Glossary

(y) '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;

(f) '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;

(u) '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;

(w) 'dataset' means a structured collection of electronic health data;

(ad) 'data quality' means the degree to which the elements of electronic health data are suitable for their intended primary and secondary use;

(aa) 'data quality and utility label' means a graphic diagram, including a scale, describing the data quality and conditions of use of a dataset;

(t) '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:

• (i) the right or obligation, in accordance with applicable Union or national law and in its capacity as a controller or joint controller, to process personal electronic health data for the provision of healthcare or care or for the purposes of public health, reimbursement, research, innovation, policy making, official statistics or patient safety or for regulatory purposes; or
• (ii) the ability to make available non-personal electronic health data through the control of the technical design of a product and related services, including by registering, providing, restricting access to or exchanging such data;

(64) The establishment of one or more health data access bodies, supporting access to electronic health data in Member States, is essential to promoting the secondary use of health-related data. Member States should therefore establish one or more health data access bodies to reflect, inter alia, their constitutional, organisational and administrative structure. However, one of those health data access bodies should be designated as a coordinator in the event there is more than one health data access body. Where a Member State establishes several health data access bodies, it should lay down rules at national level to ensure the coordinated participation of those bodies in the European Health Data Space Board (the 'EHDS Board'). That Member State should, in particular, designate one health data access body to function as a single contact point for the effective participation of those bodies, and ensure swift and smooth cooperation with other health data access bodies, the EHDS Board and the Commission. Health data access bodies could vary in terms of organisation and size, spanning from a dedicated fully fledged organisation to a unit or department in an existing organisation.