Information technology -- Concepts and usage of metadata

This document specifies the message exchange framework for communicating data element definitions with an ISO/IEC 11179-3 metadata registry (MDR). It defines message semantics, protocols and bindings for a set of transactions allowing the exchange of a commonly used subset of data element metadata with an ISO/IEC 11179-3 MDR. This document establishes the following data element message exchange interoperability specifications: — retrieving data element list from an ISO/IEC 11179-3 MDR matching the selection criteria; — retrieving metadata of a selected data element from an ISO/IEC 11179-3 MDR.

Technologies de l'information -- Concepts et utilisation des métadonnées

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Published
Publication Date
28-Jun-2020
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5060 - Close of voting Proof returned by Secretariat
Start Date
08-Jun-2020
Completion Date
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TECHNICAL ISO/IEC TR
REPORT 19583-23
First edition
2020-06
Information technology — Concepts
and usage of metadata —
Part 23:
Data element exchange (DEX) for a
subset of ISO/IEC 11179-3
Technologies de l'information — Concepts et utilisation des
métadonnées —
Partie 23: Échange d'éléments de données (DEX) pour un sous-
ensemble de l'ISO/IEC 11179-3
Reference number
ISO/IEC TR 19583-23:2020(E)
ISO/IEC 2020
---------------------- Page: 1 ----------------------
ISO/IEC TR 19583-23:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2020

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/IEC 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/IEC TR 19583-23:2020(E)
Contents Page

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

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

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

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

3 Terms, definitions and abbreviated terms ................................................................................................................................ 1

3.1 Terms and definitions ....................................................................................................................................................................... 1

3.2 Abbreviated terms ............................................................................................................................................................................... 2

4 Overview of data element exchange (DEX) specification ........................................................................................... 3

4.1 General ........................................................................................................................................................................................................... 3

4.2 Data element metadata .................................................................................................................................................................... 4

4.3 Retrieve data element list .............................................................................................................................................................. 8

4.3.1 General...................................................................................................................................................................................... 8

4.3.2 Retrieve data element list request .................................................................................................................... 8

4.3.3 Retrieve data element list response ................................................................................................................ 9

4.3.4 Protocol requirements .............................................................................................................................................10

4.4 Retrieve metadata .............................................................................................................................................................................15

4.4.1 General...................................................................................................................................................................................15

4.4.2 Retrieve metadata request ...................................................................................................................................16

4.4.3 Retrieve metadata response ...............................................................................................................................17

4.4.4 Protocol requirements .............................................................................................................................................17

Annex A (informative) .....................................................................................................................................................................................................24

Annex B (informative) .....................................................................................................................................................................................................28

Annex C (informative) ......................................................................................................................................................................................................35

Bibliography .............................................................................................................................................................................................................................38

© ISO/IEC 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/IEC TR 19583-23:2020(E)
Foreword

ISO (the International Organization for Standardization) and IEC (the International Electrotechnical

Commission) form the specialized system for worldwide standardization. National bodies that

are members of ISO or IEC participate in the development of International Standards through

technical committees established by the respective organization to deal with particular fields of

technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other

international organizations, governmental and non-governmental, in liaison with ISO and IEC, also

take part in the work.

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 document 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 and IEC 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) or the IEC

list of patent declarations received (see http:// patents .iec .ch).

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 Joint Technical Committee ISO/IEC JTC 1, Information technology,

Subcommittee SC 32, Data management and interchange.
A list of all parts in the ISO/IEC 19583 series can be found on the ISO website.

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/IEC 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/IEC TR 19583-23:2020(E)
Introduction

The ISO/IEC 11179 series addresses the semantics of data, the representation of data, and the

registration of the descriptions of that data, i.e. metadata. While ISO/IEC 11179-3 provides the basic

conceptual model for a metadata registry (MDR) in which information about metadata can be recorded

and maintained, implementers and users of the registries described in the ISO/IEC 11179 series require

further guidance to exchange data element definitions with each other via a standard-based protocol.

It is necessary to have a common protocol and message semantics to be able to communicate with an

MDR to locate the data elements given the search criteria and exchange metadata of data elements by

addressing the technical and semantic interoperability challenges.

This document was developed to describe a message exchange framework specification for

communicating a subset of data element metadata with an ISO/IEC 11179-3 MDR.
© ISO/IEC 2020 – All rights reserved v
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TECHNICAL REPORT ISO/IEC TR 19583-23:2020(E)
Information technology — Concepts and usage of
metadata —
Part 23:
Data element exchange (DEX) for a subset of ISO/IEC
11179-3
1 Scope

This document specifies the message exchange framework for communicating data element definitions

with an ISO/IEC 11179-3 metadata registry (MDR). It defines message semantics, protocols and

bindings for a set of transactions allowing the exchange of a commonly used subset of data element

metadata with an ISO/IEC 11179-3 MDR.

This document establishes the following data element message exchange interoperability specifications:

— retrieving data element list from an ISO/IEC 11179-3 MDR matching the selection criteria;

— retrieving metadata of a selected data element from an ISO/IEC 11179-3 MDR.
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 document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO/IEC 11179-3, Information technology — Metadata registries (MDR) — Part 3: Registry metamodel

and basic attributes
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO/IEC 11179-3 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at https:// www .iso .org/ obp
3.1.1
target data model
information view of an application schema

Note 1 to entry: Implementation-dependent realizations of logical information models such as XML serializations,

RDF serializations, JSON serializations and relational database schemas.
[SOURCE: ISO/TS 19129:2009, 4.1.2, modified — Note 1 to entry has been added.]
© ISO/IEC 2020 – All rights reserved 1
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ISO/IEC TR 19583-23:2020(E)
3.1.2
mapping specification

procedural functions to locate the data element in a given target data model (3.1.1)

Note 1 to entry: A mapping specification includes a mapping script (3.1.3), the type of the script (e.g. XPATH) and

the target data model on which the mapping script can be executed.
3.1.3
mapping script
executable script on a given target data model (3.1.1)
[1]

Note 1 to entry: A mapping script can be an XPATH expression to be executed on XML documents .

3.1.4
metadata consumer
actor that retrieves the metadata created by the metadata source (3.1.5)

Note 1 to entry: A metadata consumer can optionally query the metadata source (3.1.5) for a list of data elements

matching the selection criteria (3.1.6).
3.1.5
metadata source

actor responsible for creation of the data element list matching the selection criteria (3.1.6) and the

creation of metadata for a selected data element per request from the metadata consumer (3.1.4)

Note 1 to entry: A metadata source is associated with an ISO/IEC 11179-3 metadata registry.

3.1.6
selection criteria

logical expression, the criteria being satisfied only if the expression evaluates to the value TRUE

[SOURCE: ISO 10303-14:2005, 3.3.9]
3.1.7
value set
finite set in a specific correspondence with the index-set of the list
Note 1 to entry: A value set is identified with a unique ID and version.
[SOURCE: ISO 8485:1989, 5.3.1.4, modified — Note 1 to entry has been added.]
3.2 Abbreviated terms
CDASH Clinical Data Acquisition Standards Harmonization
CDISC Clinical Data Interchange Standards Consortium
DEX data element exchange
FHIR fast healthcare interoperability resources
HITSP Healthcare Information Technology Standards Panel
JSON JavaScript object notation
MDR metadata registry
NAV navigation error (due to unknown data element)
NCI National Cancer Institute
2 © ISO/IEC 2020 – All rights reserved
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ISO/IEC TR 19583-23:2020(E)
POSIX portable operating system interface
RDF resource description framework
regex regular expressions
REST representational state transfer
SDTM study data tabulation model
SPARQL simple protocol and RDF query language
SQL structured query language
XML eXtensible Markup Language
XPATH XML path language
XSD XML schema definition
VERUNK version unknown
4 Overview of data element exchange (DEX) specification
4.1 General

The objective of DEX specification is to describe a message exchange framework for communicating

a subset of administered data element definitions with an ISO/IEC 11179-3 MDR. It defines message

semantics, protocols and bindings for a set of transactions allowing the exchange of a subset of

administered data element metadata with an ISO/IEC 11179-3 MDR.
Two actors are defined as a part of this specification:

— Metadata source: The metadata source is responsible for the creation of the data element list

matching the selection criteria and the creation of metadata for a selected data element per request

from the metadata consumer. The metadata source is associated with an ISO/IEC MDR.

— Metadata consumer: The metadata consumer is responsible for the importation of metadata created

by the metadata source. The metadata consumer can optionally query the metadata source for a list

of data elements matching the selection criteria.

The following data element message exchange patterns are supported between the metadata source

and metadata consumer actors:

— Retrieving a data element list from an ISO/IEC 11179-3 MDR matching the selection criteria.

— Retrieving metadata of a selected data element from an ISO/IEC 11179-3 MDR.

Corresponding to these message exchange patterns, two transaction specifications are provided:

— retrieve data element list;
— retrieve metadata.

The retrieve data element list transaction is an optional preparatory act to retrieve the identification

information for the list of data elements matching the given the selection criteria, which can be used

in the second retrieve metadata transaction to collect the metadata of the selected data element. The

core content to be exchanged as a result of the retrieve metadata message exchange pattern is “data

element metadata”. In 4.2, details of this content are examined first since the search criteria as a part

of retrieve data element list also depends on this content specification. In 4.3 and 4.4, the transaction

specifications of retrieve data element list and retrieve metadata are presented.

© ISO/IEC 2020 – All rights reserved 3
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ISO/IEC TR 19583-23:2020(E)
4.2 Data element metadata

The data element metadata is a flattened subset of the metadata attributes defined in the ISO/IEC 11179

series as depicted in Table 1. A mapping of DEX attributes to ISO/IEC 11179-3 attributes is available in

Annex C. On top of the ISO/IEC 11179 series-based metadata of a data element, the attribute Mapping_

Specification has been added to specify the mapping of an abstract data element definition to different

target data models.

The attribute names in Tables 1 through 9 are based on ISO/IEC 11179-3. An ISO/IEC 11179 series class

attribute is specified by using the class name and attribute name separated by a period e.g. 11179_class_

name.attribute_name. The attribute name is written in the form of 11179_Class_Name if the attribute is

composing inner attributes defined within a separate table. The optionality field can have the following

values with their associated meanings:
R required
R2 required if the information is available
O optional

The string data type corresponds to xsd: string and the date data type corresponds to xsd: date. The

format for xsd: date is YYYY-MM-DD where Y is the year, M is the month, D is the day of month.

Table 1 — Data_Element metadata details
Attribute name Optionality Is repeatable Type Description
identifier R No string The universally unique iden-
tifier of the data element. This
identifier should be the same
as the identifier in the received
retrieve metadata request
message.
registration_authority_identifier R No string The authority who has defined
and registered the data element
to the metadata source.
EXAMPLES CDISC, HITSP, NCI.
See ISO/IEC 11179-3:2013
6.3.8.2.
This attribute is comprised of
international_code_designator,
organization_identifier, organi-
zation_part_identifer. All these
attributes can be used to create
the string for the registra-
tion_authority_identifier. This is
a mandatory field since the data
elements must be administered
for this specification.
version R No string The version of the data element.
designation.sign R No string The designation (name) of the
data element that can be used
for display purposes.
definition.text R No string The definition that gives an
unambiguous description of the
data element and its use.
4 © ISO/IEC 2020 – All rights reserved
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ISO/IEC TR 19583-23:2020(E)
Table 1 (continued)
Attribute name Optionality Is repeatable Type Description
registry_specifiation.context R2 No string The specific domain in which
this data element is defined.
EXAMPLES CDASH, SDTM.
If such a context is defined by
the registration authority for
this data element in the MDR,
then this attribute is mandatory.
creation_date R No date The date when this data
element is created.
effective_date R No date The date when this data
element becomes effective to
be used.
until_date R2 No date The date when the data
element is no longer expected to
be used.
last_change_date R2 No date The date when the data
element was last revised.
change_description R2 No string A note that indicates the revi-
sion reason and description of
the updates.
Data_Element_Concept R No See Table 2 for the The concept which is the mean-
details of Data_ ing part of the data element
Element_ definition. A data element is
Concept created with an association of
a data element concept and a
value domain.
Value_Domain R No See Table 3 for The domain from which the
the details of data element takes its values.
Value_Domain Each data element is composed
of a data element concept and a
value domain.
Mapping_Specification R Yes See Table 5 for The exact specification to locate
the details of the data element in a target
Mapping_ data model. This attribute is
Specification an extension on top of ISO/
IEC 11179-3.
© ISO/IEC 2020 – All rights reserved 5
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ISO/IEC TR 19583-23:2020(E)
Table 2 — Data_Element_Concept details
Attribute name Optionality Is repeatable Type Description
identifier R No string The universally unique
identifier of the data
element concept.
version R No string The version of the data
element concept.
designation.sign R No string The textual representa-
tion of the data element
concept.
object_class.designation.sign R2 No string An object class represents
a set of ideas, abstrac-
tions, or things in the real
world that are identified
with explicit boundaries
and meaning and whose
properties and behaviour
follow the same rules. This
attribute is the name of
the object class of the data
element concept.
property.designation.sign R2 No string A property is a characteris-
tic common to all members
of an object class. This
attribute is the name of
the property of the data
element concept.
Table 3 — Value_Domain details
Attribute name Optionality Is repeatable Type Description
identifier R No string The universally unique
identifier of the value
domain.
type R No string The type of the value
domain. Valid types are
defined, enumerated and
described.
datatype.name R No string The data type which
represents the character-
istics of the permissible
values for the property of
the data element.
EXAMPLE xsd: string.
unit_of_measure R2 No string Actual units in which
the associated values of
the property of the data
element are measured.
source_uri R2 No string A reference to the exter-
nal value set, if the value
domain’s type is "de-
fined" (ISO/IEC 11179-
3:2013/Amd 1:2020).
Permissible_Value R2 Yes See Table 4 for the The permissible value set
details of from which the values of
Permissible_Value. this data element can be
selected.
6 © ISO/IEC 2020 – All rights reserved
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ISO/IEC TR 19583-23:2020(E)
Table 4 — Value_Domain Permissible_Value details
Attribute name Optionality Is repeatable Type Description
permitted_value R No string The permitted value.
value_meaning.designation.sign R No string The textual
representation of
the meaning of the
permitted value.
begin_date R No date The date that this value
becomes effective.
end_date R2 No date The date that this
value becomes invalid.
Table 5 — Mapping_Specification summary
Attribute name Optionality Is repeatable Type Description
Target_Data_Model R No See Table 7 for the The data model that the data el-
details of Target_ ement is interrelated with. It can
Data_Model be a database schema, an OWL
schema, an XML schema, etc.
type R No string The type of the mapping
specification. The type should
be selected from the mapping
specification type value set (See
Table 6).
mapping_script R No string The executable script to locate
the data element in a target
data model.
EXAMPLE XPATH scripts,
SPARQL or SQL queries.
Table 6 — Mapping specification type value set
Mapping specification Description
type

XPath is a language that describes a way to locate and process items in XML docu-

XPATH ments by using an addressing syntax based on a path through the document's logical

structure or hierarchy.

SQL is an industry-standard language for creating, updating and querying relational

SQL
database management systems.
SPARQL is a standard query language and data access protocol for use with the
SPARQL
RDF data model.

A query with a set of parameters (http:// www .hl7 .org/ implement/ standards/ fhir/

FHIR Query
query .html).
Other Any mapping specification that is not one of the above types.
© ISO/IEC 2020 – All rights reserved 7
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ISO/IEC TR 19583-23:2020(E)
Table 7 — Target_Data_Model details
Attribute Optionality Is repeatable Type Description
name
name R No string The name of the target data model.
EXAMPLE ASTM/HL7 CCD.
description R No string Textual description of the target data
model. If available, the unique identifier
for the target data model can be present-
ed here.
EXAMPLE 2.16.840.1.113883.10.20.1 for
ASTM/HL7 CCD.
url R2 No string If available a reference to the schema of
the target data model.
4.3 Retrieve data element list
4.3.1 General

This transaction is used by the metadata consumer to retrieve a list of data elements from the metadata

source matching the given selection criteria. The interaction diagram is depicted in Figure 1. In 4.3.2

through 4.3.4 the triggering events for the request and response messages involved in this transaction,

the message semantics of the request and response messages and the expected action that needs to be

carried out by the receiving actors are presented.
Figure 1 — Retrieve metadata element list transaction
4.3.2 Retrieve data element list request
4.3.2.1 Trigger events

The metadata consumer wants to retrieve the metadata of a list of data elements matching the selection

criteria by defining several filters. The metadata consumer sends a retrieve data element list request to

the metadata source.
4.3.2.2 Message semantics

The metadata consumer sends a retrieve data element list request message to specify the selection

criteria to filter and return the metadata of a list of data elements. The selection criteria are represented

as a set of filters as depicted in Table 8. The metadata consumer should send zero or more filters in the

retrieve data element list request. Each filter applies a filtering criterion on the specified attribute of the

data element. Providing no filters inside the retrieve data element list request means that the metadata

consumer queries for all available data elements. More than one filter means that the metadata source

8 © ISO/IEC 2020 – All rights reserved
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ISO/IEC TR 19583-23:2020(E)

should semantically create an intersection of the matching data elements for each filter. That is, logical

AND operator is implicitly assumed on multiple filters. In 4.3.4 the protocol requirements and the

format of the message are described in full detail.
Table 8 — Filter details
Attribute Optionality Is repeatable Type Description
name
name R No string The name of the data element
attribute to apply the filter on.
operator R No string The operation of the filter. The opera-
tor should be selected from the filter
operator value set (see Table 9).
value R No string The value of the filtered attribute to
apply while executing the operator.
Table 9 — Filter operator value set
Filter Operator Description

Checks for mathematical equality of the given filter value with the value of the data

equals
element attribute.

This operator should compare the contents of the referenced attribute with the regex

[4]

match using the POSIX matching rules. If the regex matches the attribute, the data ele-

ment matches. All regex matches should be executed in case insensitive mode.
Date comparisons expects the argument in the format of xsd: date (YYYY-MM-DD)

before and compare it with the attribute using a date comparison. This operator should

filter out the dates before or equals to the given filter date.
Date comparisons expects the argument in the format of xsd: date (YYYY-MM-DD)

after and compare it with the attribute using a date comparison. This operator should

filter out the dates after or equals to the given filter date.
4.3.2.3 Expected action

The metadata source should perform matching in accordance with the filter operator rules described in

Table 9. Any data element which has metadata that matches all of the provided filters at the same time

should be included in the response. That is, multiple filters should be linked together with logical AND

operator.
4.3.3 Retrieve data element list response
4.3.3.1 Trigger events
This message will be triggered by a retrieve data element list request message.
4.3.3.2 Message semantics

The response should be a retrieve data element list response message which should have one Data_

Element_Summary attribute (presented in Table 10) for each matching data element. If no matching

data elements are found, data element list response message should be empty. In 4.3.4 the protocol

requirements and the format of the message are described in full detail.

Table 10 — Data_Element_Summary in the retrieve data element list response message

Attribute name Optionality Is repeatable Type Description
Data_Element_Summary R2 Yes See Table 11 for the de- The summary
tails of Data_Element_ information about
Summary the data element.
© ISO/IEC 2020 – All rights reserved 9
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ISO/IEC TR 19583-23:2020(E)

The atttributes of the Data_Element_Summary are presented in Table 11. The string data type

corresponds to xsd: string and the date data type corresponds to xsd: date. The format for xsd: date is

YYYY-MM-DD where Y is the year, M is the month, D is the day of month.

Table 11 — The attributes of the Data_Element_Summary in the retrieve data element list

response message
Attribute name Optionality Is repeata- Type Description
ble
identifier R No string The universally unique identifier of the
data element.
registration_authority_ R No string The authority who has defined and reg-
identifier istered the data element to the metada-
ta source
(EXAMPLES CDISC, HITSP, NCI).
version R No string The version of the data element.
designation.sign R No string The name of the data element that can
be used for display purposes
definition.text R No string Definition that gives an unambiguous de-
scription of the data element and its use.
registry_specifica
...

TECHNICAL ISO/IEC TR
REPORT 19583-23
First edition
Information technology — Concepts
and usage of metadata —
Part 23:
Data element exchange (DEX) for a
subset of ISO/IEC 11179-3
PROOF/ÉPREUVE
Reference number
ISO/IEC TR 19583-23:2020(E)
ISO/IEC 2020
---------------------- Page: 1 ----------------------
ISO/IEC TR 19583-23:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2020

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 PROOF/ÉPREUVE © ISO/IEC 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/IEC TR 19583-23:2020(E)
Contents Page

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

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

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

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

3 Terms, definitions and abbreviated terms ................................................................................................................................ 1

3.1 Terms and definitions ....................................................................................................................................................................... 1

3.2 Abbreviated terms ............................................................................................................................................................................... 2

4 Overview of data element exchange (DEX) specification ........................................................................................... 3

4.1 General ........................................................................................................................................................................................................... 3

4.2 Data element metadata .................................................................................................................................................................... 4

4.3 Retrieve data element list .............................................................................................................................................................. 8

4.3.1 General...................................................................................................................................................................................... 8

4.3.2 Retrieve data element list request .................................................................................................................... 8

4.3.3 Retrieve data element list response ................................................................................................................ 9

4.3.4 Protocol requirements .............................................................................................................................................10

4.4 Retrieve metadata .............................................................................................................................................................................15

4.4.1 General...................................................................................................................................................................................15

4.4.2 Retrieve metadata request ...................................................................................................................................16

4.4.3 Retrieve metadata response ...............................................................................................................................17

4.4.4 Protocol requirements .............................................................................................................................................17

Annex A (informative) .....................................................................................................................................................................................................24

Annex B (informative) .....................................................................................................................................................................................................28

Annex C (informative) ......................................................................................................................................................................................................35

Bibliography .............................................................................................................................................................................................................................38

© ISO/IEC 2020 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO/IEC TR 19583-23:2020(E)
Foreword

ISO (the International Organization for Standardization) and IEC (the International Electrotechnical

Commission) form the specialized system for worldwide standardization. National bodies that

are members of ISO or IEC participate in the development of International Standards through

technical committees established by the respective organization to deal with particular fields of

technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other

international organizations, governmental and non-governmental, in liaison with ISO and IEC, also

take part in the work.

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 document 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 and IEC shall not be held responsible for identifying any or all such patent

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Subcommittee SC 32, Data management and interchange.
A list of all parts in the ISO/IEC 19583 series can be found on the ISO website.

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complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO/IEC TR 19583-23:2020(E)
Introduction

The ISO/IEC 11179 series addresses the semantics of data, the representation of data, and the

registration of the descriptions of that data, i.e. metadata. While ISO/IEC 11179-3 provides the basic

conceptual model for a metadata registry (MDR) in which information about metadata can be recorded

and maintained, implementers and users of the registries described in the ISO/IEC 11179 series require

further guidance to exchange data element definitions with each other via a standard-based protocol.

It is necessary to have a common protocol and message semantics to be able to communicate with an

MDR to locate the data elements given the search criteria and exchange metadata of data elements by

addressing the technical and semantic interoperability challenges.

This document was developed to describe a message exchange framework specification for

communicating a subset of data element metadata with an ISO/IEC 11179-3 MDR.
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TECHNICAL REPORT ISO/IEC TR 19583-23:2020(E)
Information technology — Concepts and usage of
metadata —
Part 23:
Data element exchange (DEX) for a subset of ISO/IEC
11179-3
1 Scope

This document specifies the message exchange framework for communicating data element definitions

with an ISO/IEC 11179-3 metadata registry (MDR). It defines message semantics, protocols and

bindings for a set of transactions allowing the exchange of a commonly used subset of data element

metadata with an ISO/IEC 11179-3 MDR.

This document establishes the following data element message exchange interoperability specifications:

— retrieving data element list from an ISO/IEC 11179-3 MDR matching the selection criteria;

— retrieving metadata of a selected data element from an ISO/IEC 11179-3 MDR.
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 document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO/IEC 11179-3, Information technology — Metadata registries (MDR) — Part 3: Registry metamodel

and basic attributes
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO/IEC 11179-3 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at https:// www .iso .org/ obp
3.1.1
target data model
information view of an application schema

Note 1 to entry: Implementation-dependent realizations of logical information models such as XML serializations,

RDF serializations, JSON serializations and relational database schemas.
[SOURCE: ISO/TS 19129:2009, 4.1.2, modified — Note 1 to entry has been added.]
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ISO/IEC TR 19583-23:2020(E)
3.1.2
mapping specification

procedural functions to locate the data element in a given target data model (3.1.1)

Note 1 to entry: A mapping specification includes a mapping script (3.1.3), the type of the script (e.g. XPATH) and

the target data model on which the mapping script can be executed.
3.1.3
mapping script
executable script on a given target data model (3.1.1)
[1]

Note 1 to entry: A mapping script can be an XPATH expression to be executed on XML documents .

3.1.4
metadata consumer
actor that retrieves the metadata created by the metadata source (3.1.5)

Note 1 to entry: A metadata consumer can optionally query the metadata source (3.1.5) for a list of data elements

matching the selection criteria (3.1.6).
3.1.5
metadata source

actor responsible for creation of the data element list matching the selection criteria (3.1.6) and the

creation of metadata for a selected data element per request from the metadata consumer (3.1.4)

Note 1 to entry: A metadata source is associated with an ISO/IEC 11179-3 metadata registry.

3.1.6
selection criteria

logical expression, the criteria being satisfied only if the expression evaluates to the value TRUE

[SOURCE: ISO 10303-14:2005, 3.3.9]
3.1.7
value set
finite set in a specific correspondence with the index-set of the list
Note 1 to entry: A value set is identified with a unique ID and version.
[SOURCE: ISO 8485:1989, 5.3.1.4, modified — Note 1 to entry has been added.]
3.2 Abbreviated terms
CDASH Clinical Data Acquisition Standards Harmonization
CDISC Clinical Data Interchange Standards Consortium
DEX data element exchange
FHIR fast healthcare interoperability resources
HITSP Healthcare Information Technology Standards Panel
JSON JavaScript object notation
MDR metadata registry
NAV navigation error (due to unknown data element)
NCI National Cancer Institute
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ISO/IEC TR 19583-23:2020(E)
POSIX portable operating system interface
RDF resource description framework
regex regular expressions
REST representational state transfer
SDTM study data tabulation model
SPARQL simple protocol and RDF query language
SQL structured query language
XML eXtensible Markup Language
XPATH XML path language
XSD XML schema definition
VERUNK version unknown
4 Overview of data element exchange (DEX) specification
4.1 General

The objective of DEX specification is to describe a message exchange framework for communicating

a subset of administered data element definitions with an ISO/IEC 11179-3 MDR. It defines message

semantics, protocols and bindings for a set of transactions allowing the exchange of a subset of

administered data element metadata with an ISO/IEC 11179-3 MDR.
Two actors are defined as a part of this specification:

— Metadata source: The metadata source is responsible for the creation of the data element list

matching the selection criteria and the creation of metadata for a selected data element per request

from the metadata consumer. The metadata source is associated with an ISO/IEC MDR.

— Metadata consumer: The metadata consumer is responsible for the importation of metadata created

by the metadata source. The metadata consumer can optionally query the metadata source for a list

of data elements matching the selection criteria.

The following data element message exchange patterns are supported between the metadata source

and metadata consumer actors:

— Retrieving a data element list from an ISO/IEC 11179-3 MDR matching the selection criteria.

— Retrieving metadata of a selected data element from an ISO/IEC 11179-3 MDR.

Corresponding to these message exchange patterns, two transaction specifications are provided:

— retrieve data element list;
— retrieve metadata.

The retrieve data element list transaction is an optional preparatory act to retrieve the identification

information for the list of data elements matching the given the selection criteria, which can be used

in the second retrieve metadata transaction to collect the metadata of the selected data element. The

core content to be exchanged as a result of the retrieve metadata message exchange pattern is “data

element metadata”. In 4.2, details of this content are examined first since the search criteria as a part

of retrieve data element list also depends on this content specification. In 4.3 and 4.4, the transaction

specifications of retrieve data element list and retrieve metadata are presented.

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ISO/IEC TR 19583-23:2020(E)
4.2 Data element metadata

The data element metadata is a flattened subset of the metadata attributes defined in the ISO/IEC 11179

series as depicted in Table 1. A mapping of DEX attributes to ISO/IEC 11179-3 attributes is available in

Annex C. On top of the ISO/IEC 11179 series-based metadata of a data element, the attribute Mapping_

Specification has been added to specify the mapping of an abstract data element definition to different

target data models.

The attribute names in Tables 1 through 9 are based on ISO/IEC 11179-3. An ISO/IEC 11179 series class

attribute is specified by using the class name and attribute name separated by a period e.g. 11179_class_

name.attribute_name. The attribute name is written in the form of 11179_Class_Name if the attribute is

composing inner attributes defined within a separate table. The optionality field can have the following

values with their associated meanings:
R required
R2 required if the information is available
O optional

The string data type corresponds to xsd: string and the date data type corresponds to xsd: date. The

format for xsd: date is YYYY-MM-DD where Y is the year, M is the month, D is the day of month.

Table 1 — Data_Element metadata details
Attribute name Optionality Is repeatable Type Description
identifier R No string The universally unique iden-
tifier of the data element. This
identifier should be the same
as the identifier in the received
retrieve metadata request
message.
registration_authority_identifier R No string The authority who has defined
and registered the data element
to the metadata source.
EXAMPLES CDISC, HITSP, NCI.
See ISO/IEC 11179-3:2013
6.3.8.2.
This attribute is comprised of
international_code_designator,
organization_identifier, organi-
zation_part_identifer. All these
attributes can be used to create
the string for the registra-
tion_authority_identifier. This is
a mandatory field since the data
elements must be administered
for this specification.
version R No string The version of the data element.
designation.sign R No string The designation (name) of the
data element that can be used
for display purposes.
definition.text R No string The definition that gives an
unambiguous description of the
data element and its use.
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ISO/IEC TR 19583-23:2020(E)
Table 1 (continued)
Attribute name Optionality Is repeatable Type Description
registry_specifiation.context R2 No string The specific domain in which
this data element is defined.
EXAMPLES CDASH, SDTM.
If such a context is defined by
the registration authority for
this data element in the MDR,
then this attribute is mandatory.
creation_date R No date The date when this data
element is created.
effective_date R No date The date when this data
element becomes effective to
be used.
until_date R2 No date The date when the data
element is no longer expected to
be used.
last_change_date R2 No date The date when the data
element was last revised.
change_description R2 No string A note that indicates the revi-
sion reason and description of
the updates.
Data_Element_Concept R No See Table 2 for the The concept which is the mean-
details of Data_ ing part of the data element
Element_ definition. A data element is
Concept created with an association of
a data element concept and a
value domain.
Value_Domain R No See Table 3 for The domain from which the
the details of data element takes its values.
Value_Domain Each data element is composed
of a data element concept and a
value domain.
Mapping_Specification R Yes See Table 5 for The exact specification to locate
the details of the data element in a target
Mapping_ data model. This attribute is
Specification an extension on top of ISO/
IEC 11179-3.
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ISO/IEC TR 19583-23:2020(E)
Table 2 — Data_Element_Concept details
Attribute name Optionality Is repeatable Type Description
identifier R No string The universally unique
identifier of the data
element concept.
version R No string The version of the data
element concept.
designation.sign R No string The textual representa-
tion of the data element
concept.
object_class.designation.sign R2 No string An object class represents
a set of ideas, abstrac-
tions, or things in the real
world that are identified
with explicit boundaries
and meaning and whose
properties and behaviour
follow the same rules. This
attribute is the name of
the object class of the data
element concept.
property.designation.sign R2 No string A property is a characteris-
tic common to all members
of an object class. This
attribute is the name of
the property of the data
element concept.
Table 3 — Value_Domain details
Attribute name Optionality Is repeatable Type Description
identifier R No string The universally unique
identifier of the value
domain.
type R No string The type of the value
domain. Valid types are
defined, enumerated and
described.
datatype.name R No string The data type which
represents the character-
istics of the permissible
values for the property of
the data element.
EXAMPLE xsd: string.
unit_of_measure R2 No string Actual units in which
the associated values of
the property of the data
element are measured.
source_uri R2 No string A reference to the exter-
nal value set, if the value
domain’s type is "de-
fined" (ISO/IEC 11179-
3:2013/Amd 1:2020).
Permissible_Value R2 Yes See Table 4 for the The permissible value set
details of from which the values of
Permissible_Value. this data element can be
selected.
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ISO/IEC TR 19583-23:2020(E)
Table 4 — Value_Domain Permissible_Value details
Attribute name Optionality Is repeatable Type Description
permitted_value R No string The permitted value.
value_meaning.designation.sign R No string The textual
representation of
the meaning of the
permitted value.
begin_date R No date The date that this value
becomes effective.
end_date R2 No date The date that this
value becomes invalid.
Table 5 — Mapping_Specification summary
Attribute name Optionality Is repeatable Type Description
Target_Data_Model R No See Table 7 for the The data model that the data el-
details of Target_ ement is interrelated with. It can
Data_Model be a database schema, an OWL
schema, an XML schema, etc.
type R No string The type of the mapping
specification. The type should
be selected from the mapping
specification type value set (See
Table 6).
mapping_script R No string The executable script to locate
the data element in a target
data model.
EXAMPLE XPATH scripts,
SPARQL or SQL queries.
Table 6 — Mapping specification type value set
Mapping specification Description
type

XPath is a language that describes a way to locate and process items in XML docu-

XPATH ments by using an addressing syntax based on a path through the document's logical

structure or hierarchy.

SQL is an industry-standard language for creating, updating and querying relational

SQL
database management systems.
SPARQL is a standard query language and data access protocol for use with the
SPARQL
RDF data model.

A query with a set of parameters (http:// www .hl7 .org/ implement/ standards/ fhir/

FHIR Query
query .html).
Other Any mapping specification that is not one of the above types.
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ISO/IEC TR 19583-23:2020(E)
Table 7 — Target_Data_Model details
Attribute Optionality Is repeatable Type Description
name
name R No string The name of the target data model.
EXAMPLE ASTM/HL7 CCD.
description R No string Textual description of the target data
model. If available, the unique identifier
for the target data model can be present-
ed here.
EXAMPLE 2.16.840.1.113883.10.20.1 for
ASTM/HL7 CCD.
url R2 No string If available a reference to the schema of
the target data model.
4.3 Retrieve data element list
4.3.1 General

This transaction is used by the metadata consumer to retrieve a list of data elements from the metadata

source matching the given selection criteria. The interaction diagram is depicted in Figure 1. In 4.3.2

through 4.3.4 the triggering events for the request and response messages involved in this transaction,

the message semantics of the request and response messages and the expected action that needs to be

carried out by the receiving actors are presented.
Figure 1 — Retrieve metadata element list transaction
4.3.2 Retrieve data element list request
4.3.2.1 Trigger events

The metadata consumer wants to retrieve the metadata of a list of data elements matching the selection

criteria by defining several filters. The metadata consumer sends a retrieve data element list request to

the metadata source.
4.3.2.2 Message semantics

The metadata source sends a retrieve data element list request message to specify the selection criteria

to filter and return the metadata of a list of data elements. The selection criteria are represented as a

set of filters as depicted in Table 8. The metadata source should send zero or more filters in the retrieve

data element list request. each filter applies a filtering criterion on the specified attribute of the data

element. Providing no filters inside the retrieve data element list request means that the metadata

consumer queries for all available data elements. More than one filter means that the metadata source

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ISO/IEC TR 19583-23:2020(E)

should semantically create an intersection of the matching data elements for each filter. That is, logical

and operator is implicitly assumed on multiple filters. In 4.3.4 the protocol requirements and the format

of the message are described in full detail.
Table 8 — Filter details
Attribute Optionality Is repeatable Type Description
name
name R No string The name of the data element
attribute to apply the filter on.
operator R No string The operation of the filter. The opera-
tor should be selected from the filter
operator value set (see Table 9).
value R No string The value of the filtered attribute to
apply while executing the operator.
Table 9 — Filter operator value set
Filter Operator Description

Checks for mathematical equality of the given filter value with the value of the data

equals
element attribute.

This operator should compare the contents of the referenced attribute with the regex

[4]

match using the POSIX matching rules. If the regex matches the attribute, the data ele-

ment matches. All regex matches should be executed in case insensitive mode.
Date comparisons expects the argument in the format of xsd: date (YYYY-MM-DD)

before and compare it with the attribute using a date comparison. This operator should

filter out the dates before or equals to the given filter date.
Date comparisons expects the argument in the format of xsd: date (YYYY-MM-DD)

after and compare it with the attribute using a date comparison. This operator should

filter out the dates after or equals to the given filter date.
4.3.2.3 Expected action

The metadata source should perform matching in accordance with the filter operator rules described in

Table 9. Any data element which has metadata that matches all of the provided filters at the same time

should be included in the response. That is, multiple filters should be linked together with logical AND

operator.
4.3.3 Retrieve data element list response
4.3.3.1 Trigger events
This message will be triggered by a retrieve data element list request message.
4.3.3.2 Message semantics

The response should be a retrieve data element list response message which should have one Data_

Element_Summary attribute (presented in Table 10) for each matching data element. If no matching

data elements are found, data element list response message should be empty. In 4.3.4 the protocol

requirements and the format of the message are described in full detail.

Table 10 — Data_Element_Summary in the retrieve data element list response message

Attribute name Optionality Is repeatable Type Description
Data_Element_Summary R2 Yes See Table 11 for the de- The summary
tails of Data_Element_ information about
Summary the data element.
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ISO/IEC TR 19583-23:2020(E)

The atttributes of the Data_Element_Summary are presented in Table 11. The string data type

corresponds to xsd: string and the date data type corresponds to xsd: date. The format for xsd: date is

YYYY-MM-DD where Y is the year, M is the month, D is the day of month.

Table 11 — The attributes of the Data_Element_Summary in the retrieve data element list

response message
Attribute name Optionality Is repeata- Type Description
ble
identifier R No string The universally unique identifier of the
data element.
registration_authority_ R No string The authority who has defined and reg-
identifier istered the data element to the metada-
ta source
(EXAMPLES CDISC, HITSP, NCI).
version R No string The version of the data element.
designation.sign R No string The name of the data element that can
be used for display purposes
definition.text R No string Definition that gives an unambiguous de-
scription of the data element and
...

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