Traditional Chinese medicine -- Clinical document specification for prescription of traditional Chinese medicine decoction pieces

This document provides a referenced entry-level implementation template for traditional Chinese medicine decoction piece prescriptions based on HL7 CDA® Release 2.0 to support the data collection, transmission, storage and exchange of decoction piece prescriptions for electronic records. This document focuses on the description of core data of traditional Chinese medicine decoction piece prescriptions which constitute the 'medication administration' section of the clinical document body. This document does not specify the detailed content of the clinical document header or other sections and entries of the clinical document body.

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Publication Date
15-Dec-2020
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09-Nov-2020
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TECHNICAL ISO/TS
SPECIFICATION 23030
First edition
2020-12
Traditional Chinese medicine —
Clinical document specification for
prescription of traditional Chinese
medicine decoction pieces
Reference number
ISO/TS 23030:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 23030:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 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 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 23030:2020(E)
Contents Page

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

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

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

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

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

4 Entries related to core data of prescription for traditional Chinese medicine

decoction pieces .................................................................................................................................................................................................... 2

5 Entry templates of prescription for traditional Chinese medicine decoction pieces ...................2

Annex A (informative) Value sets ............................................................................................................................................................................. 8

Annex B (informative) XML example .................................................................................................................................................................... 9

Bibliography .............................................................................................................................................................................................................................12

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/TS 23030:2020(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 249, Traditional Chinese medicine.

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 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 23030:2020(E)
Introduction
® 1)

HL7 CDA Release 2.0 , which has been adopted as ISO/HL7 27932, is a document mark-up standard

that specifies the structure and semantics of clinical documents for the purpose of exchange between

healthcare providers and patients. It is necessary to establish a clinical document specification for

prescription of traditional Chinese medicine decoction pieces to support the implementation of

ISO/HL7 27932 in the context of the traditional Chinese medicine community. For implementers of HL7

CDA Release 2.0, the prescription of traditional Chinese medicine decoction pieces can be provided as

a use case to maximize the use of shared semantics.

A clinical document consists of a clinical document header and a clinical document body. A clinical

document header consists of many sections, including identification and classification, participant

author and custodian. A clinical document body consists of many sections, including diagnosis,

medication administration, cost and medication plan. Usually, the core data of the prescription of

traditional Chinese medicine decoction pieces includes information about the names and amounts of

the decoction pieces, the form of processing, the dose, preparation and decoction methods, the route of

administration, frequency, the timing of consumption and the number of packages.

This document can be applied in medical institutions that need to share their prescriptions of decoction

pieces to ensure that both or multiple parties exchange documents following the specification

with consistent syntax and semantics. This document can be used to support the data collection,

transmission, storage and exchange of decoction piece prescriptions for electronic records.

In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “can” indicates a possibility or a capability;
— “may” indicates a permission.

1) HL7 and CDA are registered trademarks of Health Level Seven International and their use does not constitute

an endorsement by HL7.
© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
TECHNICAL SPECIFICATION ISO/TS 23030:2020(E)
Traditional Chinese medicine — Clinical document
specification for prescription of traditional Chinese
medicine decoction pieces
1 Scope

This document provides a referenced entry-level implementation template for traditional Chinese

medicine decoction piece prescriptions based on HL7 CDA Release 2.0 to support the data collection,

transmission, storage and exchange of decoction piece prescriptions for electronic records. This

document focuses on the description of core data of traditional Chinese medicine decoction piece

prescriptions which constitute the 'medication administration' section of the clinical document body.

This document does not specify the detailed content of the clinical document header or other sections

and entries of the clinical document body.
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
cardinality

number of times that a data element can repeat within an individual occurrence or object view

Note 1 to entry: In the XML documents specified by this document, the cardinality of an element defines the

number of times the element can repeatedly appear at a specified position, which is used to specify the number

of allowed values for data attributes expressed by the name of the element. It is denoted by ‘m..n’: ‘m’ means the

minimum number of occurrences and ‘n’ means the maximum allowed number of times.
[SOURCE: ISO/TR 12300:2014, 2.1.5, modified]
3.2
CONF
conformance requirement

precise text definition of a characteristic required to be present in a conforming implementation

Note 1 to entry: In CONF-nnnn, nnnn is a four-digit integer. The document is based on the CDA POCD_HD000040

and XML schema document (XSD). For XML elements, cardinality, terminology and data type in CDA XSD, no

specific explanation is given in this document
[SOURCE: ISO 13584-25:2004, 3.6, modified]
© ISO 2020 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO/TS 23030:2020(E)
3.3
prescription

direction created by an authorized healthcare professional to instruct a dispensing agent regarding the

preparation and use of a medicinal product or medicinal appliance to be taken or used by a subject of care

[SOURCE: ISO 21549-7:2016, 3.22]
3.4
dose instructions

instructions pertaining to the medication, which describe the amount of administration, the frequency

or interval of dose, associated instructions for dosing or skipped doses, and other associated parameters

necessary for appropriate administration of the medication
[SOURCE: ISO/TS 17251:2016, 2.1]
4 Entries related to core data of prescription for traditional Chinese medicine
decoction pieces

The entries related to core data of prescription for traditional Chinese medicine decoction pieces

are described in Table 1, including entry of traditional Chinese medicine Medication Administration

and entry of Decoction Pieces Administration. The implementation entry template is based on

'substanceAdministration' of HL7 CDA Release 2.0. Annex B is the xml example based on the template

of core data of prescription for traditional Chinese medicine decoction pieces.

Table 1 — Entries related to core data of prescription for traditional Chinese medicine

decoction pieces
Name of entry Explanation and description

Traditional Chinese medicine medi- The entry includes information about the route of admin-

cation administration istration, frequency of drug taking and total number of
packages.

Decoction pieces administration The entry includes information about the name, dose in-

struction and special decoction method of decoction pieces.
5 Entry templates of prescription for traditional Chinese medicine decoction
pieces
5.1 Entry template of traditional Chinese medicine medication administration

The entry template of traditional Chinese medicine medication administration is described in Table 2.

The entry conforms to entry-level template 'substanceAdministration' in CDA schema of HL7 CDA

Release 2.0.

Table 2 — Elements of traditional Chinese medicine medication administration entry

Name of element Cardinality Verb Explanation and description
substanceAdministration 1..1 SHALL @classCode="SBADM" @moodCode="RQO"
-templateId 1..1 SHALL @root="2.16.840.1.113883.2.23.11.5.1.1"
A detailed description of traditional Chinese
-text 0..1 MAY
medicine administration
Execution time, number of days of drug - tak-
-effectiveTime 1..1 SHALL
ing @xsi: type = "IVL _TS"
--low 1..1 SHALL Starting time of drug taking
--high 0..1 MAY Ending time of drug taking
2 © ISO 2020 – All rights reserved
---------------------- Page: 7 ----------------------
ISO/TS 23030:2020(E)
Table 2 (continued)
Name of element Cardinality Verb Explanation and description
Frequency of drug taking
-effectiveTime 1..1 SHALL
@xsi: type = "PIVL _TS"
@value=" "
-- period 1..1 SHALL
@unit=" h"
-repeatNumber 1..1 SHALL The total packages
@code=" "
@codeSystem="2.16.840.1.113883.6.96"
-routeCode 1..1 SHALL
@codeSystemName=" SNOMED-CT"
@displayName=" "
@code
@codeSystem=" 2.16.840.1.113883.6.96"
-approachSiteCode 0..1 MAY
@codeSystemName=" SNOMED-CT"
@displayName=""
@value=" "
-doseQuantity 1..1 SHALL
@unit ="packages"
-consumable 1..1 SHALL
--man
...

TECHNICAL ISO/TS
SPECIFICATION 23030
First edition
Traditional Chinese medicine —
Clinical document specification for
prescription of TCM decoction pieces
Member bodies are requested to consult relevant national interests in ISO/TC
215 before casting their ballot to the e-Balloting application.
PROOF/ÉPREUVE
Reference number
ISO/TS 23030:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 23030:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 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 PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 23030:2020(E)
Contents Page

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

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

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

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

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

4 Entries related to core data of prescription for traditional Chinese medicine

decoction pieces .................................................................................................................................................................................................... 2

5 Entry templates of prescription for traditional Chinese medicine decoction pieces ...................2

Annex A (informative) Value sets ............................................................................................................................................................................. 8

Annex B (informative) XML example .................................................................................................................................................................... 9

Bibliography .............................................................................................................................................................................................................................12

© ISO 2020 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO/TS 23030:2020(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 249, Traditional Chinese medicine.

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 PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 23030:2020(E)
Introduction

It is necessary to establish a clinical document specification for prescription of traditional Chinese

medicine decoction pieces to support the implementation of ISO/HL7 27932 in the context of the

® 1)

traditional Chinese medicine community. HL7 CDA Release 2.0 is a document mark-up standard

that specifies the structure and semantics of clinical documents for the purpose of exchange between

healthcare providers and patients. For implementers of HL7 CDA Release 2.0, the prescription of

traditional Chinese medicine decoction pieces can be provided as a use case to maximize the use of

shared semantics.

A clinical document consists of a clinical document header and a clinical document body. A clinical

document header consists of many sections, including identification and classification, participant

author and custodian. A clinical document body consists of many sections, including diagnosis,

medication administration, cost and medication plan. Usually, the core data of the prescription of

traditional Chinese medicine decoction pieces includes information about the names and amounts of

the decoction pieces, the form of processing, the dose, preparation and decoction methods, the route of

administration, frequency, the timing of consumption and the number of packages.

This document can be applied in medical institutions that need to share their prescriptions of decoction

pieces to ensure that both or multiple parties exchange documents following the specification

with consistent syntax and semantics. This document can be used to support the data collection,

transmission, storage and exchange of decoction piece prescriptions for electronic records.

In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “can” indicates a possibility or a capability;
— “may” indicates a permission.

1) HL7 and CDA are registered trademarks of Health Level Seven International and their use does not constitute

an endorsement by HL7.
© ISO 2020 – All rights reserved PROOF/ÉPREUVE v
---------------------- Page: 5 ----------------------
TECHNICAL SPECIFICATION ISO/TS 23030:2020(E)
Traditional Chinese medicine — Clinical document
specification for prescription of TCM decoction pieces
1 Scope

This document provides a referenced entry-level implementation template for traditional Chinese

medicine decoction piece prescriptions based on HL7 CDA Release 2.0 to support the data collection,

transmission, storage and exchange of decoction piece prescriptions for electronic records. This

document focuses on the description of core data of traditional Chinese medicine decoction piece

prescriptions which constitute the 'medication administration' section of the clinical document body.

This document does not specify the detailed content of the clinical document header or other sections

and entries of the clinical document body.
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
cardinality

number of times that a data element can repeat within an individual occurrence or object view

Note 1 to entry: In the XML documents specified by this document, the cardinality of an element defines the

number of times the element can repeatedly appear at a specified position, which is used to specify the number

of allowed values for data attributes expressed by the name of the element. It is denoted by ‘m..n’: ‘m’ means the

minimum number of occurrences and ‘n’ means the maximum allowed number of times.
[SOURCE: ISO/TR 12300:2014, 2.1.5, modified]
3.2
CONF
conformance requirement

precise text definition of a characteristic required to be present in a conforming implementation

Note 1 to entry: In CONF-nnnn, nnnn is a four-digit integer. The document is based on the CDA POCD_HD000040

and XML schema document (XSD). For XML elements, cardinality, terminology and data type in CDA XSD, no

specific explanation is given in this document
[SOURCE: ISO 13584-25:2004, 3.6, modified]
3.3
prescription

direction created by an authorized healthcare professional to instruct a dispensing agent regarding the

preparation and use of a medicinal product or medicinal appliance to be taken or used by a subject of care

[SOURCE: ISO 21549-7:2016, 3.22]
© ISO 2020 – All rights reserved PROOF/ÉPREUVE 1
---------------------- Page: 6 ----------------------
ISO/TS 23030:2020(E)
3.4
dose instructions

instructions pertaining to the medication, which describe the amount of administration, the frequency

or interval of dose, associated instructions for dosing or skipped doses, and other associated parameters

necessary for appropriate administration of the medication
[SOURCE: ISO/TS 17251:2016, 2.1]
4 Entries related to core data of prescription for traditional Chinese medicine
decoction pieces

The entries related to core data of prescription for traditional Chinese medicine decoction pieces

are described in Table 1, including entry of traditional Chinese medicine Medication Administration

and entry of Decoction Pieces Administration. The implementation entry template is based on

'substanceAdministration' of HL7 CDA Release 2.0. Annex B is the xml example based on the template

of core data of prescription for TCM decoction pieces.

Table 1 — Entries related to core data of prescription for traditional Chinese medicine

decoction pieces
Name of entry Explanation and description

Traditional Chinese medicine medi- The entry includes information about the route of admin-

cation administration istration, frequency of drug taking and total number of
packages.

Decoction pieces administration The entry includes information about the name, dose in-

struction and special decoction method of decoction pieces.
5 Entry templates of prescription for traditional Chinese medicine decoction
pieces
5.1 Entry template of traditional Chinese medicine medication administration

The entry template of traditional Chinese medicine medication administration is described in Table 2.

The entry conforms to entry-level template 'substanceAdministration' in CDA schema of HL7 CDA

Release 2.0.

Table 2 — Elements of traditional Chinese medicine medication administration entry

Name of element Cardinality Verb Explanation and description
substanceAdministration 1..1 SHALL @classCode="SBADM" @moodCode={ RQO }
-templateId 1..1 SHALL @root="2.16.840.1.113883.2.23.11.5.1.1"
A detailed description of traditional Chinese
-text 0..1 MAY
medicine administration
Execution time, number of days of drug - tak-
-effectiveTime 1..1 SHALL
ing @xsi: type = "IVL _TS"
--low 1..1 SHALL Starting time of drug taking
--high 0..1 MAY Ending time of drug taking
Frequency of drug taking
-effectiveTime 1..1 SHALL
@xsi: type = "PIVL _TS"
@value=” ”
-- period 1..1 SHALL
@unit=” h”
-repeatNumber 1..1 SHALL The total packages
2 PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 7 ----------------------
ISO/TS 23030:2020(E)
Table 2 (continued)
Name of element Cardinality Verb Explanation and description
@code=” ”
@codeSystem=”2.16.840.1.113883.6.96”
-routeCode 1..1 SHALL
@codeSystemName=” SNOMED-CT”
@displayName=” ”
@code
@codeSystem=” 2.16.840.1.113883.6.96”
-approachSiteCode 0..1 MAY
@codeSystemName=” SNOMED-CT”
@displayName=””
@value=” ”
-doseQuantity 1..1 SHAL
...

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