EN ISO 11073-10472:2012

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
Foreword .3

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.
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
ISO/IEEE 11073-10472:2012(E)
©  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 stds.ipr@ieee.org
Fax + 41 22 749 09 47 Web www.ieee.org
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © IEEE 2012 – All rights reserved

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
© IEEE 2012 – All rights reserved iii

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

iv © IEEE 2012 – All rights reserved

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
© IEEE 2012 – All rights reserved v

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

vi © IEEE 2012 – All rights reserved

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.
© IEEE 2012 – All rights reserved vii

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.
© IEEE 2012 – All rights reserved 1

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
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
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:
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
Dictionary: Glossary of Terms & Definitions should be referenced for terms not defined in this clause.

Information on references can be found in Clause 2.
Notes in text, tables, and figures are given for information only and do not contain requirements needed to implement the standard.
IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854,
USA (http://standards.ieee.org/).
The IEEE Standards Dictionary: Glossary of Terms & Definitions is available at http://shop.ieee.org/.
© IEEE 2012 – All rights reserved
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
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10472:2012(E)
4 Introduction to ISO/IEEE 11073 personal health devices
4.1 General
This standard and the remainder of the series of ISO/IEEE 11073 personal health device (PHD) standards
fit in the larger context of the ISO/IEEE 11073 series of standards. The full suite of standards enables
agents to interconnect and interoperate with managers and with computerized healthcare information
systems. See the IEEE Std 11073-20601-2008 for a description of the guiding principles for this series of
ISO/IEEE 11073 Personal Health Device standards.
The IEEE Std 11073-20601-2008 standard supports the modeling and implementation of an extensive set
of personal health devices. This standard defines aspects of the medication monitor device. It describes all
aspects necessary to implement the application layer services and data exchange protocol between an
ISO/IEEE 11073 PHD medication monitor device agent and a manager. This standard defines a sub-set of
the objects and functionality contained in IEEE Std 11073-20601-2008, and extends and adds definitions
where appropriate. All new definitions are given in Annex B in Abstract Syntax Notation One (ASN.1).
Nomenclature codes referenced in this standard, which are not defined in IEEE Std 11073-20601-2008, are
normatively defined in Annex C.
4.2 Introduction to IEEE 11073-20601 modeling constructs
4.2.1 General
The ISO/IEEE 11073 series of standards, and in particular the IEEE Std 11073-20601-2008 standard, is
based on an object-oriented systems management paradigm. The overall system model is divided into three
principal components: the domain information model (DIM), the service model, and the communication
model. See IEEE Std 11073-20601-2008 for a detailed description of the modeling constructs.
4.2.2 Domain information model
The DIM is a hierarchical model that describes an agent as a set of objects. These objects and their
attributes represent the elements that control behavior and report on the status of the agent and data that an
agent can communicate to a manager. Communication between the agent and the manager is defined by the
application protocol in IEEE Std 11073-20601-2008.
4.2.3 Service model
The service model defines the conceptual mechanisms for the data exchange services. Such services are
mapped to messages that are exchanged between the agent and the manager. Protocol messages within the
ISO/IEEE 11073 series of standards are defined in ASN.1. The messages defined in IEEE Std 11073-
20601-2008 can coexist with messages defined in other standard application profiles defined in the
ISO/IEEE 11073 series of standards.
4.2.4 Communication model
In general, the communication model supports the topology of one or more agents communicating over
logical point-to-point connections to a single manager. For each logical point-to-point connection, the
dynamic system behavior is defined by a connection state machine as specified in IEEE Std 11073-20601-
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10472:2012(E)
2008. The security of this communication is largely determined by, but not limited to, the physical security
of the device along with the inherent security of the underlying transports. Additional security may be
defined by future revisions of IEEE Std 11073-20601-2008.
4.2.5 Implementing the models
An agent implementing this standard shall implement all mandatory elements of the information, service,
and communication models as well as all conditional elements where the condition is met. The agent
should implement the recommended elements, and it may implement any combination of the optional
elements. A manager implementing this standard shall utilize at least one of the mandatory, conditional,
recommended, or optional elements. In this context, “utilize” means to use the element as part of the
primary function of the manager device. For example, a manager whose primary function is to display data
would need to display a piece of data in the element in order to utilize it.
5 Medication monitor device concepts and modalities
5.1 General
This clause presents the general concepts of medication monitor devices. In the context of personal health
devices in this family of standards, a medication monitor is a device that provides a record of the person’s
usage of medication. The medication monitor is expected to enable improvements in a person’s compliance
to taking medication as prescribed.
NOTE—The scope is purposely broad to cover a wide spectrum of device implementations in the area of medication
adherence and to allow basic standards to be applied early in the development of this new application. It is anticipated
that subsequent releases may build on this basis as processes mature, additional needs may be identified, and
potentially related global standards emerge, for example, for medication nomenclature.
Currently it is widely estimated that only 30–60% of people adhere to a prescribed regimen including many
people that stop taking medication early in the therapy. Consequences of non-compliance can be severe. It
is estimated that many hospital and care home admissions are avoidable when compliance improves.
Readers interested in investigating the subject further are referred to the wide range of studies that have
been conducted. References and bibliographies can be located at
⎯ The Cochrane Collaboration
⎯ The Healthcare Compliancy Packaging Council
⎯ The National Institute for Clinical Excellence (NICE) is publishing extensive Medicines
Concordance and Adherence Guidelines
In the literature, the terms “adherence,” “compliance,” “compliancy,” and “concordance” are used
interchangeably to describe the same problem—a person not adhering to medication advice.
The medication monitor enables improvements in two of the main causes of poor compliancy, memory, and
feedback. Consumers, care givers, and health professionals have access to an objective diary of medication
related events and notified of exceptional situations when appropriate.

www.cochrane.org
www.hcpc-europe.org and www.unitdose.org for USA
http://www.nice.org.uk/
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10472:2012(E)
The goal of this medication monitor specialization is to provide a common interface representing the
medical regimen by recording the location of the medication dispensed within the medication package,
dosage, estimated time of ingestion etc. This interface is generic and independent of the nature of the
dispensing/monitoring mechanisms.
A medication monitor is usually integrated into one of several types of packaged medication, for example:
⎯ Blister packs
⎯ Carded blister packs
⎯ Bottles
⎯ Mechanical dispensers
⎯ Compartmented trays or cassettes
⎯ Inhalers
⎯ Vial packs, syringe packs, etc.
⎯ Simple insulin injection device (this is intended for the much more sophisticated insulin pumps)
Devices may be either designed for a single course of medication (disposable) or for refilling and re-usage.
A blister pack is typically designed for one-time usage, whereas a mechanical dispenser may be refilled
many times.
In some cases, the medication monitor may be separate from the medication package and rely on the
consumer to record dosage events rather than have this done automatically when, for example, a pill is
removed from a blister.
Devices may be mobile, traveling with the consumer, or they may be located in the person’s home at all
times.
The actual method used to assess when a dose is dispensed varies depending on the device type. A carded
blister pack has means to detect when and which pill is removed from a blister. A smart bottle cap may just
record when the cap is removed. An even simpler device may be a reminder feature attached to a pack of
medication and, when acknowledged by pressing a button, that event is taken to be a dosage event.
This standard also supports reporting exception conditions that may make the medicine useless, for
example, storage outside a temperature range or medication end-of-life. Other data that may be reported
could, for example, include the time at which a package seal was broken.
5.2 Model usage examples
5.2.1 General
This clause shows how the object model described within this standard could be applied to some real world
device implementations. These are only meant to be example proof points of how a particular situation
could be implemented with this model. The examples are presented as a demonstration of the possible ways
in which an application might be implemented, and are not intended to be prescriptive nor exhaustive.
5.2.2 Sequenced medication monitor example types
This subclause details medication monitor examples where the position of the medication are significant (or
at least make sense) and the amount of medication at that position is fixed. What is meant by fixed amount
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10472:2012(E)
is that the medication amount in a location does not change once the device is loaded. This still allows for
the medication amounts to vary from location to location.
These devices could be modeled with the fixed-dosage medication dispensed object.
⎯ Carded blister holding a (finite) number of sequenced (numbered) doses. Doses could be tablets,
capsules, ampoules, vials, pre-filled syringes, sachets, etc.
⎯ Carded blister containing multiple medications e.g., a maintenance dose to take daily, and an
emergency stronger dose to take as needed.
⎯ Compartmented, refillable drug container. The typical device comprises a calendar means, labeled
morning, mid-day, evening, night, weekdays Monday through Sunday and eventually week numbers.
⎯ Compartmented disposable container. Each compartment contains multiple pills to be taken together.
⎯ Revolver-like medication dispenser. By the means of a user twist, a revolver mechanism is rotated one
notch and a single dose can be dispensed. By the nature of the design, each dose is removed in a strict
sequence.
5.2.3 Non-sequenced medication monitor example types
Medication monitor examples where dose positions are not applicable and the amount of medication is
determined at dosage dispensing time. These devices could be modeled using the variable-dosage
medication dispensed events.
⎯ Standard medication bottle with a switch in the lid. This type considers a removed lid to be a single
medication event.
⎯ Simple blister holder with a switch. This type considers a removed and re-inserted blister to be a single
medication event.
⎯ Motorized/automated medication dispenser. Various types allow dispensing of a dose from a container
into a bin at pre-set times. When the bin is opened and the dose taken out, this is considered to be a
dose event.
⎯ Inhaler with a variable dose. The typical (asthma-) inhaler allows for a variable dose by the means of
an aerosol being dispensed in “x number of puffs” or a solid drug being dispensed in number of
“twists”.
⎯ Injection device. The typical (insulin-) injection pen comprises means of recording an injection dose.
⎯ An “infusion”: variable amount of drug administered as a fluid or gas. Probably the maker defines the
quantity e.g., 10 cc to be equivalent to a dose. So dispensing of 20 cc is recorded as two 10 cc doses at
the same time.
5.3 Medication dispensed
The medication monitor shall always include a mechanism for recording medication dispensed events and
providing an indication of the time and date that a medication is removed from its package. There is no
intention to mandate that the medication monitor should also be able to detect that the medication is
actually ingested, injected, inhaled, or otherwise absorbed into the person’s body.
The modeling of these medication dispensed events is done via two different objects depending on the
physical type of the medication. The fixed-dosage medication dispensed object is used for cases where the
dosage is not changeable and does not vary during dispensing (e.g., pills). The variable-dosage medication
dispensed object is used when the dosage may vary and/or be changeable at dispensing (e.g., gases or
liquids).
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10472:2012(E)
5.4 Status reporter
The medication monitor may include a mechanism that reports status. The specific status may include any
of the following:
⎯ Medication not dispensed as expected – the medication was not dispensed within the regimen
allowed timing. Conceptually, a regimen would be a preferred time interval for the medication.
This status would be raised when the regimen is violated by no medication having been taken
within the specified time interval.
⎯ Medication dispensed unexpectedly – the medication was dispensed outside the regimen allowed
timing. Conceptually, a regimen would be a preferred time interval for the medication. This status
would be raised when the regimen is violated by the medication having been taken outside the
specified time interval.
⎯ Medication unfit – the medication monitor has determined that the medication has become unfit.
⎯ Tampering – the medication monitor has determined that tampering has occurred.
⎯ Optimum environmental conditions have been exceeded high/low – environmental conditions such
as temperature for example, have been exceeded.
⎯ Expiration – the medication has expired and is beyond specified use by date.
⎯ Non-compliance yellow/red – the medication monitor has determined that the person’s usage is not
in compliance. Non-compliance generally means that the medication regimen is not being followed
adequately. The severity of non-compliance is indicated in two levels. Yellow is the first level and
indicates that consumer advising may be indicated. Red is the second level and indicates that
consumer intervention is indicated.
⎯ Course completed – the full course of loaded medication has been dispensed.
⎯ Medication taken incorrectly – the medication monitor has determined that the person has taken the
medication incorrectly.
⎯ Consumer side effects – the medication monitor has determined that the person may be
experiencing side effects. Side effects is a general term to indicate a range of perceived consumer
abnormalities that a medication monitor may be able to detect.
⎯ Course reloaded – the full course of medication has been reloaded.
⎯ Medication monitor inoperable – the medication monitor is no longer able to perform adequa
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