Health Informatics - Automatic identification and data capture marking and labelling - Subject of care and individual provider identification (ISO 18530:2021)

This document outlines the standards needed to identify and label the Subject of Care (SoC) and the
Individual Provider on objects such as identification (wrist) bands, identification tags or other objects,
to enable automatic data capture using data carriers in the care delivery process.
It provides for a unique SoC identification that can be used for other purposes, such as recording the
identity of the SoC in individual health records.
This document serves as a reference for any organization which plans to implement or improve
Automatic Identification and Data Capture (AIDC) in their delivery of care process. It is based on the
use of the GS1® system of standards. Other solutions, such as using other identification systems (for
example, systems based on ISBT 128), are possible but not addressed by this document.
This document describes good practices to reduce/avoid variation and workarounds which challenge
the efficiency of AIDC at the point of care and compromise patient safety[5][6].
This document specifies how to manage identifiers in the AIDC process, and completes the information
found in ISO/TS 22220 and ISO/TS 27527.

Medizinische Informatik - Automatische Identifikation und Datenerfassungskennzeichnung und -beschriftung - Identifikation von Behandelten und individuellen Anbietern (ISO 18530:2021)

Informatique de santé - identification lisible par capture automatique et marquage - identification des sujets de soins de santé et des professionnels de la santé (ISO 18530:2021)

Zdravstvena informatika - Samodejna identifikacija ter zajem podatkov za označevanje in etiketiranje - Predmet varstva in posamezna identifikacija (ISO 18530:2021)

General Information

Status
Published
Public Enquiry End Date
26-Mar-2020
Publication Date
15-Apr-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
18-Mar-2021
Due Date
23-May-2021
Completion Date
16-Apr-2021

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SLOVENSKI STANDARD
SIST EN ISO 18530:2021
01-maj-2021
Nadomešča:
SIST-TS CEN ISO/TS 18530:2016
Zdravstvena informatika - Samodejna identifikacija ter zajem podatkov za
označevanje in etiketiranje - Predmet varstva in posamezna identifikacija (ISO
18530:2021)

Health Informatics - Automatic identification and data capture marking and labelling -

Subject of care and individual provider identification (ISO 18530:2021)
Medizinische Informatik - Automatische Identifikation und

Datenerfassungskennzeichnung und -beschriftung - Identifikation von Behandelten und

individuellen Anbietern (ISO 18530:2021)

Informatique de santé - identification lisible par capture automatique et marquage -

identification des sujets de soins de santé et des professionnels de la santé (ISO

18530:2021)
Ta slovenski standard je istoveten z: EN ISO 18530:2021
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 18530:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 18530:2021
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SIST EN ISO 18530:2021
EN ISO 18530
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2021
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes CEN ISO/TS 18530:2015
English Version
Health Informatics - Automatic identification and data
capture marking and labelling - Subject of care and
individual provider identification (ISO 18530:2021)

Informatique de santé - Marquage et étiquetage à l'aide Medizinische Informatik - Automatische Identifikation

de l'identification et de la saisie automatiques des und Datenerfassungskennzeichnung und -beschriftung

données - Identification du sujet des soins et du - Identifikation von Behandelten und individuellen

prestataire considéré (ISO 18530:2021) Anbietern (ISO 18530:2021)
This European Standard was approved by CEN on 11 June 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18530:2021 E

worldwide for CEN national Members.
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SIST EN ISO 18530:2021
EN ISO 18530:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 18530:2021
EN ISO 18530:2021 (E)
European foreword

This document (EN ISO 18530:2021) has been prepared by Technical Committee ISO/TC 215 "Health

informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the

secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by August 2021, and conflicting national standards shall

be withdrawn at the latest by August 2021.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes CEN ISO/TS 18530:2015.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 18530:2021 has been approved by CEN as EN ISO 18530:2021 without any modification.

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SIST EN ISO 18530:2021
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SIST EN ISO 18530:2021
INTERNATIONAL ISO
STANDARD 18530
First edition
2021-01
Health informatics — Automatic
identification and data capture
marking and labelling — Subject
of care and individual provider
identification
Informatique de santé — Marquage et étiquetage à l’aide de
l’identification et de la saisie automatiques des données —
Identification du sujet des soins et du prestataire considéré
Reference number
ISO 18530:2021(E)
ISO 2021
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SIST EN ISO 18530:2021
ISO 18530:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 18530:2021
ISO 18530:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 GS1® specifications and ISO deliverables.................................................................................................................................. 3

5 Data structures and semantics .............................................................................................................................................................. 3

5.1 Application identifiers ...................................................................................................................................................................... 3

5.2 Global service relation number (GSRN) ............................................................................................................................ 4

5.3 Service relation instance number (SRIN) ........................................................................................................................ 4

6 SoC and Individual Provider identification as a recognized priority ............................................................4

6.1 General ........................................................................................................................................................................................................... 4

6.2 Supported processes .......................................................................................................................................................................... 5

7 The purpose of globally unique identification ...................................................................................................................... 6

7.1 SoC identification and data processing .............................................................................................................................. 6

7.2 Implementation challenges .......................................................................................................................................................... 6

7.3 Symbol placement on identification bands .................................................................................................................... 6

7.4 Individual Provider identification .......................................................................................................................................... 7

Annex A (informative) Examples of use cases (UC) ............................................................................................................................... 8

Bibliography .............................................................................................................................................................................................................................51

© ISO 2021 – All rights reserved iii
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SIST EN ISO 18530:2021
ISO 18530:2021(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.

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 of 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 www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration

with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health

informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna

Agreement).

This first edition cancels and replaces ISO/TS 18530:2014, which has been technically revised.

The main changes compared to the previous edition are as follows:
— new definitions added;
— use case and UML diagrams updated;
— bibliography expanded.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
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SIST EN ISO 18530:2021
ISO 18530:2021(E)
Introduction

The delivery of healthcare relies heavily on the ability to uniquely and accurately identify people when

they attend for care, i.e. the Subject of Care (SoC), as well as, when they provide care, i.e. the Individual

Provider.

Health informatics, supporting healthcare delivery, requires a clear specification to identify the SoC

and the Individual Provider so that they are correctly associated with the health information contained

within a healthcare application. This has led to the need to capture and share information across

different systems and healthcare applications.

Data carriers, such as barcodes and Radio Frequency Identification (RFID), commonly referred to

as Automatic Identification and Data Capture (AIDC), have amplified the importance of defining the

identifier data structures for the SoC and Individual Provider to prevent ambiguity when information

is being captured. AIDC provides a wide spectrum of solutions, in particular, regarding optical carriers

(such as barcodes). Furthermore, the semantics of data carried is defined by a number of organizations

(also named “issuing agencies”), some of them having commercial activities, others nation-wide

missions, as well as, standard development organizations. This document focuses on the use of the

® 1)

GS1 System of Standards since a considerable majority of supplies in healthcare around the world

are identified in accordance to this multisectorial and global system of standards. Interoperability is

easier to secure once a single system of standards is used in the healthcare setting.

Interoperability, where information is shared and used by different information systems, requires

a common SoC and Individual Provider identification semantic to ensure that shared information is

consistent and unambiguous. The same SoC and Individual Provider are accurately identified, referenced

and cross-referenced in each system. Effective data capture systems and information sharing is the key

to improving the care of SoCs and delivery by Individual Providers in terms of conformance, accuracy

and integrity of the health data.

In hospitals, a SoC (as in-patient) usually experiences a large number of care instances. Examples of

these instances include: prescriptions and medicinal product administration, laboratory testing of

SoC bio-samples and subsequent analysis and reporting. Each of these instances requires accurate

reconciliation of the instance and delivery to the SoC. Healthcare providers (i.e. organizations that

deliver healthcare to the SoC) have introduced AIDC technology based barcodes to help capture the

SoC's identity, as well as, identification of other related items such as biology samples, so that manual

key entry can be replaced by AIDC. In the complex hospital environment with many care instances, the

need for uniqueness of identifications is generally recognized, since this avoids identification conflicts,

overlaps, uncertainty and risks.

The use of AIDC in the context of chronic care reinforces the need for standards. The SoC in the chronic

care instance is not always in the same fixed location where a single technology is available. AIDC can

therefore be interoperable with a variety of technologies, solutions and devices. This will enable a

continuum of care.

As out-patients, SoCs may be self-medicating. A SoC undergoing treatment for chronic conditions, in

particular, should administer and record their medication according to a prescribed treatment plan.

This treatment plan can be very prescriptive, on an as-needed basis, or be preventive in nature to avoid

dangerous clinical outcomes.

There is also a need to manage and clinically monitor the treatment plan for the SoC for safety and

stock purposes. AIDC enables capture of the SoC’s identification, medicinal product, administration

event, recording of relevant data about the medicinal product administered and other data such as

batch number, expiration information and amount used. This should be done for in-patients as well as

out-patients. This same data capture can be used to efficiently manage and replenish stock.

1) GS1 is a registered trademark. This information is given for the convenience of users of this document and does

not constitute an endorsement by ISO.
© ISO 2021 – All rights reserved v
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SIST EN ISO 18530:2021
ISO 18530:2021(E)

Benefits from unique SoC Identification in AIDC can be documented from the following three examples:

— Patient, as well as, data can travel outside a provider's environment: Following a devastating tornado

in Joplin, Missouri, USA, in 2011, 183 SoCs from St John's Hospital had to be swiftly evacuated to

other regional hospitals. Under such “chaotic” conditions, a patient identifier that is truly unique

would prevent replacing identification bands immediately for every SoC admitted to a different

hospital.

— For regional referral laboratories, especially those performing blood bank testing: positively

identifying SoCs and linking them to previous records, is essential for patient safety. Two different

SoC with the same name, hospitalized at two different facilities using identical patient identification

numbering schemes (perhaps because they use the same IT system), could lead to serious errors.

— A provider uses two identifiers for the management of care processes: the “patient identification”

and the “case identification”. One provider organized the number banks for the two identifiers in

such a way, that data collision was excluded. After years of use of that solution, number banks started

overlapping without anyone noticing, until two SoCs were having the same numbers, one of “patient

identification”, the other for “care identification”. A mismatch with serious incident occurred.

vi © ISO 2021 – All rights reserved
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SIST EN ISO 18530:2021
INTERNATIONAL STANDARD ISO 18530:2021(E)
Health informatics — Automatic identification and data
capture marking and labelling — Subject of care and
individual provider identification
1 Scope

This document outlines the standards needed to identify and label the Subject of Care (SoC) and the

Individual Provider on objects such as identification (wrist) bands, identification tags or other objects,

to enable automatic data capture using data carriers in the care delivery process.

It provides for a unique SoC identification that can be used for other purposes, such as recording the

identity of the SoC in individual health records.

This document serves as a reference for any organization which plans to implement or improve

Automatic Identification and Data Capture (AIDC) in their delivery of care process. It is based on the

use of the GS1® system of standards. Other solutions, such as using other identification systems (for

example, systems based on ISBT 128), are possible but not addressed by this document.

This document describes good practices to reduce/avoid variation and workarounds which challenge

[5][6]
the efficiency of AIDC at the point of care and compromise patient safety .

This document specifies how to manage identifiers in the AIDC process, and completes the information

found in ISO/TS 22220 and ISO/TS 27527.
2 Normative references
There are no normative references in this document.
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:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
application identifier

GS1® prefix that defines the meaning and purpose of the data element that follows, as defined in

ISO/IEC 15418 and GS1® General Specifications
[SOURCE: ISO/IEC 19762:2016, 01.01.82]
3.2
automatic identification and data capture
AIDC

methods or technologies for automatically identifying objects, collecting data about them, and entering

that data directly into computer systems, eliminating manual entry

Note 1 to entry: The methods or technologies typically considered as part of AIDC include barcodes, which can be

linear or 2-dimensional symbols, and Radio Frequency Identification (RFID) tags/chips.

© ISO 2021 – All rights reserved 1
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SIST EN ISO 18530:2021
ISO 18530:2021(E)
3.3
data capture

deliberate action that results in the registration of a record into a record keeping system

3.4
care unit
ward

subdivision of an organization where the subject of care (3.15) receives the care they need during

their stay
3.5
global service relation number
GSRN

identification key to identify the relationship between an organization offering services and the

recipient or provider of services

Note 1 to entry: GSRN are encoded on data carriers with an Application Identifier 8018 for the recipient of a

service (Subject of Care) and with an Application Identifier 8017 for the provider of a service (Individual

Provider).
3.6
healthcare provider
organization or facility that delivers healthcare to subjects of care
3.7
integrating the healthcare enterprise
IHE®

initiative by healthcare professionals and industry to improve the way computer systems in healthcare

share information

Note 1 to entry: IHE® promotes the coordinated use of established standards to address specific clinical need in

support of optimal patient care.

Note 2 to entry: Systems developed in accordance with IHE® communicate with one another better, are easier to

implement, and enable care providers to use information more effectively.
3.8
individual provider
person who provides or is a potential provider of a health care service

Note 1 to entry: An individual provider is an individual person and is not considered to be a group of providers.

Note 2 to entry: Not all health care providers are recognized by professional bodies. It is for this reason that

'health care professional' has not been used to describe them. All health care professionals are providers, but not

all providers are health care professionals.
3.9
individual provider identification

unique number or code issued for the purpose of identifying an individual provider

3.10
information system

organized collection of hardware, software, supplies, policies, procedures and people that stores,

processes and provides access to information

2) GSRN is the GS1® identifier for service relations and is supplied by the GS1® System. This information is given

for the convenience of users of this document and does not constitute an endorsement by ISO of the service relation

identifier named. Equivalent products may be used if they can be shown to lead to the same results.

3) IHE is the registered trademark of the Healthcare Information Management Systems Society. This information

is given for the convenience of users of this document and does not constitute an endorsement by ISO.

2 © ISO 2021 – All rights reserved
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SIST EN ISO 18530:2021
ISO 18530:2021(E)
3.11
machine readable code

code, readable by a machine, which contains information used to establish a relationship between a

physical object such as a medical product package and data sources such as medical, production,

logistical and/or reimbursement coding systems
3.12
record

recorded information, in any form, including data in computer systems, created or received and

maintained by an organization or person in the transaction of business or the conduct of affairs and

kept as evidence of such activity
3.13
registration
act of giving a record a unique identity in a record keeping system
3.14
service relation instance number
SRIN

attribute to a global service relation number (3.5) to identify an instance within a care process

EXAMPLE An identification band, an order sheet, a test-tube, etc.
3.15
subject of care
SoC
person seeking to receive, receiving or having received health care
4 GS1® specifications and ISO deliverables

In this document, automatic identification and data capture (AIDC) refers to selected data carriers which

are widely used across many industries, jurisdictions and which are already based on and specified in

ISO deliverables. The benefit of this approach is to use the already widely available applications and

devices for encoding and reading the different types of data carriers. It should, however, be noted that

certain types of data carriers such as data matrix may only be read by image-based scanners.

AIDC solutions should be in accordance with GS1® general specifications, which in-turn are based on

ISO deliverables. If the recommendation is followed, then information contained in the data carriers

shall be structured and standardized according to the GS1® semantics. The identification key (global

service relation number, GSRN) is the identifier for service relations (such as SoC and Individual

Providers) and is supplied by the GS1® System of Standards.
5 Data structures and semantics
5.1 Application identifiers

The GS1® item identification system and related encoding standard are complemented by the GS1®

maintained application identifiers, hereafter referred to as “GS1® Application Identifiers” or “GS1®

AIs”. This document comprises two principal elements that are the key to any encoding system: the

data content and the data carrier.
The use of GS1® AIs is subject to the rules established by GS1®.

GS1® maintains a list of over 200 AIs which support various processes with automatic identification

and data capture.
© ISO 2021 – All rights reserved 3
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SIST EN ISO 18530:2021
ISO 18530:2021(E)
5.2 Global service relation number (GSRN)

The GSRN is the GS1® Identification Key used to identify the relationship between an organization

offering services and the recipient or provider of services. The key comprises of a GS1® Company

Prefix, Service Reference and Check Digit, with an 18 numeric digits fix length.

Two different AIs are used to distinguish SoC from individual provider as illustrated in Figure 1.

Figure 1 — Global service relation number (GSRN)
5.3 Service relation instance number (SRIN)

The SRIN is an attribute to the GSRN which allows distinguishing different encounters during the

same episode, or the reuse of the same GSRN in different episodes. SRIN is a 10 numeric digits variable

length filed. AI 8019 shall only be used in conjunction with AI 8017 or 8018; Figure 2 illustrates the

combination for a SoC.
Figure 2 — Service relation instance number (SRIN)

For the purpose of this document, for conformance with ISBT 128, the SRIN shall be used as a fixed

length string with the first two digits (NN) reserved for the ISBT 128 location code (Table RT018); the

selection of the remaining eight (8) digits is left to the discretion of the user and may be incremental.

6 SoC and Individual Provider identification as a recognized priority
6.1 General

The World Health Organization (WHO) and the Joint Commission International (JCI) have developed

a list of priority solutions to enhance patient (meaning SoC) safety. Among the list of solutions WHO

and JCI recommended is the use of AIDC technology (when the technical framework permits). Among

[1] [2]

the "Nine patient safety solutions" given by WHO, the second solution addresses patient (SoC)

identification and the use of “barcodes” to reduce the risk of identification errors. Other solutions

(communication during patient hand-over; performance of correct procedures at correct body site;

assuring medication accuracy at transitions in care) require security of a patient’s (SoC’s) identification.

4 © ISO 2021 – All rights reserved
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SIST EN ISO 18530:2021
ISO 18530:2021(E)

Annex A illustrates how SoC and Individual Provider identification should be enabled for different

types of healthcare care use cases. If used, the Annex A explains the type of care and how AIDC can be

implemented as a good practice in different use cases. The following use cases (UC) are included:

— UC 01 to 04 covers the typical overall SoC flow through a hospital (see Figure A.1);

— UC 05 to 11 describes specific care instances that might arise within a hospital environment (see

Figure A.2);
— UC 12 to
...

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