IEC 80001-1:2021

FINAL
INTERNATIONAL IEC/FDIS
DRAFT
STANDARD 80001-1
ISO/TC 215
Safety, effectiveness and security
Secretariat: ANSI
in the implementation and use
Voting begins on:
2021-02-12 of connected medical devices or
connected health software —
Voting terminates on:
2021-04-09
Part 1:
Application of risk management
Member bodies are requested to consult relevant national interests in IEC/SC
62A before casting their ballot to the e-Balloting application.
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Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
IEC/FDIS 80001-1:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. IEC 2021

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IEC/FDIS 80001-1:2021(E)

ii © IEC 2021 – All rights reserved

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CONTENTS
FOREWORD . 4
INTRODUCTION . 7
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 9
4 Principles . 11
5 Framework . 12
5.1 General . 12
5.2 Leadership and commitment . 12
5.3 Integrating RISK MANAGEMENT . 12
5.4 Design/planning . 12
5.4.1 General . 12
5.4.2 RISK MANAGEMENT FILE . 13
5.4.3 Understanding the organization and the SOCIOTECHNICAL ECOSYSTEM . 13
5.4.4 Articulating RISK MANAGEMENT commitment . 14
5.4.5 Assigning organizational roles, authorities, responsibilities and
accountabilities . 14
5.4.6 Allocating resources . 15
5.4.7 Establishing communication and consultation . 15
5.5 Implementation . 15
5.6 Evaluation . 16
5.7 Improvement . 16
6 RISK MANAGEMENT PROCESS . 16
6.1 Generic requirements. 16
6.1.1 General . 16
6.1.2 RISK ANALYSIS . 17
6.1.3 RISK EVALUATION . 19
6.1.4 RISK CONTROL . 19
6.2 Lifecycle specific requirements . 22
6.2.1 General . 22
6.2.2 Acquisition . 22
6.2.3 Installation, customization and configuration . 22
6.2.4 Integration, data migration, transition and validation . 23
6.2.5 Implementation, workflow optimization and training . 23
6.2.6 Operation and maintenance . 23
6.2.7 Decommission . 25
Annex A (informative) IEC 80001-1 requirements mapping table . 26
Annex B (informative) Guidance for accompanying document Information . 33
B.1 Foreword . 33
B.2 Information system categorization . 34
B.3 Overview. 34
B.4 Reference documents . 34
B.5 System level description . 34
B.5.1 Environment description . 34
B.5.2 Network ports, protocols and services . 35

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B.5.3 Purpose of connection to the health IT infrastructure . 35
B.5.4 Networking requirements . 35
B.5.5 Required IT-network services . 35
B.5.6 Data flows and protocols . 35
B.6 Security and user access . 36
B.6.1 General . 36
B.6.2 Malware / antivirus / whitelisting . 36
B.6.3 Security exclusions . 36
B.6.4 System access . 36
B.7 RISK MANAGEMENT . 38
Bibliography . 39

Figure 1 – Lifecycle framework addressing safety, effectiveness and security of health

IT software and health IT systems. 8
Figure 2 – RISK MANAGEMENT PROCESS . 13

Table A.1 – IEC 80001-1 requirements table . 26
Table B.1 – Organization name and location . 33
Table B.2 – Cybersecurity device characterization level . 34
Table B.3 – Ports, protocols and services . 35
Table B.4 – Information system name and title . 36
Table B.5 – Roles and privileges . 37

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

SAFETY, EFFECTIVENESS AND SECURITY IN THE IMPLEMENTATION
AND USE OF CONNECTED MEDICAL DEVICES
OR CONNECTED HEALTH SOFTWARE –

Part 1: Application of risk management

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
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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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.
International Standard IEC 80001-1 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 of ISO Technical
Committee 215: Health informatics.
It is published as a double logo standard.
This second edition cancels and replaces the first edition published in 2010. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) structure changed to better align with ISO 31000;
b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT;

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IEC FDIS 80001-1 © IEC 2021 – 5 –
c) communication of the value, intention and purpose of RISK MANAGEMENT through principles
that support preservation of the KEY PROPERTIES during the implementation and use of
connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.
The text of this document is based on the following documents:
FDIS Report on voting
62A/XX/FDIS 62A/XX/RVD

Full information on the voting for the approval of this document can be found in the report on
voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
• requirements and definitions: roman type;
• test specifications: italic type;
• informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
• TERMS DEFINED IN CLAUSE 3 OF THIS DOCUMENT OR AS NOTED ARE PRINTED IN SMALL CAPITALS.
In referring to the structure of this document, the term
• “clause” means one of the five numbered divisions within the table of contents, inclusive of
all subdivisions (e.g. Clause 5 includes subclauses 5.1, 5.2, etc.);
• “subclause” means a numbered subdivision of a clause (e.g. 5.1, 5.2 and 5.3 are all
subclauses of Clause 5).
References to clauses within this document are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
• “shall” means that compliance with a requirement or a test is mandatory for compliance with
this document;
• “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
• “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
A list of all parts of the IEC 80001 series, published under the general title Safety, effectiveness
and security in the implementation and use of connected medical devices or connected health
software, can be found on the IEC website.
Future standards in this series will carry the new general title as cited above. Titles of existing
standards in this series will be updated at the time of the next edition.

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The committee has decided that the contents of this standard will remain unchanged until the
stability date indicated on the IEC website under "https://webstore.iec.ch" in the data related to
the specific standard. At this date, the standard will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

IMPORTANT – The "colour inside" logo on the cover page of this document indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.

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IEC FDIS 80001-1 © IEC 2021 – 7 –
INTRODUCTION
HEALTHCARE DELIVERY ORGANIZATIONS rely on safe, effective and secure systems as business-
critical factors. However, ineffective management of the implementation and use of connected
systems can threaten the ability to deliver health services.
Connected systems that deliver health services, generally involve multiple software
applications, various medical devices and complex HEALTH IT SYSTEMS that rely upon shared
infrastructure including wired or wireless networks, point to point connections, application
servers and data storage, interface engines, security and performance management software,
etc. These HEALTH IT INFRASTRUCTURES are often used for both clinical (e.g. patient monitoring
systems) and non-clinical organizational functions (e.g. accounting, scheduling, social
networking, multimedia, file sharing). These connected systems can involve small departmental
networks to large integrated infrastructures spanning multiple locations as well as cloud-based
services operated by third parties. The requirements in this document are intended for multiple
stakeholders involved in the application of RISK MANAGEMENT to systems that include HEALTH IT
SYSTEMS and / or HEALTH IT INFRASTRUCTURE.
Within the context of ISO 81001-1, this document covers the generic lifecycle phase
“implementation and clinical use” (see the lifecycle diagram in Figure 1).

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Figure 1 – Lifecycle framework addressing safety, effectiveness and security
of health IT software and health IT systems
This document facilitates ORGANIZATIONS in using or adapting existing work practices and
processes, personnel and tools wherever practicable to address the requirements of this
document. For example, if an organization has an existing RISK MANAGEMENT PROCESS, this can
be used or adapted to support the three KEY PROPERTIES of SAFETY, EFFECTIVENESS, and
SECURITY. Requirements are defined such that they can be evaluated and as such support an
ORGANIZATION in verifying and demonstrating the degree of compliance with this document.
The RISK MANAGEMENT requirements of this document are based upon existing concepts adapted
and extended for use by all stakeholders supporting implementation and clinical use of
connected HEALTH SOFTWARE and HEALTH IT SYSTEMS (including medical devices). This
document aligns with ISO 81001-1, ISO Guide 63, IEC Guide 120.

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SAFETY, EFFECTIVENESS AND SECURITY IN THE IMPLEMENTATION
AND USE OF CONNECTED MEDICAL DEVICES
OR CONNECTED HEALTH SOFTWARE –

Part 1: Application of risk management



1 Scope
This document specifies general requirements for ORGANIZATIONS in the application of RISK
before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT
MANAGEMENT
INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY
whilst engaging appropriate stakeholders.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this standard. For dated references, only the edition cited applies.
For undated references, the latest edition of the referenced document (including any
amendments) applies.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE With the exception of the terms and definitions listed in this clause, all terms and definitions used in this
standard are taken from ISO 81001-1:20—.
3.1
CONSEQUENCE
outcome of an event affecting objectives
Note 1 to entry: A CONSEQUENCE can be certain or uncertain and can have positive or negative direct or indirect
effects on objectives.
Note 2 to entry: CONSEQUENCES can be expressed qualitatively or quantitatively.
Note 3 to entry: Any CONSEQUENCE can escalate through cascading and cumulative effects.
[SOURCE:ISO 31000:2018, 3.6]

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3.2
HEALTHCARE
care activities, services, management or supplies related to the health of an individual or
population
Note 1 to entry: This includes more than performing procedures for subjects of care. It includes, for example, the
management of information about patients, health status and relations within the HEALTHCARE delivery framework
and may also include the management of clinical knowledge.
[SOURCE: ISO 13940:2015, 3.1.1, modified – The definition was reworded to include
population.]
3.3
INCIDENT
unplanned interruption to a service a reduction in the quality of a service or an event that has
not yet impacted the service to the customer or user
[SOURCE: ISO/IEC 20000-1:2018, 3.2.5]
3.4
INITIAL RISK
RISK derived during risk estimation taking into consideration any retained RISK control measures
[SOURCE: ISO/IEC/IEEE 15026-1:2019, 3.3.3, modified – The definition was reworded.]
3.5
LIKELIHOOD
chance of something happening
Note 1 to entry: In risk management terminology, the word “LIKELIHOOD” is used to refer to the chance of something
happening, whether defined, measured or determined objectively or subjectively, qualitatively or quantitatively, and
described using general terms or mathematically (such as a probability or a frequency over a given time period).
Note 2 to entry: The English term “LIKELIHOOD” does not have a direct equivalent in some languages; instead, the
equivalent of the term “probability” is often used. However, in English, “probability” is often narrowly interpreted as
a mathematical term. Therefore, in risk management terminology, “LIKELIHOOD” is used with the intent that it should
have the same broad interpretation as the term “probability” has in many languages other than English.
[SOURCE: ISO 31000:2018, 3.7]
3.6
PROCESS
set of interrelated or interacting activities which transforms inputs into outputs
Note 1 to entry: The term “activities” covers use of resources.
[SOURCE: IEC 80001-1:2010, 2.19]
3.7
HEALTH IT RISK MANAGER
person accountable for risk management of a health IT system
[SOURCE: IEC 80001-1:2010, 2.17, modified – Replacement of the term "medical IT-network
risk manager" with "health risk manager", and replacement in the definition "medical IT-network"
with "health IT system".]

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3.8
RISK MANAGEMENT PLAN
description of how the elements and resources of the risk management PROCESS will be
implemented within an organization or project
[SOURCE: ISO/IEC 16085:2006, 3.11]
4 Principles
The following principles provide the basis for RISK MANAGEMENT. They communicate the value,
intention and purpose of RISK MANAGEMENT and their application supports the preservation of
the KEY PROPERTIES during the implementation and use of HEALTH IT SYSTEMS within a HEALTH IT
INFRASTRUCTURE:
– RISK MANAGEMENT is an integral part of an ORGANIZATION’S activities at all stages of the
HEALTH IT SYSTEM lifecycle;
– accountability for the RISK MANAGEMENT PROCESS remains with the HEALTHCARE DELIVERY
ORGANIZATION;
– a HEALTHCARE DELIVERY ORGANIZATION may assign responsibility for RISK MANAGEMENT of the
HEALTH IT SYSTEM and/or HEALTH IT INFRASTRUCTURE to a different ORGANIZATION such as
providers of HEALTH IT SYSTEMS, HEALTH IT INFRASTRUCTURE or a collaboration of HEALTHCARE
DELIVERY ORGANIZATIONS.
RISK MANAGEMENT creates and protects value. It contributes to the demonstrable maintenance
or/and improvement of SAFETY, EFFECTIVENESS and SECURITY in the implementation and use of
connected HEALTH IT SYSTEMS.
– A structured and comprehensive approach to RISK MANAGEMENT contributes to consistent
and comparable clinical outcomes;
– The RISK MANAGEMENT PROCESS is scalable and can be customised and made proportionate
to the ORGANIZATION’S objectives;
– Appropriate and timely involvement of stakeholders leads to improved awareness and
alignment across the ORGANIZATION and enables informed RISK MANAGEMENT;
– RISKS can emerge, change or disappear as new HEALTHCARE tools and methodologies are
developed. Proactive RISK MANAGEMENT anticipates, detects, acknowledges and responds to
changes and events in a timely manner;
– The inputs to RISK MANAGEMENT are based on historical and current information, as well as
future expectations. RISK MANAGEMENT explicitly considers any limitations and uncertainties
associated with such information and expectations. Information should be timely, clear and
available to relevant stakeholders;
– The SOCIOTECHNICAL ECOSYSTEM significantly influences all aspects of RISK MANAGEMENT at
each level within the HEALTHCARE DELIVERY ORGANIZATION and at each lifecycle stage; and
– RISK MANAGEMENT is a continuous activity, improved through learning and experience. RISK
MANAGEMENT strengthens the ORGANIZATION resilience and supports the ORGANIZATION’S
business needs and objectives.
NOTE RISK is balanced across the KEY PROPERTIES wherever practical.

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5 Framework
5.1 General
The purpose of the RISK MANAGEMENT framework is to assist the ORGANIZATION in integrating the
RISK MANAGEMENT with other significant activities and functions. Effective RISK MANAGEMENT
depends on its integration with the governance of the ORGANIZATION, including decision-making.
This requires support from all stakeholders, particularly TOP MANAGEMENT. Requirements in this
document apply to HEALTHCARE DELIVERY ORGANIZATIONS and other ORGANIZATIONS seeking
conformance with this RISK MANAGEMENT framework. Those requirements that apply to
HEALTHCARE DELIVERY ORGANIZATIONS only are clearly identified.
5.2 Leadership and commitment
It is the responsibility of the TOP MANAGEMENT of the ORGANIZATION to ensure that RISK
MANAGEMENT is implemented throughout the HEALTH IT SYSTEM lifecycle, and that its effectiveness
is evaluated.
The ORGANIZATION shall establish and adhere to a defined PROCESS for RISK MANAGEMENT.
5.3 Integrating RISK MANAGEMENT
Effective integration of RISK MANAGEMENT relies on an understanding of the ORGANIZATION’S
structures and context. Structures differ depending on the ORGANIZATION’S purpose, goals and
complexity. The RISK is managed in every part of the ORGANIZATION’S structure. Everyone in an
ORGANIZATION is responsible for managing RISK.
RISK MANAGEMENT is a dynamic and iterative PROCESS that can be customised to the
Integrating
ORGANIZATION’S culture and objectives. The RISK MANAGEMENT should be part of, and not
separate from, organizational purpose, governance, leadership, commitment, strategy,
objectives and operations.
5.4 Design/planning
5.4.1 General
The safe acquisition, installation, integration, implementation, clinical use, maintenance and
decommissioning of a HEALTH IT SYSTEM is dependent on effective RISK MANAGEMENT planning.
Planning activities apply to new implementations and modifications to existing HEALTH IT
SYSTEMS.
HEALTH IT SYSTEM RISK MANAGEMENT PLAN is to document and schedule the
The purpose of the
RISK MANAGEMENT activities throughout all lifecycle phases of the HEALTH IT SYSTEM and describe
how a specific HEALTH IT SYSTEM project will adhere to the RISK MANAGEMENT PLAN. The RISK
MANAGEMENT PROCESS which establishes the requirements of this document is depicted at
Figure 2 and applies throughout the lifecycle of the HEALTH IT SYSTEM.

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Figure 2 – RISK MANAGEMENT PROCESS
The extent of the RISK MANAGEMENT PLAN should be flexible and commensurate with the scale
and scope of functionality of the HEALTH IT SYSTEM whilst addressing the RISK MANAGEMENT
requirements specified within this document. The contents of the RISK MANAGEMENT PLAN should
include:
– a framework for RISK ANALYSIS;
– defined risk acceptance criteria for individual risks and the overall RESIDUAL RISK;
– a list of the relevant procedures, policies and resources required; and
– a reference to any ACCOMPANYING DOCUMENTS
5.4.2 RISK MANAGEMENT FILE
The ORGANIZATION shall:
a) establish, at the start of a project, a HEALTH IT SYSTEM RISK MANAGEMENT FILE;
b) maintain the RISK MANAGEMENT FILE throughout the lifecycle of the HEALTH IT SYSTEM; and
c) ensure that the RISK MANAGEMENT FILE is recoverable in the event of failure.
The HEALTH IT SYSTEM RISK MANAGEMENT FILE provides a store of all records which relate to the
RISK MANAGEMENT PROCESS and any decisions that influence RISK MANAGEMENT.
5.4.3 Understanding the organization and the SOCIOTECHNICAL ECOSYSTEM
Before starting the design and implementation of the RISK MANAGEMENT PLAN it is important to
evaluate and understand the internal and external SOCIOTECHNICAL ECOSYSTEM as this
...