ISO/TS 17251:2016
(Main)Health informatics — Business requirements for a syntax to exchange structured dose information for medicinal products
Health informatics — Business requirements for a syntax to exchange structured dose information for medicinal products
ISO/TS 17251:2016 specifies the business requirements for the structured content of structured or semi-structured dose instructions for recording dose instructions in the electronic health record (EHR), supporting clinical decision support, and in exchanging medication orders, as applicable to primary, secondary and tertiary care. NOTE See 2.9, note to entry, regarding the use of "medication order" and "prescription". Comprehension of dose instructions by the patient is an overarching consideration for patient safety and the best patient outcomes. Related factors are discussed, but are not part of the primary scope. It does not define an information model, except to the extent that those information model concepts are necessary to define business requirements. Outside the scope of ISO/TS 17251:2016 are: - the functionality of health, clinical and/or pharmacy systems; - other kinds of content of health, clinical or pharmacy systems that are needed to support the whole process of health care providers, such as: - wide range of knowledge about medicines that would be handled in drug knowledge databases and decision support systems; - the complete medical record (EHR); - a medicinal product dictionary.
Informatique de santé — Exigences d'affaire pour une syntaxe d'échange d'informations de dose structurée pour les produits médicaux
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TECHNICAL ISO/TS
SPECIFICATION 17251
First edition
2016-07-01
Health informatics — Business
requirements for a syntax to exchange
structured dose information for
medicinal products
Informatique de santé — Exigences d’affaire pour une syntaxe
d’échange d’informations de dose structurée pour les produits
médicaux
Reference number
ISO/TS 17251:2016(E)
©
ISO 2016
---------------------- Page: 1 ----------------------
ISO/TS 17251:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 17251:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Conformance . 2
4 Business requirements for structured dose instructions . 3
4.1 General . 3
4.2 Use cases . 3
4.3 Elements of a dose instruction . 3
4.4 Information requirements . 4
4.4.1 General. 4
4.4.2 Infrastructure . 5
4.4.3 Text representation . 5
4.4.4 Administration amount . . 5
4.4.5 Route/site of administration . 5
4.4.6 Timing of dose event(s) . 6
4.4.7 Conditional administration . . 7
4.4.8 Patient-specific information . 7
4.4.9 Ancillary information . . 8
Bibliography . 9
© ISO 2016 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/TS 17251:2016(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
iv © ISO 2016 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 17251:2016(E)
Introduction
The requirements for the exchange of structured dose instructions are intended to be independent
of any technology standard or software platform and have been developed with the aim of specifying
the necessary clinical and business requirements precisely and unambiguously. Implementation
of the requirements within a suitable medium designed to support communication of healthcare
information can provide support to clinicians and their applications in storing, retrieving, using, and
above all, communicating dose instructions information to other clinicians, their applications, and most
importantly, to the patient.
The primary audiences for this Technical Specification are software developers building clinical IT
systems.
© ISO 2016 – All rights reserved v
---------------------- Page: 5 ----------------------
TECHNICAL SPECIFICATION ISO/TS 17251:2016(E)
Health informatics — Business requirements for a syntax
to exchange structured dose information for medicinal
products
1 Scope
This Technical Specification specifies the business requirements for the structured content of
structured or semi-structured dose instructions for recording dose instructions in the electronic health
record (EHR), supporting clinical decision support, and in exchanging medication orders, as applicable
to primary, secondary and tertiary care.
NOTE See 2.9, note to entry, regarding the use of “medication order” and “prescription”.
Comprehension of dose instructions by the patient is an overarching consideration for patient safety
and the best patient outcomes. Related factors are discussed, but are not part of the primary scope.
This Technical Specification does not define an information model, except to the extent that those
information model concepts are necessary to define business requirements.
Outside the scope of this Technical Specification are:
— the functionality of health, clinical and/or pharmacy systems;
— other kinds of content of health, clinical or pharmacy systems that are needed to support the whole
process of health care providers, such as:
— wide range of knowledge about medicines that would be handled in drug knowledge databases
and decision support systems;
— the complete medical record (EHR);
— a medicinal product dictionary.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
dose instructions
instructions pertaining to the medication, which describe the amount of medication per dose, method
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
2.2
dose syntax
structured dose instructions
structured set of data elements which represent the dose instructions in a consistent, computable format
2.3
structured information
information assembled from predefined concepts (vocabulary or code set) using an organizational
scheme (information model)
© ISO 2016 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO/TS 17251:2016(E)
2.4
unstructured information
information assembled from narrative words and word fragments, following either casual conventions
or language-specific grammatical rules
2.5
semi-structured information
information containing both structured content and unstructured content
2.6
sig
directions to be written on a package or label for the use of the patient
Note 1 to entry: Sig (sometimes written as SIG) appears to be an acronym, but is an abbreviation of the Latin term
“signā”.
Note 2 to entry: In the context of this Technical Specification, “sig” had the same meaning as “dose instructions”
(see 4.1).
2.7
storage and handling information
information provided to the patient/caregiver regarding the appropriated conditions to maximize the
shelf life of the medicinal product
Note 1 to entry: While essential information, this does not directly relate to administration and is not within the
scope of this Technical Specification.
2.8
medication order
documented instruction on intended therapy for an individual person with a medicinal product issued
by an authorized health professional
Note 1 to entry: There is no inherent limitation on the setting for the medication order (inpatient, ambulatory, etc.).
[SOURCE: ISO/TR 22790:2007]
2.9
prescription
directions created by an authorized health 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
Note 1 to entry: In the context of this Technical Specification, “prescription” or “medication order” could be
used. We have chosen to use “medication order”. In this sense, we imply that “medication order” is inclusive of
“prescription.”
[SOURCE: ISO/TR 22790:2007]
2.10
message syntax
structured set of data elements which represent the medication order in a consistent computable format
3 Conformance
Systems that create or consume electronic medication orders can claim conformance to this Technical
Specification when it fulfils all requirements in Clause 4.
2 © ISO 2016 – All rights reserved
---------------------- Page: 7 ----------------------
ISO/TS 17251:2016(E)
4 Business requirements for structured dose instructions
4.1 General
The business requirements for structured dose information shall focus on the primary goal of ensuring
that the patient receives the appropriate medication dose at the appropriate time in a consistent
manner. In addition to the patient-centric aspects, certain information is required to achieve this goal.
The following requirements address both patient and information aspects.
NOTE The following conformance statements refer to either, or both, the message syntax and the dose
syntax. Requirements which are not unique to the dose instructions, or useful in other components of a
medication order, are described as part of the “message syntax”. Requirements which are specific to the dose
instructions are described as part of the “dose syntax”.
4.2 Use cases
Dose instructions serve the following use cases.
— Indicating the right dosage during prescribing.
— Recording the indicated dosage in the EHR:
— to be used in clinical decision support systems, like dose checking;
— exchange of information between health care providers.
— Indicating comprehensible dose instructions on the patient label in order to make clear how to
use the medicine. Comprehension may not be a component of the dose instructions specifically,
but comprehension does influence the presentation of the instructions to the patient. Patient
comprehension information shall be present in the medication order in some manner such that the
dispenser can create appropriate instructions for the patient or caregiver.
4.3 Elements of a dose instruction
Based on the use cases, the elements of a dose instruction include the following.
— Text representation. The purpose of this Technical Specification is to specify requirements for
structured dose instructions. However, some parts of a dose instruction cannot be captured
in structured information. To support a human readable text of the whole dose instruction of a
certain medicine, a textual representation of the whole dose instructions will remain an important
element. This textual representation includes both the structured and the unstructured part of
the dose instruction. Also, if a scenario occurs which prevents the structured content from being
produced, the textual representation is then necessary for communicating the dose instruction. The
structured content and the textual content, if both are present, shall agree, neither omitting nor
adding any significant content between the two.
— Amount of medication to be administered at each dose event.
— This may be comprised of a number of units of presentation (e.g. “1 tablet”) or a number and
unit of measure (e.g. “5 ml”, “500 mg”). Calculated amounts (e.g. “50 mg/kg body weight)
may be appropriate in some cases, however an explicit amount is generally preferred over an
implied amount.
— The administered amount may vary over time (e.g. tapered dose) or relative to other parameters
(e.g. insulin sliding scale).
— The administered amount may be a range (1 to 2 tablets).
— The administered amount should be quantified whenever possible. Indeterminate and non-
quantifiable amounts (e.g. “apply a thin film”, “use a pea-sized amount”) should be quantified
© ISO 2016 – All rights reserved 3
---------------------- Page: 8 ----------------------
ISO/TS 17251:2016(E)
wherever possible (e.g. “apply 1 to 2 ml”, “use 1 to 2 gm”) or the non-quantifiable portion
included in a text representation element.
— Rout
...
TECHNICAL ISO/TS
SPECIFICATION 17251
First edition
Health informatics — Business
requirements for a syntax to exchange
structured dose information for
medicinal products
Informatique de santé — Exigences d’affaire pour une syntaxe
d’échange d’informations de dose structurée pour les produits
médicaux
PROOF/ÉPREUVE
Reference number
ISO/TS 17251:2016(E)
©
ISO 2016
---------------------- Page: 1 ----------------------
ISO/TS 17251:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii PROOF/ÉPREUVE © ISO 2016 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 17251:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Conformance . 2
4 Business requirements for structured dose instructions . 3
4.1 General . 3
4.2 Use cases . 3
4.3 Elements of a dose instruction . 3
4.4 Information requirements . 4
4.4.1 General. 4
4.4.2 Infrastructure . 5
4.4.3 Text representation . 5
4.4.4 Administration Amount . 5
4.4.5 Route/site of administration . 5
4.4.6 Timing of dose event(s) . 6
4.4.7 Conditional administration . . 7
4.4.8 Patient-specific information . 7
4.4.9 Ancillary information . . 8
Bibliography . 9
© ISO 2016 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO/TS 17251:2016(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
iv PROOF/ÉPREUVE © ISO 2016 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 17251:2016(E)
Introduction
The requirements for the exchange of structured dose instructions is intended to be independent of
any technology standard or software platform and has been developed with the aim of specifying
the necessary The requirements for the exchange of structured dose instructions are intended to
be independent of any technology standard or software platform and have been developed with the
aim of specifying the necessary clinical and business requirements precisely and unambiguously.
Implementation of the requirements within a suitable medium designed to support communication
of healthcare information should provide support to clinicians and their applications in storing,
retrieving, using, and above all, communicating dose instructions information to other clinicians, their
applications, and most importantly, to the patient.
The primary audiences for this Technical Specification are software developers building clinical IT
systems.
© ISO 2016 – All rights reserved PROOF/ÉPREUVE v
---------------------- Page: 5 ----------------------
TECHNICAL SPECIFICATION ISO/TS 17251:2016(E)
Health informatics — Business requirements for a syntax
to exchange structured dose information for medicinal
products
1 Scope
This Technical Specification specifies the business requirements for the structured content of
structured or semi-structured dose instructions for recording dose instructions in the electronic health
record (EHR), supporting clinical decision support, and in exchanging medication orders, as applicable
to primary, secondary and tertiary care.
NOTE See 2.9, note to entry, regarding the use of “medication order” and “prescription”.
Comprehension of dose instructions by the patient is an overarching consideration for patient safety
and the best patient outcomes. Related factors are discussed, but are not part of the primary scope.
This Technical Specification does not define an information model, except to the extent that those
information model concepts are necessary to define business requirements.
Outside the scope of this Technical Specification are:
— the functionality of health, clinical and/or pharmacy systems;
— other kinds of content of health, clinical or pharmacy systems that are needed to support the whole
process of health care providers, such as:
— wide range of knowledge about medicines that would be handled in drug knowledge databases
and decision support systems;
— the complete medical record (EHR);
— a medicinal product dictionary.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
dose instructions
instructions pertaining to the medication, which describe the amount of medication per dose, method
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
2.2
dose syntax
structured dose instructions
structured set of data elements which represent the dose instructions in a consistent, computable format
2.3
structured information
information assembled from predefined concepts (vocabulary or code set) using an organizational
scheme (information model)
© ISO 2016 – All rights reserved PROOF/ÉPREUVE 1
---------------------- Page: 6 ----------------------
ISO/TS 17251:2016(E)
2.4
unstructured information
information assembled from narrative words and word fragments, following either casual conventions
or language-specific grammatical rules
2.5
semi-structured information
information containing both structured content and unstructured content
2.6
sig
directions to be written on a package or label for the use of the patient
Note 1 to entry: Sig (sometimes written as SIG) appears to be an acronym, but is an abbreviation of the Latin term
“signā”.
Note 2 to entry: In the context of this Technical Specification, “sig” had the same meaning as “dose instructions”
(see 4.1).
2.7
storage and handling information
information provided to the patient/caregiver regarding the appropriated conditions to maximize the
shelf life of the medicinal product
Note 1 to entry: While essential information, this does not directly relate to administration and is not within the
scope of this Technical Specification.
2.8
medication order
documented instruction on intended therapy for an individual person with a medicinal product issued
by an authorized health professional
Note 1 to entry: There is no inherent limitation on the setting for the medication order (inpatient, ambulatory, etc.).
[SOURCE: ISO/TR 22790:2007]
2.9
prescription
directions created by an authorized health 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
Note 1 to entry: In the context of this Technical Specification, “prescription” or “medication order” could be
used. We have chosen to use “medication order”. In this sense, we imply that “medication order” is inclusive of
“prescription.”
[SOURCE: ISO/TR 22790:2007]
2.10
message syntax
structured set of data elements which represent the medication order in a consistent computable format
3 Conformance
Systems that create or consume electronic medication orders can claim conformance to this Technical
Specification when it fulfils all requirements in Clause 4.
2 PROOF/ÉPREUVE © ISO 2016 – All rights reserved
---------------------- Page: 7 ----------------------
ISO/TS 17251:2016(E)
4 Business requirements for structured dose instructions
4.1 General
The business requirements for structured dose information shall focus on the primary goal of ensuring
that the patient receives the appropriate medication dose at the appropriate time in a consistent
manner. In addition to the patient-centric aspects, certain information is required to achieve this goal.
The following requirements address both patient and information aspects.
NOTE The following conformance statements refer to either, or both, the message syntax and the dose
syntax. Requirements which are not unique to the dose instructions, or useful in other components of a
medication order, are described as part of the “message syntax”. Requirements which are specific to the dose
instructions are described as part of the “dose syntax”.
4.2 Use cases
Dose instructions serve the following use cases.
— Indicating the right dosage during prescribing.
— Recording the indicated dosage in the HER:
— to be used in clinical decision support systems, like dose checking;
— exchange of information between health care providers.
— Indicating comprehensible dose instructions on the patient label in order to make clear how to
use the medicine. Comprehension may not be a component of the dose instructions specifically,
but comprehension does influence the presentation of the instructions to the patient. Patient
comprehension information shall be present in the medication order in some manner such that the
dispenser can create appropriate instructions for the patient or caregiver.
4.3 Elements of a dose instruction
Based on the use cases, the elements of a dose instruction include the following.
— Text representation. The purpose of this Technical Specification is to specify requirements for
structured dose instructions. However, some parts of a dose instruction cannot be captured
in structured information. To support a human readable text of the whole dose instruction of a
certain medicine, a textual representation of the whole dose instructions will remain an important
element. This textual representation includes both the structured and the unstructured part of
the dose instruction. Also, if a scenario occurs which prevents the structured content from being
produced, the textual representation is then necessary for communicating the dose instruction. The
structured content and the textual content, if both are present, shall agree, neither omitting nor
adding any significant content between the two.
— Amount of medication to be administered at each dose event.
— This may be comprised of a number of units of presentation (e.g. “1 tablet”) or a number and
unit of measure (e.g. “5 ml”, “500 mg”). Calculated amounts (e.g. “50 mg/kg body weight)
may be appropriate in some cases, however an explicit amount is generally preferred over an
implied amount.
— The administered amount may vary over time (e.g. tapered dose) or relative to other parameters
(e.g. insulin sliding scale).
— The administered amount may be a range (1 to 2 tablets).
— The administered amount should be quantified whenever possible. Indeterminate and non-
quantifiable amounts (e.g. “apply a thin film”, “use a pea-sized amount”) should be quantified
© ISO 2016 – All rights reserved PROOF/ÉPREUVE 3
---------------------- Page: 8 ----------------------
ISO/TS 17251:2016(E)
wherever possible (e.g. “apply 1 to
...
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