ISO/TS 20405:2018

TECHNICAL ISO/TS
SPECIFICATION 20405
First edition
2018-05
Health informatics — Framework of
event data and reporting definitions
for the safety of health software
Informatique de santé — Cadre des données relatives aux événements
et de compte-rendu des définitions pour la sécurité des logiciels de santé
Reference number
©
ISO 2018
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles, data concepts and process model . 2
4.1 General . 2
4.2 Principles . 3
4.2.1 General. 3
4.2.2 Proactivity . 3
4.2.3 Objectivity . 3
4.2.4 Accountability . 3
4.2.5 Transparency . 3
4.2.6 Preparedness . 3
4.2.7 Comprehensiveness . 4
4.3 Data concepts . 4
4.3.1 General. 4
4.3.2 Accuracy . 4
4.3.3 Timeliness. 4
4.3.4 Comparability . 4
4.3.5 Usability . 4
4.3.6 Relevance . . 5
4.4 Process model . 5
4.4.1 General. 5
4.4.2 Recording . 5
4.4.3 Analysing . 5
4.4.4 Reporting . 5
5 Patient safety data elements . 6
5.1 General . 6
5.2 Event information . . 6
5.2.1 General. 6
5.2.2 Event identification . 6
5.2.3 Event date and time . . 6
5.2.4 Report date . 6
5.2.5 Event reporter information . 6
5.2.6 Event supplementary information . 7
5.3 Event categorization. 7
5.4 Event classification . 7
5.4.1 General. 7
5.4.2 Information input/output errors . 8
Annex A (informative) Information on various health software surveillance systems .13
Bibliography .15
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2018 – All rights reserved

Introduction
Patient safety is a major, worldwide concern in healthcare.
Individuals and organizations representing an array of roles, responsibilities, interests and
relationships have become involved, including clinical professionals, academic researchers and patient
advocates, as well as government and health regulatory authorities, and of course public and private
sector corporations delivering healthcare.
Since 1999, patient safety has been a consistent focus of deliberation and action at national and
international levels, including at ISO and IEC. Existing standards have been revised and new ones
developed to incorporate recognized and emerging best practices in patient safety, in particular with
respect to risk analysis, prevention and mitigation.
While these efforts have been supported by local, regional and global initiatives to improve patient
safety, a consensus-based framework approach to the identification and reporting of incidents, near-
misses and unsafe conditions with respect to the safety of health software has not been articulated.
This is a significant gap when considering:
1) the rapidly increasing use of health information technology (HIT) in healthcare delivery,
2) the greater uptake and implementation of products on a more global basis, and
3) the rapidly expanding endeavour towards achieving greater interoperability, based on standards
and specifications, of previously 'stand-alone' or otherwise heterogeneous health software
systems.
[[16]]
Considering this gap, it is useful to return to the Institute of Medicine's report which noted that
improved surveillance mechanisms are needed to identify, capture, and investigate adverse events to
continually improve the safety of HIT.
In the context of achieving a framework approach, it is important to understand that the use of the
term “Identification” in this document refers to the capacity to describe health software safety events,
in suitable quantitative and qualitative fashion through concepts, definitions, and processes, so as to
provide the most useful information in support of current and future efforts to avoid or mitigate patient
safety incidents.
Indeed several nations already have a variety of general and specific reporting regimes with respect
to the safety of health software, including but not limited to the Agency for Healthcare Research and
Quality's (AHRQ) common formats approach, the National Health Service (NHS) England's National
Reporting and Learning System (NRLS), Japan's Medical Near-Miss/Adverse Event Reporting Project,
among many others (see Annex A). Academic research in this area is also growing, including the
classification for problems associated with IT systems in healthcare. These regimes as well as academic
research have helped greatly in the preparation of this document.
This document is based upon a primary focus of patient safety. It is therefore principally concerned with
setting out suitable definitions that describe data in most/all events where health software performs
adversely (either in a stand-alone sense, or when interoperability is involved between distinct systems)
and thereby poses a risk to patients.
Using this framework approach, it is anticipated that incidents, near-misses and unsafe conditions
involv
...