IEC 81001-5-1:2021

FINAL
INTERNATIONAL IEC/FDIS
DRAFT
STANDARD 81001-5-1
ISO/TC 215
Health software and health IT systems
Secretariat: ANSI
safety, effectiveness and security —
Voting begins on:
2021-09-10
Part 5-1:
Voting terminates on:
Security — Activities in the product
2021-11-05
life cycle
This draft is submitted to a parallel vote in ISO and in IEC.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
IEC/FDIS 81001-5-1:2021(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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CONTENTS
FOREWORD . 5
INTRODUCTION . 7
0.1 Structure . 7
0.2 Field of application . 8
0.3 Conformance . 8
1 Scope . 10
2 Normative references . 10
3 Terms and definitions . 11
4 General requirements . 18
4.1 Quality management . 18
4.1.1 Quality management system . 18
4.1.2 Identification of responsibilities . 18
4.1.3 Identification of applicability . 18
4.1.4 SECURITY expertise . 18
4.1.5 SOFTWARE ITEMS from third-party suppliers. 19
4.1.6 Continuous improvement . 19
4.1.7 Disclosing SECURITY-related issues . 19
4.1.8 Periodic review of SECURITY defect management . 19
4.1.9 ACCOMPANYING DOCUMENTATION review . 20
4.2 SECURITY RISK MANAGEMENT . 20
4.3 SOFTWARE ITEM classification relating to risk transfer. 20
5 Software development PROCESS . 21
5.1 Software development planning . 21
5.1.1 ACTIVITIES in the LIFE CYCLE PROCESS . 21
5.1.2 Development environment SECURITY . 21
5.1.3 Secure coding standards . 21
5.2 HEALTH SOFTWARE requirements analysis . 21
5.2.1 HEALTH SOFTWARE SECURITY requirements . 21
5.2.2 SECURITY requirements review . 22
5.2.3 SECURITY risks for REQUIRED SOFTWARE . 22
5.3 Software architectural design . 22
5.3.1 DEFENSE-IN-DEPTH ARCHITECTURE/design . 22
5.3.2 Secure design best practices . 22
5.3.3 SECURITY architectural design review . 23
5.4 Software design . 23
5.4.1 Software design best practices . 23
5.4.2 Secure design . 23
5.4.3 Secure HEALTH SOFTWARE interfaces . 23
5.4.4 Detailed design VERIFICATION for SECURITY . 24
5.5 Software unit implementation and VERIFICATION . 24
5.5.1 Secure coding standards . 24
5.5.2 SECURITY implementation review . 24
5.6 Software integration testing . 25
5.7 Software system testing . 25
5.7.1 SECURITY requirements testing . 25
5.7.2 THREAT mitigation testing . 25
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5.7.3 VULNERABILITY testing . 25
5.7.4 Penetration testing . 26
5.7.5 Managing conflicts of interest between testers and developers . 26
5.8 Software release . 26
5.8.1 Resolve findings prior to release . 26
5.8.2 Release documentation . 27
5.8.3 File INTEGRITY . 27
5.8.4 Controls for private keys . 27
5.8.5 Assessing and addressing SECURITY-related issues . 27
5.8.6 ACTIVITY completion . 27
5.8.7 SECURE decommissioning guidelines for HEALTH SOFTWARE . 27
6 SOFTWARE MAINTENANCE PROCESS . 28
6.1 Establish SOFTWARE MAINTENANCE plan . 28
6.1.1 Timely delivery of SECURITY updates . 28
6.2 Problem and modification analysis . 28
6.2.1 Monitoring public incident reports . 28
6.2.2 SECURITY update VERIFICATION . 28
6.3 Modification implementation . 29
6.3.1 SUPPORTED SOFTWARE SECURITY update documentation . 29
6.3.2 MAINTAINED SOFTWARE SECURITY update delivery . 29
6.3.3 MAINTAINED SOFTWARE SECURITY update INTEGRITY . 29
7 SECURITY RISK MANAGEMENT PROCESS . 29
7.1 RISK MANAGEMENT context . 29
7.1.1 General . 29
7.1.2 PRODUCT SECURITY CONTEXT . 29
7.2 Identification of VULNERABILITIES, THREATS and associated adverse impacts . 30
7.3 Estimation and evaluation of SECURITY risk. 31
7.4 Controlling SECURITY risks . 31
7.5 Monitoring the effectiveness of RISK CONTROLS . 31
8 Software CONFIGURATION MANAGEMENT PROCESS . 32
9 Software problem resolution PROCESS . 32
9.1 Overview. 32
9.2 Receiving notifications about VULNERABILITIES . 32
9.3 Reviewing VULNERABILITIES . 32
9.4 Analysing VULNERABILITIES. 33
9.5 Addressing SECURITY-related issues . 33
Annex A (informative) Rationale . 35
A.1 Relationship to IEC 62443 . 35
A.2 Relationship to IEC 62304 . 36
A.3 Risk transfer . 37
A.3.1 Overview . 37
A.3.2 MAINTAINED SOFTWARE . 37
A.3.3 SUPPORTED SOFTWARE . 37
A.3.4 REQUIRED SOFTWARE . 37
A.4 Secure coding best practices . 38
Annex B (informative) Guidance on implementation of SECURITY LIFE CYCLE ACTIVITIES . 39
B.1 Overview. 39
B.2 Related work . 39
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B.3 THREAT / RISK ANALYSIS . 39
B.4 THREAT and RISK MANAGEMENT . 40
B.5 Software development planning . 40
B.5.1 Development . 40
B.5.2 HEALTH SOFTWARE requirements analysis . 41
B.5.3 Software architectural design . 41
B.5.4 Software unit implementation and VERIFICATION . 41
B.5.5 Secure implementation . 42
B.5.6 Not used . 42
B.5.7 Software system testing . 42
Annex C (informative) THREAT MODELLING . 44
C.1 General . 44
C.2 ATTACK-defense trees . 44
C.3 CAPEC / OWASP / SANS . 44
C.4 CWSS . 44
C.5 DREAD . 45
C.6 List known potential VULNERABILITIES . 45
C.7 OCTAVE . 45
C.8 STRIDE . 45
C.9 Trike . 45
C.10 VAST . 45
Annex D (informative) Relation to practices in IEC 62443-4-1:2018 . 46
D.1 IEC 81001-5-1 to IEC 62443-4-1:2018 . 46
D.2 IEC 62443-4-1:2018 to IEC 81001-5-1 . 47
Annex E (informative) Documents specified in IEC 62443-4-1 . 48
E.1 Overview. 48
E.2 Release documentation. 48
E.2.1 PRODUCT documentation . 48
E.2.2 HEALTH SOFTWARE DEFENSE-IN-DEPTH documentation . 49
E.2.3 DEFENSE-IN-DEPTH measures expected in the environment . 49
E.2.4 SECURITY hardening guidelines . 49
E.2.5 SECURITY update information . 50
E.3 Documents for decommissioning HEALTH SOFTWARE . 50
Annex F (normative) TRANSITIONAL HEALTH SOFTWARE . 51
F.1 Overview. 51
F.2 Development assessment and gap closure activities . 51
F.3 Rationale for use of TRANSITIONAL HEALTH SOFTWARE . 52
F.4 Post-release ACTIVITIES . 52
Annex G (normative) Object identifiers . 53
Bibliography . 54

Figure 1 – HEALTH SOFTWARE field of application . 8
Figure 2 – HEALTH SOFTWARE LIFE CYCLE PROCESSES . 10

Table A.1 – Required level of independence of testers from developers . 36
Table G.1 – Object identifiers for conformance concepts of this document . 53

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IEC/FDIS 81001-5-1:2021(E)
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

HEALTH SOFTWARE AND HEALTH IT SYSTEMS SAFETY,
EFFECTIVENESS AND SECURITY –

Part 5-1: Security –
Activities in the product life cycle

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,
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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
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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.
International Standard IEC 81001-5-1 has been prepared by a Joint Working Group of IEC
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.
The text of this document is based on the following documents:
Draft Report on voting
62A/XX/FDIS 62A/XX/RVD

Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
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IEC/FDIS 81001-5-1:2021(E)
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This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications.
In this document, the following print types are used:
– requirements and definitions: roman 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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
A list of all parts in the IEC 81001 series, published under the general title Health software and
health IT systems safety, effectiveness and security, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document 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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INTRODUCTION
0.1 Structure
PROCESS standards for HEALTH SOFTWARE provide a specification of ACTIVITIES that will be
performed by the MANUFACTURER – including software incorporated in medical devices –as a
part of a development LIFE CYCLE. The normative clauses of this document are intended to
provide minimum best practices for a secure software LIFE CYCLE. Local legislation and
regulation are considered.
PROCESS requirements (Clause 4 through Clause 9) have been derived from the
1
IEC 62443-4-1[11] PRODUCT LIFE CYCLE management. Implementations of these specifications
can extend existing PROCESSES at the MANUFACTURER’s organization – notably existing
PROCESSES conforming to IEC 62304[8]. This document can therefore support conformance to
IEC 62443-4-1[11].
Normative clauses of this document specify ACTIVITIES that are the responsibility of the
MANUFACTURER. The HEALTH SOFTWARE LIFE CYCLE can be part of an incorporating PRODUCT
project. Some ACTIVITIES specified in this document depend on input and support from the
PRODUCT LIFE CYCLE (for example to define specific criteria). Examples include:
• RISK MANAGEMENT;
• requirements;
• testing;
• post-release (after first placing HEALTH SOFTWARE on the market).
In cases where ACTIVITIES for HEALTH SOFTWARE need support from PROCESSES at the PRODUCT
level, Clause 4 through Clause 9 of this document specify respective requirements beyond the
HEALTH SOFTWARE LIFE CYCLE.
PROCESSES, but
Similar to IEC 62304[8], this document does not prescribe a specific system of
Clause 4 through Clause 9 of this document specify ACTIVITIES that are performed during the
HEALTH SOFTWARE LIFE CYCLE.
Clause 4 specifies that MANUFACTURERS develop and maintain HEALTH SOFTWARE within a quality
management system (see 4.1) and a RISK MANAGEMENT SYSTEM (4.2).
Clause 5 through Clause 8 specify ACTIVITIES and resulting output as part of the software LIFE
PROCESS implemented by the MANUFACTURER. These specifications are arranged in the
CYCLE
ordering of IEC 62304[8].
Clause 9 specifies ACTIVITIES and resulting output as part of the problem resolution PROCESS
implemented by the MANUFACTURER.
The scope of this document is limited to HEALTH SOFTWARE and its connectivity to its INTENDED
ENVIRONMENT OF USE, based on IEC 62304[8], but with emphasis on CYBERSECURITY.
For expression of provisions in this document,
– “can” is used to describe a possibility or capability; and
– “must” is used to express an external constraint.
___________
1
 Numbers in square brackets refer to the Bibliography.
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NOTE HEALTH SOFTWARE can be placed on the market as software, as part of a medical device, as part of hardware
specifically intended for health use, as a medical device (SaMD), or as a PRODUCT for other health use. (See
Figure 2).
0.2 Field of application
This document applies to the development and maintenance of HEALTH SOFTWARE by a
MANUFACTURER, but recognizes the critical importance of bi-lateral communication with
organizations (e.g. HEALTHCARE DELIVERY ORGANIZATIONS, HDOS) who have SECURITY
responsibilities for the HEALTH SOFTWARE and the systems it is incorporated into, once the
software has been developed and released. The ISO/IEC 81001-5 series of standards (for
which this is part -1), is therefore being designed to include future parts addressing SECURITY
that apply to the implementation, operations and use phases of the LIFE CYCLE for organizations
such as HDOs.
A medical device software is a subset of HEALTH SOFTWARE. A practical Venn diagram of HEALTH
SOFTWARE types is shown in Figure 1. Therefore, this document applies to:
– software as part of a medical device;
– software as part of hardware specifically intended for health use;
– software as a medical device (SaMD); and
– software-only PRODUCT for other health use.
NOTE In this document, the scope of software considered part of the LIFE CYCLE ACTIVITIES for secure HEALTH
SOFTWARE is larger and includes more software (drivers, platforms, operating systems) than for SAFETY, because for
SECURITY the focus will be on any use including foreseeable unauthorized access rather than just the INTENDED USE.

[SOURCE: IEC 82304-1[18]]
Figure 1 – HEALTH SOFTWARE field of application
0.3 Conformance
Conformance with this document focuses on the implementation of requirements regarding
PROCESSES, ACTIVITIES, and TASKS – and can be claimed in one of two alternative ways:
• for HEALTH SOFTWARE by implementing requirements in Clause 4 through Clause 9 of this
document,
TRANSITIONAL HEALTH SOFTWARE by only implementing the PROCESSES, ACTIVITIES, and
• for
TASKS identified in Annex F.
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This document is designed to assist in the implementation of the PROCESSES required by
IEC 62443-4-1, however, conformance to this document is not necessarily a sufficient condition
for conformance to IEC 62443-4-1[11]. More guidance on coverage can be found in Annex D.
MANUFACTURERS can implement the specifications for Annex E in order to achieve conformance
of documentation to IEC 62443-4-1[11].
Clause 4 through Clause 9 of this document require establishing one or more PROCESSES that
include identified ACTIVITIES. Per these normative parts of this document, the LIFE CYCLE
PROCESSES implement these ACTIVITIES. None of the requirements in this document requires to
implement these ACTIVITIES as one single PROCESS or as separate PROCESSES. The ACTIVITIES
specified in this document will typically be part of an existing LIFE CYCLE PROCESS.


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HEALTH SOFTWARE AND HEALTH IT SYSTEMS SAFETY,
EFFECTIVENESS AND SECURITY –

Part 5-1: Security –
Activities in the product life cycle



1 Scope
This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH
SOFTWARE needed to support conformance to IEC 62443-4-1[11] – taking the specific needs for
HEALTH SOFTWARE into account. The set of PROCESSES, ACTIVITIES, and TASKS described in this
document establishes a common framework for secure HEALTH SOFTWARE LIFE CYCLE
PROCESSES. An informal overview of activities for HEALTH SOFTWARE is shown in Figure 2.
...