SIST EN ISO/IEEE 11073-10472:2025
(Main)Health informatics - Device interoperability - Part 10472: Personal Health Device Communication - Device Specialization - Medication Monitor (ISO/IEEE 11073-10472:2024)
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
- Public Enquiry End Date
- 29-Jun-2024
- Publication Date
- 17-Nov-2025
- Technical Committee
- ITC - Information technology
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 29-Oct-2025
- Due Date
- 03-Jan-2026
- Completion Date
- 18-Nov-2025
Relations
- Effective Date
- 01-Dec-2025
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.
Frequently Asked Questions
SIST EN ISO/IEEE 11073-10472:2025 is a standard published by the Slovenian Institute for Standardization (SIST). 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.
SIST 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.
SIST EN ISO/IEEE 11073-10472:2025 has the following relationships with other standards: It is inter standard links to SIST EN ISO 11073-10472:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase SIST 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 SIST 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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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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Available at: https://ieeexplore.ieee.org/browse/standards/collection/ieee.
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Available at: https://standards.ieee.org/about/sasb/patcom/materials.html.
© IEEE 2024 – All rights reserved
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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
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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
...
La norme SIST EN ISO/IEEE 11073-10472:2025 se distingue par son approche systématique et exhaustive concernant la communication entre dispositifs de surveillance des médicaments et les gestionnaires tels que les téléphones mobiles et les ordinateurs personnels. Cette norme s'inscrit dans le cadre de la famille ISO/IEEE 11073, qui vise à établir des normes de communication pour l'interopérabilité des dispositifs médicaux. L'une des principales forces de cette norme est sa capacité à établir une définition normative pour la communication entre les dispositifs de surveillance des médicaments et les systèmes de gestion. Grâce à l'utilisation de termes spécifiques, de codes et de formats bien définis, la norme réduit l'ambiguïté dans les environnements de télésanté, favorisant ainsi une interopérabilité efficace. En intégrant des portions appropriées de normes existantes, y compris la terminologie et les modèles d'information de l'ISO/IEEE 11073, la norme garantit une cohérence qui est essentielle pour assurer le bon fonctionnement des dispositifs de santé personnels. Elle définit clairement les fonctionnalités de communication essentielles pour les appareils de surveillance des médicaments, permettant ainsi l'adhérence des utilisateurs à leurs régimes médicamenteux, ce qui est crucial dans le domaine de la santé. La pertinence de la norme SIST EN ISO/IEEE 11073-10472:2025 est manifeste dans le contexte actuel, où les dispositifs de santé connectés jouent un rôle de plus en plus important dans la gestion des soins médicaux. En facilitant une communication harmonieuse entre différents dispositifs, cette norme soutient la création d'écosystèmes de santé plus intégrés et efficaces, répondant ainsi aux besoins croissants de suivi et d'adhérence médicamenteuse. En résumé, la norme se positionne comme un cadre fondamental qui favorise l’interopérabilité et la communication entre les dispositifs de surveillance de médicaments et leurs gestionnaires, en contribuant de manière significative à l’amélioration des pratiques de soins de santé modernes.
Die SIST EN ISO/IEEE 11073-10472:2025 ist ein bedeutender Standard innerhalb der Normenfamilie ISO/IEEE 11073, der sich auf die Interoperabilität von medizinischen Geräten konzentriert, insbesondere auf die Kommunikation zwischen Medikamentenüberwachungsgeräten und Managementsystemen. Der Umfang des Standards umfasst die Standardisierung der Kommunikation für Geräte, die die Einhaltung von Medikamentenregimen überwachen, und fördert die Plug-and-Play-Interoperabilität. Ein hervorstechendes Merkmal dieses Standards ist seine normative Definition der Kommunikationsprotokolle, die sowohl für Endanwendergeräte wie Smartphones und Personal Computer als auch für spezifische medizinische Geräte relevant ist. Durch die Verwendung etablierter Terminologie und Informationsmodelle der ISO/IEEE 11073 werden sprachliche Mehrdeutigkeiten minimiert und die Interoperabilität zwischen verschiedenen Systemen weiter optimiert. Ein weiterer wichtiger Aspekt ist die Festlegung spezifischer Termincodes, Formate und Verhaltensweisen, die in telemedizinischen Umgebungen verwendet werden. Diese Spezifikationen sorgen dafür, dass die Kommunikation zwischen den Medikamentenmonitoren und den angeschlossenen Geräten effektiv und fehlerfrei erfolgt, was besonders in kritischen Gesundheitsanwendungen von großer Bedeutung ist. Die Relevanz der SIST EN ISO/IEEE 11073-10472:2025 kann nicht hoch genug eingeschätzt werden, da sie es ermöglicht, dass verschiedene Hersteller von personalisierten Gesundheitsgeräten ihre Produkte miteinander kommunizieren lassen. Dadurch wird nicht nur die Benutzerfreundlichkeit erhöht, sondern auch das Potenzial von telemedizinischen Anwendungen maximiert, was zu einer besseren Patientenversorgung und -überwachung führt. Zusammenfassend lässt sich sagen, dass der Standard SIST EN ISO/IEEE 11073-10472:2025 eine zentrale Rolle bei der Förderung der Interoperabilität im Bereich der Gesundheitsinformatik spielt, indem er klare Richtlinien für die Kommunikation zwischen Medikamentenmonitoren und Managementsystemen bereitstellt.
このSIST EN ISO/IEEE 11073-10472:2025標準は、医療情報学の分野における重要な一歩であり、個人の健康デバイス間の相互運用性を確立するための基盤を提供します。この標準は、medication monitor(投薬モニター)に特化しており、薬の服用状況を測定し、管理者(ゼルフォンやパーソナルコンピュータなど)にその結果を伝えるデバイスの通信機能を規定しています。 この標準の強みは、ISO/IEEE 11073ファミリーの規格に基づく明確な通信定義を持つことであり、デバイス間の接続が容易なプラグアンドプレイの相互運用性を促進します。既存の標準における適切な部分を活用し、特定の用語コードやフォーマット、動作を明確にすることで、テレヘルス環境内での曖昧さを排除し、相互運用性を実現しています。このアプローチは、異なるデバイス間での通信をスムーズにし、医療サービスの質を向上させる関連性を提供します。 さらに、投薬モニターにおける共通の通信機能コアを定義することで、医療提供者や患者がスムーズにデータをやり取りできる環境を整えています。これにより、投薬遵守のモニタリングが一層効果的に行われ、患者の健康管理を支援する重要な役割を果たすことが期待されます。 このように、SIST EN ISO/IEEE 11073-10472:2025標準は、医療情報システムにおける相互運用性の向上に寄与し、投薬モニターの実用性と信頼性を高めるための重要な基盤となっています。
The SIST EN ISO/IEEE 11073-10472:2025 standard significantly enhances the field of health informatics by focusing on device interoperability, particularly for medication monitoring devices. The scope of this standard establishes a clear normative framework for communication between medication monitoring devices and their managing systems, such as smartphones, personal computers, and health appliances. This comprehensive approach underpins the standard's importance in ensuring a seamless integration of diverse health devices within healthcare environments, thereby fostering greater efficiency and reliability in medication management. One of the key strengths of this standard is its emphasis on plug-and-play interoperability, which is crucial in today’s rapidly evolving telehealth landscape. By leveraging established terminology and information models from the existing ISO/IEEE 11073 family, the standard minimizes ambiguity and promotes compatibility among various devices. This is particularly vital for ensuring that healthcare providers and patients can confidently rely on data from medication monitors, facilitating improved adherence to medication regimens. The specification of specific term codes, formats, and behaviors within the standard enhances its relevance in real-world applications. By detailing the essential communication functionality required for medication monitors, the standard not only supports device manufacturers but also augments the quality of care that users can expect. The ability to accurately measure and communicate a user’s adherence to prescribed medications can lead to better health outcomes and more targeted interventions from healthcare professionals. Overall, the SIST EN ISO/IEEE 11073-10472:2025 standard stands as a pivotal document in health informatics, providing a robust framework for device interoperability. Its focus on medication monitors within telehealth environments is particularly timely, addressing the growing need for interconnected healthcare solutions that prioritize both user engagement and clinical effectiveness.
SIST EN ISO/IEEE 11073-10472:2025 표준은 의료 기기 상호 운용성의 중요한 부분을 다루며, 개별 건강 기기 간의 통신을 규명하는 데 있어 매우 유용한 길잡이가 됩니다. 이 표준은 약물 모니터링 장치와 관리 시스템(예: 휴대폰, 개인 컴퓨터, 개인 건강 기기, 셋톱 박스) 간의 통신을 위한 규범적 정의를 수립하여, 플러그 앤 플레이 방식의 상호 운용성을 가능하게 합니다. 이 문서는 기존 표준에서 적절한 부분을 활용하여 통신의 일관성을 강조하고 있으며, ISO/IEEE 11073 용어, 정보 모델 및 애플리케이션 프로파일을 포함하여 상호 운용성을 위한 기준을 설정합니다. 특히, 약물 모니터는 사용자가 약물 요법을 준수하는 정도를 판단하고 이를 관리자와 통신할 수 있는 능력을 가진 장치로 정의됩니다. 이러한 정의는 의료 환경에서의 약물 처방 준수 관리를 효율적으로 지원합니다. SIST EN ISO/IEEE 11073-10472:2025는 특정 용어 코드, 형식 및 행동을 규정하여 텔레헬스 환경에서의 모호성을 제한하며, 이를 통해 사용자는 일관되고 명확한 정보 전달을 받을 수 있습니다. 이로 인해 기존의 의료 기기와 소프트웨어 간의 통신이 보다 고도화되고 간편해져, 사용자 경험을 향상시키는 데 기여합니다. 따라서, 이 표준은 의료 기기 간의 통신의 원활함을 보장하는 데 필수적이며, 향후 의료 정보학 분야에서의 기기 상호 운용성과 관련된 발전을 지원할 것으로 기대됩니다. 전반적으로, SIST EN ISO/IEEE 11073-10472:2025는 약물 모니터링 장치의 기능성을 강화하고, 의료 제공자와 환자 간의 소통을 개선하는 데 중요한 역할을 합니다.










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