SIST EN ISO 11073-10472:2013

Health Informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor (ISO 11073-10472:2012)

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between medication monitoring devices and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for medication monitors. In this context, medication monitors are defined as devices that have the ability to determine and communicate (to a manager) measures of a user’s adherence to a medication regime.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10472: Gerätespezifikation - Medikamentenmonitoring (ISO 11073-10472:2012)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10472: Spécialisation de dispositif - Moniteur de médication (ISO 11073-10472:2012)

Dans le contexte de la famille de normes ISO/IEEE 11073 relatives à la communication de dispositifs, l'ISO/IEEE 11073-10472:2012 établit une définition normative de la communication entre des dispositifs de surveillance de médication et des gestionnaires (par exemple, des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé et des boîtiers décodeurs) d'une manière qui permet une interopérabilité du type prêt à l'emploi. Elle s'appuie sur les parties appropriées de normes existantes, y compris la terminologie et les modèles d'informations de l'ISO/IEEE 11073. Elle spécifie l'utilisation de codes, de formats et de comportements en termes spécifiques dans les environnements de télésanté, en limitant les choix à des cadres de travail de base en faveur de l'interopérabilité. L'ISO/IEEE 11073-10472:2012 définit un noyau commun de fonctionnalités de communication pour les moniteurs de surveillance de médication.

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10472. del: Specialne naprave - Naprava za nadzor jemanja zdravil (ISO 11073-10472:2012)

Ta standard v okviru skupine standardov za komunikacijo naprav ISO/IEEE 11073 določa normativno opredelitev komunikacije med napravami za nadzor jemanja zdravil in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami, digitalnimi sprejemniki) na način, ki omogoča interoperabilnost Plug and Play. Standard temelji na ustreznih delih obstoječih standardov, vključno s terminologijo iz standarda ISO/IEEE 11073 in informacijskimi modeli. Določa uporabo posebnih kod izrazov, formatov in vedenj v telemedicinskih okoljih ter v korist interoperabilnosti omejuje dvoumnost osnovnih okvirov. Ta standard določa skupno jedro komunikacijske funkcionalnosti za naprave za nadzor jemanja zdravil. Naprave za nadzor jemanja zdravil so v tem okviru opredeljene kot naprave, ki lahko določijo in (upravljalni napravi) sporočijo ukrepe uporabnikovega upoštevanja jemanja zdravil.

General Information

• Status: Published
• Publication Date: 26-Dec-2012
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 23-Nov-2012
• Due Date: 28-Jan-2013
• Completion Date: 27-Dec-2012
• Ref Project: EN ISO 11073-10472:2012 - Health Informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor (ISO 11073-10472:2012)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11073-10472:2013
01-januar-2013
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10472. del:
Specialne naprave - Naprava za nadzor jemanja zdravil (ISO 11073-10472:2012)
Health Informatics - Personal health device communication - Part 10472: Device
specialization - Medication monitor (ISO 11073-10472:2012)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10472: Gerätespezifikation - Medikamentenmonitoring (ISO 11073-10472:2012)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10472: Spécialisation de dispositif - Moniteur de médication (ISO 11073-10472:2012)
Ta slovenski standard je istoveten z: EN ISO 11073-10472:2012
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-10472:2013 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11073-10472:2013

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SIST EN ISO 11073-10472:2013


EUROPEAN STANDARD
EN ISO 11073-10472

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2012
ICS 35.240.80
English Version
Health Informatics - Personal health device communication -
Part 10472: Device specialization - Medication monitor (ISO
11073-10472:2012)
Informatique de santé - Communication entre dispositifs de Medizinische Informatik - Kommunikation von Geräten für
santé personnels - Partie 10472: Spécialisation des die persönliche Gesundheit - Teil 10472:
dispositifs - Moniteur de surveillance de médication (ISO Gerätespezifikation - Medikamentenmonitoring (ISO 11073-
11073-10472:2012) 10472:2012)
This European Standard was approved by CEN on 20 October 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10472:2012: E
worldwide for CEN national Members.

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SIST EN ISO 11073-10472:2013
EN ISO 11073-10472:2012 (E)
Contents Page
Foreword .3

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SIST EN ISO 11073-10472:2013
EN ISO 11073-10472:2012 (E)
Foreword
This document (EN ISO 11073-10472:2012) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of
which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the
latest by May 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11073-10472:2012 has been approved by CEN as a EN ISO 11073-10472:2012 without any
modification.

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SIST EN ISO 11073-10472:2013

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SIST EN ISO 11073-10472:2013

INTERNATIONAL ISO/IEEE
STANDARD 11073-10472
First edition
2012-11-01


Health informatics — Personal health
device communication —
Part 10472:
Device specialization — Medication
monitor
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10472: Spécialisation de dispositif — Moniteur de médication




Reference number
ISO/IEEE 11073-10472:2012(E)

©
ISO 2012
©
 IEEE 2012

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SIST EN ISO 11073-10472:2013
ISO/IEEE 11073-10472:2012(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2012
©  IEEE 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective
address below.
ISO copyright office Institute of Electrical and Electronics Engineers, Inc.
Case postale 56  CH-1211 Geneva 20 3 Park Avenue, New York  NY 10016-5997, USA
Tel. + 41 22 749 01 11 E-mail [e-mail]
Fax + 41 22 749 09 47 Web www.ieee.org
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

© ISO 2012 – All rights reserved
ii © IEEE 2012 – All rights reserved

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SIST EN ISO 11073-10472:2013
ISO/IEEE 11073-10472:2012(E)
Contents

1. Overview . 1

1.1 Scope . 1
1.2 Purpose . 2
1.3 Context . 2
2. Normative references. 2
3. Definitions, acronyms, and abbreviations . 2
3.1 Definitions . 3
3.2 Acronyms and abbreviations . 3
4. Introduction to ISO/IEEE 11073 personal health devices . 4
4.1 General . 4
4.2 Introduction to IEEE 11073-20601 modeling constructs . 4
5. Medication monitor device concepts and modalities. 5
5.1 General . 5
5.2 Model usage examples. 6
5.3 Medication dispensed . 7
5.4 Status reporter. 8
5.5 User feedback . 8
5.6 Usage patterns. 9
6. Medication monitor domain information model. 9
6.1 Overview . 9
6.2 Class extensions. 9
6.3 Object instance diagram . 10
6.4 Types of configuration. 11
6.5 Medical device system object. 12
6.6 Numeric objects. 16
6.7 Real-time sample array objects. 22
6.8 Enumeration objects . 22
6.9 PM-store objects. 27
6.10 Scanner objects. 30
6.11 Class extension objects. 31
6.12 Medication monitor information model extensibility rules . 31
7. Medication monitor service model . 31
7.1 General . 31
7.2 Object access services. 31
7.3 Object access event report services . 32
8. Medication monitor communication model. 33
8.1 Overview . 33
8.2 Communications characteristics . 33
8.3 Association procedure . 33
8.4 Configuring procedure. 35
8.5 Operating procedure . 41
8.6 Time synchronization . 42
9. Test associations. 42
© ISO 2012 – All rights reserved
© IEEE 2012 – All rights reserved iii

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SIST EN ISO 11073-10472:2013
ISO/IEEE 11073-10472:2012(E)

9.1 Behavior with standard configuration. 42
9.2 Behavior with extended configurations . 43
10. Conformance . 43
10.1 Applicability . 43
10.2 Conformance specification . 43
10.3 Levels of conformance . 44
10.4 Implementation conformance statements . 44
Annex A (informative) Bibliography . 50
Annex B (normative) Any additional ASN.1 definitions . 51
Annex C (normative) Allocation of identifiers. 52
Annex D (informative) Message sequence examples. 53
Annex E (informative) Protocol data unit examples . 55
E.1 General. 55
E.2 Association information exchange . 55
E.3 Configuration information exchange. 58
E.4 GET MDS attributes service . 61
E.5 Data reporting. 62
E.6 Disassociation . 63

Annex F (informative) IEEE list of participants . 64

© ISO 2012 – All rights reserved
iv © IEEE 2012 – All rights reserved

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SIST EN ISO 11073-10472:2013
ISO/IEEE 11073-10472:2012(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.
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its standards
through a consensus development process, approved by the American National Standards Institute, which
brings together volunteers representing varied viewpoints and interests to achieve the final product. Volunteers
are not necessarily members of the Institute and serve without compensation. While the IEEE administers the
process and establishes rules to promote fairness in the consensus development process, the IEEE does not
independently evaluate, test, or verify the accuracy of any of the information contained in its standards.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is called to the possibility that implementation of this standard may require the use of subject matter
covered by patent rights. By publication of this standard, no position is taken with respect to the existence or
validity of any patent rights in connection therewith. ISO/IEEE is not responsible for identifying essential
patents or patent claims for which a license may be required, for conducting inquiries into the legal validity or
scope of patents or patent claims or determining whether any licensing terms or conditions provided in
connection with submission of a Letter of Assurance or a Patent Statement and Licensing Declaration Form, if
any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expressly
advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is
entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards
Association.
ISO/IEEE 11073-10472 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10472-2010). It was adopted by Technical Committee
ISO/TC 215, Health informatics, in parallel with its approval by the ISO member bodies, under the “fast-track
procedure” defined in the Partner Standards Development Organization cooperation agreement between ISO
and IEEE. IEEE is responsible for the maintenance of this document with participation and input from ISO
member bodies.
ISO/IEEE 11073 consists of the following parts, under the general title Health informatics — Personal health
device communication (text in parentheses gives a variant of subtitle):
 Part 10101: (Point-of-care medical device communication) Nomenclature
 Part 10201: (Point-of-care medical device communication) Domain information model
 Part 10404: Device specialization — Pulse oximeter
 Part 10407: Device specialization — Blood pressure monitor
 Part 10408: Device specialization — Thermometer
 Part 10415: Device specialization — Weighing scale
© ISO 2012 – All rights reserved
© IEEE 2012 – All rights reserved v

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SIST EN ISO 11073-10472:2013
ISO/IEEE 11073-10472:2012(E)
 Part 10417: Device specialization — Glucose meter
 Part 10420: Device specialization — Body composition analyzer
 Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)
 Part 10471: Device specialization — Independant living activity hub
 Part 10472: Device specialization — Medication monitor
 Part 20101: (Point-of-care medical device communication) Application profiles — Base standard
 Part 20601: Application profile — Optimized exchange protocol
 Part 30200: (Point-of-care medical device communication) Transport profile — Cable connected
 Part 30300: (Point-of-care medical device communication) Transport profile — Infrared wireless
 Part 30400: (Point-of-care medical device communication) Interface profile — Cabled Ethernet
 Part 90101: (Point-of-care medical device communication) Analytical instruments — Point-of-care test
 Part 91064: (Standard communication protocol) Computer-assisted electrocardiography
 Part 92001: (Medical waveform format) — Encoding rules

© ISO 2012 – All rights reserved
vi © IEEE 2012 – All rights reserved

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SIST EN ISO 11073-10472:2013
ISO/IEEE 11073-10472:2012(E)

Introduction
This introduction is not part of IEEE Std 11073-10472-2012, Health Informatics—Personal health device
communication—Part 10472: Device specialization—Medication monitor.
ISO/IEEE 11073 standards enable communication between medical devices and external computer
systems. Within the context of the ISO/IEEE 11073 family of standards for device communication, this
standard establishes a normative definition of the communication between medication monitoring devices
and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner
that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including
ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats,
and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of
interoperability. This standard defines a common core of communication functionality for medication
monitors. In this context, medication monitors are defined as devices that have the ability to determine and
communicate (to a manager) measures of a user’s adherence to a medication regime.
© ISO 2012 – All rights reserved
© IEEE 2012 – All rights reserved vii

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SIST EN ISO 11073-10472:2013

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SIST EN ISO 11073-10472:2013
ISO/IEEE 11073-10472:2012(E)

Health informatics — Personal health device
communication —
Part 10472:
Device specialization — Medication monitor

IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or
environmental protection in all circumstances. Implementers of the standard are responsible for
determining appropriate safety, security, environmental, and health practices or regulatory
requirements.
This IEEE document is made available for use subject to important notices and legal disclaimers.
These notices and disclaimers appear in all publications containing this document and may
be found under the heading “Important Notice” or “Important Notices and Disclaimers
Concerning IEEE Documents.” They can also be obtained on request from IEEE or viewed at
http://standards.ieee.org/IPR/disclaimers.html.
1 Overview
1.1 Scope
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard
establishes a normative definition of the communication between medication monitoring devices and
managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that
enables plug-and-play interoperability. It leverages appropriate portions of existing standards including
ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats,
and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of
interoperability. This standard defines a common core of communication functionality for medication
monitors. In this context, medication monitors are defined as devices that have the ability to determine and
communicate (to a manager) measures of a user’s adherence to a medication regime.
© ISO 2012 – All rights reserved
© IEEE 2012 – All rights reserved 1

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SIST EN ISO 11073-10472:2013
ISO/IEEE 11073-10472:2012(E)
1.2 Purpose
This standard addresses a need for an openly defined, independent standard for controlling information
exchange to and from personal health devices and managers (e.g., cell phones, personal computers,
personal health appliances, set top boxes). Interoperability is key to growing the potential market for these
devices and enabling people to be better informed participants in the management of their health.
1.3 Context
1
See IEEE Std 11073-20601-2008 for an overview of the environment within which this standard is
written.
This document, IEEE Std 11073-10472-2010, defines the device specialization for the medication monitor,
being a specific agent type, and it provides a description of the device concepts, its capabilities, and its
implementation according to this standard.
This standard is based on IEEE Std 11073-20601-2008, which in turn draws information from both
ISO/IEEE 11073-10201:2004 [B2] and ISO/IEEE 11073-20101:2004 [B3]. The medical device encoding
rules (MDER) used within this standard are fully described in IEEE Std 11073-20601-2008.
This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B1]
and adds new nomenclature codes for the purposes of this standard. Between this standard and IEEE Std
11073-20601-2008 all required nomenclature codes for implementation are documented.
NOTE—In this standard, IEEE Std 11073-104zz is used to refer to the collection of device specialization standards that
2
utilize IEEE Std 11073-20601-2008, where zz can be any number from 01 to 99, inclusive.
2 Normative references
The following referenced documents are indispensable for the application of this document (i.e., they must
be understood and used, so each referenced document is cited in text and its relationship to this document is
explained). For dated references, only the edition cited applies. For undated references, the latest edition of
the referenced document (including any amendments or corrigenda) applies.
IEEE Std 11073-20601-2008, Health informatics—Personal health device communication—Part 20601:
3
Application profile—Optimized exchange protocol.
NOTE—See Annex A for all informative material referenced by this standard.
3 Definitions, acronyms, and abbreviations
For the purposes of this document, the following terms and definitions apply. The IEEE Standards
4
Dictionary: Glossary of Terms & Definitions should be referenced for terms not defined in this clause.


1
Information on references can be found in Clause 2.
2
Notes in text, tables, and figures are given for information only and do not contain requirements needed to implement the standard.
3
IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854,
USA (http://standards.ieee.org/).
4
The IEEE Standards Dictionary: Glossary of Terms & Definitions is available at http://shop.ieee.org/.
© ISO 2012 – All rights reserved
© IEEE 2012 – All rights reserved
2

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SIST EN ISO 11073-10472:2013
ISO/IEEE 11073-10472:2012(E)
3.1 Definitions
3.1.1 agent: A node that collects and transmits personal health data to an associated manager.
3.1.2 class: In object-oriented modeling, it describes the attributes, methods, and events that objects instantiated
from the class utilize.
3.1.3 compute engine: See: manager.
3.1.4 device: A term used to refer to a physical apparatus implementing either an agent or a manager role.
3.1.5 handle: An unsigned 16-bit number that is locally unique and identifies one of the object instances within
an agent.
3.1.6 manager: A node receiving data from one or more agent systems. Some examples of managers include a
cellular phone, health appliance, set top box, or a computer system.
3.1.7 obj-handle: See: handle.
3.1.8 object: In object-oriented modeling, a particular instantiation of a class. The instantiation realizes
attributes, methods, and events from the class.
3.1.9 personal health device: A device used in personal health applications.
3.1.10 personal telehealth device: See: personal health device.
3.2 Acronyms and abbreviations
APDU application protocol data unit
ASN.1 abstract syntax notation one
DIM domain information model
EUI-64 extended unique identifier (64 bits)
ICS implementation conformance statements
ISO International Organization for Standardization
MDC medical device communication
MDER medical device encoding rules
MDS medical device system
MOC managed object class
PDU protocol data unit
PHD personal health device
VMO virtual medical object
VMS virtual medical system


© ISO 2012 – All rights reserved
© IEEE 2012 – All rights reserved
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ISO/IEEE 11073-10472:2012(E)
4 Introduction to ISO/IEEE 11073 personal health devices
4.1 General
This standa
...