IEC/TR 80001-2-8:2016

IEC TR 80001-2-8
Edition 1.0 2016-05
TECHNICAL
REPORT
Application of risk management for IT-networks incorporating medical devices –
Part 2-8: Application guidance – Guidance on standards for establishing the
security capabilities identified in IEC TR 80001-2-2
IEC TR 80001-2-8:2016-05(en)

---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2016 IEC, Geneva, Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.


IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch

About the IEC

The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bi bliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 15 additional

documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.

---------------------- Page: 2 ----------------------
IEC TR 80001-2-8


Edition 1.0 2016-05




TECHNICAL



REPORT




















Application of risk management for IT-networks incorporating medical devices –

Part 2-8: Application guidance – Guidance on standards for establishing the

security capabilities identified in IEC TR 80001-2-2


























INTERNATIONAL

ELECTROTECHNICAL


COMMISSION





ICS 11.040.01 ISBN 978-2-8322-3412-9



  Warning! Make sure that you obtained this publication from an authorized distributor.

---------------------- Page: 3 ----------------------
– 2 – IEC TR 80001-2-8:2016 © IEC 2016
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 9
2 Normative references. 9
3 Terms and definitions . 10
4 Guidance for establishing SECURITY CAPABILITIES . 13
4.1 General . 13
4.2 Automatic logoff – ALOF . 14
4.3 Audit controls – AUDT . 15
4.4 Authorization – AUTH . 17
4.5 Configuration of security features – CNFS . 19
4.6 Cyber security product upgrades – CSUP . 21
4.7 HEALTH DATA de-identification – DIDT . 24
4.8 Data backup and disaster recovery – DTBK . 25
4.9 Emergency access – EMRG . 27
4.10 HEALTH DATA integrity and authenticity – IGAU . 28
4.11 Malware detection/protection – MLDP . 30
4.12 Node authentication – NAUT . 32
4.13 Person authentication – PAUT . 35
4.14 Physical locks on device – PLOK . 37
4.15 Third-party components in product lifecycle roadmaps – RDMP . 39
4.16 System and application hardening – SAHD . 42
4.17 Security guides – SGUD . 44
4.18 HEALTH DATA storage confidentiality – STCF . 47
4.19 Transmission confidentiality – TXCF . 48
4.20 Transmission integrity – TXIG . 50
Bibliography . 51

Table 1 – ALOF controls . 14
Table 2 – AUDT controls . 16
Table 3 – AUTH controls . 18
Table 4 – CNFS controls . 20
Table 5 – CSUP controls . 22
Table 6 – DIDT controls . 24
Table 7 – DTBK controls . 26
Table 8 – EMRG controls . 28
Table 9 – IGAU controls . 29
Table 10 – MLDP controls . 30
Table 11 – NAUT controls . 33
Table 12 – PAUT controls . 36
Table 13 – PLOK controls . 38
Table 14 – RDMP controls . 40
Table 15 – SAHD controls . 43

---------------------- Page: 4 ----------------------
IEC TR 80001-2-8:2016 © IEC 2016 – 3 –
Table 16 – SGUD controls. 45
Table 17 – STCF controls . 48
Table 18 – TXCF controls . 49
Table 19 – TXIG controls . 50

---------------------- Page: 5 ----------------------
– 4 – IEC TR 80001-2-8:2016 © IEC 2016
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –

Part 2-8: Application guidance – Guidance on standards for
establishing the security capabilities identified in IEC TR 80001-2-2

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 80001-2-8, which is a technical report, has been prepared by subcommittee 62A:
Common aspects of electrical equipment used in medical practice, of IEC technical committee
62: Electrical equipment in medical practice, and ISO technical committee 215: Health
1)
informatics.
___________
1)
This document contains original material that is © 2013, Dundalk Institute of Technology, Ireland. Permission is
granted to ISO and IEC to reproduce and circulate this material, this being without prejudice to the rights of
Dundalk Institute of Technology to exploit the original text elsewhere.

---------------------- Page: 6 ----------------------
IEC TR 80001-2-8:2016 © IEC 2016 – 5 –
It is published as a double logo technical report.
The text of this technical report is based on the following documents of IEC:
Enquiry draft Report on voting
62A/1018/DTR 62A/1043A/RVC

Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table. In ISO, the standard has been approved by
14 P-members out of 31 having cast a vote.
This publication has been drafted in accordance with the ISO IEC Directives, Part 2.
Terms used throughout this technical report that have been defined in Clause 3 appear in
SMALL CAPITALS.
A list of all parts of the IEC 80001 series, published under the general title Application of risk
management for it-networks incorporating medical devices, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

---------------------- Page: 7 ----------------------
– 6 – IEC TR 80001-2-8:2016 © IEC 2016
INTRODUCTION
The IEC 80001-1 standard, the Application of risk management to IT-networks incorporating
medical devices, provides the roles, responsibilities and activities necessary for RISK
MANAGEMENT. IEC TR 80001-2-2, the Application of risk management for IT-networks
incorporating medical devices – Part 2-2: Guidance for the disclosure and communication of
medical device security needs, risks and controls is a technical report that provides additional
guidance in relation to how SECURITY CAPABILITIES might be referenced (disclosed and
discussed) in both the RISK MANAGEMENT PROCESS and stakeholder communications and
agreements. This technical report provides guidance for the establishment of each of the
SECURITY CAPABILITIES presented in IEC TR 80001-2-2.
IEC TR 80001-2-2 contains an informative set of common, descriptive SECURITY CAPABILITIES
intended to be the starting point for a security-centric discussion between the vendor and
purchaser or among a larger group of stakeholders involved in a MEDICAL DEVICE IT-NETWORK
project. Scalability is possible across a range of different sizes of RESPONSIBLE ORGANIZATIONS
(henceforth called healthcare delivery organizations – HDOs) as each evaluates RISK using
the SECURITY CAPABILITIES and decides what to include or not to include according to their RISK
tolerance and available resources. This documentation can be used by HDOs as input to their
IEC 80001 PROCESS or to form the basis of RESPONSIBILITY AGREEMENTS among stakeholders.
Other IEC 80001 technical reports will provide step-by-step guidance in the RISK MANAGEMENT
PROCESS. IEC TR 80001-2-2 SECURITY CAPABILITIES encourage the disclosure of more detailed
SECURITY CONTROLS. This technical report identifies SECURITY CONTROLS from key security
standards which aim to provide guidance to a RESPONSIBLE ORGANIZATION when adapting the
framework outlined in IEC TR 80001-2-2.
The framework outlined in IEC TR 80001-2-2 requires shared responsibility between HDOs
and MEDICAL DEVICE manufacturers (MDMs). Similarly, this guidance applies to both
stakeholders, as a shared responsibility, to ensure safe MEDICAL DEVICE IT networks. In order
to build a secure MEDICAL DEVICE IT network a joint effort from both stakeholders is required.
A SECURITY CAPABILITY, as defined in IEC TR 80001-2-2, represents a broad category of
2)
technical, administrative and/or organizational SECURITY CONTROLS required to manage RISKS
to confidentiality, integrity, availability and accountability of data and systems. This document
presents these categories of SECURITY CONTROLS prescribed for a system and the operational
environment to establish SECURITY CAPABILITIES to protect the confidentiality, integrity,
availability and accountability of data and systems. The SECURITY CONTROLS support the
maintenance of confidentiality and the protection from malicious intrusion that might lead to
compromises in integrity or system/data availability. The SECURITY CONTROLS for each
3)
SECURITY CAPABILITY can be added to as the need arises . Controls are intended to protect
both data and systems but special attention is given to the protection of both PRIVATE DATA
and its subset called HEALTH DATA.
In addition to providing a basis for discussing RISK and respective roles and responsibilities
toward RISK MANAGEMENT, this report is intended to supply:
a) Health Delivery Organizations (HDOs) with a catalogue of management, operational and
administrative SECURITY CONTROLS to maintain the EFFECTIVENESS of a SECURITY CAPABILITY
for a MEDICAL DEVICE on a MEDICAL DEVICE IT-NETWORK;
b) MEDICAL DEVICE manufacturers (MDMs) with a catalogue of technical SECURITY CONTROLS
for the establishment of each of the 19 SECURITY CAPABILITIES.
___________
2)
For the purpose of consistency throughout this report, the term SECURITY CONTROLS refers to the technical,
administrative and organizational controls/safeguards prescribed to establish SECURITY CAPABILITIES.
3)
The selection of SECURITY CAPABILITIES and SECURITY CONTROLS will vary due to the diversity of MEDICAL DEVICE
products and context in relation to environment and INTENDED USE. Therefore, this technical report is not
intended as a “one size fits all” solution.

---------------------- Page: 8 ----------------------
IEC TR 80001-2-8:2016 © IEC 2016 – 7 –
This report presents the 19 SECURITY CAPABILITIES, their respective “requirement goal” and
“user need” (identical to that in IEC TR 80001-2-2) with a corresponding list of SECURITY
CONTROLS from a number of security standards. The security standards used for mapping
4)
SECURITY CONTROLS to SECURITY CAPABILITIES include :
• NIST SP 800-53, Revision 4, Recommended Security Controls for Federal Information
Systems and Organizations
NIST Special Publication 800-53 covers the steps in the RISK MANAGEMENT Framework
that address SECURITY CONTROL selection for federal information systems in accordance
with the security requirements in Federal Information Processing Standard (FIPS) 200.
This includes selecting an initial set of baseline SECURITY CONTROLS based on a FIPS 199
worst-case impact analysis, tailoring the baseline SECURITY CONTROLS, and supplementing
the SECURITY CONTROLS based on an organizational assessment of RISK. The security rules
cover 17 areas including access control, incident response, business continuity, and
disaster recoverability.
• ISO IEC 15408-2:2008, Information technology – Security techniques – Evaluation criteria
for IT security – Part 2: Security functional components
This standard defines the content and presentation of the security functional requirements
to be assessed in a security evaluation using ISO IEC 15408. It contains a comprehensive
catalogue of predefined security functional components that will fulfil the most common
security needs of the marketplace. These are organized using a hierarchical structure of
classes, families and components, and supported by comprehensive user notes.
This standard also provides guidance on the specification of customized security
requirements where no suitable predefined security functional components exist.
• ISO IEC 15408-3:2008, Information technology – Security techniques – Evaluation criteria
for IT security – Part 3: Security assurance components
This standard defines the assurance requirements of the evaluation criteria. It includes the
evaluation assurance levels that define a scale for measuring assurance for component
targets of evaluation (TOEs), the composed assurance packages that define a scale for
measuring assurance for composed TOEs, the individual assurance components from
which the assurance levels and packages are composed, and the criteria for evaluation of
protection profiles and security targets.
This standard defines the content and presentation of the assurance requirements in the
form of assurance classes, families and components and provides guidance on the
organization of new assurance requirements. The assurance components within the
assurance families are presented in a hierarchical order.
• IEC 62443-3-3:2013, Industrial communication networks – Network and system security –
Part 3-3: System security requirements and security levels
This standard provides detailed technical control system requirements (SRs) associated
with the seven foundational requirements (FRs) described in IEC TS 62443-1-1 including
defining the requirements for control system capability security levels, SL-C (control
system). These requirements would be used by various members of the industrial
automation and control system (IACS) community along with the defined zones and
conduits for the system under consideration (SuC) while developing the appropriate
control system target SL, SL-T(control system), for a specific asset.
• ISO IEC 27002:2013, Information technology – Security techniques – Code of practice for
information security controls
This standard outlines guidelines for organizational information security standards and
information security management practices including the selection, implementation and
management of controls taking into consideration the organization's information security
RISK environment(s). It is designed to be used by organizations that intend to:
___________
4)
The selection of security standards used in this technical report does not represent an exhaustive list of all
potentially useful standards.

---------------------- Page: 9 ----------------------
– 8 – IEC TR 80001-2-8:2016 © IEC 2016
1) select controls within the PROCESS of implementing a MEDICAL DEVICE system based on
ISO IEC 27001;
2) implement commonly accepted information SECURITY CONTROLS;
3) develop their own information security management guidelines.
5)
• ISO 27799:— , Health informatics – Information security management in health using ISO
IEC 27002
This standard defines guidelines to support the interpretation and implementation in health
informatics of ISO IEC 27002 and is a companion to that standard.
It specifies a set of detailed controls for managing health information security and provides
health information security best practice guidelines. By implementing this International
Standard, HDOs and other custodians of health information will be able to ensure a
minimum requisite level of security that is appropriate to their organization's
circumstances and that will maintain the confidentiality, integrity and availability of
personal health information.

___________
5)
To be published.

---------------------- Page: 10 ----------------------
IEC TR 80001-2-8:2016 © IEC 2016 – 9 –
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –

Part 2-8: Application guidance – Guidance on standards for
establishing the security capabilities identified in IEC TR 80001-2-2



1 Scope
This part of IEC 80001, which is a Technical Report, provides guidance to Health Delivery
Organizations (HDOs) and MEDICAL DEVICE manufacturers (MDMs) for the application of the
framework outlined in IEC TR 80001-2-2. Managing the RISK in connecting MEDICAL DEVICES to
IT-NETWORKS requires the disclosure of security-related capabilities and RISKS.
IEC TR 80001-2-2 presents a framework for this disclosure and the security dialog that
surrounds the IEC 80001-1 RISK MANAGEMENT of IT-NETWORKS. IEC TR 80001-2-2 presents an
informative set of common, descriptive security-related capabilities that are useful in terms of
gaining an understanding of user needs. This report addresses each of the SECURITY
CAPABILITIES and identifies SECURITY CONTROLS for consideration by HDOs and MDMs during
RISK MANAGEMENT activities, supplier selection, device selection, device implementation,
operation etc.
It is not intended that the security standards referenced herein are exhaustive of all useful
standards; rather, the purpose of this technical report is to identify SECURITY CONTROLS, which
exist in these particular security standards (listed in the introduction of this technical report),
that apply to each of the SECURITY CAPABILITIES.
This report provides guidance to HDOs and MDMs for the selection and implementation of
management, operational, administrative and technical SECURITY CONTROLS to protect the
confidentiality, integrity, availability and accountability of data and systems during
development, operation and disposal.
All 19 SECURITY CAPABILITIES are not required in every case and the identified SECURITY
CAPABILITIES included in this report should not be considered exhaustive in nature. The
selection of SECURITY CAPABILITIES and SECURITY CONTROLS should be based on the RISK
EVALUATION and the RISK tolerance with consideration for protection of patient SAFETY, life and
health. INTENDED USE, operational environment, network structure and local factors should
also determine which SECURITY CAPABILITIES are necessary and which SECURITY CONTROLS
most suitably assist in establishing that SECURITY CAPABILITY.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical
devices – Part 1: Roles, responsibilities and activities

---------------------- Page: 11 ----------------------
– 10 – IEC TR 80001-2-8:2016 © IEC 2016
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
6)
needs, risks and controls
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
DATA AND SYSTEMS SECURITY
operational state of a MEDICAL IT-NETWORK in which information assets (data and systems) are
reasonably protected from degradation of confidentiality, integrity, and availability
[SOURCE: IEC 80001-1:2010, 2.5]
3.2
EFFECTIVENESS
ability to produce the intended result for the patient and the RESPONSIBLE ORGANIZATION
[SOURCE: IEC 80001-1:2010, 2.6]
3.3
HARM
physical injury or damage to the health of people, or damage to property or the environment,
or reduction in EFFECTIVENESS, or breach of DATA AND SYSTEMS SECURITY
[SOURCE: IEC 80001-1:2010, 2.8]
3.4
HAZARD
potential source of HARM
[SOURCE: IEC 80001-1:2010, 2.9]
3.5
HEALTH DATA
PRIVATE DATA that indicates physical or mental health
Note 1 to entry: This term generically defines PRIVATE DATA and it subset, HEALTH DATA, within this report to permit
users of this report to adapt it easily to different privacy compliance laws and regulations. For example, in Europe,
the requirements might be taken and references changed to “Personal Data” and “Sensitive Data”; in the USA,
HEALTH DATA might be changed to “Protected Health Information (PHI)” while making adjustments to text as
necessary.
3.6
INTENDED USE
INTENDED PURPOSE
use for which a product, PROCESS or service is intended according to the specifications,
instructions and information provided by the manufacturer
[SOURCE: IEC 80001-1:2010, 2.10]
___________
6)
IEC TR 80001-2-2 contains many additional standards, policies and reference materials which are also
indispensable for
...