IEC/TR 80001-2-3:2012
(Main)Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
IEC/TR 80001-2-3:2012(E), which is a technical report, supports the Healthcare Delivery Organizations (HDO) in the risk management of medical IT-networks that incorporate one or more wireless links. The report, as part of IEC 80001, considers the use of wirelessly networked medical devices on a medical IT-network and offers practical techniques to address the unique risk management requirements of operating wirelessly enabled medical devices in a safe, secure and effective manner. The targeted audience for this technical report is the HDO IT department, biomedical and clinical engineering departments, risk managers, and the people responsible for design and operation of the wireless IT network.
Application du management du risque aux réseaux des technologies de l'information contenant les dispositifs médicaux — Partie 2-3: Directives pour les réseaux sans fil
General Information
Standards Content (Sample)
IEC/TR 80001-2-3
Edition 1.0 2012-07
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –
Part 2-3: Guidance for wireless networks
IEC/TR 80001-2-3:2012(E)
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IEC/TR 80001-2-3
Edition 1.0 2012-07
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –
Part 2-3: Guidance for wireless networks
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
X
ICS 11.040.01; 35.240.80 ISBN 978-2-83220-203-6
Warning! Make sure that you obtained this publication from an authorized distributor.
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– 2 – TR 80001-2-3 © IEC:2012(E)
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope and object . 9
1.1 Scope . 9
1.2 Objective . 9
1.3 HDO scalability . 10
2 Normative references . 10
3 Terms and definitions . 11
4 Wireless MEDICAL IT-NETWORK: An introduction . 21
4.1 Basics . 21
4.2 Enterprise MEDICAL IT-NETWORK . 22
4.3 Use of VLANs and SSIDs . 22
4.4 Wide area MEDICAL IT-NETWORK . 23
4.5 Smart phone applications . 24
4.5.1 General . 24
4.5.2 Application clinical functionality . 24
4.5.3 Cellular networks . 24
4.5.4 Smart phone coexistence . 25
4.5.5 Wireless data security . 25
4.6 DISTRIBUTED ANTENNA SYSTEMS . 25
5 Wireless MEDICAL IT-NETWORKS: Planning and design. 26
5.1 Clinical systems and their impact on the wireless network . 26
5.1.1 Defining the clinical SLA . 26
5.1.2 Creating partnerships . 26
5.1.3 Geographical location . 26
5.1.4 Clinical use case . 27
5.2 MEDICAL DEVICE wireless capabilities . 27
5.3 MEDICAL DEVICE capabilities and networking traffic profile . 27
5.4 Network performance requirements . 27
5.5 QoS mechanisms . 28
5.6 Receiver capabilities . 28
5.7 Received signal strength and SNR versus data rates . 29
5.8 Capacity versus coverage versus AP density. 30
5.9 Deterministic versus non-deterministic wireless access protocol. 31
5.10 Planning and design summary . 31
6 Wireless MEDICAL IT-NETWORKS: Deployment and configuration . 31
6.1 RISKS versus benefit of a wireless communications system . 31
6.2 Licensed versus unlicensed spectrum . 31
6.3 Interference sources . 32
6.4 Spectrum usage and allocation . 32
6.4.1 Device coexistence . 32
6.4.2 Spectrum management . 32
6.4.3 Capacity management . 33
6.5 Wireless network configuration (802.11 specific) . 33
6.5.1 General . 33
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TR 80001-2-3 © IEC:2012(E) – 3 –
6.5.2 VLAN and SSID . 33
6.5.3 Authentication and encryption . 33
6.5.4 Vendor proprietary extensions . 34
6.5.5 Cellular and proprietary networks . 34
6.5.6 Network availability. 34
6.6 VERIFICATION testing . 35
6.6.1 General . 35
6.6.2 Pre GO-LIVE VERIFICATION testing . 35
6.6.3 GO-LIVE VERIFICATION testing . 35
7 Wireless MEDICAL IT-NETWORKS: Management and support . 36
7.1 General . 36
7.2 Network and application management . 36
7.3 Policies and procedures . 36
7.4 Change control . 36
8 General RISK CONTROL measures . 37
8.1 General . 37
8.2 Determining baseline networking performance . 37
8.3 Designing for coverage signal strength . 37
8.4 Segregating traffic and data types . 38
8.5 Environmental and physical changes . 38
8.6 Maintaining a clean RF environment . 38
8.7 Capacity planning . 38
8.7.1 General . 38
8.7.2 5 GHz and DYNAMIC FREQUENCY SELECTION (DFS) . 39
8.7.3 Security measures and planning . 39
8.8 RF spectrum use . 40
8.9 Device and application classification . 40
8.10 Guest or smart phone access . 40
8.11 WLAN infrastructure configuration . 41
8.12 External partnering with both MEDICAL DEVICE and networking manufacturer. 41
8.13 Redundancy . 41
Annex A (informative) Clinical use cases and network traffic profiles . 42
Annex B (informative) Questions to consider . 44
Bibliography . 48
Figure 1 – Focus of technical report . 8
Figure 2 – HDO MEDICAL IT-NETWORK . 23
Figure 3 – Wireless WAN connectivity . 24
Figure 4 – SIGNAL TO NOISE RATIO . 29
Table A.1 – Example clinical use cases and network traffic profiles . 43
Table A.2 – Network profile parameters . 43
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
APPLICATION OF RISK MANAGEMENT FOR
IT-NETWORKS INCORPORATING MEDICAL DEVICES –
Part 2-3: Guidance for wireless networks
FOREWORD
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The main task of IEC technical committees is to prepare International Standards. However, a
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example "state of the art".
IEC 80001-2-3, which is a technical report, has been prepared by a Joint Working Group of
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 informatics.
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TR 80001-2-3 © IEC:2012(E) – 5 –
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/784/DTR 62A/804/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.
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.
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INTRODUCTION
0.1 Background
Wireless communications has been a key technology enabling the connectivity of MEDICAL
DEVICES for decades. Early examples of the use of wireless technologies and MEDICAL DEVICES
include ambulatory cardiac monitoring systems in hospitals and telemetry systems used by
paramedics over wide area wireless networks. While these solutions were based on
proprietary technology, the advent of off-the-shelf standards-based approaches has resulted
in increasingly ubiquitous wireless communications systems both indoors and outdoors.
These provide and enable compelling and varied use cases for connection between MEDICAL
DEVICES and information systems. Wireless technology has great benefits; however, as with
any technology, certain RISKS are introduced that can affect the three KEY PROPERTIES of
SAFETY, EFFECTIVENESS, and DATA AND SYSTEMS SECURITY. This document will review the
challenges associated with wireless technologies and provide guidance regarding the safe,
effective, and secure use of MEDICAL DEVICES on a wireless MEDICAL IT-NETWORK. This is done
in a framework that follows the RISK MANAGEMENT PROCESS as defined by the IEC 80001-1
standard.
The targeted audience for this technical report is the HDO IT department, biomedical and
clinical engineering departments, risk managers, and the people responsible for design and
operation of the wireless IT network.
For the purposes of this technical report, “should” is used to indicate that amongst several
possibilities to meet a requirement, one is recommended as being particularly suitable without
mentioning or excluding others, or that a certain course of action is preferred but not
necessarily required. This term is not to be interpreted as indicating requirement.
0.2 Organization of the technical report
This technical report is divided into five main clauses, a bibliography and two annexes.
Clause 4 provides an overview of a wireless MEDICAL IT-NETWORK and reviews varying types of
wireless technologies and their applicability to healthcare. The next three clauses focus on
the high level steps involved with understanding and defining the networking performance
RISK CONTROL measures regarding the creation a
characteristics, requirements and associated
MEDICAL IT-NETWORK, namely:
a) planning and design;
b) deployment and implementation; and
c) operational management.
Clause 8 provides general RISK CONTROL measures that might be applicable to an HDO's
unique MEDICAL IT-NETWORK. Finally, a bibliography is included that lists references for further
exploration. Annex A offers a table that suggests a mapping between MEDICAL DEVICE data
types and associated networking QUALITY OF SERVICE priorities. Annex B is a checklist
questionnaire for assistance in performing a RISK ANALYSIS.
0.3 Clinical functionality and use case
One of the fundamental concepts that this technical report emphasizes is that MEDICAL DEVICES
have networking characteristics that are similar to other types of general purpose devices and
applications; yet the repercussions of not properly designing and managing the network to
ensure the SERVICE LEVEL AGREEMENT of the MEDICAL DEVICES could negatively impact clinical
functionality. This can lead to erroneous diagnostics and/or missed treatment that can
ultimately affect patient health outcome. In this technical report, clinical functionality and the
clinical use case are interchangeable; they are a reference to the means by which a clinician
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TR 80001-2-3 © IEC:2012(E) – 7 –
(nurse, physician, etc.) performs their clinical duties across the wireless network, and includes
the component of patient care and SAFETY. These are components in the overall context as it
is referred to in the step-by-step technical report, IEC 80001-2-1, and this information is
required for a complete RISK ANALYSIS. A typical example is a nurse who is remotely
monitoring a patient from the nursing central station using a patient monitor at the bedside
that is wirelessly connected to the network. The clinical functionality is the remote monitoring
of a patient’s health.
0.4 Wireless guidance and RISK MANAGEMENT
The wireless link between a patient and the remote clinician is now a component of the
clinical functionality and may impact the KEY PROPERTIES of SAFETY and DATA AND SYSTEMS
SECURITY. While the benefits of wireless access are well known and documented, typically the
MEDICAL DEVICE and a clinician is more likely, or has a higher
wireless link between a
probability, of experiencing a loss of connectivity versus that of a wired connection. This is a
motivation behind the creation and focus of this technical report.
Because the definitions of HAZARD, HAZARDOUS SITUATIONS, HARM and causes are use case
specific to each HDO, this document should be used in conjunction with both the IEC 80001-1
and IEC/TR 80001-2-1 at a minimum.
RISK MANAGEMENT aspect of this technical report. The
Figure 1 provides an overview of the
column of boxes on the left of the figure is an overview (for this technical report’s purpose) of
the 10 steps of RISK MANAGEMENT as defined in the IEC/TR 80001-2-1. The center boxes show
the steps of the RISK MANAGEMENT PROCESS that this technical report is focused on. They are
the following in terms of the RISK MANAGEMENT PROCESS:
– The cause is an event that can turn a HAZARD into a HAZARDOUS SITUATION. Examples of
causes in a wireless network are RF interference, wireless network misconfiguration, or
networking device failure.
– A HAZARD associated in the context of wireless connectivity is the loss or impairment of
connectivity in a medical system. This disruption in connectivity can negatively impact the
ability of a MEDICAL DEVICE or clinical system to perform its intended function.
– A HAZARDOUS SITUATION is a circumstance in which the MEDICAL DEVICE or clinical
functionality is exposed to a HAZARD. For example, a clinician is monitoring a patient at the
nursing station (clinical functionality is remote monitoring). If RF interference causes the
wireless network to be disabled (loss of connectivity is the HAZARD), then the patient is no
longer being remotely monitored (HAZARDOUS SITUATION).
– The RISK CONTROL measures as used in this technical report are the steps taken to reduce
the probability of the occurrence of a HAZARDOUS SITUATION (referred to as P1 in
IEC/TR 80001-2-1), or the steps taken to reduce the probability of HARM once the
HAZARDOUS SITUATION has occurred (referred to as P2 in IEC/TR 80001-2-1). A P1 RISK
measure example might be RF redundancy or networking change control
CONTROL
procedures. A P2 RISK CONTROL measure example might be the sequence of actions that a
nurse would take if notified that the connectivity is lost between a patient monitor and
central station.
The majority of this technical report focuses on the design and RISK CONTROL measures
associated with wireless technologies. However, and this is another motivation for engaging
with the clinicians early in the planning phase, the role of the clinicians in mitigating against
Patient HARM should be clearly reviewed. In the example used in the bulleted steps above, the
clinician might have a documented procedure to follow during network outages; when the
network experiences loss of connectivity the clinician can follow a procedure where they need
to attend to the patient directly.
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IEC 1299/12
Figure 1 – Focus of technical report
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TR 80001-2-3 © IEC:2012(E) – 9 –
APPLICATION OF RISK MANAGEMENT FOR
IT-NETWORKS INCORPORATING MEDICAL DEVICES –
Part 2-3: Guidance for wireless networks
1 Scope and object
1.1 Scope
This part of IEC 80001 supports the HDO in the RISK MANAGEMENT of MEDICAL IT-NETWORKS
that incorporate one or more wireless links. The report provides technical background
concerning wireless technology and examples of HAZARDS to be considered when wireless
technology is used in MEDICAL IT-NETWORKS and suggests RISK CONTROL measures to reduce
the probability of UNINTENDED CONSEQUENCES.
1.2 Objective
This Technical Report, as part of IEC 80001 considers the use of wirelessly networked
MEDICAL DEVICES on a MEDICAL IT-NETWORK and offers practical techniques to address the
unique RISK MANAGEMENT requirements of operating wirelessly enabled MEDICAL DEVICES in a
safe, secure and effective manner.
This technical report is focused on wireless technologies from an agnostic viewpoint; however,
there are particular wireless technologies that are predominant in HDOS (e.g. 802.11) and are
discussed in more detail. Where appropriate, these differences are pointed out and
discussed. In addition, while it does not focus on a single wireless technology, it is assumed
that the attached wired infrastructure is an Ethernet-based IP network.
It is not the intent of this document to propose a regimented step-by-step PROCESS for
implementing a wireless MEDICAL IT-NETWORK or mitigating the RISK associated with a
particular wireless technology. There are many reasons which conspire against such an effort
and chief among them are:
– There are many different wireless technologies available, each with their PHY, MAC and
upper layer characteristics with varying degrees of control available to the HDO.
– Many wireless technologies are in an evolving stage of development and are still subject
to frequent and significant changes.
– HDOs, depending on their needs, might utilize varying combinations of wireless
technologies to meet their particular requirements. Each technology should require its own
independent RISK ANALYSIS and RISK CONTROL measures that should be reviewed
systemically (aggregate RISKS ANALYSIS).
– Each HDO will have their own unique clinical use cases and network topologies and will
perform their own unique RISK ANALYSIS and management that will differ from other HDOs.
Instead, this technical report acknowledges a generalized or high level approach relative to a
step-by-step PROCESS review that both inherently and intentionally considers HAZARDS, the
causes leading to HAZARDOUS SITUATIONS, and RISK CONTROL measures. The general approach
that this technical report follows is the following:
a) Pose the question: does the use case of the device require wireless connectivity? This is
not a trivial question but this technical report assumes the answer is “yes”.
b) Define the clinical use-cases/functionality by bringing together the clinicians, biomedical
engineering staff and whoever else might be involved in the use and support of the
MEDICAL DEVICES.
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c) Review the wireless specifications and capabilities of the MEDICAL DEVICE(S) and systems
and create baseline networking performance requirements.
d) Create the clinical SLA by mapping the networking performance requirements to the
clinical functionality. See Table A.1 for examples regarding this mapping.
e) Match
...
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