- care
means 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 support his or her personal autonomy;
- data permit
means 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;
- data quality
means the degree to which the elements of electronic health data are suitable for their intended primary use and secondary use;
- data quality and utility label
means a graphic diagram, including a scale, describing the data quality and conditions of use of a dataset;
- dataset
means a structured collection of electronic health data;
- dataset catalogue
means 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;
- dataset of high impact for secondary use
means a dataset the re-use of which is associated with significant benefits due to its relevance for health research;
- EHR
means 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;
- electronic health data
means personal or non-personal electronic health data;
- electronic health data access service
means an online service, such as a portal or an application for 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 access;
- European interoperability software component for EHR systems
means a 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 independent of the European logging software component for EHR systems;
- European logging software component for EHR systems
means a 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. of Annex II thereto, and which is independent of the European interoperability software component for EHR systems;
- health data holder
means 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 sectors, developing or manufacturing wellness applications, performing research in relation to the healthcare or care sectors or acting as a mortality registry, as well as any Union institution, body, office or agency, that has either:
- health data user
means a 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 HealthData@EU;
- health professional access service
means a service, supported by an EHR system, that enables health professionals to access data of natural persons under their treatment;
- interoperability
means the ability of organisations, as well as of software applications or devices from the same manufacturer or different manufacturers, to interact through the processes they support, involving the exchange of information and knowledge, without changing the content of the data, between those organisations, software applications or devices;
- non-personal electronic health data
means 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;
- personal electronic health data
means data concerning health and genetic data, processed in an electronic form;
- primary use
means 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 relevant social, administrative or reimbursement services;
- putting into service
means the first use, for its intended purpose, in the Union of an EHR system covered by this Regulation;
- registration of electronic health data
means 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;
- risk
means the combination of the probability of an occurrence of a hazard causing harm to health, safety or information security and the degree of severity of such harm;
- secondary use
means 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;
- serious incident
means any malfunction or deterioration in the characteristics or performance of an EHR system made available on the market that directly or indirectly leads, might have led or might lead to any of the following:
- software component
means a 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 components;
- wellness application
means any 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 than the provision of healthcare.