CEN/TC 251/WG 2 - Terminology and knowledge representation

This document applies to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
This document specifies the basic structure of the data contained within the medication data object, but does not specify or mandate particular data sets for storage on devices.
The purpose of this document is for cards to provide information to other health professionals and to the patient or its non-professional caregiver.
It can also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets.
Medication data include the following four components:
—     medication notes: additional information related to medication and the safe use of medicines by the patient such as medication history, sensitivities and allergies;
—     medication prescriptions: to carry a new prescription from the prescriber to the dispenser/pharmacy;
—     medication dispensed: the records of medications dispensed for the patient;
—     medication references: pointers to other systems that contain information that makes up medication prescription and the authority to dispense.
The following topics are beyond the scope of this document:
—     physical or logical solutions for the practical functioning of particular types of data cards;
—     how the message is processed further “downstream” of the interface between two systems;
—     the form which the data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere.
NOTE            Not only does the definition of “medicinal products” differ from country to country, but also the same name can relate to entirely different products in some countries. Therefore, it is important to consider the safety of the patient when the card is used across borders.
This document describes and defines the Medication data objects used within or referenced by patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
This document does not describe nor define the common objects defined within ISO 21549-2.

This document describes and defines the basic structure of the identification data objects held on healthcare data cards, but it does not specify particular data sets for storage on devices.
This document does not apply to the detailed functions and mechanisms of the following services (although its structures can accommodate suitable data objects elsewhere specified):
—    security functions and related services that are likely to be specified by users for data cards depending on their specific application, e.g. confidentiality protection, data integrity protection and authentication of persons and devices related to these functions;
—    access control services;
—    the initialization and issuing process (which begins the operating lifetime of an individual data card, and by which the data card is prepared for the data to be subsequently communicated to it according to this document).
Therefore, this document does not cover:
—    physical or logical solutions for the practical functioning of particular types of data card;
—    the forms that data take for use outside the data card, or the way in which such data are visibly represented on the data card or elsewhere.

Within the context of secure plug-and-play interoperability, cybersecurity is the process and capability of preventing unauthorized access or modification, misuse, denial of use, or the unauthorized use of information that is stored on, accessed from, or transferred to and from a PHD/PoCD. The process part of cybersecurity is risk analysis of use cases specific to a PHD/PoCD.
For PHDs/PoCDs, this standard defines an iterative, systematic, scalable, and auditable approach to identification of cybersecurity vulnerabilities and estimation of risk. This iterative vulnerability assessment uses the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme and the embedded Common Vulnerability Scoring System (eCVSS). The assessment includes system context, system decomposition, pre-mitigation scoring, mitigation, and post-mitigation scoring and iterates until the remaining vulnerabilities are reduced to an acceptable level of risk.

Within the context of secure plug-and-play interoperability, cybersecurity is the process and capability of preventing unauthorized access or modification, misuse, denial of use, or the unauthorized use of information that is stored on, accessed from, or transferred to and from a PHD/PoCD. The capability part of cybersecurity is information security controls related to both digital data and the relationships to safety and usability.
For PHDs/PoCDs, this standard defines a security baseline of application layer cybersecurity mitigation techniques for certain use cases or for times when certain criteria are met. This standard provides a scalable information security toolbox appropriate for PHD/PoCD interfaces, which fulfills the intersection of requirements and recommendations from National Institute of Standards and Technology (NIST) and the European Network and Information Security Agency (ENISA). This standard maps to the NIST cybersecurity framework [B15]; IEC TR 80001-2-2 [B8]; and the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme. The mitigation techniques are based on the extended CIA triad (Clause 4) and are described generally to allow manufacturers to determine the most appropriate algorithms and implementations.

This document provides quality requirements for health apps and defines a health app quality label in order to visualize the quality and reliability of health apps.
This document is applicable to health apps, which are a special form of health software. It covers the entire life cycle of health apps.
This document is intended for use by app manufacturers as well as app assessment organizations in order to communicate the quality and reliability of a health app. Consumers, patients, carers, health care professionals and their organizations, health authorities, health insurers and the wider public can use the health app quality label and report when recommending or selecting a health app for use, or for adoption in care guidelines, care pathways and care contracts.
NOTE 1   Health apps can be subject to national legislation, such as for medical devices.
NOTE 2   See Annex C for additional details on the scope.
Outside the scope of this document are guidelines to comply to the medical device regulation.

This document defines a nomenclature for communication of information from point-of-care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object-oriented information model that is for medical device communication.

This document specifies the common conventions required for the cart-to-host as well as cart-to-cart interchange of specific patient data (demographic, recording, ...), ECG signal data, ECG measurement and ECG interpretation results.
This document specifies the content and structure of the information which is to be interchanged between digital ECG carts and computer ECG management systems, as well as other computer systems where ECG data can be stored

The scope of this standard is a service-oriented medical device architecture and communication protocol specification for distributed system of Point-of-Care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices. It identifies the functional components, their communication relationships as well as the binding of the components and communication relationships to protocol specifications.

This document specifies a set of representational primitives and semantic relations needed for an unambiguous representation of explicit time-related expressions in health informatics. This document does not introduce or force a specific ontology of time, nor does it force the use of a fixed representation scheme for such an ontology. Rather this document provides a set of principles for syntactic and semantic representation that allow the comparability of specific ontologies on time, and the exchange of time-related information that is expressed explicitly.
This document applies to both the representation of actual phenomena occurring in the real world (e.g. registrations in medical records) and to the description of concepts (e.g. medical knowledge bases).
This document is applicable to
a)    developers of medical information systems where there might be a need for explicit time-related concepts for internal organization (e.g. temporal data bases, temporal reasoning systems),
b)    information modellers or knowledge engineers building models for the systems mentioned in a),
c)    experts involved in the development of semantic standards on precise subdomains in health care where time-related information needs to be covered, (e.g. in the study of pathochronology, i.e. the discipline dealing with the time course of specific diseases), and
d)    developers of interchange formats for messages in which time-related information is embedded.
This document is not intended to be used directly for
—          representing what is true in time,
—          reasoning about time, or
—          representation of metrological time.

ISO/IEEE 11073-10427:2018 establishes a normative defi nition of communication between devices containing a power source (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) in a manner that enables plug-and-play interoperability. Using existing terminology, information profi les, applica-tion profi le standards, and transport standards as defi ned in other ISO/IEEE 11073 standards, this standard de-fi nes a common core of communication functionality of personal health devices (PHDs) containing a battery, including: 1) current device power status (e.g., on mains or on battery); 2) power charge status (e.g., percent of full charge); and 3) estimated time remaining (e.g., minutes).

ISO 12052:2017, within the field of health informatics, addresses the exchange of digital images and information related to the production and management of those images, between both medical imaging equipment and systems concerned with the management and communication of that information.
ISO 12052:2017 facilitates interoperability of medical imaging equipment by specifying:
-      for network communications, a set of protocols to be followed by devices claiming conformance to this document;
-      the syntax and semantics of Commands and associated information which can be exchanged using these protocols;
-      for media communication, a set of media storage services to be followed by devices claiming conformance to this document, as well as a File Format and a medical directory structure to facilitate access to the images and related information stored on interchange media;
-      information that is to be supplied with an implementation for which conformance to this document is claimed.
ISO 12052:2017 does not specify:
-      the implementation details of any features of the DICOM standard on a device claiming conformance;
-      the overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming conformance to this document;
-      a testing/validation procedure to assess an implementation's conformance to this document.
ISO 12052:2017 pertains to the field of medical informatics. Within that field, it addresses the exchange of digital information between medical imaging equipment and other systems. Because such equipment may interoperate with other medical devices and information systems, the scope of this document needs to overlap with other areas of medical informatics. However, this document does not address the full breadth of this field.
ISO 12052:2017 has been developed with an emphasis on diagnostic medical imaging as practiced in radiology, cardiology, pathology, dentistry, ophthalmology and related disciplines, and image-based therapies such as interventional radiology, radiotherapy and surgery. However, it is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary, and other medical environments.
ISO 12052:2017 facilitates interoperability of systems claiming conformance in a multi-vendor environment, but does not, by itself, guarantee interoperability.

ISO - Corrected version

Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10417:2017 establishes a normative definition of communication between personal telehealth glucose meter devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and 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, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth glucose meters.

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth cardiovascular fitness and activity monitor devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) is established in this standard in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability is specified. A common core of communication functionality for personal telehealth cardiovascular fitness and activity monitor devices is defined in this standard.

Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to these scenarios and environments are also presented.

Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal strength fitness devices and managers (e.g., cell phones, personal computers, personal health appliances, and 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 optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth strength fitness devices. In this context, strength fitness devices are being used broadly to cover strength fitness devices that measure musculo-skeletal strength-conditioning activities.
Keywords: medical device communication, personal health devices, strength fitness equipment

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between sleep apnea breathing therapy equipment (SABTE) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes), in a manner that enables plug-and-play interoperability, is established in this standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for SABTE. In this context, SABTE is defined as a device that is intended to alleviate the symptoms of a patient who suffers from sleep apnea by delivering a therapeutic breathing pressure to the patient. SABTE is primarily used in the home health-care environment by a lay operator without direct professional supervision.

ISO corr

2014-03-04 GVN: Draft for minor revision received in ISO/CS (see notification of 2014-03-03 in dataservice).

ISO/IEEE 11073-10102:2014 extends the IEEE 11073-10101 Nomenclature by providing support for ECG annotation terminology. It may be used either in conjunction with other IEEE 11073 standards (e.g. ISO/IEEE 11073-10201:2001) or independently with other standards. The major subject areas addressed by the nomenclature include ECG beat annotations, wave component annotations, rhythm annotations, and noise annotations. Additional "global" and "per-lead" numeric observation identifiers, ECG lead systems, and additional ECG lead identifiers also are defined.

ISO/IEEE 11073-10418:2013 establishes a normative definition of communication between personal telehealth International Normalized Ratio (INR) devices (agents) and managers (e.g. cell phones, personal computers, personal health appliances and set top boxes) in a manner that enables plug-and-play interoperability. Work done in other ISO/IEEE 11073 standards is leveraged, including existing terminology, information profiles, application profile standards and transport standards. The use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability is specified. A common core of functionality of INR devices is defined in ISO/IEEE 11073-10418:2013. In the context of personal health devices, the measurement of the prothrombin time (PT) that is used to assess the level of anticoagulant therapy and its presentation as the International Normalized Ratio compared to the prothrombin time of normal blood plasma is referred to in INR monitoring. Applications of the INR monitor include the management of the therapeutic level of anticoagulant used in the treatment of a variety of conditions. The data modeling and its transport shim layer according to ISO/IEEE 11073-20601:2010 are provided by ISO/IEEE 11073:10418:2013, and the measurement method is not specified.

ISO 21549-2:2014 establishes a common framework for the content and the structure of common objects used to construct data held on patient healthcare data cards. It is also applicable to common objects referenced by other data objects.
ISO 21549-2:2014 is applicable to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
ISO 21549-2:2014 specifies the basic structure of the data, but does not specify or mandate particular data-sets for storage on devices.

ISO 21549-4:2014 is applicable to situations in which clinical data additional to the limited clinical data defined in ISO 21549‑3 is recorded on or transported by patient healthcare data cards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
ISO 21549-4:2014 specifies the basic structure of the data contained within the data object extended clinical data, but does not specify or mandate particular data sets for storage on devices.

ISO 21549-3:2014 is applicable to situations in which limited clinical data are recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
ISO 21549-3:2014 describes and defines the limited clinical data objects used in or referenced by patient healthcards using UML, plain text and abstract syntax notation (ASN.1).
ISO 21549-3:2014 specifies the basic structure of the data contained within the data object limited clinical data, but does not specify or mandate particular data sets for storage on devices.

ISO/IEEE 11073-10103:2014 extends the base nomenclature provided in IEEE 11073 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation are defined in this nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices require the management of summary interrogation information from all vendor devices and systems in a central system such as an Electronic Health Records (EHR) system or a device clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC) Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates the transfer of data from the vendor proprietary systems to the clinic EHR or device clinic management system.

ISO 21549-1:2013 defines a general structure for the different types of data to be defined in other parts of ISO 21549 using UML notation. ISO 21549 defines data structures held on patient healthcards compliant with the physical dimensions of ID-1 cards, as defined by ISO/IEC 7810.

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability is established in ISO/IEEE11073-10406:2012.
Appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models are leveraged. The use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability is specified. A common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices is defined. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analysing the detected electrical activity to determine known cardiac phenomena.
ISO/IEEE 11073-10406:2012 is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g. ECG and respiration rate).

Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10472:2012 establishes 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) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. ISO/IEEE 11073-10472:2012 defines a common core of communication functionality for personal telehealth medication monitor devices.

The application of the Ethernet family (IEEE Std 802.3-2008) of protocols for use in medical device communication is addressed in ISO/IEEE 11073-30400:2012. The scope is limited to referencing the appropriate Ethernet family specifications and calling out any specific special needs or requirements of the ISO/IEEE 11073 environment, with a particular focus on easing interoperability and controlling costs.

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication is established in ISO/IEEE 11073-10421:2012 between personal telehealth peak expiratory flow monitor devices and compute engines (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors is specified in telehealth environments restricting optionality in base frameworks in favor of interoperability. A common core of communication functionality is defined for personal telehealth peak expiratory flow monitor devices.

ISO/IEEE 11073-10471:2010 establishes a normative definition of the communication between independent living activity hubs and managers (e.g., cell phones, personal computers, personal health appliances and set top boxes) in a manner that enables plug-and-play (PnP) 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 favour of interoperability.
ISO/IEEE 11073-10471:2010 defines a common core of communication functionality for independent living activity hubs. In this context, independent living activity hubs are defined as devices that communicate with simple situation monitors (binary sensors), normalize information received from the simple environmental monitors, and provide this normalized information to one or more managers. This information can be examined (for example) to determine when a person's activities/behaviour have deviated significantly from what is normal for them such that relevant parties can be notified. Independent living activity hubs will normalize information from the following simple situation monitors (binary sensors) for the initial release of the proposed standard: fall sensor, motion sensor, door sensor, bed/chair occupancy sensor, light switch sensor, smoke sensor, (ambient) temperature threshold sensor, personal emergency response system (PERS), and enuresis sensor (bed-wetting).
ISO/IEEE 11073-10471:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and managers

ISO 21549‑8:2010 defines a way to facilitate access to distributed patient records and/or administrative information using healthcards. It defines the structure and elements of “links” typically stored in healthcards and representing references to individual patients' records as well as to subcomponents of them. Access control mechanisms, data protection mechanisms, access methods and other security services are outside the scope of ISO 21549‑8:2010.

ISO 21549-6:2008 is applicable to situations in which administrative data are recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
ISO 21549-6:2008 specifies the basic structure of the data contained within the data object administrative data, but does not specify or mandate particular data sets for storage on devices.
The detailed functions and mechanisms of the following services are not within the scope of this ISO 21549-6:2008, although its structures can accommodate suitable data objects elsewhere specified:
the encoding of free text data;
security functions and related services that are likely to be specified by users for data cards depending on their specific application, e.g. confidentiality protection, data integrity protection, and authentication of persons and devices related to these functions;
access control services that may depend on active use of some data card classes such as microprocessor cards;
the initialization and issuing process, which begins the operating lifetime of an individual data card, and by which the data card is prepared for the data to be subsequently communicated to it according to this part of ISO 21549.

This work item will address how procedures for identification of patients and r related objects can be carried out to minimize the risk of error with potential serious safety hazards. Patient related objects include pure information objects (records, referral messages, prescriptions, etc.) and physical objects obtained from the patient such as e.g. blood samples for biochemistry analysis, tissues for histopathology, organs for transplantation as well as objects intended to be used for a specific patient (a medication, a prosthesis, a transplant such as blood or blood product, special diets etc).

ISO/IEEE 11073-30200:2004 describes an IrDA-based, cable-connected local area network (LAN) for the interconnection of computers and medical devices and is suitable for new device designs, but is particularly targeted to modifications of legacy devices.
The term legacy devices refers to equipment that is
already in use in clinical facilities;in active production at the facilities of medical device manufacturers;beyond the initial stages of engineering development.

ISO/IEEE 11073-20101:2004 provides the upper layer [i.e., the International Organization for Standardization's (ISO's) open systems interconnection (OSI) application, presentation layer, and session layer] services and protocols for information exchange under the ISO/IEEE 11073 standards for medical device communications (MDC).
ISO/IEEE 11073-20101:2004 is the base standard of the ISO/IEEE 11073-20000 medical device application profiles (MDAP), as harmonized through the Committee for European Normalization (CEN) and ISO.

ISO/IEEE 11073-30300:2004 defines an IrDA-based transport profile for medical device communication that uses short-range infrared, as a companion standard to ISO/IEEE 11073-30200, which specifies a cable-connected physical layer.
ISO/IEEE 11073-30300:2004 also supports use cases consistent with industry practice for handheld personal digital assistants (PDAs) and network APs that support IrDA-infrared communication.

This document is concerned with QoS as it applies to interactions between components of distributed healthcare IT systems.  The scope is not limited to network infrastructures; it includes the QoS requirements of information storage and processing IT systems.  The related areas of security and financial cost considerations are not within the primary scope of the document, although they are considered briefly.  
Of course, an informatics system with a high QoS does not guarantee a high standard of healthcare in terms of clinical outcomes or patient care.  The quality of healthcare delivered to patients (the ultimate "users") depends upon a number of external factors such as the experience and competence of the healthcare professional(s) or institution(s) involved.  Potential QoS characteristics for the total healthcare delivery process such as mortality rate, clinical outcome, etc. are therefore not within the scope of this report.
The report contains no provisions to avoid the incorporation of bad or dangerous practice into healthcare IT systems.  It is possible to circumvent good clinical practice with technical solutions which may cause bad practice.  This vital issue is not covered by this report.  To take an example scenario:
A patient consults a doctor, who takes a blood sample and arranges to see the patient again in two weeks.
a)   A "good" practice doctor sees and reviews the blood test result as soon as it comes back from the laboratory and then files it if no action is required.
b)   A "bad" practice doctor sees and reviews the blood test results only when he reviews the patient's case on the patient's next visit.  This case is not defensible if the patient has a preventable adverse event and takes legal action (source: MPS Casebook Summer 1997).  
The healthcare information system put into the medical practice in electronic form could build-in either practice (a) or practice (b).  This report does not consider the clinical quality assurance mechanism fo

ISO 18812:2003 specifies general messages for electronic information exchange between analytical instruments (AIs) and laboratory information systems (LISs) within a clinical laboratory. It is applicable to the specialities of clinical chemistry/biochemistry, haematology, toxicology, microbiology, virology and immunology. It is not applicable to the blood transfusion and blood bank speciality
ISO 18812:2003 covers the specification of messages used by communicating parties and the syntax in which they are communicated. It does not cover the transport mechanisms used for the message interchange.
ISO 18812:2003 is applicable only to character-based message information. It is not applicable to the communication of graphical or image information.

This standard specifies the base set of Participant Key Purposes (PKPs) for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.

ISO 21549-7:2016 applies to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
ISO 21549-7:2016 specifies the basic structure of the data contained within the medication data object, but does not specify or mandate particular data sets for storage on devices.
The purpose of this document is for cards to provide information to other health professionals and to the patient or its non-professional caregiver.
It can also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets.
Medication data include the following four components:
-      medication notes: additional information related to medication and the safe use of medicines by the patient such as medication history, sensitivities and allergies;
-      medication prescriptions: to carry a new prescription from the prescriber to the dispenser/pharmacy;
-      medication dispensed: the records of medications dispensed for the patient;
-      medication references: pointers to other systems that contain information that makes up medication prescription and the authority to dispense.
The following topics are beyond the scope of this document:
-      physical or logical solutions for the practical functioning of particular types of data cards;
-      how the message is processed further "downstream" of the interface between two systems;
-      the form which the data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere.
NOTE          Not only does the definition of "medicinal products" differ from country to country, but also the same name can relate to entirely different products in some countries. Therefore, it is important to consider the safety of the patient when the card is used across borders.
ISO 21549-7:2016 describes and defines the Medication data objects used within or referenced by patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
ISO 21549-7:2016 does not describe nor define the common objects defined within ISO 21549-2, even though they are referenced and utilized within this document.

ISO 21549-5:2015 describes and defines the basic structure of the identification data objects held on healthcare data cards, but does not specify particular data sets for storage on devices.
The detailed functions and mechanisms of the following services are not within the scope of this part of ISO 21549 (although its structures can accommodate suitable data objects elsewhere specified):
-      security functions and related services that are likely to be specified by users for data cards depending on their specific application, e.g. confidentiality protection, data integrity protection and authentication of persons and devices related to these functions;
-      access control services;
-      the initialization and issuing process (which begins the operating lifetime of an individual data card, and by which the data card is prepared for the data to be subsequently communicated to it according to this part of ISO 21549).
The following topics are therefore beyond the scope of this part of ISO 21549:
-      physical or logical solutions for the practical functioning of particular types of data card;
-      the forms that data take for use outside the data card, or the way in which such data are visibly represented on the data card or elsewhere.

ISO/IEEE 11073-10419:2016 defines the device specialization for the insulin pump, being a specific agent type, and provides a description of the device concepts, its capabilities, and its implementation according to this standard.
ISO/IEEE 11073-10419:2016 is based on IEEE Std 11073-20601-2014, which in turn draw information from both ISO/IEEE 11073-10201:2004 [B7]2 and ISO/IEEE 11073-20101:2004 [B8]. The medical device encoding rules (MDERs) used within this standard are fully described in IEEE Std 11073-20601-2014.
ISO/IEEE 11073-10419:2016 reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B6] and adds new nomenclature codes for the purposes of this standard. Among this standard and IEEE Std 11073-20601-2014, all required nomenclature codes for implementation are documented.

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard defines a common framework for making an abstract model of personal health data available in  transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.

Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10420:2012 establishes a normative definition of the communication between personal body composition analyzing 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 IEEE 11073-20601 information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. ISO/IEEE 11073-10420:2012 defines a common core of communication functionality for personal telehealth body composition analyzer devices. In this context, body composition analyzer devices are being used broadly to cover body composition analyzer devices that measure body impedances, and compute the various body components including body fat from the impedance.

ISO/IEEE 11073-10404:2010 establishes a normative definition of communication between personal telehealth pulse oximeter devices and computer engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play (PnP) interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards and transport standards. It specifies the use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability.
ISO/IEEE 11073-10404:2010 defines a common core of communication functionality for personal telehealth pulse oximeters and addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.

ISO/IEEE 11073-10408:2010 establishes a normative definition of communication between personal telehealth thermometer devices and computer engines (e.g., cell phones, personal computers, personal health appliances, and 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, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth thermometers.
ISO/IEEE 11073-10408:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.

ISO/IEEE 11073-10415:2010 establishes a normative definition of communication between personal telehealth weighing scale devices and computer engines (e.g., cell phones, personal computers, personal health appliances, and 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, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth weighing scales.
ISO/IEEE 11073-10415:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.

ISO/IEEE 11073-10407:2010 establishes a normative definition of communication between personal telehealth blood pressure monitor devices and computer engines (e.g., cell phones, personal computers, personal health appliances, and 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, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth blood pressure monitors.
ISO/IEEE 11073-10407:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.