27 éléments avec cette étiquette.
EnglishFrançaisany software, or any combination of hardware and software, intended by the manufacturer to be used by a natural person, for the processing of electronic health data, specifically for providing information on the health of natural persons, or the delivery of care for purposes other th...
EnglishFrançaisa discrete part of software which provides a specific functionality or performs specific functions or procedures and which can operate independently or in conjunction with other componentsune partie distincte d’un logiciel qui propose une fonctionnalité spécifique ou exécute des fonc...
EnglishFrançaisan incident or malfunctioning of an AI system that directly or indirectly leads to any of the following:---- (a) the death of a person, or serious harm to a person’s health;---- (b) a serious and irreversible disruption of the management or operation of critical infrastructure;---- (...
the processing of electronic health data for the purposes set out in Chapter IV of this Regulation, other than the initial purposes for which they were collected or produced Art.
EnglishFrançaisthe combination of the probability of an occurrence of harm and the severity of that harmla combinaison de la probabilité d’un préjudice et de la sévérité de celui-ciArt.
the recording of health data in an electronic format, through the manual entry of such data, through the collection of such data by a device, or through the conversion of non-electronic health data into an electronic format, to be processed in an EHR system or a wellness application Art.
EnglishFrançaisthe supply of an AI system for first use directly to the deployer or for own use in the Union for its intended purpose la fourniture d’un système d’IA en vue d’une première utilisation directement au déployeur ou pour usage propre dans l’Union, conformément à la destination du systèm...
the processing of electronic health data for the provision of healthcare, in order to assess, maintain or restore the state of health of the natural person to whom those data relate, including the prescription, dispensation and provision of medicinal products and medical devices, as well as for rele...
data concerning health and genetic data, processed in an electronic form Art. 2(2)(a) EHDS.
electronic health data other than personal electronic health data, including both data that have been anonymised so that they no longer relate to an identified or identifiable natural person (the ‘data subject’) and data that have never related to a data subject Art.
EnglishFrançaisa service, supported by an EHR system, that enables health professionals to access data of natural persons under their treatment (Art.
EnglishFrançaisa natural or legal person, including Union institutions, bodies, offices or agencies, which has been granted lawful access to electronic health data for secondary use pursuant to a data permit, a health data request approval or an access approval by an authorised participant in Healt...
|---|---| |English|Français| any natural or legal person, public authority, agency or other body in the healthcare or the care sectors, including reimbursement services where necessary, as well as any natural or legal person developing products or services intended for the health, healthcare or care...
EnglishFrançaisa software component of the EHR system which provides logging information related to access by health professionals or other individuals to priority categories of personal electronic health data established under this Regulation, in the format defined in point 3.2.
EnglishFrançaisa software component of the EHR system which provides and receives personal electronic health data under a priority category for primary use established under this Regulation in the European electronic health record exchange format provided for in this Regulation and which is indepen...
a collection of electronic health data related to a natural person and collected in the health system, processed for the purpose of the provision of healthcare Art.
any system whereby the software, or a combination of the hardware and the software of that system, allows personal electronic health data that belong to the priority categories of personal electronic health data established under this Regulation to be stored, intermediated, exported, imported, conve...
personal or non-personal electronic health data Art. 2(2)(c) EHDS.
an online service, such as a portal or an application or mobile devices, that enables natural persons not acting in a professional capacity to access their own electronic health data or the electronic health data of those natural persons whose electronic health data they are legally authorised to ac...
a structured collection of electronic health data Art. 2(2)(w) EHDS.
a dataset the re-use of which is associated with significant benefits due to its relevance for health research Art. 2(2)(x) EHDS.
a collection of dataset descriptions, arranged in a systematic manner and including a user-oriented public part, in which information concerning individual dataset parameters is accessible by electronic means through an online portal Art.
the degree to which the elements of electronic health data are suitable for their intended primary use and secondary use Art. 2(2)(z) EHDS.
a graphic diagram, including a scale, describing the data quality and conditions of use of a dataset Art. 2(2)(aa) EHDS.
an administrative decision issued to a health data user by a health data access body to process certain electronic health data specified in the data permit for specific secondary use purposes, based on conditions laid down in Chapter IV of this Regulation Art.
EnglishFrançaisa marking by which a provider indicates that an AI system is in conformity with the requirements set out in Chapter III, Section 2 and other applicable Union harmonisation legislation, providing for its affixingArt.
a professional service the purpose of which is to address the specific needs of a natural person who, on account of impairment or other physical or mental conditions, requires assistance, including preventive and supportive measures, to carry out essential activities of daily living in order to supp...