M/255 - Health care informatics

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 patientheld
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, even
though they are referenced and utilized within this document.

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.

This part of ISO 21549 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.

This part of ISO 21549 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.

EN ISO 21549-3 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. This part of ISO 21549 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).” This part of ISO 21549 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. In particular the data contained within the data objects in Limited clinical data are intended to aid the delivery of emergency care, whilst are by themselves neither intended, nor fit for purpose for the total of information provision for the delivery of emergency care. 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): - the encoding of free text data; - security functions and related services which are likely to be specified by users for data cards depending on their specific application, for example: confidentiality protection, data integrity protection, and authentication of persons and devices related to these functions; - access control services which may depend on active use of some data card classes such as microprocessor cards; - the initialisation 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 cards; - how the message is processed further "downstream" of the interface between two systems; - the form which data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere.

EN ISO 21549-2 establishes a common framework for the content and the structure of common objects used to construct or referenced by other data objects data held on patient healthcare data cards. This part of ISO 21549 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. This part of ISO 21549 specifies the basic structure of the 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 part of ISO 21549, (although its structures can accommodate suitable data objects elsewhere specified): - the encoding of free text data; - security functions and related services which are likely to be specified by users for data cards depending on their specific application, for example: confidentiality protection, data integrity protection, and authentication of persons and devices related to these functions; - access control services which 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). 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 cards; - how the message is processed further ‘downstream’ of the interface between two systems; - the form which data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere.

EN ISO 21549-4 is applicable to situations in which such data is recorded on or transported by patient healthcare data cards compliant with the physical dimensions of ID-1 cards defined by ISO 7810. This International Standard 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. In order to facilitate interoperability, whenever an application is built for use in the healthcare domain in compliance with this International standard, data items required for that application shall be drawn from the list of objects (some of which are extensible) as provided in clauses 6 to 8. These shall then be used in conjunction with other data defined in other parts of this International Standard. The detailed functions and mechanisms of the following services are not within the scope of this International Standard, (although its structures can accommodate suitable data objects elsewhere specified): - the encoding of free text data - security functions and related services which are likely to be specified by users for data cards depending on their specific application, for example: confidentiality protection, data integrity protection, and authentication of persons and devices related to these functions; - access control services which may depend on active use of some data card classes such as microprocessor cards; - the initialisation 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 Draft international standard). The following topics are therefore beyond the scope of this International Standard: - 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 data takes for use outside the data card, or the way in which such data is visibly represented on the data card or

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.

This part of ISO 21549 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.

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.

This part of ISO 21549 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 this part of ISO 21549.

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.

1.1   Purpose
This European Standard provides a structure aiding the representation, e.g. systematic terms or coding systems, of dedicated kinds of property, including dedicated kinds of quantity, in laboratory medicine.  The structure for representation is intended to facilitate the unambiguous communication of messages containing information about properties.
1.2   Field of application
This European Standard is applicable to all branches of laboratory medicine and other bodies offering laboratory analytic services. Examinations performed in the physician's office, at the bedside, or in the home are considered to be part of the laboratory medicine domain and thus this European Standard applies.
1.3   Uses
This structure for representation constitutes the essential basis for development of nomenclatures and coding systems intended for use in unambiguous and fully informative communication about properties, which fall within the field of application. Every such communication, including requests to and reports from clinical laboratories, and information retrieval for management reporting, research and reimbursement, will require additional information which is outside the scope of this European Standard.
1.4   Limitations
It should be emphasized that it is not the purpose of this European Standard to standardize the language used by health care practitioners in requesting or reporting clinical laboratory data.  It may, however, be used as a guide by those who wish to adopt systematic terms for routine requesting and reporting of laboratory data.
The syntax used for representing dedicated kinds-of-property is outside the scope of this European Standard, as are syntactic rules for the construction of codes in coding schemes.
The purpose is not to standardize the presentation of properties or kinds-of-property in user interfaces of computer systems nor the presentation in printed documents.

1.1   Purpose
This European Standard provides a structure aiding the representation, e.g. systematic terms or coding systems, of dedicated kinds of property, including dedicated kinds of quantity, in laboratory medicine.  The structure for representation is intended to facilitate the unambiguous communication of messages containing information about properties.
1.2   Field of application
This European Standard is applicable to all branches of laboratory medicine and other bodies offering laboratory analytic services. Examinations performed in the physician's office, at the bedside, or in the home are considered to be part of the laboratory medicine domain and thus this European Standard applies.
1.3   Uses
This structure for representation constitutes the essential basis for development of nomenclatures and coding systems intended for use in unambiguous and fully informative communication about properties, which fall within the field of application. Every such communication, including requests to and reports from clinical laboratories, and information retrieval for management reporting, research and reimbursement, will require additional information which is outside the scope of this European Standard.
1.4   Limitations
It should be emphasized that it is not the purpose of this European Standard to standardize the language used by health care practitioners in requesting or reporting clinical laboratory data.  It may, however, be used as a guide by those who wish to adopt systematic terms for routine requesting and reporting of laboratory data.
The syntax used for representing dedicated kinds-of-property is outside the scope of this European Standard, as are syntactic rules for the construction of codes in coding schemes.
The purpose is not to standardize the presentation of properties or kinds-of-property in user interfaces of computer systems nor the presentation in printed documents.

This document is intended for use by parties to the design, development, acquisition, use and monitoring of health-care related information and information systems. It provides a list of units of measurement to be used in representing values of measurable quantities in health sciences.
The International System of Units forms the basis for this EN. Units with their associated kinds-of-quantity are arranged in order of dimension in Tables 1, 2 and 4 (Clause 5), and in Annex A.
Different kinds-of-quantity may apply to a given combination of component(s) and system. Often the different quantities are interconvertible and examples of such interconvertibility are given in Annex C.
Tables of conversion factors (Annex A) are provided from units in current use to SI units or their multiples.
To represent the result of a measurement (Clause 6), this EN addresses requirements for the following:
3   relational operator (Clause 4)
3   numerical value (Subclause 6.1)
3   uncertainty of measurement (Subclause 6.2; Annex D)
3   unit of measurement (Clause 5).
This EN covers the requirements for representation of these data elements in displayed and printed form, and provides an approach for support of languages in non-Roman alphabets (Clause 7).
The scope of this standard is limited to textual representation. Support is not provided for the display or printing of images or graphs.
This standard does not cover the requirements for expression of the results of measurements in speech, speech synthesis or handwriting. It does not cover the form and syntax of requests for clinical measurements, nor detailed aspects of data transmission. It refers the user to other CEN standards that address the detailed specification of the interchange format. It does not address the syntax for recording of natural-language statements about quantities, such as those used in recording information about drugs dispensed or about treatment of patients. It does not cover the units of financial quantitie

This document is intended for use by parties to the design, development, acquisition, use and monitoring of health-care related information and information systems. It provides a list of units of measurement to be used in representing values of measurable quantities in health sciences.
The International System of Units forms the basis for this EN. Units with their associated kinds-of-quantity are arranged in order of dimension in Tables 1, 2 and 4 (Clause 5), and in Annex A.
Different kinds-of-quantity may apply to a given combination of component(s) and system. Often the different quantities are interconvertible and examples of such interconvertibility are given in Annex C.
Tables of conversion factors (Annex A) are provided from units in current use to SI units or their multiples.
To represent the result of a measurement (Clause 6), this EN addresses requirements for the following:
¾   relational operator (Clause 4)
¾   numerical value (Subclause 6.1)
¾   uncertainty of measurement (Subclause 6.2; Annex D)
¾   unit of measurement (Clause 5).
This EN covers the requirements for representation of these data elements in displayed and printed form, and provides an approach for support of languages in non-Roman alphabets (Clause 7).
The scope of this standard is limited to textual representation. Support is not provided for the display or printing of images or graphs.
This standard does not cover the requirements for expression of the results of measurements in speech, speech synthesis or handwriting. It does not cover the form and syntax of requests for clinical measurements, nor detailed aspects of data transmission. It refers the user to other CEN standards that address the detailed specification of the interchange format. It does not address the syntax for recording of natural-language statements about quantities, such as those used in recording information about drugs dispensed or about treatment of patients. It does not cover the units of financial quantitie

This European Standard specifies a procedure for the registration of coding schemes used in health for any purpose. It also specifies the allocation of a unique Health Coding Scheme Designator to each registered coding scheme. A code value can thus be given an unambiguous meaning by association with a HCD.
The method by which a HCD and a code value are associated is not defined by this European Standard. The association is achieved in any manner appropriate to the syntax used.
This European Standard does not specify the coding schemes to be used in health, give guidance on their selection nor describe methods of representing information in coded form.
Coding schemes maintained by different Responsible Organisations may also be used in combinations. Such combinations can be considered as templates, and as such they lie outside the scope of the current document.

1.1   Main purpose
The purpose of this European Standard is to establish the characteristics and the conformance rules required to synthetically describe the organisation and content of a terminological system in health. This European Standard has been developed to allow the production of specific standards on categorial structures for particular healthcare subject fields with the minimum requirements to support meaningful exchange of information.
This European Standard is applicable to:
- facilitate the construction of new terminological systems in a regular form which will increase their coherence and expressiveness;
- facilitate maintenance of terminological systems;
- increase consistency and coherence of existing terminological system;
- allow systematic cross-references between items of different types of terminological systems;
- facilitate convergence among terminological systems;
- make explicit the overlap between different health care domains terminological systems;
- provide elements for negotiation about integration of different terminological systems into information systems between the respective developers;
- enable the systematic evaluation of terminological systems.
1.2   Target groups
The target groups for this European Standard are:
- designers of specialised standard healthcare terminological categorial structures;
- developers of healthcare terminological systems including classifications and coding systems;
- producers of services for terminological systems and designers of software including natural language processing;
- information modellers, knowledge engineers, and standards developers building models for health information management systems;
- developers of information systems that require an explicit system of concepts;
- developers of mark-up standards for representation of healthcare documents
(continued)

This European Standard specifies a procedure for the registration of coding schemes used in health for any purpose. It also specifies the allocation of a unique Health Coding Scheme Designator to each registered coding scheme. A code value can thus be given an unambiguous meaning by association with a HCD.
The method by which a HCD and a code value are associated is not defined by this European Standard. The association is achieved in any manner appropriate to the syntax used.
This European Standard does not specify the coding schemes to be used in health, give guidance on their selection nor describe methods of representing information in coded form.
Coding schemes maintained by different Responsible Organisations may also be used in combinations. Such combinations can be considered as templates, and as such they lie outside the scope of the current document.

1.1   Main purpose
The purpose of this European Standard is to establish the characteristics and the conformance rules required to synthetically describe the organisation and content of a terminological system in health. This European Standard has been developed to allow the production of specific standards on categorial structures for particular healthcare subject fields with the minimum requirements to support meaningful exchange of information.
This European Standard is applicable to:
- facilitate the construction of new terminological systems in a regular form which will increase their coherence and expressiveness;
- facilitate maintenance of terminological systems;
- increase consistency and coherence of existing terminological system;
- allow systematic cross-references between items of different types of terminological systems;
- facilitate convergence among terminological systems;
- make explicit the overlap between different health care domains terminological systems;
- provide elements for negotiation about integration of different terminological systems into information systems between the respective developers;
- enable the systematic evaluation of terminological systems.
1.2   Target groups
The target groups for this European Standard are:
- designers of specialised standard healthcare terminological categorial structures;
- developers of healthcare terminological systems including classifications and coding systems;
- producers of services for terminological systems and designers of software including natural language processing;
- information modellers, knowledge engineers, and standards developers building models for health information management systems;
- developers of information systems that require an explicit system of concepts;
- developers of mark-up standards for representation of healthcare documents
(continued)

The resolution 679 of CEN/TC 251 decides on the creation of a new WI under VA/ISO (ISO 18812) for the revision of ENV 13728 (NT/010626)

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 methodology has been applied in a first health care domain through the work of PT008 (WI 27). A technical report is required which fully defines the methodology used and extends it to meet the requirements of future messages development activities. An associated procedure is required to manage a directory of objects and attributes.

1.1 This European Prestandard specifies general administrative messages for electronic information exchange between healthcare information systems. 1.2 The messages defined in this European Prestandard provide for an identification framwork for both administrative and non-administrative purposes.1.3 The messages identified in this European Prestandard pay especial attention to identification of both the individual and records pertaining to them and the registration of the individual on healthcare information systems.

This European Prestandard establishes the Healthcare Information Framework (HIF) as a logical mappling between the healthcare environment and informatics applications which support and facilitate clinical and other functions. This European Prestandard specifies the set of requirements, recommendations and guidelines which apply to developments within CEN/TC 251 which enable consistent development and evolution of healthcare domain specific informatics standards.

This document specifies a set of representational primitives and semantic relations required 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 is applicable to:
1)   developers of medical information systems in which the need is felt to have explicit time-related concepts for internal organization (e.g. temporal data bases, temporal reasoning systems);
2)   information modellers or knowledge engineers building models for the systems mentioned in (1);
3)   experts involved in the development of semantic standards on precise subdomains in health care where time-related information need to be covered, (e.g. in the study of Pathochronology, i.e. the discipline dealing with the time course of specific diseases);
4)   developers of interchange formats for messages in which time-related information is embedded.
This document is not intended to be used directly for:
1)   representing what is true in time;
2)   reasoning about time;
3)   representation of metrological time (which is covered in other standards).

This document specifies a set of representational primitives and semantic relations required 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 is applicable to:
1)   developers of medical information systems in which the need is felt to have explicit time-related concepts for internal organization (e.g. temporal data bases, temporal reasoning systems);
2)   information modellers or knowledge engineers building models for the systems mentioned in (1);
3)   experts involved in the development of semantic standards on precise subdomains in health care where time-related information need to be covered, (e.g. in the study of Pathochronology, i.e. the discipline dealing with the time course of specific diseases);
4)   developers of interchange formats for messages in which time-related information is embedded.
This document is not intended to be used directly for:
1)   representing what is true in time;
2)   reasoning about time;
3)   representation of metrological time (which is covered in other standards).

This part of the European Prestandard specifies the information to be registeredfor information objects used in EDI for the purpose of information interchange related to healthcare. The information objects and the information relating to them are recorded in a way which is designed to be independent of interchange format and to facilitate the use of the information objects to construct imple- mentable message specifications. This E.P. does not cover the registration of information objects which fall within layers 1-7 of the Basic Reference Model ofOpen Systems Interconnection ISO 7498.

This part of the European Prestandard specifies the information to be registeredfor information objects used in EDI for the purpose of information interchange related to healthcare. The information objects and the information relating to them are recorded in a way which is designed to be independent of interchange format and to facilitate the use of the information objects to construct imple- mentable message specifications. This E.P. does not cover the registration of information objects which fall within layers 1-7 of the Basic Reference Model ofOpen Systems Interconnection ISO 7498.

This part of ISO 21549 is applicable to situations in which such data are recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO 7810. This part of ISO 21549 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 part of ISO 21549 is for cards to provide information to other health professionals and to the patient or to their non-professional care giver. It may also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets. Medication data includes the following four components: medication notes: the list of all medication for a patient; medication prescriptions: to carry a new prescription from the prescriber to the dispenser/pharmacy; medication dispensed: the records of medications bought by the patient; medication references: pointers to other systems that contain information that makes up a medication prescription and the authority to dispense.

ISO 21549-7:2007 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 21549-7:2007 is applicable to situations in which such data are recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO 7810.
ISO 21549-7:2007 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 ISO 21549-7:2007 is for cards to provide information to other health professionals and to the patient or its non-professional care giver.
It may also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets.

ISO 21549-5:2008 establishes a common framework for the content and the structure of identification data held on healthcare data cards. It specifies the basic structure of the data, 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 ISO 21549-5:2008 (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 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 ISO 21549-5:2008.

ISO 21549-5:2008 establishes a common framework for the content and the structure of identification data held on healthcare data cards. It specifies the basic structure of the data, 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 ISO 21549-5:2008 (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 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 ISO 21549-5:2008.

This European Prestandard specifies the necessary requirements (clauses 5, 6 and 7) for the categorial structure of systems of concepts for medical device groups (clause 4). This prestandard is meant to be used by organizations involved with the development or maintenance of nomenclatures and coding systems for medical devices, and by designers of databases or information systems involving medical devices.

The purpose of this European PreStandard is to define the semantic categories related to the identification of medicinal products and to establish a categorial structure that allows the description of the organization of the semantic categories representing the underlying system of characteristics.

This European Prestandard specifies the necessary requirements (clauses 5, 6 and 7) for the categorial structure of systems of concepts for medical device groups (clause 4). This prestandard is meant to be used by organizations involved with the development or maintenance of nomenclatures and coding systems for medical devices, and by designers of databases or information systems involving medical devices.

The purpose of this European PreStandard is to define the semantic categories related to the identification of medicinal products and to establish a categorial structure that allows the description of the organization of the semantic categories representing the underlying system of characteristics.

This European Prestandard defines a digital signature algorithm for use in European Health Care should such an algorithm be required. The full functionality of the use of this core algorithm for various applications, requires additional specifications of protocol elements related to the application requirements. These may be user agreements and/or may be parts of future standards for e.g. security of health care communication or health care records.

This European Prestandard specifies a procedure for the registration of infor- mation objects used in electronic data interchange messages (EDI) for the purpose of information interchange related to healthcare. The naming and definition of the information objects is covered in Part 1 of this European Prestandard. This European Prestandard does not specify the file organisation techniques, storage media, programming languages, etc., to be used in its implementation.

Migrated from Progress Sheet (TC Comment) (2000-07-10): CEN report in course of approval of BT C 36/1996 N 4507 (TD: 1996-06-05) ++ RES BT 75/1996 document as CEN report (268/1995 - see Edward Hirst)

This European Prestandard establishes a common framework for the content and the structure of identification, administrative and common clinical data. It applies exclusively to situations in which such data are recorded on or transported by Intermittently Connected Devices (ICDs) which are intended for use in healthcare. This European Prestandard specifies the basic structure of the data, but does not specify particular data-sets for storage on devices.

ISO 21549-2:2004 establishes a common framework for the content and the structure of common objects used to construct or referenced by other data-object data held on patient healthcare data cards.
It is applicable to situations in which such data are recorded on or transported by patient healthcards whose physical dimensions are compliant with those of ID-1 cards as defined by ISO/IEC 7810.
It specifies the basic structure of the data, but does not specify or mandate particular data-sets for storage on devices.

ISO 21549-3:2004 describes and defines the limited clinical data objects used in or referenced by patient-held health data cards using UML, plain text and abstract syntax notation (ASN.1).
It is applicable to situations in which such data are recorded on or transported by patient healthcards whose physical dimensions are compliant with those of ID-1 cards as defined by ISO/IEC 7810.
It 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. In particular, the data contained within the data objects in limited clinical data are intended to aid the delivery of emergency care, but are by themselves neither intended, nor suitable, for the provision of all the information required.

This part of ISO 21549 is applicable to situations in which such data are recorded on or transported by patient healthcare data cards compliant with the physical dimensions of ID-1 cards defined by ISO 7810. This part of ISO 21549 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. In order to facilitate interoperability, whenever an application is built for use in the healthcare domain in compliance with ISO 21549, data items required for that application shall be drawn from the list of objects (some of which are extensible) as provided in Clauses 6 and 7. These shall then be used in conjunction with other data defined in other parts of ISO 21549. 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 specified elsewhere): the encoding of free text data; security functions and related services, which are likely to be specified by users for data cards depending on their specific application, for example: confidentiality protection, data integrity protection, and authentication of persons and devices related to these functions; access control services, which 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). 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 cards; how the message is processed further "downstream" of the interface between two systems; the form which data takes for use outside the data card, or the way in which such data are visibly represented on the data card or elsewhere.

ISO 21549-4:2006 is applicable to situations in which such data are recorded on or transported by patient healthcare data cards compliant with the physical dimensions of ID-1 cards defined by ISO 7810.
ISO 21549-4:2006 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 21549-2:2004 establishes a common framework for the content and the structure of common objects used to construct or referenced by other data-object data held on patient healthcare data cards.
It is applicable to situations in which such data are recorded on or transported by patient healthcards whose physical dimensions are compliant with those of ID-1 cards as defined by ISO/IEC 7810.
It specifies the basic structure of the data, but does not specify or mandate particular data-sets for storage on devices.

ISO 21549-3:2004 describes and defines the limited clinical data objects used in or referenced by patient-held health data cards using UML, plain text and abstract syntax notation (ASN.1).
It is applicable to situations in which such data are recorded on or transported by patient healthcards whose physical dimensions are compliant with those of ID-1 cards as defined by ISO/IEC 7810.
It 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. In particular, the data contained within the data objects in limited clinical data are intended to aid the delivery of emergency care, but are by themselves neither intended, nor suitable, for the provision of all the information required.

ISO 21549-1:2004 is Part 1 of a multi-part standard that defines data structures held on patient healthcards compliant with the physical dimensions of ID-1 cards as defined by ISO/IEC 7810. This part of ISO 21549 does not apply to multiapplication cards. It defines a general structure for the different types of data defined in the other parts of the standard using UML notation.