Health informatics - Device interoperability - Part 10472: Personal Health Device Communication - Device Specialization - Medication Monitor (ISO/IEEE 11073-10472:2024)

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, information models and application profile. 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 - Interoperabilität von Geräten - Teil 10472: Kommunikation von Geräten für die persönliche Gesundheit - Gerätespezifikation - Medikamentenmonitoring (ISO/IEEE 11073-10472:2024)

Informatique de santé - Interopérabilité des dispositifs - Partie 10472: Communication entre dispositifs de santé personnels - Spécialisation des dispositifs - Moniteur de surveillance de médication (ISO/IEEE 11073-10472:2024)

Dans le contexte de la famille de normes ISO/IEEE 11073 relatives à la communication entre des dispositifs, la présente norme établit une définition normative de la communication entre des moniteurs 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 surles parties appropriées de normes existantes, y compris la terminologie, des modèles d’informations et le profil d’application 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 l’ambiguïté  dans les cadres de travail de base en faveur de l’interopérabilité. La présente norme définit un noyau commun de fonctionnalités de communication pour les moniteurs de surveillance de médication. Dans ce contexte, les moniteurs de surveillance de médication sont définis comme des dispositifs qui ont la capacité de déterminer et de communiquer (à un gestionnaire) les mesures permettant de vérifier qu’un utilisateur suit correctement un régime de médication prescrit.

Zdravstvena informatika - Interoperabilnost naprav - 10472. del: Komunikacija osebnih medicinskih naprav - Specialne naprave - Naprava za nadzor jemanja zdravil (ISO/IEEE 11073-10472:2024)

General Information

Status
Published
Publication Date
30-Sep-2025
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
01-Oct-2025
Completion Date
01-Oct-2025

Relations

Effective Date
08-Nov-2023

EN ISO/IEEE 11073-10472:2025 - Medication Monitor (ISO/IEEE 11073-10472:2024)

Overview

EN ISO/IEEE 11073-10472:2025 defines a normative communication profile for personal health device medication monitors to enable plug-and-play device interoperability with managers such as cell phones, PCs, personal health appliances and set‑top boxes. Within the ISO/IEEE 11073 family, this device specialization specifies the common core of communication functionality, leverages existing terminology, information models and transport/application profiles, and reduces optionality in base frameworks to improve interoperability in telehealth environments. The second edition adds features such as Base‑Offset‑Time support and updated association and configuration rules.

Key topics and technical requirements

  • Normative communication definition between medication monitors and managers for reliable device communication.
  • Use of standardized ISO/IEEE 11073 terminology, information models and application profile elements to avoid ambiguity.
  • Specification of term codes, formats and behaviors required for medication adherence data exchange (restricting optionality to favour interoperability).
  • Support for Base‑Offset‑Time and updated standard configurations based on it.
  • Updated association details, qualifier recommendations (e.g., for MDS/DIM objects) and rules for DIM extensibility.
  • Compliance and alignment with other parts of the 11073 family and related standards to ensure consistent semantics and protocol behavior.
  • Examples and conformance guidance to assist implementation in telehealth scenarios.

Applications

This standard is directly applicable to implementations where medication adherence data must be collected, exchanged and interpreted across devices and software:

  • Home and remote monitoring systems for medication adherence.
  • Mobile health apps and gateways that receive data from smart pill dispensers, connected medication monitors and adherence sensors.
  • Telehealth platforms and personal health management systems integrating adherence metrics into clinical workflows.
  • Clinical trials and research where standardized, interoperable adherence data are required.
  • Pharmacy services and care coordination platforms that aggregate patient medication-use data.

Who should use this standard

  • Medical device manufacturers building medication monitors and connected adherence devices.
  • Firmware and embedded software developers implementing the 11073 device stack.
  • Mobile app and telehealth platform developers integrating personal health device data.
  • Systems integrators, interoperability architects and healthcare IT vendors.
  • Standards and regulatory professionals assessing conformance and device interoperability.

Related standards

  • ISO/IEEE 11073 series (device communication and information models)
  • ISO/IEEE 11073-20601 and IEEE Std 11073-10101 (protocol and nomenclature foundations)
  • Other ISO/IEEE 11073 device specialization parts (11073-104xx)

Keywords: ISO/IEEE 11073, medication monitor, device interoperability, personal health devices, telehealth, plug-and-play, device communication, medication adherence.

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EN ISO/IEEE 11073-10472:2025

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Frequently Asked Questions

EN ISO/IEEE 11073-10472:2025 is a standard published by the European Committee for Standardization (CEN). Its full title is "Health informatics - Device interoperability - Part 10472: Personal Health Device Communication - Device Specialization - Medication Monitor (ISO/IEEE 11073-10472:2024)". This standard covers: 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, information models and application profile. 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.

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, information models and application profile. 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.

EN ISO/IEEE 11073-10472:2025 is classified under the following ICS (International Classification for Standards) categories: 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.

EN ISO/IEEE 11073-10472:2025 has the following relationships with other standards: It is inter standard links to EN ISO 11073-10472:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

You can purchase EN ISO/IEEE 11073-10472:2025 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.

Standards Content (Sample)


SLOVENSKI STANDARD
01-december-2025
Nadomešča:
SIST EN ISO 11073-10472:2013
Zdravstvena informatika - Interoperabilnost naprav - 10472. del: Komunikacija
osebnih medicinskih naprav - Specialne naprave - Naprava za nadzor jemanja
zdravil (ISO/IEEE 11073-10472:2024)
Health informatics - Device interoperability - Part 10472: Personal Health Device
Communication - Device Specialization - Medication Monitor (ISO/IEEE 11073-
10472:2024)
Medizinische Informatik - Interoperabilität von Geräten - Teil 10472: Kommunikation von
Geräten für die persönliche Gesundheit - Gerätespezifikation - Medikamentenmonitoring
(ISO/IEEE 11073-10472:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10472: Communication
entre dispositifs de santé personnels - Spécialisation des dispositifs - Moniteur de
surveillance de médication (ISO/IEEE 11073-10472:2024)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-10472:2025
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO/IEEE 11073-
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2025
ICS 35.240.80 Supersedes EN ISO 11073-10472:2012
English Version
Health informatics - Device interoperability - Part 10472:
Personal Health Device Communication - Device
Specialization - Medication Monitor (ISO/IEEE 11073-
10472:2024)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Interoperabilität von
- Partie 10472: Communication entre dispositifs de Geräten - Teil 10472: Kommunikation von Geräten für
santé personnels - Spécialisation des dispositifs - die persönliche Gesundheit - Gerätespezifikation -
Moniteur de surveillance de médication (ISO/IEEE Medikamentenmonitoring (ISO/IEEE 11073-
11073-10472:2024) 10472:2024)
This European Standard was approved by CEN on 30 September 2024.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEEE 11073-10472:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO/IEEE 11073-10472:2025) 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 April 2026, and conflicting national standards shall be
withdrawn at the latest by April 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11073-10472:2012.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10472:2024 has been approved by CEN as EN ISO/IEEE 11073-
10472:2025 without any modification.

International
Standard
ISO/IEEE
11073-10472
Second edition
Health informatics — Device
2024-09
interoperability —
Part 10472:
Personal health device
communication — Device
specialization — Medication monitor
Informatique de santé — Interopérabilité des dispositifs —
Partie 10472: Communication entre dispositifs de santé
personnels — Spécialisation des dispositifs — Moniteur de
surveillance de médication
Reference number
ISO/IEEE 11073-10472:2024(en) © IEEE 2024

ISO/IEEE 11073-10472:2024(en)
© IEEE 2024
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© IEEE 2024 – All rights reserved
ii
ISO/IEEE 11073-10472:2024(en)
Foreword
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ISO/IEEE 11073-10472 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10472) and drafted in accordance with its editorial rules. It
was adopted, under the “fast-track procedure” defined in the Partner Standards Development Organization
cooperation agreement between ISO and IEEE, by Technical Committee ISO/TC 215, Health informatics.
This second edition cancels and replaces the first edition (ISO/IEEE 11073-10472:2012), which has been
technically revised.
The main changes are as follows:
— added support for Base-Offset-Time;
— defined new standard configurations based on BaseOffsetTime;
— updated Clause 2 to include ISO/IEEE 11073-20601 and IEEE Std 11073-10101;
— updated version of this device specialization;
— updated the association details based on new version;
— updated the wording in 6.3 regarding the Observational;
© IEEE 2024 – All rights reserved
iii
ISO/IEEE 11073-10472:2024(en)
— updated the examples in 8.4.2 and Annex E, to indicate the support of BaseOffsetTime;
— updated the qualifier in MDS and other objects to recommend BaseOffsetTime; also
updated the description of the qualifiers in 6.5;
— added some text to 6.12 to further elaborate the DIM extensibility rule;
— corrected the use condition of GET MDS at E.4.1;
— updated the text in 8.5.2 regarding attribute-id-list, in order to be compliant with ISO/IEC
11073-20601;
— added subclause 3.4—Compliance with other standards;
— removed the year in bibliography to represent the latest version;
— extended Table 1 to specify qualifier details for all possible configurations;
— updated the wording at 1.3 and 4.1 regarding the precedence of nomenclature between
11073-10101, 11073-20601, 11073-104xx and this standard;
— updated the usage of nomenclature-version. Tied it with the corresponding protocol-version.
A list of all parts in the ISO 11073 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.
© IEEE 2024 – All rights reserved
iv
ISO/IEEE 11073-10472:2024(en)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication, a
normative definition of communication between personal telehealth medication monitor devices and
compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) is
established by this standard in a manner that enables plug-and-play interoperability. Appropriate portions of
existing standards including ISO/IEEE 11073 terminology, information models, application profile standards,
and transport standards are leveraged. The use of specific term codes, formats, and behaviors in telehealth
environments restricting optionality in base frameworks in favor of interoperability are specified. A common
core of communication functionality for personal telehealth medication monitor devices is defined in this
standard.
Keywords: device communication, IEEE 11073-10472™, medication monitor, personal health devices

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© IEEE 2024 – All rights reserved
viii
ISO/IEEE 11073-10472:2024(en)
Participants
At the time this standard was completed, the Personal Health Devices Working Group had the following membership:
Daidi Zhong, Chair
Malcolm Clarke, Vice-chair
Raymond Krasinski, Secretary
Karsten Aalders Nigel Cox Kai Hassing
Charles R. Abbruscato Hans Crommenacker Avi Hauser
Nabil Abujbara Tomio Crosley Nathaniel Heintzman
Maher Abuzaid Allen Curtis Charles Henderson
James Agnew Jesús Daniel Trigo Jun-Ho Her
Manfred Aigner David Davenport Timothy L. Hirou
Jorge Alberola Russell Davis Allen Hobbs
David Aparisi Sushil K. Deka Alex Holland
Lawrence Arne Ciro de la Vega Arto Holopainen
Diego B. Arquillo Jim Dello Stritto Kris Holtzclaw
Serafin Arroyo Kent Dicks Robert Hoy
Muhammad Asim Hyoungho Do Anne Huang
Kit August Fangjie Dong Guiling Huang
Doug Baird Jonathan Dougherty Haofei Huang
David Baker Xiaolian Duan Zhiyong Huang
Anindya Bakshi Sourav Dutta David Hughes
Ananth Balasubramanian Jakob Ehrensvard Robert D. Hughes
Sunlee Bang Fredrik Einberg Jiyoung Huh
M. Jonathan Barkley Javier Escayola Calvo Hugh Hunter
Gilberto Barrón Mark Estes Philip O. Isaacson
David Bean Leonardo Estevez Atsushi Ito
John Bell Bosco T. Fernandes Michael Jaffe
Olivia Bellamou-Huet Christoph Fischer Praduman Jain
Rudy Belliardi Morten Flintrup Hu Jin
Daniel Bernstein Russell Foster Danny Jochelson
George A. Bertos Eric Freudenthal Akiyoshi Kabe
Chris Biernacki Matthias Frohner Steve Kahle
Ola Björsne Ken Fuchs Tomio Kamioka
Thomas Blackadar Jing Gao James J. Kang
Thomas Bluethner Marcus Garbe Kei Kariya
Douglas P. Bogia John Garguilo Andy Kaschl
Xavier Boniface Liang Ge Junzo Kashihara
Shannon Boucousis Rick Geimer Ralph Kent
Lyle G. Bullock, Jr. Igor Gejdos Laurie M. Kermes
Bernard Burg Ferenc Gerbovics Sanjay R. Kharche
Chris Burns Alan Godfrey Ahmad Kheirandish
Jeremy Byford-Rew Nicolae Goga Junhyung Kim
Satya Calloji Julian Goldman Minho Kim
Carole C. Carey Raul Gonzalez Gomez Min-Joon Kim
Craig Carlson Chris Gough Taekon Kim
Santiago Carot-Nemesio Channa Gowda Tetsuya Kimura
Seungchul Chae Charles M. Gropper Michael J. Kirwan
Yao Chen Amit Gupta Alfred Kloos
Jing Cheng Jeff Guttmacher Edward Koch
Peggy Chien Rasmus Haahr Jeongmee Koh
David Chiu Christian Habermann Jean-Marc Koller
Jinyong Choi Michael Hagerty John Koon
Chia-Chin Chong Jerry Hahn Patty Krantz
Jinhan Chung Robert Hall Alexander Kraus
John A. Cogan Shu Han Ramesh Krishna
John T. Collins Nathaniel Hamming Geoffrey Kruse
Cory Condek Rickey L. Hampton Falko Kuester
Todd H. Cooper Sten Hanke Rafael Lajara
Sandra Costanzo Aki Harma Pierre Landau
Douglas Coup Jordan Hartmann Jaechul Lee
© IEEE 2024 – All rights reserved
ix
ISO/IEEE 11073-10472:2024(en)
JongMuk Lee Phillip E. Pash Hermanni Suominen
Kyong Ho Lee TongBi Pei Lee Surprenant
Rami Lee Soren Petersen Ravi Swami
Sungkee Lee James Petisce Ray Sweidan
Woojae Lee Peter Piction Na Tang
Jing Li Michael Pliskin Haruyuyki Tatsumi
Qiong Li Varshney Prabodh Isabel Tejero
Xiangchen Li Jeff Price Chn Jonas Tirén
Xiaoyu Li Harald Prinzhorn Janet Traub
Patrick Lichter Lifei Qian Gary Tschautscher
Jisoon Lim Harry Qiu Masato Tsuchid
Wei-Jung Lo Tanzilur Rahman Ken Tubman
Charles Lowe Lin Ran Akib Uddin
Ling Luo Phillip Raymond Sunil Unadkat
Don Ludolph Terrie Reed Fabio Urbani
Christian Luszick Barry Reinhold Philipp Urbauer
Bob MacWilliams Brian Reinhold Laura Vanzago
Srikkanth Madhurbootheswaran John G. Rhoads Alpo Värri
Miriam L. Makhlouf Jeffrey S. Robbins Andrei Vasilateanu
M. Sabarimalai Manikandan Chris Roberts Dalimar Velez
Romain Marmot Moskowitz Robert Martha Velezis
Sandra Martinez Stefan Robert Rudi Voon
Miguel Martínez de EsproncedaCámara Scott M. Robertson Isobel Walker
Peter Mayhew Timothy Robertson David Wang
Jim McCain Sean Rocke Jerry P. Wang
LászlóMeleg David Rosales Shiwei Wang
Alexander Mense Bill Saltzstein Yao Wang
Behnaz Minaei Giovanna Sannino Yi Wang
Jinsei Miyazaki Jose A. Santos-Cadenas Steve Warren
Madhu Mohan Stefan Sauermann Fujio Watanabe
Erik Moll John Sawyer Toru Watsuji
Darr Moore Alois Schloegl Kathleen Wible
Chris Morel Paul S. Schluter Paul Williamson
Carsten Mueglitz Mark G. Schnell Jia-Rong Wu
Soundharya Nagasubramanian Richard A. Schrenker Will Wykeham
Alex Neefus Antonio Scorpiniti Ariton Xhafa
Trong-Nghia Nguyen-Dobinsky KwangSeok Seo Ricky Yang
Michael E. Nidd Riccardo Serafin Melanie S. Yeung
Jim Niswander Sid Shaw Qiang Yin
Hiroaki Niwamoto Frank Shen Done-Sik Yoo
Thomas Norgall Min Shih Zhi Yu
Yoshiteru Nozoe Mazen Shihabi Jianchao Zeng
Abraham Ofek Redmond Shouldice Jason Zhang
Sternly K. Simon Zerui Zhang
Brett Olive Marjorie Skubic Shibai Zhao
Begonya Otal Robert Smith Yu Zhao
Marco Paleari Ivan Soh Liang Zheng
Bud Panjwani Motoki Sone Yuanhong Zhong
Carl Pantiskas Emily Sopensky Qing Zhou
Harry P. Pappas Rajagopalan Srinivasan Miha Zoubek
Hanna Park Nicholas Steblay Szymon Zyskoter
Jong-Tae Park Lars Steubesand
Myungeun Park John (Ivo) Stivoric
The following members of the individual Standards Association balloting group voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Robert Aiello Michael Faughn Stuart Kerry
Pradeep Balachandran Ken Fuchs Raymond Krasinski
Pin Chang Charles M. Gropper Erik Moll
Malcolm Clarke Werner Hoelzl Rajesh Murthy
Javier Espina Piotr Karocki Bansi Patel
© IEEE 2024 – All rights reserved
x
ISO/IEEE 11073-10472:2024(en)
Harry Solomon Yu Yuan
Scott M. Robertson Walter Struppler Oren Yuen
Stefan Schlichting John Vergis Daidi Zhong

When the IEEE SA Standards Board approved this standard on 30 March 2023, it had the following membership:
David J. Law, Chair
Ted Burse, Vice Chair
Gary Hoffman, Past Chair
Konstantinos Karachalios, Secretary

Sara R. Biyabani Joseph S. Levy Paul Nikolich
Doug Edwards Howard Li Annette D. Reilly
Ramy Ahmed Fathy Gui Lin Robby Robson
Guido R. Hiertz Johnny Daozhuang Lin Lei Wang
Yousef Kimiagar Xiaohui Liu F. Keith Waters
Joseph L. Koepfinger* Kevin W. Lu Karl Weber
Thomas Koshy Daleep C. Mohla Philip B. Winston
John D. Kulick Andrew Myles Don Wright
*Member Emeritus
© IEEE 2024 – All rights reserved
xi
ISO/IEEE 11073-10472:2024(en)
Introduction
This introduction is not part of IEEE Std 11073-10472-2023, IEEE Standard for Health Informatics—Device Interoperability—Part 10472:
Personal Health Device Communication—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.
© IEEE 2024 – All rights reserved
xii
ISO/IEEE 11073-10472:2024(en)
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 1
1.3 Word usage . 1
1.4 Context . 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations . 2
3.1 Definitions . 2
3.2 Acronyms and abbreviations . 3
4. Introduction to ISO/IEEE 11073 personal health devices . 3
4.1 General . 3
4.2 Introduction to IEEE 11073-20601 modeling constructs . 4
4.3 Compliance with other standards . 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 . 7
5.5 User feedback . 8
5.6 Usage patterns . 8
6. Medication monitor domain information model . 9
6.1 Overview . 9
6.2 Class extensions . 9
6.3 Object instance diagram . 9
6.4 Types of configuration . 10
6.5 Medical device system object . 11
6.6 Numeric objects . 15
6.7 Real-time sample array objects. 25
6.8 Enumeration objects . 25
6.9 PM-store objects . 29
6.10 Scanner objects . 32
6.11 Class extension objects . 32
6.12 Medication monitor information model extensibility rules . 32
7. Medication monitor service model . 33
7.1 General . 33
7.2 Object access services . 33
7.3 Object access event report services . 34
8. Medication monitor communication model . 35
8.1 Overview . 35
8.2 Communications characteristics . 35
8.3 Association procedure . 35
8.4 Configuring procedure . 37
8.5 Operating procedure . 44
8.6 Time synchronization . 45
9. Test associations . 45
9.1 Behavior with standard configuration . 45
© IEEE 2024 – All rights reserved
xiii
ISO/IEEE 11073-10472:2024(en)
9.2 Behavior with extended configurations . 45
10. Conformance . 45
10.1 Applicability . 45
10.2 Conformance specification . 46
10.3 Levels of conformance . 46
10.4 Implementation conformance statements (ICSs) . 46
Annex A (informative) Bibliography . 52
Annex B (normative) Any additional ASN.1 definitions . 53
Annex C (normative) Allocation of identifiers . 54
Annex D (informative) Message sequence examples . 55
Annex E (informative) Protocol data unit examples . 57
E.1 General . 57
E.2 Association information exchange . 57
E.3 Configuration information exchange . 60
E.4 GET MDS attributes service . 62
E.5 Data reporting . 63
E.6 Disassociation . 64
Annex F (informative) Revisio
...

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Die Norm EN ISO/IEEE 11073-10472:2025 stellt einen wichtigen Schritt in der Entwicklung der Interoperabilität von Gesundheitsgeräten dar, insbesondere im Bereich der Medikamentenüberwachung. Der Anwendungsbereich dieser Norm umfasst die Kommunikation zwischen Medikamentenüberwachungsgeräten und den jeweiligen Managern, wie beispielsweise Mobiltelefonen, Personal Computern und anderen persönlichen Gesundheitsgeräten. Die zentrale Stärke der Norm liegt in der Festlegung einer normativen Definition, die eine Plug-and-Play-Interoperabilität ermöglicht. Ein herausragendes Merkmal dieser Norm ist die Integration bestehender Standards, insbesondere der Terminologie, Informationsmodelle und Anwendungsprofile der ISO/IEEE 11073-Reihe. Dies fördert nicht nur die Konsistenz in der Kommunikation zwischen verschiedenen Geräten, sondern verringert auch die Ambiguität im Hinblick auf Kommunikationsprotokolle. Durch die Spezifikation spezifischer Begriffscodes, Formate und Verhaltensweisen in Telehealth-Umgebungen wird sichergestellt, dass die Kommunikation zwischen Medikamentenmonitoren und ihren Managern klar und eindeutig ist. Die Norm definiert zudem einen gemeinsamen Kern an Kommunikationsfunktionen für Medikamentenmonitore. Dies ist besonders relevant, da es eine Grundlage für die Entwicklung innovativer Produkte im Gesundheitswesen bietet, die auf die Bedürfnisse von Nutzern zugeschnitten sind, die ihre Medikamenteneinhaltung überwachen möchten. In Zeiten, in denen Telemedizin und digitale Gesundheitslösungen zunehmend an Bedeutung gewinnen, schafft diese Norm eine verlässliche Infrastruktur für die Integration solcher Technologien. Zusammenfassend lässt sich sagen, dass die EN ISO/IEEE 11073-10472:2025 eine entscheidende Norm für die Verbesserung der Kommunikation zwischen Medikamentenüberwachungsgeräten und -managern darstellt. Ihre klaren Vorgaben schaffen Voraussetzungen für eine effektive Interoperabilität, was eine verbesserte Patientenversorgung und eine höhere Effizienz im Gesundheitswesen fördert.

La norme EN ISO/IEEE 11073-10472:2025 se positionne comme un élément essentiel dans le domaine de l'informatique de la santé, en particulier pour la communication entre dispositifs de santé à domicile. Sa portée se concentre sur l'interopérabilité des dispositifs de surveillance des médicaments, garantissant que ces appareils peuvent communiquer efficacement avec divers gestionnaires, y compris des téléphones mobiles, des ordinateurs personnels et d'autres appareils de santé personnels. L'un des principaux atouts de cette norme réside dans son approche normative qui facilite une communication claire et sans ambiguïté entre les dispositifs de surveillance des médicaments et les systèmes de gestion. Cela est accentué par l'utilisation d'un vocabulaire et de modèles d'information provenant de la famille de normes ISO/IEEE 11073, qui assure une continuité et une cohérence essentielle. En définissant des codes de termes spécifiques, des formats et des comportements dans les environnements de télésanté, la norme limite les ambiguïtés et favorise une interopérabilité fluide entre les dispositifs, ce qui est crucial dans le suivi de l'adhésion du patient à son régime médicamenteux. En outre, EN ISO/IEEE 11073-10472:2025 promeut une fonctionnalité de communication commune qui permet aux dispositifs de monitoring de médicaments de fonctionner de manière plug-and-play. Cette caractéristique est particulièrement pertinente dans le contexte actuel, où la demande pour des solutions de santé connectées et intégrées ne cesse de croître. La norme facilite l'intégration de nouveaux dispositifs sans nécessiter de modifications majeures des systèmes existants, ce qui augmente l'efficacité et la satisfaction des utilisateurs. Dans un paysage où la technologie évolue rapidement, la norme EN ISO/IEEE 11073-10472:2025 revêt une grande importance pour les fabricants de dispositifs de santé, les développeurs de logiciels et les professionnels de la santé. Sa capacité à standardiser la communication en matière de suivi des médicaments contribue significativement à l'amélioration de la gestion des soins de santé, à la réduction des erreurs médicamenteuses et à l'optimisation de l'expérience utilisateur.

SIST EN ISO/IEEE 11073-10472:2025 표준은 건강 정보학 분야의 장치 상호 운용성에 중점을 두고 있으며, 특히 개인 건강 장치 통신을 위한 약물 모니터링 장치의 특화된 정의를 제공합니다. 이 표준의 범위는 ISO/IEEE 11073 표준군의 기존 요소를 활용하여 약물 모니터링 장치와 장치 관리자(예: 휴대폰, 개인용 컴퓨터, 개인 건강 기기, 셋톱 박스) 간의 통신을 명확하고 일관되게 정의하는 데 초점을 맞추고 있습니다. SIST EN ISO/IEEE 11073-10472:2025의 주요 강점은 플러그 앤 플레이 상호 운용성을 지원하는 데 철저히 준비된 점입니다. 표준은 약물 모니터링 장치가 사용자의 약물 복용 준수 상황을 판단하고 이를 장치 관리자에게 전달하는 기능을 정의합니다. 이를 통해 의료 환경에서의 불확실성을 최소화하고, 확대된 호환성을 제공합니다. 또한, 통신 기능의 핵심 공통 요소를 정의하여 개발자와 제조사들이 직접 활용할 수 있는 명확한 기준을 마련합니다. 이 표준은 특히 원격 의료 환경에서 통신의 명확성을 보장하기 위한 특정 용어 코드, 포맷 및 행동을 지정함으로써 사용자의 복잡성을 낮추고, 보다 안전하고 신뢰할 수 있는 약물 관리 경험을 제공합니다. 조화로운 정보 모델과 애플리케이션 프로파일을 포함하여, 이 표준의 적용은 향후 개인 건강 장치의 발전과 보편적 사용을 촉진할 것으로 기대됩니다. 결론적으로, SIST EN ISO/IEEE 11073-10472:2025 표준은 약물 모니터링 장치의 상호 운용성을 위한 필수적인 프레임워크를 제시하며, 이는 개인의 건강 관리 개선과 효율적인 의료 서비스 제공에 큰 기여를 할 것입니다.

The standard EN ISO/IEEE 11073-10472:2025 plays a crucial role in the domain of health informatics, specifically within the interoperability of personal health devices. Its scope centers on establishing a normative framework for communication between medication monitoring devices and managers, which include personal computers, cell phones, and various health appliances. This scope is particularly significant as it addresses the need for seamless interaction among diverse health technology, supporting a plug-and-play approach that is essential for enhancing usability and accessibility in telehealth environments. One of the primary strengths of this standard lies in its utilization of existing standards, such as ISO/IEEE 11073 terminology, information models, and application profiles. By building upon established frameworks, the document fosters a recognizable and reliable method for device communication, thereby minimizing the potential for ambiguity that can often arise in technological interactions. The clarity provided by specific term codes, formats, and behaviors is essential for ensuring that medication monitors can effectively communicate adherence measures to their management devices. Moreover, the standard encapsulates a common core functionality for medication monitors, which is particularly relevant in today's digital health landscape. As medication adherence becomes increasingly complex for patients, having a standardized approach to monitor and communicate adherence metrics is invaluable. It not only promotes interoperability but also enhances patient outcomes by ensuring that the data shared is accurate and actionable. In summary, EN ISO/IEEE 11073-10472:2025 stands out for its structured approach to integrating personal health devices, addressing interoperability in a comprehensive manner that is pertinent to the evolving needs of telehealth services. The focus on defining communication standards for medication monitoring is a timely and necessary advancement in the field of health informatics.

SIST EN ISO/IEEE 11073-10472:2025は、医療情報学におけるデバイス相互運用性を扱う標準であり、特に個人健康デバイスの通信に関する重要な枠組みを提供しています。この標準は、薬物モニターのために制定されたもので、ISO/IEEE 11073ファミリーの一部として位置付けられています。 本標準の範囲は、薬物監視デバイスとマネージャ(携帯電話、パソコン、個人健康機器、セットトップボックスなど)との間の通信に関する規範を確立しています。この通信は、プラグアンドプレイの相互運用性を可能にするものであり、ユーザーが薬物治療に従う度合いを決定し、マネージャにその情報を伝える能力を持つデバイスとして薬物モニターが定義されています。 本標準の強みは、既存の標準(特にISO/IEEE 11073の用語、情報モデル、アプリケーションプロファイル)から適切な部分を活用している点にあります。このアプローチにより、医療現場における通信の曖昧さを排除し、相互運用性の向上を図っています。さらに、特定の用語コード、フォーマット、および行動を指定することにより、テレヘルス環境でのコミュニケーションの機能が共通のコアとして定義されています。 このように、SIST EN ISO/IEEE 11073-10472:2025は、医薬品モニタリングデバイスの通信における相互運用性の確保に向けた強力な基盤を提供しており、その関連性は今後の医療システムにおいてますます高まることが予想されます。特に、医療従事者と患者のインターフェースを容易にし、モニタリングによる効果を最大限に引き出すことが期待されています。この標準の広告により、医療技術の進化を支える堅牢な枠組みが提供されることに間違いありません。