ISO/TR 80001-2-6:2014
(Main)Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
ISO/TR 80001-2-6:2014 provides guidance on implementing RESPONSIBILITY AGREEMENTS, which are described in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a MEDICAL DEVICE into an IT-NETWORK in order to support compliance to IEC 80001-1. Stakeholders may include RESPONSIBLE ORGANIZATIONS, IT suppliers, MEDICAL DEVICE manufacturers and others. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the complete lifecycle of the resulting MEDICAL IT-NETWORK.
Application de la gestion des risques pour les réseaux intégrant appareils médicaux — Partie 2-6: Application guidage — Orientation des accords de responsabilité
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TECHNICAL ISO/TR
REPORT 80001-2-6
First edition
2014-12-01
Application of risk management for
IT-networks incorporating medical
device —
Part 2-6:
Application guidance — Guidance for
responsibility agreements
Application de la gestion des risques pour les réseaux intégrant
appareils médicaux —
Partie 2-6: Application guidage — Orientation des accords de
responsabilité
Reference number
©
ISO 2014
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any
means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission.
Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
Case postale 56 CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
ISO TR 80001-2-6:2014(E)
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
1.1 Purpose . 1
1.2 Prerequisites . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Key aspects for RESPONSIBILITY AGREEMENTS . 5
4.1 Reasons and rationale . 5
4.2 Participants . 5
4.3 Proposed types of RESPONSIBILITY AGREEMENTS . 5
4.4 Communication control . 5
4.4.1 Bilateral versus multilateral RESPONSIBILITY AGREEMENTS . 5
4.4.2 Non-disclosure agreements . 5
4.4.3 Update of information and documentation . 6
4.5 Responsibility for establishing . 6
4.6 Methods for determination and of responsibilities . 6
4.7 Life cycle considerations. 6
5 Elements of a RESPONSIBILITY AGREEMENT . 7
Annex A (informative) RACI chart . 11
Annex B (informative) Typical documents . 12
ISO TR 80001-2-6:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO TR 80001-2-6 was prepared by Technical Committee ISO/TC 215, Health informatics, jointly with IEC
Subcommittee IEC/SC 62A.
ISO/IEC TR 80001 consists of the following parts, under the general title Application of risk management for
IT-networks incorporating medical devices.
Part 1: Roles, responsibilities and activities
Part 2-1: Step-by-step risk management of medical IT-networks – Practical applications and examples
Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and
controls
Part 2-3: Guidance for wireless networks
Part 2-4: Application guidance – General implementation guidance for Healthcare Delivery Organizations
Part 2-5: Application guidance – Guidance on distributed alarm systems (in development)
Part 2-6: Application guidance – Guidance for responsibility agreements
Part 2-7: IT-networks incorporating medical devices - Part 2-7: Application Guidance - Guidance for
Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1 (in
development)
Part 2-8: 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
80001-2-2 (in development)
iv © ISO 2014 – All rights reserved
ISO TR 80001-2-6:2014(E)
Introduction
0.1 Background
IEC 80001-1 was developed to meet the need to managing RISKS associated with the increasing prevalence of
MEDICAL DEVICES being connected to general purpose IT-NETWORKS. The standard introduces the notion of a
RESPONSIBILITY AGREEMENT covering roles and responsibilities of the stakeholders. This Technical Report
provides practical guidance to RESPONSIBLE ORGANIZATIONS on establishing a RESPONSIBILITY AGREEMENT
among all stakeholders involved, namely the RESPONSIBLE ORGANIZATION, the MEDICAL DEVICE manufacturer(s)
and the IT supplier(s).
Examples of situations where a RESPONSIBILITY AGREEMENT could prove useful when an IT-NETWORK
incorporates MEDICAL DEVICES. The benefits of the RESPONSIBILITY AGREEMENT include:
a) The roles and responsibilities of the stakeholders are identified and communicated in written form.
It is essential to have a clear understanding of the clinical dependencies on the network and to identify
the roles and responsibilities of the stakeholders, including clinical staff and the MEDICAL DEVICE
manufacturers.
The organization or department responsible for configurations control and maintenance of the IT-
NETWORK should have, or establish if necessary, change control procedures to manage the RISKS to
services supported by the network arising from the implementation of changes to network (e.g. software
upgrade to network components).
EXAMPLE 1 Common examples include software upgrades for antivirus software or bug fixes in networking
switches and routers. Before upgrading hard/soft/firmware on infrastructure supporting MEDICAL DEVICES and medical
systems, it is important that MEDICAL DEVICES that can be impacted are identified through an impact assessment. To
undertake such an assessment requires either detailed engineering knowledge of each component and its
dependencies or for example, the co-operation of the respective manufacturer. Whichever party takes responsibility
for this should then review and validate their systems on the new hard/soft/firmware. It is also important to ensure
that whenever practicable, there is a back-out/regression plan which has also been tested. In this scenario, the
RESPONSIBILITY AGREEMENT would set out the responsibilities of each party, e.g., How such activities would be initiated,
who would notify whom, when, with what information and how would they be expected to respond. There have
already been documented instances where MEDICAL DEVICES have been adversely affected from such changes and
this was one reason for US FDA's "Guidance for Industry - Cybersecurity for Networked Medical Devices Containing
Off-the-Shelf (OTS) Software." See:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077812.htm
b) A clinical user of a MEDICAL DEVICE can desire to connect the MEDICAL DEVICE to a general purpose IT-
NETWORK. Having a PROCESS in place to inform and involve relevant stakeholders early in the planning
stage (i.e., prior to go live) could help avert uninformed decision making and implementation that could
adversely impact other clinical systems that rely on the IT-NETWORK.
EXAMPLE 2 Demand already exists for this capability, e.g., delivery of MEDICAL DEVICE alarms via wireless
communications devices carried by PATIENT care staff, automated/remote programming of infusion therapy pumps
and Admit/Discharge/Transfer data feeds to medical monitoring systems. When doing so requires multiple otherwise
independent stakeholders to be responsible for aspects of the system’s development, implementation and operation,
and maintenance, it is imperative that all stakeholders are explicitly aware and accepting of their responsibilities. A
RESPONSIBILITY AGREEMENT serves as a vehicle to accomplish this.
ISO TR 80001-2-6:2014(E)
0.2 Normative requirements from IEC 80001-1
In addition to the languages of subclause 4.3.4 describing the RESPONSIBILITY AGREEMENT, subclauses 3.5 and
3.6 require information to be made available to the RESPONSIBLE ORGANIZATION by MEDICAL DEVICE
manufacturers and IT supplier, respectively. Both subclauses acknowledge the possibility that the information
identified may be insufficient to address the RESPONSIBLE ORGANIZATION’S RISK MANAGEMENT needs by
including the following notes:
NOTE 1 Where the content made available does not meet the RESPONSIBLE ORGANIZATION'S RISK MANAGEMENT need,
additional content can be made available under a RESPONSIBILITY AGREEMENT.
NOTE 2 A RESPONSIBILITY AGREEMENT between the RESPONSIBLE ORGANIZATION and a MEDICAL DEVICE manufacturer can
be used to identify and share the documentation needed.
vi © ISO 2014 – All rights reserved
TECHNICAL REPORT ISO TR 80001-2-6:2014(E)
Application of risk management for IT-networks incorporating
medical devices — Part 2-6: Application guidance — Part 2-6:
Guidance for responsiblity agreements
1 Scope
1.1 Purpose
This Technical Report provides guidance on implementing RESPONSIBILITY AGREEMENTS, which are described
in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the
incorporation of a MEDICAL DEVICE into an IT-NETWORK in order to support compliance to IEC 80001-1.
Stakeholders may include RESPONSIBLE ORGANIZATIONS, IT suppliers, MEDICAL DEVICE manufacturers and
others. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the
complete lifecycle of the resulting MEDICAL IT-NETWORK.
1.2 Prerequisites
The RESPONSIBLE ORGANIZATION’S (ROs) TOP MANAGEMENT has accepted responsibility for the successful
implementation of IEC 80001-1. As required by IEC 80001-1, the RO has created and approved policies for
the RISK MANAGEMENT PROCESS and RISK acceptability criteria while balancing the three KEY PROPERTIES with
the mission of the RO. The RO has identified and provisioned adequate resources and assigned qualified
personnel to perform tasks related to the standard. The RO has appointed a MEDICAL IT-NETWORK RISK
MANAGER and is prepared to establish the RESPONSIBILITY AGREEMENT.
2 Normative references
The following document, in whole or in part, is normatively referenced in this document and is indispensable
for its application. As a dated reference, only the edition cited applies.
IEC 80001-1:2010, Application of risk management for IT -networks incorporating medical devices – Part 1:
Roles, responsibilities and activities
3 Terms and definitions
3.1
CHANGE PERMIT
outcome of the RISK MANAGEMENT PROCESS consisting of a document that allows a specified change or type of
change without further RISK MANAGEMENT activities subject to specified constraints
[SOURCE: IEC 80001-1:2010, 2.3]
3.2
DATA AND SYSTEM 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
ISO TR 80001-2-6:2014(E)
[SOURCE: IEC 80001-1:2010, 2.5]
3.3
EFFECTIVENESS
ability to produce the intended
...
TECHNICAL ISO/TR
REPORT 80001-2-6
First edition
2014-12-01
Application of risk management for
IT-networks incorporating medical
device —
Part 2-6:
Application guidance — Guidance for
responsibility agreements
Application de la gestion des risques pour les réseaux intégrant
appareils médicaux —
Partie 2-6: Application guidage — Orientation des accords de
responsabilité
Reference number
©
ISO 2014
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any
means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission.
Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
Case postale 56 CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
ISO TR 80001-2-6:2014(E)
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
1.1 Purpose . 1
1.2 Prerequisites . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Key aspects for RESPONSIBILITY AGREEMENTS . 5
4.1 Reasons and rationale . 5
4.2 Participants . 5
4.3 Proposed types of RESPONSIBILITY AGREEMENTS . 5
4.4 Communication control . 5
4.4.1 Bilateral versus multilateral RESPONSIBILITY AGREEMENTS . 5
4.4.2 Non-disclosure agreements . 5
4.4.3 Update of information and documentation . 6
4.5 Responsibility for establishing . 6
4.6 Methods for determination and of responsibilities . 6
4.7 Life cycle considerations. 6
5 Elements of a RESPONSIBILITY AGREEMENT . 7
Annex A (informative) RACI chart . 11
Annex B (informative) Typical documents . 12
ISO TR 80001-2-6:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO TR 80001-2-6 was prepared by Technical Committee ISO/TC 215, Health informatics, jointly with IEC
Subcommittee IEC/SC 62A.
ISO/IEC TR 80001 consists of the following parts, under the general title Application of risk management for
IT-networks incorporating medical devices.
Part 1: Roles, responsibilities and activities
Part 2-1: Step-by-step risk management of medical IT-networks – Practical applications and examples
Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and
controls
Part 2-3: Guidance for wireless networks
Part 2-4: Application guidance – General implementation guidance for Healthcare Delivery Organizations
Part 2-5: Application guidance – Guidance on distributed alarm systems (in development)
Part 2-6: Application guidance – Guidance for responsibility agreements
Part 2-7: IT-networks incorporating medical devices - Part 2-7: Application Guidance - Guidance for
Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1 (in
development)
Part 2-8: 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
80001-2-2 (in development)
iv © ISO 2014 – All rights reserved
ISO TR 80001-2-6:2014(E)
Introduction
0.1 Background
IEC 80001-1 was developed to meet the need to managing RISKS associated with the increasing prevalence of
MEDICAL DEVICES being connected to general purpose IT-NETWORKS. The standard introduces the notion of a
RESPONSIBILITY AGREEMENT covering roles and responsibilities of the stakeholders. This Technical Report
provides practical guidance to RESPONSIBLE ORGANIZATIONS on establishing a RESPONSIBILITY AGREEMENT
among all stakeholders involved, namely the RESPONSIBLE ORGANIZATION, the MEDICAL DEVICE manufacturer(s)
and the IT supplier(s).
Examples of situations where a RESPONSIBILITY AGREEMENT could prove useful when an IT-NETWORK
incorporates MEDICAL DEVICES. The benefits of the RESPONSIBILITY AGREEMENT include:
a) The roles and responsibilities of the stakeholders are identified and communicated in written form.
It is essential to have a clear understanding of the clinical dependencies on the network and to identify
the roles and responsibilities of the stakeholders, including clinical staff and the MEDICAL DEVICE
manufacturers.
The organization or department responsible for configurations control and maintenance of the IT-
NETWORK should have, or establish if necessary, change control procedures to manage the RISKS to
services supported by the network arising from the implementation of changes to network (e.g. software
upgrade to network components).
EXAMPLE 1 Common examples include software upgrades for antivirus software or bug fixes in networking
switches and routers. Before upgrading hard/soft/firmware on infrastructure supporting MEDICAL DEVICES and medical
systems, it is important that MEDICAL DEVICES that can be impacted are identified through an impact assessment. To
undertake such an assessment requires either detailed engineering knowledge of each component and its
dependencies or for example, the co-operation of the respective manufacturer. Whichever party takes responsibility
for this should then review and validate their systems on the new hard/soft/firmware. It is also important to ensure
that whenever practicable, there is a back-out/regression plan which has also been tested. In this scenario, the
RESPONSIBILITY AGREEMENT would set out the responsibilities of each party, e.g., How such activities would be initiated,
who would notify whom, when, with what information and how would they be expected to respond. There have
already been documented instances where MEDICAL DEVICES have been adversely affected from such changes and
this was one reason for US FDA's "Guidance for Industry - Cybersecurity for Networked Medical Devices Containing
Off-the-Shelf (OTS) Software." See:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077812.htm
b) A clinical user of a MEDICAL DEVICE can desire to connect the MEDICAL DEVICE to a general purpose IT-
NETWORK. Having a PROCESS in place to inform and involve relevant stakeholders early in the planning
stage (i.e., prior to go live) could help avert uninformed decision making and implementation that could
adversely impact other clinical systems that rely on the IT-NETWORK.
EXAMPLE 2 Demand already exists for this capability, e.g., delivery of MEDICAL DEVICE alarms via wireless
communications devices carried by PATIENT care staff, automated/remote programming of infusion therapy pumps
and Admit/Discharge/Transfer data feeds to medical monitoring systems. When doing so requires multiple otherwise
independent stakeholders to be responsible for aspects of the system’s development, implementation and operation,
and maintenance, it is imperative that all stakeholders are explicitly aware and accepting of their responsibilities. A
RESPONSIBILITY AGREEMENT serves as a vehicle to accomplish this.
ISO TR 80001-2-6:2014(E)
0.2 Normative requirements from IEC 80001-1
In addition to the languages of subclause 4.3.4 describing the RESPONSIBILITY AGREEMENT, subclauses 3.5 and
3.6 require information to be made available to the RESPONSIBLE ORGANIZATION by MEDICAL DEVICE
manufacturers and IT supplier, respectively. Both subclauses acknowledge the possibility that the information
identified may be insufficient to address the RESPONSIBLE ORGANIZATION’S RISK MANAGEMENT needs by
including the following notes:
NOTE 1 Where the content made available does not meet the RESPONSIBLE ORGANIZATION'S RISK MANAGEMENT need,
additional content can be made available under a RESPONSIBILITY AGREEMENT.
NOTE 2 A RESPONSIBILITY AGREEMENT between the RESPONSIBLE ORGANIZATION and a MEDICAL DEVICE manufacturer can
be used to identify and share the documentation needed.
vi © ISO 2014 – All rights reserved
TECHNICAL REPORT ISO TR 80001-2-6:2014(E)
Application of risk management for IT-networks incorporating
medical devices — Part 2-6: Application guidance — Part 2-6:
Guidance for responsiblity agreements
1 Scope
1.1 Purpose
This Technical Report provides guidance on implementing RESPONSIBILITY AGREEMENTS, which are described
in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the
incorporation of a MEDICAL DEVICE into an IT-NETWORK in order to support compliance to IEC 80001-1.
Stakeholders may include RESPONSIBLE ORGANIZATIONS, IT suppliers, MEDICAL DEVICE manufacturers and
others. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the
complete lifecycle of the resulting MEDICAL IT-NETWORK.
1.2 Prerequisites
The RESPONSIBLE ORGANIZATION’S (ROs) TOP MANAGEMENT has accepted responsibility for the successful
implementation of IEC 80001-1. As required by IEC 80001-1, the RO has created and approved policies for
the RISK MANAGEMENT PROCESS and RISK acceptability criteria while balancing the three KEY PROPERTIES with
the mission of the RO. The RO has identified and provisioned adequate resources and assigned qualified
personnel to perform tasks related to the standard. The RO has appointed a MEDICAL IT-NETWORK RISK
MANAGER and is prepared to establish the RESPONSIBILITY AGREEMENT.
2 Normative references
The following document, in whole or in part, is normatively referenced in this document and is indispensable
for its application. As a dated reference, only the edition cited applies.
IEC 80001-1:2010, Application of risk management for IT -networks incorporating medical devices – Part 1:
Roles, responsibilities and activities
3 Terms and definitions
3.1
CHANGE PERMIT
outcome of the RISK MANAGEMENT PROCESS consisting of a document that allows a specified change or type of
change without further RISK MANAGEMENT activities subject to specified constraints
[SOURCE: IEC 80001-1:2010, 2.3]
3.2
DATA AND SYSTEM 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
ISO TR 80001-2-6:2014(E)
[SOURCE: IEC 80001-1:2010, 2.5]
3.3
EFFECTIVENESS
ability to produce the intended
...
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