ISO 21549-7:2024 健康情報学 | ページ 6

3.1

attribute

characteristic of an object or entity

3.2

batch

amount of material which is uniform in character and quantity as shown by compliance with production and quality assurance test requirements and produced during a defined validated process of manufacture

3.3

coding scheme

collection of rules that maps the elements of one set onto the elements of a second set

[SOURCE:ISO/TS 21089:2018, 3.33]

3.4

data object

instance of some information object class (3.10) , being composed of a set of fields which conform to the field specifications of the class

3.5

dispenser

healthcare professional (3.9) which is a representation of an individual, professionally responsible for filling/dispensing the prescription (3.21)

Note 1 to entry: This is usually the pharmacist but it can be other individuals according to local jurisdictions.

3.6

healthcare

care

activities, services or supplies related to the health of an individual

Note 1 to entry: This includes more than performing procedures for subjects of care. It includes, for example, the management of information about patients, health status and relations within the healthcare framework.

[SOURCE:ISO 13940:2015, 3.1.1, modified — The preferred term “care” has been added; “care activities” has been replaced by “activities”, “management or supplies” has been replaced by “supplies”; in Note 1 to entry “healthcare delivery framework and may also include the management of clinical knowledge” has been replaced by “healthcare framework”.]

3.7

healthcare data card

machine-readable card conformant to specific requirements intended for use within the healthcare domain

Note 1 to entry: The requirements are given in ISO/IEC 7810.

3.8

healthcare party

organization (3.15) or person involved in the direct or indirect provision of healthcare services to an individual or to a population

3.9

healthcare professional

person entrusted with the direct or indirect provision of defined healthcare services to a subject of care (3.24) or a population of subjects of care

3.10

information object class

set of fields, forming a template for the definition of a potentially unbounded collection of information objects, the instances of the class

[SOURCE:ISO/IEC 8824-2:2021, 3.4.10, modified — Note 1 to entry has been removed.]

3.11

ingredient

substance (3.25) included as a component in a product

Note 1 to entry: In this context, product refers to pharmaceutical product (3.18) .

3.12

magistral medicinal product

extemporaneous medicinal product

medicinal product (3.13) manufactured in a pharmacy or pharmacy department, which is based on a recipe and intended to be used for one and only one subject of care (3.24)

Note 1 to entry: A magistral/extemporaneous medicinal product is also a pharmaceutical product (3.18) .

3.13

medicinal product

substance (3.25) or combination of substances, which can be administered to human beings or animals for treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify physiological functions

Note 1 to entry: A medicinal product may contain one or more manufactured items and one or more pharmaceutical products (3.18) .

Note 2 to entry: In certain jurisdictions, a medicinal product is be defined as any substance or combination of substances which can be used to make a medical diagnosis.

3.14

medicinal product package

delivery unit of a medicinal product (3.13) in an outer container (3.16)

3.15

organization

unique framework of authority within which a person or persons act, or are designated to act towards some purpose

Note 1 to entry: Groupings or subdivisions of an organization may also be considered as organizations where there is a need to identify them for information interchange.

3.16

outer container

container that serves as an external layer of a package

3.17

payment guarantor

organization (3.15) responsible for the total or partial reimbursement or payment of the price of the medicinal product (3.13)

3.18

pharmaceutical product

qualitative and quantitative composition of a medicinal product (3.13) in the dose form approved for administration in line with the regulated product information

Note 1 to entry: A medicinal product may contain one or more pharmaceutical products.

Note 2 to entry: In many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item must undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.

[SOURCE:ISO 11616:2017, 3.1.24, modified — “administration” has been replaced by “administration in line with the regulated product information”; a new note 1 to entry has been added, the original note 1 to entry has become note 2 to entry.]

3.19

prescriber

healthcare professional (3.9) authorized to issue prescriptions (3.21)

3.20

prescribing

process of creating a prescription (3.21)

3.21

prescription

direction created by an authorized healthcare professional (3.9) , to instruct a dispensing agent regarding the preparation and use of a medicinal product (3.13) or medicinal appliance to be taken or used by a subject of care (3.24)

3.22

prescription item

specification created by an authorized healthcare professional (3.9) , to instruct a dispensing agent regarding the preparation and use of single medicinal product (3.13) /medicinal appliance or to inform other parties following dispensing regarding the preparation and use of a single dispensed medicinal product/medicinal appliance

Note 1 to entry: A prescription item may contain administrative details needed for dispensing or derived from dispensing, but does not contain information about the prescriber (3.19) or the subject of care (3.24) for whom the prescription item is prescribed or to whom it has been dispensed.

3.23

prescription set

collection of one or more prescription item(s) (3.22) prescribed and/or dispensed as a unit

3.24

subject of care

person or defined group of persons receiving or registered as eligible to receive healthcare services or having received healthcare services

3.25

substance

matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical

Note 1 to entry: Substances can be either single substances mixture substances or one of a group of specified substances. Single substances shall be defined using a minimally sufficient set of data elements divided into five types: chemical, protein, nucleic acid, polymer and structurally diverse. Substances may be salts, solvates, free acids, free bases, mixtures of related compounds that are either isolated or synthesized together. Pharmacopoeial terminology and defining characteristics will be used when available and appropriate. Defining elements are dependent on the type of substance.

Note 2 to entry: Discrete existence refers to the ability of a substance to exist independently of any other substance. Substances can either be well-defined entities containing definite chemical structures, synthetic (i.e. isomeric mixtures) or naturally-occurring (i.e. conjugated oestrogens) mixtures of chemicals containing definite molecular structures or materials derived from plants, animals, microorganisms or inorganic matrices for which the chemical structure may be unknown or difficult to define. Substances may be salts, solvates, free acids, free bases, mixtures of related compounds that are either isolated or synthesized together.

[SOURCE:ISO 11238:2018, 3.84, modified — The original Note 1 to entry has been deleted, Notes 2 and 3 to entry have been adapted.]