISBN 978-2-8322-3907-0
– 2 – IEC TR 80001-2-9:2017 © IEC 2017
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 8
2 Normative references . 8
3 Terms, definitions and abbreviated terms . 9
3.1 Terms and definitions . 9
3.2 Abbreviated terms . 12
4 ASSURANCE case . 12
5 Use of this document . 13
5.1 Intended use . 13
5.2 Intended audience . 13
5.2.1 Intended purpose . 13
5.2.2 MEDICAL DEVICE MANUFACTURERS (MDM) . 13
5.2.3 Healthcare delivery organizations (HDO) . 14
5.2.4 Other stakeholders . 15
6 General guidelines. 15
6.1 General . 15
6.2 Overview of the SECURITY CASE framework . 15
6.3 Notation . 16
6.3.1 Components of a SECURITY CASE . 16
6.3.2 Goal . 16
6.3.3 Strategy . 17
6.3.4 Justification . 17
6.3.5 Context . 17
6.3.6 Solution (EVIDENCE) . 18
6.3.7 Stakeholder . 18
6.3.8 Notation extensions . 18
7 Developing the SECURITY CASE . 19
8 SECURITY CASE change management . 28
Annex A (informative) Exemplar SECURITY PATTERNS . 29
A.1 General . 29
A.2 Exemplar SECURITY PATTERN for person authentication (PAUT) — SECURITY
CAPABILITY PAUT established by MDM for a medical system . 29
A.2.1 Goal G6: Replay attack mitigated. 29
A.2.2 Goal G8: ‘Man-in-the-middle’ attack mitigated. 29
A.2.3 Goal G10: Brute force attack mitigated . 29
A.2.4 Goal G13, G14: Denial of service attacks due to account lockout
controls mitigated . 30
A.3 Exemplar SECURITY PATTERN for automatic logoff (ALOF) established for a
thin client terminal system . 31
A.3.1 Goal: Patient safety RISK with short session timeouts in OR mitigated . 31
A.3.2 Goal: Patient safety RISK with restoring sessions in the OR and ICU
mitigated . 31
A.4 Exemplar SECURITY PATTERN for audit controls (AUDT) for a system or a
device in a HDO facility such as a pharmacy system or an EMR, where
multiple people require access to the same data set— Goal G6: Keep a
correct audit trail of attending staff in the OR while sessions are kept open . 33
Bibliography . 35
Figure 1 – Example GOAL (top-level) . 17
Figure 2 – Example strategy . 17
Figure 3 – Example justification . 17
Figure 4 – Example context . 18
Figure 5 – Example solution (EVIDENCE) . 18
Figure 6 – Example stakeholder . 18
Figure 7 – Leading components – Steps 1 through 9 . 19
Figure 8 – SECURITY CAPABILITY pattern . 22
Figure 9 – SECURITY CASE structure . 27
Figure A.1 – Exemplar SECURITY PATTERN for PAUT . 30
Figure A.2 – Exemplar SECURITY PATTERN for ALOF . 32
Figure A.3 – Exemplar SECURITY PATTERN for AUDT . 34
Table 1 – Notation extensions . 18
Table 2 – SECURiTY CASE steps 1 through 9 . 20
Table 3 – SECURITY CASE steps 10 through 26 . 23
– 4 – IEC TR 80001-2-9:2017 © IEC 2017
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –
Part 2-9: Application guidance – Guidance for use of security assurance
cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
FOREWORD
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