Article 2

‘metadata’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;

‘non-personal data’ means data other than personal data;

‘connected product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;

‘related service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected product;

‘processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction;

‘data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction;

‘same service type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities;

‘data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868;

‘data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;

‘user’ means a natural or legal person that owns a connected product or to whom temporary rights to use that connected product have been contractually transferred, or that receives related services;

‘data recipient’ means a natural or legal person, acting for purposes which are related to that person’s trade, business, craft or profession, other than the user of a connected product or related service, to whom the data holder makes data available, including a third party following a request by the user to the data holder or in accordance with a legal obligation under Union law or national legislation adopted in accordance with Union law;

‘product data’ means data generated by the use of a connected product that the manufacturer designed to be retrievable, via an electronic communications service, physical connection or on-device access, by a user, data holder or a third party, including, where relevant, the manufacturer;

‘related service data’ means data representing the digitisation of user actions or of events related to the connected product, recorded intentionally by the user or generated as a by-product of the user’s action during the provision of a related service by the provider;

‘readily available data’ means product data and related service data that a data holder lawfully obtains or can lawfully obtain from the connected product or related service, without disproportionate effort going beyond a simple operation;

‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

‘trade secret holder’ means a trade secret holder as defined in Article 2, point (2), of Directive (EU) 2016/943;

‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;

‘making available on the market’ means any supply of a connected product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of a connected product on the Union market;

‘consumer’ means any natural person who is acting for purposes which are outside that person’s trade, business, craft or profession;

‘enterprise’ means a natural or legal person that, in relation to contracts and practices covered by this Regulation, is acting for purposes which are related to that person’s trade, business, craft or profession;

‘small enterprise’ means a small enterprise as defined in Article 2(2) of the Annex to Recommendation 2003/361/EC;

‘microenterprise’ means a microenterprise as defined in Article 2(3) of the Annex to Recommendation 2003/361/EC;

‘Union bodies’ means the Union bodies, offices and agencies set up by or pursuant to acts adopted on the basis of the Treaty on European Union, the TFEU or the Treaty establishing the European Atomic Energy Community;

‘public sector body’ means national, regional or local authorities of the Member States and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies;

‘public emergency’ means an exceptional situation, limited in time, such as a public health emergency, an emergency resulting from natural disasters, a human-induced major disaster, including a major cybersecurity incident, negatively affecting the population of the Union or the whole or part of a Member State, with a risk of serious and lasting repercussions for living conditions or economic stability, financial stability, or the substantial and immediate degradation of economic assets in the Union or the relevant Member State and which is determined or officially declared in accordance with the relevant procedures under Union or national law;

‘customer’ means a natural or legal person that has entered into a contractual relationship with a provider of data processing services with the objective of using one or more data processing services;

‘virtual assistants’ means software that can process demands, tasks or questions including those based on audio, written input, gestures or motions, and that, based on those demands, tasks or questions, provides access to other services or controls the functions of connected products;

‘digital assets’ means elements in digital form, including applications, for which the customer has the right of use, independently from the contractual relationship with the data processing service it intends to switch from;

‘on-premises ICT infrastructure’ means ICT infrastructure and computing resources owned, rented or leased by the customer, located in the data centre of the customer itself and operated by the customer or by a third-party;

‘switching’ means the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same service type, or other service, offered by a different provider of data processing services, or to an on-premises ICT infrastructure, including through extracting, transforming and uploading the data;

‘data egress charges’ means data transfer fees charged to customers for extracting their data through the network from the ICT infrastructure of a provider of data processing services to the system of a different provider or to on-premises ICT infrastructure;

‘switching charges’ means charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises ICT infrastructure, including data egress charges;

‘functional equivalence’ means re-establishing on the basis of the customer’s exportable data and digital assets, a minimum level of functionality in the environment of a new data processing service of the same service type after the switching process, where the destination data processing service delivers a materially comparable outcome in response to the same input for shared features supplied to the customer under the contract;

‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including metadata, directly or indirectly generated, or cogenerated, by the customer’s use of the data processing service, excluding any assets or data protected by intellectual property rights, or constituting a trade secret, of providers of data processing services or third parties;

‘smart contract’ means a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering;

‘interoperability’ means the ability of two or more data spaces or communication networks, systems, connected products, applications, data processing services or components to exchange and use data in order to perform their functions;

‘open interoperability specification’ means a technical specification in the field of information and communication technologies which is performance oriented towards achieving interoperability between data processing services;

‘common specifications’ means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation;

‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012.

‘data’ means any digital representation of acts, facts or information and any compilation of such acts, facts or information, including in the form of sound, visual or audio-visual recording;

‘metadata’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;

‘non-personal data’ means data other than personal data;

‘consent’ means consent as defined in Article 4, point (11), of Regulation (EU) 2016/679;

‘permission’ means giving data users the right to the processing of non-personal data;

‘connected product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;

‘related service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected product;

‘processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction;

‘data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction;

‘same service type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities;

‘data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868;

‘data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;

‘user’ means a natural or legal person that owns a connected product or to whom temporary rights to use that connected product have been contractually transferred, or that receives related services;

‘data holder’ means a natural or legal person that has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation adopted in accordance with Union law, to use or make available data, including, where contractually agreed, product data or related service data, which it has retrieved or generated during the provision of a related service;

‘data recipient’ means a natural or legal person, acting for purposes which are related to that person’s trade, business, craft or profession, other than the user of a connected product or related service, to whom the data holder makes data available, including a third party following a request by the user to the data holder or in accordance with a legal obligation under Union law or national legislation adopted in accordance with Union law;

‘product data’ means data generated by the use of a connected product that the manufacturer designed to be retrievable, via an electronic communications service, physical connection or on-device access, by a user, data holder or a third party, including, where relevant, the manufacturer;

‘related service data’ means data representing the digitisation of user actions or of events related to the connected product, recorded intentionally by the user or generated as a by-product of the user’s action during the provision of a related service by the provider;

‘readily available data’ means product data and related service data that a data holder lawfully obtains or can lawfully obtain from the connected product or related service, without disproportionate effort going beyond a simple operation;

‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

‘trade secret holder’ means a trade secret holder as defined in Article 2, point (2), of Directive (EU) 2016/943;

‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;

‘making available on the market’ means any supply of a connected product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of a connected product on the Union market;

‘consumer’ means any natural person who is acting for purposes which are outside that person’s trade, business, craft or profession;

‘enterprise’ means a natural or legal person that, in relation to contracts and practices covered by this Regulation, is acting for purposes which are related to that person’s trade, business, craft or profession;

‘small enterprise’ means a small enterprise as defined in Article 2(2) of the Annex to Recommendation 2003/361/EC;

‘microenterprise’ means a microenterprise as defined in Article 2(3) of the Annex to Recommendation 2003/361/EC;

‘Union bodies’ means the Union bodies, offices and agencies set up by or pursuant to acts adopted on the basis of the Treaty on European Union, the TFEU or the Treaty establishing the European Atomic Energy Community;

‘public sector body’ means national, regional or local authorities of the Member States and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies;

‘bodies governed by public law’ means bodies that have all of the following characteristics:

1. (a)

   they are established for the specific purpose of meeting needs in the general interest, not having an industrial or commercial character;

2. (b)

   they have legal personality;

3. (c)

   they are financed, for the most part by the State, regional or local authorities, or by other bodies governed by public law; or are subject to management supervision by those authorities or bodies; or have an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities, or by other bodies governed by public law;

‘public undertaking’ means any undertaking over which a public sector body may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it. A dominant influence on the part of the public sector bodies shall be presumed in any of the following cases in which those bodies, directly or indirectly:

1. (a)

   hold the majority of the undertaking's subscribed capital;

2. (b)

   control the majority of the votes attaching to shares issued by the undertaking;

3. (c)

   can appoint more than half of the undertaking's administrative, management or supervisory body;

‘public emergency’ means an exceptional situation, limited in time, such as a public health emergency, an emergency resulting from natural disasters, a human-induced major disaster, including a major cybersecurity incident, negatively affecting the population of the Union or the whole or part of a Member State, with a risk of serious and lasting repercussions for living conditions or economic stability, financial stability, or the substantial and immediate degradation of economic assets in the Union or the relevant Member State and which is determined or officially declared in accordance with the relevant procedures under Union or national law;

‘customer’ means a natural or legal person that has entered into a contractual relationship with a provider of data processing services with the objective of using one or more data processing services;

‘virtual assistants’ means software that can process demands, tasks or questions including those based on audio, written input, gestures or motions, and that, based on those demands, tasks or questions, provides access to other services or controls the functions of connected products;

‘digital assets’ means elements in digital form, including applications, for which the customer has the right of use, independently from the contractual relationship with the data processing service it intends to switch from;

‘on-premises ICT infrastructure’ means ICT infrastructure and computing resources owned, rented or leased by the customer, located in the data centre of the customer itself and operated by the customer or by a third-party;

‘switching’ means the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same service type, or other service, offered by a different provider of data processing services, or to an on-premises ICT infrastructure, including through extracting, transforming and uploading the data;

‘data egress charges’ means data transfer fees charged to customers for extracting their data through the network from the ICT infrastructure of a provider of data processing services to the system of a different provider or to on-premises ICT infrastructure;

‘switching charges’ means charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises ICT infrastructure, including data egress charges;

‘functional equivalence’ means re-establishing on the basis of the customer’s exportable data and digital assets, a minimum level of functionality in the environment of a new data processing service of the same service type after the switching process, where the destination data processing service delivers a materially comparable outcome in response to the same input for shared features supplied to the customer under the contract;

‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including metadata, directly or indirectly generated, or cogenerated, by the customer’s use of the data processing service, excluding any assets or data protected by intellectual property rights, or constituting a trade secret, of providers of data processing services or third parties;

‘data intermediation service’ means a service which aims to establish relationships of an economic character for the purposes of data sharing between an undetermined number of data subjects or data holders and data users, through technical, legal or other means, including for the purpose of exercising the rights of data subjects in relation to personal data, and which :

1. (1)

   do not have as their main purpose the intermediation of copyright-protected content;

2. (2)

   are not jointly procured by several legal persons for exclusive use among them;

‘data altruism’ means the voluntary sharing of data on the basis of the consent of data subjects to process personal data pertaining to them, or of permissions of data holders to allow the use of their non-personal data without seeking or receiving a reward that goes beyond compensation related to the costs that they incur where they make their data available for objectives of general interest as provided for in national law, where applicable, such as healthcare, combating climate change, improving mobility, facilitating the development, production and dissemination of official statistics, improving the provision of public services, public policy making or scientific research purposes in the general interest;

‘smart contract’ means a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering;

‘interoperability’ means the ability of two or more data spaces or communication networks, systems, connected products, applications, data processing services or components to exchange and use data in order to perform their functions;

‘open interoperability specification’ means a technical specification in the field of information and communication technologies which is performance oriented towards achieving interoperability between data processing services;

‘common specifications’ means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation;

‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012.

‘medium-sized enterprise’ means a medium-sized enterprise as defined in Article 2 of Annex I to Recommendation 2003/361/EC;

‘small mid-cap’ or ‘SMC’ means a small mid-cap enterprise as defined in Article 2 of the Annex to Commission Recommendation (EU) 2025/1099;

‘university’ means a public sector body that provides post-secondary-school higher education leading to academic degrees;

‘standard licence’ means a set of predefined re-use conditions in a digital format, preferably compatible with standardised public licences available online;

‘document’ means:

1. (a)

   any content that is non-digital whatever its medium (paper or as a sound, visual or audiovisual recording); or

2. (b)

   any part of such content;

‘dynamic data’ means data and documents in a digital form, subject to frequent or real-time updates, in particular because of their volatility or rapid obsolescence; data generated by sensors are typically considered to be dynamic data;

‘research data’ means data , other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

‘re-use’ means the use by natural persons or legal entities of documents held by:

1. (a)

   public sector bodies, for commercial or non-commercial purposes other than the initial purpose within the public task for which the documents were produced, except for the exchange of documents between public sector bodies purely in pursuit of their public tasks; or

2. (b)

   public undertakings, under Chapter VIIc Section 2 for commercial or non-commercial purposes other than for the initial purpose of providing services in the general interest for which the documents were produced, except for the exchange of documents between public undertakings and public sector bodies purely in pursuit of the public tasks of public sector bodies;

‘high-value datasets’ means data and documents the re-use of which is associated with important benefits for society, the environment and the economy, in particular because of their suitability for the creation of value-added services, applications and new, high-quality and decent jobs, and because of the number of potential beneficiaries of the value-added services and applications based on those data and documents;

‘certain categories of protected data’ means data and documents held by public sector bodies which are protected on the grounds of

1. (a)

   commercial confidentiality, including business, professional and company secrets;

2. (b)

   statistical confidentiality;

3. (c)

   the protection of intellectual property rights of third parties; or

4. (d)

   the protection of personal data, insofar as such data fall outside the scope of Section 2 of Chapter VIIc;

‘secure processing environment’ means the physical or virtual environment and organisational means to ensure compliance with Union law in particular with regard to data subjects’ rights, intellectual property rights, and commercial and statistical confidentiality, integrity and accessibility, as well as with applicable national law, and to allow the entity providing the secure processing environment to determine and supervise all data processing actions, including the display, storage, download and export of data and the calculation of derivative data through computational algorithms;

‘re-user’ means a natural or legal person who was granted the right to re-use data or documents held by a public sector body or a public undertaking under Chapter VIIc or to research data or certain categories of protected data;

‘machine-readable format’ means a file format structured so that software applications can easily identify, recognise and extract specific data, including individual statements of fact, and their internal structure;

‘open format’ means a file format that is platform-independent and made available to the public without any restriction that impedes the re-use of documents;

‘formal open standard’ means a standard which has been laid down in written form, detailing specifications for the requirements on how to ensure software interoperability;

‘reasonable return on investment’ means a percentage of the overall charge, in addition to the amount needed to recover the eligible costs, not exceeding 5 percentage points above the fixed interest rate of the ECB;

‘data localisation requirement’ means any obligation, prohibition, condition, limit or other requirement provided for in the laws, regulations or administrative provisions of a Member State or resulting from general and consistent administrative practices in a Member State and in bodies governed by public law, including in the field of public procurement, without prejudice to Directive 2014/24/EU, which imposes the processing of data in the territory of a specific Member State or hinders the processing of data in any other Member State;

‘pseudonymisation’ means pseudonymisation as referred to under Article 4(5) of Regulation (EU) 2016/679.

‘metadata’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;

‘non-personal data’ means data other than personal data;

‘connected product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;

‘related service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected product;

‘processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction;

‘data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction;

‘same service type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities;

‘data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868;

‘data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;

‘user’ means a natural or legal person that owns a connected product or to whom temporary rights to use that connected product have been contractually transferred, or that receives related services;

‘data recipient’ means a natural or legal person, acting for purposes which are related to that person’s trade, business, craft or profession, other than the user of a connected product or related service, to whom the data holder makes data available, including a third party following a request by the user to the data holder or in accordance with a legal obligation under Union law or national legislation adopted in accordance with Union law;

‘product data’ means data generated by the use of a connected product that the manufacturer designed to be retrievable, via an electronic communications service, physical connection or on-device access, by a user, data holder or a third party, including, where relevant, the manufacturer;

‘related service data’ means data representing the digitisation of user actions or of events related to the connected product, recorded intentionally by the user or generated as a by-product of the user’s action during the provision of a related service by the provider;

‘readily available data’ means product data and related service data that a data holder lawfully obtains or can lawfully obtain from the connected product or related service, without disproportionate effort going beyond a simple operation;

‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

‘trade secret holder’ means a trade secret holder as defined in Article 2, point (2), of Directive (EU) 2016/943;

‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;

‘making available on the market’ means any supply of a connected product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of a connected product on the Union market;

‘consumer’ means any natural person who is acting for purposes which are outside that person’s trade, business, craft or profession;

‘enterprise’ means a natural or legal person that, in relation to contracts and practices covered by this Regulation, is acting for purposes which are related to that person’s trade, business, craft or profession;

‘small enterprise’ means a small enterprise as defined in Article 2(2) of the Annex to Recommendation 2003/361/EC;

‘microenterprise’ means a microenterprise as defined in Article 2(3) of the Annex to Recommendation 2003/361/EC;

‘Union bodies’ means the Union bodies, offices and agencies set up by or pursuant to acts adopted on the basis of the Treaty on European Union, the TFEU or the Treaty establishing the European Atomic Energy Community;

‘public sector body’ means national, regional or local authorities of the Member States and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies;

‘public emergency’ means an exceptional situation, limited in time, such as a public health emergency, an emergency resulting from natural disasters, a human-induced major disaster, including a major cybersecurity incident, negatively affecting the population of the Union or the whole or part of a Member State, with a risk of serious and lasting repercussions for living conditions or economic stability, financial stability, or the substantial and immediate degradation of economic assets in the Union or the relevant Member State and which is determined or officially declared in accordance with the relevant procedures under Union or national law;

‘customer’ means a natural or legal person that has entered into a contractual relationship with a provider of data processing services with the objective of using one or more data processing services;

‘virtual assistants’ means software that can process demands, tasks or questions including those based on audio, written input, gestures or motions, and that, based on those demands, tasks or questions, provides access to other services or controls the functions of connected products;

‘digital assets’ means elements in digital form, including applications, for which the customer has the right of use, independently from the contractual relationship with the data processing service it intends to switch from;

‘on-premises ICT infrastructure’ means ICT infrastructure and computing resources owned, rented or leased by the customer, located in the data centre of the customer itself and operated by the customer or by a third-party;

‘switching’ means the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same service type, or other service, offered by a different provider of data processing services, or to an on-premises ICT infrastructure, including through extracting, transforming and uploading the data;

‘data egress charges’ means data transfer fees charged to customers for extracting their data through the network from the ICT infrastructure of a provider of data processing services to the system of a different provider or to on-premises ICT infrastructure;

‘switching charges’ means charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises ICT infrastructure, including data egress charges;

‘functional equivalence’ means re-establishing on the basis of the customer’s exportable data and digital assets, a minimum level of functionality in the environment of a new data processing service of the same service type after the switching process, where the destination data processing service delivers a materially comparable outcome in response to the same input for shared features supplied to the customer under the contract;

‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including metadata, directly or indirectly generated, or cogenerated, by the customer’s use of the data processing service, excluding any assets or data protected by intellectual property rights, or constituting a trade secret, of providers of data processing services or third parties;

‘smart contract’ means a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering;

‘interoperability’ means the ability of two or more data spaces or communication networks, systems, connected products, applications, data processing services or components to exchange and use data in order to perform their functions;

‘open interoperability specification’ means a technical specification in the field of information and communication technologies which is performance oriented towards achieving interoperability between data processing services;

‘common specifications’ means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation;

‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012.

‘data’ means any digital representation of acts, facts or information and any compilation of such acts, facts or information, including in the form of sound, visual or audio-visual recording;

‘metadata’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;

‘non-personal data’ means data other than personal data;

‘consent’ means consent as defined in Article 4, point (11), of Regulation (EU) 2016/679;

‘permission’ means giving data users the right to the processing of non-personal data;

‘access’ means data use, in accordance with specific technical, legal or organisational requirements, without necessarily implying the transmission or downloading of data;

‘connected product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;

‘related service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected product;

‘processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction;

‘data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction;

‘same service type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities;

‘data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868;

‘data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;

‘user’ means a natural or legal person that owns a connected product or to whom temporary rights to use that connected product have been contractually transferred, or that receives related services;

‘data holder’ means a natural or legal person that has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation adopted in accordance with Union law, to use or make available data, including, where contractually agreed, product data or related service data, which it has retrieved or generated during the provision of a related service;

‘data recipient’ means a natural or legal person, acting for purposes which are related to that person’s trade, business, craft or profession, other than the user of a connected product or related service, to whom the data holder makes data available, including a third party following a request by the user to the data holder or in accordance with a legal obligation under Union law or national legislation adopted in accordance with Union law;

‘product data’ means data generated by the use of a connected product that the manufacturer designed to be retrievable, via an electronic communications service, physical connection or on-device access, by a user, data holder or a third party, including, where relevant, the manufacturer;

‘related service data’ means data representing the digitisation of user actions or of events related to the connected product, recorded intentionally by the user or generated as a by-product of the user’s action during the provision of a related service by the provider;

‘readily available data’ means product data and related service data that a data holder lawfully obtains or can lawfully obtain from the connected product or related service, without disproportionate effort going beyond a simple operation;

‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

‘trade secret holder’ means a trade secret holder as defined in Article 2, point (2), of Directive (EU) 2016/943;

‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;

‘making available on the market’ means any supply of a connected product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of a connected product on the Union market;

‘consumer’ means any natural person who is acting for purposes which are outside that person’s trade, business, craft or profession;

‘enterprise’ means a natural or legal person that, in relation to contracts and practices covered by this Regulation, is acting for purposes which are related to that person’s trade, business, craft or profession;

‘small enterprise’ means a small enterprise as defined in Article 2(2) of the Annex to Recommendation 2003/361/EC;

‘microenterprise’ means a microenterprise as defined in Article 2(3) of the Annex to Recommendation 2003/361/EC;

‘Union bodies’ means the Union bodies, offices and agencies set up by or pursuant to acts adopted on the basis of the Treaty on European Union, the TFEU or the Treaty establishing the European Atomic Energy Community;

‘public sector body’ means national, regional or local authorities of the Member States and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies;

‘bodies governed by public law’ means bodies that have all of the following characteristics:

1. (a)

   they are established for the specific purpose of meeting needs in the general interest, not having an industrial or commercial character;

2. (b)

   they have legal personality;

3. (c)

   they are financed, for the most part by the State, regional or local authorities, or by other bodies governed by public law; or are subject to management supervision by those authorities or bodies; or have an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities, or by other bodies governed by public law;

‘public undertaking’ means any undertaking over which a public sector body may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it. A dominant influence on the part of the public sector bodies shall be presumed in any of the following cases in which those bodies, directly or indirectly:

1. (a)

   hold the majority of the undertaking's subscribed capital;

2. (b)

   control the majority of the votes attaching to shares issued by the undertaking;

3. (c)

   can appoint more than half of the undertaking's administrative, management or supervisory body;

‘public emergency’ means an exceptional situation, limited in time, such as a public health emergency, an emergency resulting from natural disasters, a human-induced major disaster, including a major cybersecurity incident, negatively affecting the population of the Union or the whole or part of a Member State, with a risk of serious and lasting repercussions for living conditions or economic stability, financial stability, or the substantial and immediate degradation of economic assets in the Union or the relevant Member State and which is determined or officially declared in accordance with the relevant procedures under Union or national law;

‘customer’ means a natural or legal person that has entered into a contractual relationship with a provider of data processing services with the objective of using one or more data processing services;

‘virtual assistants’ means software that can process demands, tasks or questions including those based on audio, written input, gestures or motions, and that, based on those demands, tasks or questions, provides access to other services or controls the functions of connected products;

‘digital assets’ means elements in digital form, including applications, for which the customer has the right of use, independently from the contractual relationship with the data processing service it intends to switch from;

‘on-premises ICT infrastructure’ means ICT infrastructure and computing resources owned, rented or leased by the customer, located in the data centre of the customer itself and operated by the customer or by a third-party;

‘switching’ means the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same service type, or other service, offered by a different provider of data processing services, or to an on-premises ICT infrastructure, including through extracting, transforming and uploading the data;

‘data egress charges’ means data transfer fees charged to customers for extracting their data through the network from the ICT infrastructure of a provider of data processing services to the system of a different provider or to on-premises ICT infrastructure;

‘switching charges’ means charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises ICT infrastructure, including data egress charges;

‘functional equivalence’ means re-establishing on the basis of the customer’s exportable data and digital assets, a minimum level of functionality in the environment of a new data processing service of the same service type after the switching process, where the destination data processing service delivers a materially comparable outcome in response to the same input for shared features supplied to the customer under the contract;

‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including metadata, directly or indirectly generated, or cogenerated, by the customer’s use of the data processing service, excluding any assets or data protected by intellectual property rights, or constituting a trade secret, of providers of data processing services or third parties;

‘data altruism’ means the voluntary sharing of data on the basis of the consent of data subjects to process personal data pertaining to them, or of permissions of data holders to allow the use of their non-personal data without seeking or receiving a reward that goes beyond compensation related to the costs that they incur where they make their data available for objectives of general interest as provided for in national law, where applicable, such as healthcare, combating climate change, improving mobility, facilitating the development, production and dissemination of official statistics, improving the provision of public services, public policy making or scientific research purposes in the general interest;

‘smart contract’ means a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering;

‘interoperability’ means the ability of two or more data spaces or communication networks, systems, connected products, applications, data processing services or components to exchange and use data in order to perform their functions;

‘open interoperability specification’ means a technical specification in the field of information and communication technologies which is performance oriented towards achieving interoperability between data processing services;

‘common specifications’ means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation;

‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012.

‘medium-sized enterprise’ means a medium-sized enterprise as defined in Article 2 of Annex I to Recommendation 2003/361/EC;

‘small mid-cap’ or ‘SMC’ means a small mid-cap enterprise as defined in Article 2 of the Annex to Commission Recommendation (EU) 2025/1099;

‘university’ means a public sector body that provides post-secondary-school higher education leading to academic degrees;

‘standard licence’ means a set of predefined re-use conditions in a digital format, preferably compatible with standardised public licences available online;

‘document’ means:

1. (a)

   any content that is non-digital whatever its medium (paper or as a sound, visual or audiovisual recording); or

2. (b)

   any part of such content;

‘dynamic data’ means data and documents in a digital form, subject to frequent or real-time updates, in particular because of their volatility or rapid obsolescence; data generated by sensors are typically considered to be dynamic data;

‘research data’ means data , other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

‘re-use’ means the use by natural persons or legal entities of documents held by:

1. (a)

   public sector bodies, for commercial or non-commercial purposes other than the initial purpose within the public task for which the documents were produced, except for the exchange of documents between public sector bodies purely in pursuit of their public tasks; or

2. (b)

   public undertakings, under Chapter VIIc Section 2 for commercial or non-commercial purposes other than for the initial purpose of providing services in the general interest for which the documents were produced, except for the exchange of documents between public undertakings and public sector bodies purely in pursuit of the public tasks of public sector bodies;

‘high-value datasets’ means data and documents the re-use of which is associated with important benefits for society, the environment and the economy, in particular because of their suitability for the creation of value-added services, applications and new, high-quality and decent jobs, and because of the number of potential beneficiaries of the value-added services and applications based on those data and documents;

‘certain categories of protected data’ means data and documents held by public sector bodies which are protected on the grounds of

1. (a)

   commercial confidentiality, including business, professional and company secrets;

2. (b)

   statistical confidentiality;

3. (c)

   the protection of intellectual property rights of third parties; or

4. (d)

   the protection of personal data, insofar as such data fall outside the scope of Section 2 of Chapter VIIc;

‘secure processing environment’ means the physical or virtual environment and organisational means to ensure compliance with Union law in particular with regard to data subjects’ rights, intellectual property rights, and commercial and statistical confidentiality, integrity and accessibility, as well as with applicable national law, and to allow the entity providing the secure processing environment to determine and supervise all data processing actions, including the display, storage, download and export of data and the calculation of derivative data through computational algorithms;

‘re-user’ means a natural or legal person who was granted the right to re-use data or documents held by a public sector body or a public undertaking under Chapter VIIc or to research data or certain categories of protected data;

‘machine-readable format’ means a file format structured so that software applications can easily identify, recognise and extract specific data, including individual statements of fact, and their internal structure;

‘open format’ means a file format that is platform-independent and made available to the public without any restriction that impedes the re-use of documents;

‘formal open standard’ means a standard which has been laid down in written form, detailing specifications for the requirements on how to ensure software interoperability;

‘reasonable return on investment’ means a percentage of the overall charge, in addition to the amount needed to recover the eligible costs, not exceeding 5 percentage points above the fixed interest rate of the ECB;

‘data localisation requirement’ means any obligation, prohibition, condition, limit or other requirement provided for in the laws, regulations or administrative provisions of a Member State or resulting from general and consistent administrative practices in a Member State and in bodies governed by public law, including in the field of public procurement, without prejudice to Directive 2014/24/EU, which imposes the processing of data in the territory of a specific Member State or hinders the processing of data in any other Member State;

‘pseudonymisation’ means pseudonymisation as referred to under Article 4(5) of Regulation (EU) 2016/679.

‘metadata’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;

‘non-personal data’ means data other than personal data;

‘connected product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;

‘related service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected product;

‘processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction;

‘data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction;

‘same service type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities;

‘data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868;

‘data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;

‘user’ means a natural or legal person that owns a connected product or to whom temporary rights to use that connected product have been contractually transferred, or that receives related services;

‘data recipient’ means a natural or legal person, acting for purposes which are related to that person’s trade, business, craft or profession, other than the user of a connected product or related service, to whom the data holder makes data available, including a third party following a request by the user to the data holder or in accordance with a legal obligation under Union law or national legislation adopted in accordance with Union law;

‘product data’ means data generated by the use of a connected product that the manufacturer designed to be retrievable, via an electronic communications service, physical connection or on-device access, by a user, data holder or a third party, including, where relevant, the manufacturer;

‘related service data’ means data representing the digitisation of user actions or of events related to the connected product, recorded intentionally by the user or generated as a by-product of the user’s action during the provision of a related service by the provider;

‘readily available data’ means product data and related service data that a data holder lawfully obtains or can lawfully obtain from the connected product or related service, without disproportionate effort going beyond a simple operation;

‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

‘trade secret holder’ means a trade secret holder as defined in Article 2, point (2), of Directive (EU) 2016/943;

‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;

‘making available on the market’ means any supply of a connected product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of a connected product on the Union market;

‘consumer’ means any natural person who is acting for purposes which are outside that person’s trade, business, craft or profession;

‘enterprise’ means a natural or legal person that, in relation to contracts and practices covered by this Regulation, is acting for purposes which are related to that person’s trade, business, craft or profession;

‘small enterprise’ means a small enterprise as defined in Article 2(2) of the Annex to Recommendation 2003/361/EC;

‘microenterprise’ means a microenterprise as defined in Article 2(3) of the Annex to Recommendation 2003/361/EC;

‘Union bodies’ means the Union bodies, offices and agencies set up by or pursuant to acts adopted on the basis of the Treaty on European Union, the TFEU or the Treaty establishing the European Atomic Energy Community;

‘public sector body’ means national, regional or local authorities of the Member States and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies;

‘public emergency’ means an exceptional situation, limited in time, such as a public health emergency, an emergency resulting from natural disasters, a human-induced major disaster, including a major cybersecurity incident, negatively affecting the population of the Union or the whole or part of a Member State, with a risk of serious and lasting repercussions for living conditions or economic stability, financial stability, or the substantial and immediate degradation of economic assets in the Union or the relevant Member State and which is determined or officially declared in accordance with the relevant procedures under Union or national law;

‘customer’ means a natural or legal person that has entered into a contractual relationship with a provider of data processing services with the objective of using one or more data processing services;

‘virtual assistants’ means software that can process demands, tasks or questions including those based on audio, written input, gestures or motions, and that, based on those demands, tasks or questions, provides access to other services or controls the functions of connected products;

‘digital assets’ means elements in digital form, including applications, for which the customer has the right of use, independently from the contractual relationship with the data processing service it intends to switch from;

‘on-premises ICT infrastructure’ means ICT infrastructure and computing resources owned, rented or leased by the customer, located in the data centre of the customer itself and operated by the customer or by a third-party;

‘switching’ means the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same service type, or other service, offered by a different provider of data processing services, or to an on-premises ICT infrastructure, including through extracting, transforming and uploading the data;

‘data egress charges’ means data transfer fees charged to customers for extracting their data through the network from the ICT infrastructure of a provider of data processing services to the system of a different provider or to on-premises ICT infrastructure;

‘switching charges’ means charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises ICT infrastructure, including data egress charges;

‘functional equivalence’ means re-establishing on the basis of the customer’s exportable data and digital assets, a minimum level of functionality in the environment of a new data processing service of the same service type after the switching process, where the destination data processing service delivers a materially comparable outcome in response to the same input for shared features supplied to the customer under the contract;

‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including metadata, directly or indirectly generated, or cogenerated, by the customer’s use of the data processing service, excluding any assets or data protected by intellectual property rights, or constituting a trade secret, of providers of data processing services or third parties;

‘smart contract’ means a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering;

‘interoperability’ means the ability of two or more data spaces or communication networks, systems, connected products, applications, data processing services or components to exchange and use data in order to perform their functions;

‘open interoperability specification’ means a technical specification in the field of information and communication technologies which is performance oriented towards achieving interoperability between data processing services;

‘common specifications’ means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation;

‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012.

‘metadata’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;

‘non-personal data’ means data other than personal data;

‘consent’ means consent as defined in Article 4, point (11), of Regulation (EU) 2016/679;

‘permission’ means giving data users the right to the processing of non-personal data;

‘access’ means data use, in accordance with specific technical, legal or organisational requirements, without necessarily implying the transmission or downloading of data;

‘connected product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;

‘related service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected product;

‘processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction;

‘data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction;

‘same service type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities;

‘data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868;

‘data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;

‘user’ means a natural or legal person that owns a connected product or to whom temporary rights to use that connected product have been contractually transferred, or that receives related services;

‘data holder’ means a natural or legal person that has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation adopted in accordance with Union law, to use or make available data, including, where contractually agreed, product data or related service data, which it has retrieved or generated during the provision of a related service;

‘data recipient’ means a natural or legal person, acting for purposes which are related to that person’s trade, business, craft or profession, other than the user of a connected product or related service, to whom the data holder makes data available, including a third party following a request by the user to the data holder or in accordance with a legal obligation under Union law or national legislation adopted in accordance with Union law;

‘product data’ means data generated by the use of a connected product that the manufacturer designed to be retrievable, via an electronic communications service, physical connection or on-device access, by a user, data holder or a third party, including, where relevant, the manufacturer;

‘related service data’ means data representing the digitisation of user actions or of events related to the connected product, recorded intentionally by the user or generated as a by-product of the user’s action during the provision of a related service by the provider;

‘readily available data’ means product data and related service data that a data holder lawfully obtains or can lawfully obtain from the connected product or related service, without disproportionate effort going beyond a simple operation;

‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

‘trade secret holder’ means a trade secret holder as defined in Article 2, point (2), of Directive (EU) 2016/943;

‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;

‘making available on the market’ means any supply of a connected product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of a connected product on the Union market;

‘consumer’ means any natural person who is acting for purposes which are outside that person’s trade, business, craft or profession;

‘enterprise’ means a natural or legal person that, in relation to contracts and practices covered by this Regulation, is acting for purposes which are related to that person’s trade, business, craft or profession;

‘small enterprise’ means a small enterprise as defined in Article 2(2) of the Annex to Recommendation 2003/361/EC;

‘microenterprise’ means a microenterprise as defined in Article 2(3) of the Annex to Recommendation 2003/361/EC;

‘Union bodies’ means the Union bodies, offices and agencies set up by or pursuant to acts adopted on the basis of the Treaty on European Union, the TFEU or the Treaty establishing the European Atomic Energy Community;

‘public sector body’ means national, regional or local authorities of the Member States and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies;

‘bodies governed by public law’ means bodies that have all of the following characteristics:

1. (a)

   they are established for the specific purpose of meeting needs in the general interest, not having an industrial or commercial character;

2. (b)

   they have legal personality;

3. (c)

   they are financed, for the most part by the State, regional or local authorities, or by other bodies governed by public law; or are subject to management supervision by those authorities or bodies; or have an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities, or by other bodies governed by public law;

‘public undertaking’ means any undertaking over which a public sector body may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it. A dominant influence on the part of the public sector bodies shall be presumed in any of the following cases in which those bodies, directly or indirectly:

1. (a)

   hold the majority of the undertaking's subscribed capital;

2. (b)

   control the majority of the votes attaching to shares issued by the undertaking;

3. (c)

   can appoint more than half of the undertaking's administrative, management or supervisory body;

‘public emergency’ means an exceptional situation, limited in time, such as a public health emergency, an emergency resulting from natural disasters, a human-induced major disaster, including a major cybersecurity incident, negatively affecting the population of the Union or the whole or part of a Member State, with a risk of serious and lasting repercussions for living conditions or economic stability, financial stability, or the substantial and immediate degradation of economic assets in the Union or the relevant Member State and which is determined or officially declared in accordance with the relevant procedures under Union or national law;

‘customer’ means a natural or legal person that has entered into a contractual relationship with a provider of data processing services with the objective of using one or more data processing services;

‘virtual assistants’ means software that can process demands, tasks or questions including those based on audio, written input, gestures or motions, and that, based on those demands, tasks or questions, provides access to other services or controls the functions of connected products;

‘digital assets’ means elements in digital form, including applications, for which the customer has the right of use, independently from the contractual relationship with the data processing service it intends to switch from;

‘on-premises ICT infrastructure’ means ICT infrastructure and computing resources owned, rented or leased by the customer, located in the data centre of the customer itself and operated by the customer or by a third-party;

‘switching’ means the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same service type, or other service, offered by a different provider of data processing services, or to an on-premises ICT infrastructure, including through extracting, transforming and uploading the data;

‘data egress charges’ means data transfer fees charged to customers for extracting their data through the network from the ICT infrastructure of a provider of data processing services to the system of a different provider or to on-premises ICT infrastructure;

‘switching charges’ means charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises ICT infrastructure, including data egress charges;

‘functional equivalence’ means re-establishing on the basis of the customer’s exportable data and digital assets, a minimum level of functionality in the environment of a new data processing service of the same service type after the switching process, where the destination data processing service delivers a materially comparable outcome in response to the same input for shared features supplied to the customer under the contract;

‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including metadata, directly or indirectly generated, or cogenerated, by the customer’s use of the data processing service, excluding any assets or data protected by intellectual property rights, or constituting a trade secret, of providers of data processing services or third parties;

‘data intermediation service’ means a service which aims to establish relationships of an economic character for the purposes of data sharing between an undetermined number of data subjects or data holders and data users, through technical, legal or other means, including for the purpose of exercising the rights of data subjects in relation to personal data, and which :

1. (1)

   do not have as their main purpose the intermediation of copyright-protected content;

2. (2)

   are not jointly procured by several legal persons for exclusive use among them;

‘data altruism’ means the voluntary sharing of data on the basis of the consent of data subjects to process personal data pertaining to them, or of permissions of data holders to allow the use of their non-personal data without seeking or receiving a reward that goes beyond compensation related to the costs that they incur where they make their data available for objectives of general interest as provided for in national law, where applicable, such as healthcare, combating climate change, improving mobility, facilitating the development, production and dissemination of official statistics, improving the provision of public services, public policy making or scientific research purposes in the general interest;

‘smart contract’ means a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering;

‘interoperability’ means the ability of two or more data spaces or communication networks, systems, connected products, applications, data processing services or components to exchange and use data in order to perform their functions;

‘open interoperability specification’ means a technical specification in the field of information and communication technologies which is performance oriented towards achieving interoperability between data processing services;

‘common specifications’ means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation;

‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012.

‘medium-sized enterprise’ means a medium-sized enterprise as defined in Article 2 of Annex I to Recommendation 2003/361/EC;

‘small mid-cap’ or ‘SMC’ means a small mid-cap enterprise as defined in Article 2 of the Annex to Commission Recommendation (EU) 2025/1099;

‘university’ means a public sector body that provides post-secondary-school higher education leading to academic degrees;

‘standard licence’ means a set of predefined re-use conditions in a digital format, preferably compatible with standardised public licences available online;

‘document’ means:

1. (a)

   any content that is non-digital whatever its medium (paper or as a sound, visual or audiovisual recording); or

2. (b)

   any part of such content;

‘dynamic data’ means data and documents in a digital form, subject to frequent or real-time updates, in particular because of their volatility or rapid obsolescence; data generated by sensors are typically considered to be dynamic data;

‘research data’ means data , other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

‘re-use’ means the use by natural persons or legal entities of documents held by:

1. (a)

   public sector bodies, for commercial or non-commercial purposes other than the initial purpose within the public task for which the documents were produced, except for the exchange of documents between public sector bodies purely in pursuit of their public tasks; or

2. (b)

   public undertakings, under Chapter VIIc Section 2 for commercial or non-commercial purposes other than for the initial purpose of providing services in the general interest for which the documents were produced, except for the exchange of documents between public undertakings and public sector bodies purely in pursuit of the public tasks of public sector bodies;

‘high-value datasets’ means data and documents the re-use of which is associated with important benefits for society, the environment and the economy, in particular because of their suitability for the creation of value-added services, applications and new, high-quality and decent jobs, and because of the number of potential beneficiaries of the value-added services and applications based on those data and documents;

‘certain categories of protected data’ means data and documents held by public sector bodies which are protected on the grounds of

1. (a)

   commercial confidentiality, including business, professional and company secrets;

2. (b)

   statistical confidentiality;

3. (c)

   the protection of intellectual property rights of third parties; or

4. (d)

   the protection of personal data, insofar as such data fall outside the scope of Section 2 of Chapter VIIc;

‘secure processing environment’ means the physical or virtual environment and organisational means to ensure compliance with Union law in particular with regard to data subjects’ rights, intellectual property rights, and commercial and statistical confidentiality, integrity and accessibility, as well as with applicable national law, and to allow the entity providing the secure processing environment to determine and supervise all data processing actions, including the display, storage, download and export of data and the calculation of derivative data through computational algorithms;

‘re-user’ means a natural or legal person who was granted the right to re-use data or documents held by a public sector body or a public undertaking under Chapter VIIc or to research data or certain categories of protected data;

‘machine-readable format’ means a file format structured so that software applications can easily identify, recognise and extract specific data, including individual statements of fact, and their internal structure;

‘open format’ means a file format that is platform-independent and made available to the public without any restriction that impedes the re-use of documents;

‘formal open standard’ means a standard which has been laid down in written form, detailing specifications for the requirements on how to ensure software interoperability;

‘reasonable return on investment’ means a percentage of the overall charge, in addition to the amount needed to recover the eligible costs, not exceeding 5 percentage points above the fixed interest rate of the ECB;

‘data localisation requirement’ means any obligation, prohibition, condition, limit or other requirement provided for in the laws, regulations or administrative provisions of a Member State or resulting from general and consistent administrative practices in a Member State and in bodies governed by public law, including in the field of public procurement, without prejudice to Directive 2014/24/EU, which imposes the processing of data in the territory of a specific Member State or hinders the processing of data in any other Member State;

‘pseudonymisation’ means pseudonymisation as referred to under Article 4(5) of Regulation (EU) 2016/679.

‘data’ means any digital representation of acts, facts or information and any compilation of such acts, facts or information, including in the form of sound, visual or audio-visual recording;

‘metadata’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;

‘non-personal data’ means data other than personal data;

‘connected product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;

‘related service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected product;

‘processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction;

‘data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction;

‘same service type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities;

‘data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868;

‘data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;

‘user’ means a natural or legal person that owns a connected product or to whom temporary rights to use that connected product have been contractually transferred, or that receives related services;

‘data recipient’ means a natural or legal person, acting for purposes which are related to that person’s trade, business, craft or profession, other than the user of a connected product or related service, to whom the data holder makes data available, including a third party following a request by the user to the data holder or in accordance with a legal obligation under Union law or national legislation adopted in accordance with Union law;

‘product data’ means data generated by the use of a connected product that the manufacturer designed to be retrievable, via an electronic communications service, physical connection or on-device access, by a user, data holder or a third party, including, where relevant, the manufacturer;

‘related service data’ means data representing the digitisation of user actions or of events related to the connected product, recorded intentionally by the user or generated as a by-product of the user’s action during the provision of a related service by the provider;

‘readily available data’ means product data and related service data that a data holder lawfully obtains or can lawfully obtain from the connected product or related service, without disproportionate effort going beyond a simple operation;

‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

‘trade secret holder’ means a trade secret holder as defined in Article 2, point (2), of Directive (EU) 2016/943;

‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;

‘making available on the market’ means any supply of a connected product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of a connected product on the Union market;

‘consumer’ means any natural person who is acting for purposes which are outside that person’s trade, business, craft or profession;

‘enterprise’ means a natural or legal person that, in relation to contracts and practices covered by this Regulation, is acting for purposes which are related to that person’s trade, business, craft or profession;

‘small enterprise’ means a small enterprise as defined in Article 2(2) of the Annex to Recommendation 2003/361/EC;

‘microenterprise’ means a microenterprise as defined in Article 2(3) of the Annex to Recommendation 2003/361/EC;

‘Union bodies’ means the Union bodies, offices and agencies set up by or pursuant to acts adopted on the basis of the Treaty on European Union, the TFEU or the Treaty establishing the European Atomic Energy Community;

‘public sector body’ means national, regional or local authorities of the Member States and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies;

‘customer’ means a natural or legal person that has entered into a contractual relationship with a provider of data processing services with the objective of using one or more data processing services;

‘virtual assistants’ means software that can process demands, tasks or questions including those based on audio, written input, gestures or motions, and that, based on those demands, tasks or questions, provides access to other services or controls the functions of connected products;

‘digital assets’ means elements in digital form, including applications, for which the customer has the right of use, independently from the contractual relationship with the data processing service it intends to switch from;

‘on-premises ICT infrastructure’ means ICT infrastructure and computing resources owned, rented or leased by the customer, located in the data centre of the customer itself and operated by the customer or by a third-party;

‘switching’ means the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same service type, or other service, offered by a different provider of data processing services, or to an on-premises ICT infrastructure, including through extracting, transforming and uploading the data;

‘data egress charges’ means data transfer fees charged to customers for extracting their data through the network from the ICT infrastructure of a provider of data processing services to the system of a different provider or to on-premises ICT infrastructure;

‘switching charges’ means charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises ICT infrastructure, including data egress charges;

‘functional equivalence’ means re-establishing on the basis of the customer’s exportable data and digital assets, a minimum level of functionality in the environment of a new data processing service of the same service type after the switching process, where the destination data processing service delivers a materially comparable outcome in response to the same input for shared features supplied to the customer under the contract;

‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including metadata, directly or indirectly generated, or cogenerated, by the customer’s use of the data processing service, excluding any assets or data protected by intellectual property rights, or constituting a trade secret, of providers of data processing services or third parties;

‘smart contract’ means a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering;

‘interoperability’ means the ability of two or more data spaces or communication networks, systems, connected products, applications, data processing services or components to exchange and use data in order to perform their functions;

‘open interoperability specification’ means a technical specification in the field of information and communication technologies which is performance oriented towards achieving interoperability between data processing services;

‘common specifications’ means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation;

‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012.

‘data’ means any digital representation of acts, facts or information and any compilation of such acts, facts or information, including in the form of sound, visual or audio-visual recording;

‘metadata’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;

‘non-personal data’ means data other than personal data;

‘consent’ means consent as defined in Article 4, point (11), of Regulation (EU) 2016/679;

‘permission’ means giving data users the right to the processing of non-personal data;

‘connected product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;

‘related service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected product;

‘processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction;

‘data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction;

‘same service type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities;

‘data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868;

‘data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;

‘user’ means a natural or legal person that owns a connected product or to whom temporary rights to use that connected product have been contractually transferred, or that receives related services;

‘data holder’ means a natural or legal person that has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation adopted in accordance with Union law, to use or make available data, including, where contractually agreed, product data or related service data, which it has retrieved or generated during the provision of a related service;

‘data recipient’ means a natural or legal person, acting for purposes which are related to that person’s trade, business, craft or profession, other than the user of a connected product or related service, to whom the data holder makes data available, including a third party following a request by the user to the data holder or in accordance with a legal obligation under Union law or national legislation adopted in accordance with Union law;

‘product data’ means data generated by the use of a connected product that the manufacturer designed to be retrievable, via an electronic communications service, physical connection or on-device access, by a user, data holder or a third party, including, where relevant, the manufacturer;

‘related service data’ means data representing the digitisation of user actions or of events related to the connected product, recorded intentionally by the user or generated as a by-product of the user’s action during the provision of a related service by the provider;

‘readily available data’ means product data and related service data that a data holder lawfully obtains or can lawfully obtain from the connected product or related service, without disproportionate effort going beyond a simple operation;

‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

‘trade secret holder’ means a trade secret holder as defined in Article 2, point (2), of Directive (EU) 2016/943;

‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;

‘making available on the market’ means any supply of a connected product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of a connected product on the Union market;

‘consumer’ means any natural person who is acting for purposes which are outside that person’s trade, business, craft or profession;

‘enterprise’ means a natural or legal person that, in relation to contracts and practices covered by this Regulation, is acting for purposes which are related to that person’s trade, business, craft or profession;

‘small enterprise’ means a small enterprise as defined in Article 2(2) of the Annex to Recommendation 2003/361/EC;

‘microenterprise’ means a microenterprise as defined in Article 2(3) of the Annex to Recommendation 2003/361/EC;

‘Union bodies’ means the Union bodies, offices and agencies set up by or pursuant to acts adopted on the basis of the Treaty on European Union, the TFEU or the Treaty establishing the European Atomic Energy Community;

‘public sector body’ means national, regional or local authorities of the Member States and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies;

‘bodies governed by public law’ means bodies that have all of the following characteristics:

1. (a)

   they are established for the specific purpose of meeting needs in the general interest, not having an industrial or commercial character;

2. (b)

   they have legal personality;

3. (c)

   they are financed, for the most part by the State, regional or local authorities, or by other bodies governed by public law; or are subject to management supervision by those authorities or bodies; or have an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities, or by other bodies governed by public law;

‘public undertaking’ means any undertaking over which a public sector body may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it. A dominant influence on the part of the public sector bodies shall be presumed in any of the following cases in which those bodies, directly or indirectly:

1. (a)

   hold the majority of the undertaking's subscribed capital;

2. (b)

   control the majority of the votes attaching to shares issued by the undertaking;

3. (c)

   can appoint more than half of the undertaking's administrative, management or supervisory body;

‘public emergency’ means an exceptional situation, limited in time, such as a public health emergency, an emergency resulting from natural disasters, a human-induced major disaster, including a major cybersecurity incident, negatively affecting the population of the Union or the whole or part of a Member State, with a risk of serious and lasting repercussions for living conditions or economic stability, financial stability, or the substantial and immediate degradation of economic assets in the Union or the relevant Member State and which is determined or officially declared in accordance with the relevant procedures under Union or national law;

‘customer’ means a natural or legal person that has entered into a contractual relationship with a provider of data processing services with the objective of using one or more data processing services;

‘virtual assistants’ means software that can process demands, tasks or questions including those based on audio, written input, gestures or motions, and that, based on those demands, tasks or questions, provides access to other services or controls the functions of connected products;

‘digital assets’ means elements in digital form, including applications, for which the customer has the right of use, independently from the contractual relationship with the data processing service it intends to switch from;

‘on-premises ICT infrastructure’ means ICT infrastructure and computing resources owned, rented or leased by the customer, located in the data centre of the customer itself and operated by the customer or by a third-party;

‘switching’ means the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same service type, or other service, offered by a different provider of data processing services, or to an on-premises ICT infrastructure, including through extracting, transforming and uploading the data;

‘data egress charges’ means data transfer fees charged to customers for extracting their data through the network from the ICT infrastructure of a provider of data processing services to the system of a different provider or to on-premises ICT infrastructure;

‘switching charges’ means charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises ICT infrastructure, including data egress charges;

‘functional equivalence’ means re-establishing on the basis of the customer’s exportable data and digital assets, a minimum level of functionality in the environment of a new data processing service of the same service type after the switching process, where the destination data processing service delivers a materially comparable outcome in response to the same input for shared features supplied to the customer under the contract;

‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including metadata, directly or indirectly generated, or cogenerated, by the customer’s use of the data processing service, excluding any assets or data protected by intellectual property rights, or constituting a trade secret, of providers of data processing services or third parties;

‘data intermediation service’ means a service which aims to establish relationships of an economic character for the purposes of data sharing between an undetermined number of data subjects or data holders and data users, through technical, legal or other means, including for the purpose of exercising the rights of data subjects in relation to personal data, and which :

1. (1)

   do not have as their main purpose the intermediation of copyright-protected content;

2. (2)

   are not jointly procured by several legal persons for exclusive use among them;

‘data altruism’ means the voluntary sharing of data on the basis of the consent of data subjects to process personal data pertaining to them, or of permissions of data holders to allow the use of their non-personal data without seeking or receiving a reward that goes beyond compensation related to the costs that they incur where they make their data available for objectives of general interest as provided for in national law, where applicable, such as healthcare, combating climate change, improving mobility, facilitating the development, production and dissemination of official statistics, improving the provision of public services, public policy making or scientific research purposes in the general interest;

‘smart contract’ means a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering;

‘interoperability’ means the ability of two or more data spaces or communication networks, systems, connected products, applications, data processing services or components to exchange and use data in order to perform their functions;

‘open interoperability specification’ means a technical specification in the field of information and communication technologies which is performance oriented towards achieving interoperability between data processing services;

‘common specifications’ means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation;

‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012.

‘medium-sized enterprise’ means a medium-sized enterprise as defined in Article 2 of Annex I to Recommendation 2003/361/EC;

‘small mid-cap’ or ‘SMC’ means a small mid-cap enterprise as defined in Article 2 of the Annex to Commission Recommendation (EU) 2025/1099;

‘university’ means a public sector body that provides post-secondary-school higher education leading to academic degrees;

‘standard licence’ means a set of predefined re-use conditions in a digital format, preferably compatible with standardised public licences available online;

‘document’ means:

1. (a)

   any content that is non-digital whatever its medium (paper or as a sound, visual or audiovisual recording); or

2. (b)

   any part of such content;

‘dynamic data’ means data and documents in a digital form, subject to frequent or real-time updates, in particular because of their volatility or rapid obsolescence; data generated by sensors are typically considered to be dynamic data;

‘research data’ means data , other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

‘re-use’ means the use by natural persons or legal entities of documents held by:

1. (a)

   public sector bodies, for commercial or non-commercial purposes other than the initial purpose within the public task for which the documents were produced, except for the exchange of documents between public sector bodies purely in pursuit of their public tasks; or

2. (b)

   public undertakings, under Chapter VIIc Section 2 for commercial or non-commercial purposes other than for the initial purpose of providing services in the general interest for which the documents were produced, except for the exchange of documents between public undertakings and public sector bodies purely in pursuit of the public tasks of public sector bodies;

‘high-value datasets’ means data and documents the re-use of which is associated with important benefits for society, the environment and the economy, in particular because of their suitability for the creation of value-added services, applications and new, high-quality and decent jobs, and because of the number of potential beneficiaries of the value-added services and applications based on those data and documents;

‘certain categories of protected data’ means data and documents held by public sector bodies which are protected on the grounds of

1. (a)

   commercial confidentiality, including business, professional and company secrets;

2. (b)

   statistical confidentiality;

3. (c)

   the protection of intellectual property rights of third parties; or

4. (d)

   the protection of personal data, insofar as such data fall outside the scope of Section 2 of Chapter VIIc;

‘secure processing environment’ means the physical or virtual environment and organisational means to ensure compliance with Union law in particular with regard to data subjects’ rights, intellectual property rights, and commercial and statistical confidentiality, integrity and accessibility, as well as with applicable national law, and to allow the entity providing the secure processing environment to determine and supervise all data processing actions, including the display, storage, download and export of data and the calculation of derivative data through computational algorithms;

‘re-user’ means a natural or legal person who was granted the right to re-use data or documents held by a public sector body or a public undertaking under Chapter VIIc or to research data or certain categories of protected data;

‘machine-readable format’ means a file format structured so that software applications can easily identify, recognise and extract specific data, including individual statements of fact, and their internal structure;

‘open format’ means a file format that is platform-independent and made available to the public without any restriction that impedes the re-use of documents;

‘formal open standard’ means a standard which has been laid down in written form, detailing specifications for the requirements on how to ensure software interoperability;

‘reasonable return on investment’ means a percentage of the overall charge, in addition to the amount needed to recover the eligible costs, not exceeding 5 percentage points above the fixed interest rate of the ECB;

‘data localisation requirement’ means any obligation, prohibition, condition, limit or other requirement provided for in the laws, regulations or administrative provisions of a Member State or resulting from general and consistent administrative practices in a Member State and in bodies governed by public law, including in the field of public procurement, without prejudice to Directive 2014/24/EU, which imposes the processing of data in the territory of a specific Member State or hinders the processing of data in any other Member State;

‘pseudonymisation’ means pseudonymisation as referred to under Article 4(5) of Regulation (EU) 2016/679.

‘data’ means any digital representation of acts, facts or information and any compilation of such acts, facts or information, including in the form of sound, visual or audio-visual recording;

‘metadata’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;

‘non-personal data’ means data other than personal data;

‘connected product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;

‘related service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected product;

‘processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction;

‘data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction;

‘same service type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities;

‘data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868;

‘data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;

‘user’ means a natural or legal person that owns a connected product or to whom temporary rights to use that connected product have been contractually transferred, or that receives related services;