Preámbulo

Considerando que:

(1) In recent years, data-driven technologies have had transformative effects on all sectors of the economy. The proliferation of products connected to the internet in particular has increased the volume and potential value of data for consumers, businesses and society. High-quality and interoperable data from different domains increase competitiveness and innovation and ensure sustainable economic growth. The same data may be used and reused for a variety of purposes and to an unlimited degree, without any loss of quality or quantity.

(2) Barriers to data sharing prevent an optimal allocation of data for the benefit of society. Those barriers include a lack of incentives for data holders to enter voluntarily into data sharing agreements, uncertainty about rights and obligations in relation to data, the costs of contracting and implementing technical interfaces, the high level of fragmentation of information in data silos, poor metadata management, the absence of standards for semantic and technical interoperability, bottlenecks impeding data access, a lack of common data sharing practices and the abuse of contractual imbalances with regard to data access and use.

(3) In sectors characterised by the presence of microenterprises, small enterprises and medium-sized enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC (5) (SMEs), there is often a lack of digital capacities and skills to collect, analyse and use data, and access is frequently restricted where one actor holds them in the system or due to a lack of interoperability between data, between data services or across borders.

(4) In order to respond to the needs of the digital economy and to remove barriers to a well-functioning internal market for data, it is necessary to lay down a harmonised framework specifying who is entitled to use product data or related service data, under which conditions and on what basis. Accordingly, Member States should not adopt or maintain additional national requirements regarding matters falling within the scope of this Regulation, unless explicitly provided for herein, since this would affect its direct and uniform application. Moreover, action at Union level should be without prejudice to obligations and commitments in the international trade agreements concluded by the Union.

(5) This Regulation ensures that users of a connected product or related service in the Union can access, in a timely manner, the data generated by the use of that connected product or related service and that those users can use the data, including by sharing them with third parties of their choice. It imposes the obligation on data holders to make data available to users and third parties of the user’s choice in certain circumstances. It also ensures that data holders make data available to data recipients in the Union under fair, reasonable and non-discriminatory terms and conditions and in a transparent manner. Private law rules are key in the overall framework for data sharing. Therefore, this Regulation adapts rules of contract law and prevents the exploitation of contractual imbalances that hinder fair access to and use of data. This Regulation also ensures that data holders make available to public sector bodies, the Commission, the European Central Bank or Union bodies, where there is an exceptional need, the data that are necessary for the performance of a specific task carried out in the public interest. In addition, this Regulation seeks to facilitate switching between data processing services and to enhance the interoperability of data and of data sharing mechanisms and services in the Union. This Regulation should not be interpreted as recognising or conferring any new right on data holders to use data generated by the use of a connected product or related service.

(6) Data generation is the result of the actions of at least two actors, in particular the designer or manufacturer of a connected product, who may in many cases also be a provider of related services, and the user of the connected product or related service. It gives rise to questions of fairness in the digital economy as the data recorded by connected products or related services are an important input for aftermarket, ancillary and other services. In order to realise the important economic benefits of data, including by way of data sharing on the basis of voluntary agreements and the development of data-driven value creation by Union enterprises, a general approach to assigning rights regarding access to and the use of data is preferable to awarding exclusive rights of access and use. This Regulation provides for horizontal rules which could be followed by Union or national law that addresses the specific situations of the relevant sectors.

(7) The fundamental right to the protection of personal data is safeguarded, in particular, by Regulations (EU) 2016/679 (6) and (EU) 2018/1725 (7) of the European Parliament and of the Council. Directive 2002/58/EC of the European Parliament and of the Council (8) additionally protects private life and the confidentiality of communications, including by way of conditions on any personal and non-personal data storing in, and access from, terminal equipment. Those Union legislative acts provide the basis for sustainable and responsible data processing, including where datasets include a mix of personal and non-personal data. This Regulation complements and is without prejudice to Union law on the protection of personal data and privacy, in particular Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive 2002/58/EC. No provision of this Regulation should be applied or interpreted in such a way as to diminish or limit the right to the protection of personal data or the right to privacy and confidentiality of communications. Any processing of personal data pursuant to this Regulation should comply with Union data protection law, including the requirement of a valid legal basis for processing under Article 6 of Regulation (EU) 2016/679 and, where relevant, the conditions of Article 9 of that Regulation and of Article 5(3) of Directive 2002/58/EC. This Regulation does not constitute a legal basis for the collection or generation of personal data by the data holder. This Regulation imposes an obligation on data holders to make personal data available to users or third parties of a user’s choice upon that user’s request. Such access should be provided to personal data that are processed by the data holder on the basis of any of the legal bases referred to in Article 6 of Regulation (EU) 2016/679. Where the user is not the data subject, this Regulation does not create a legal basis for providing access to personal data or for making personal data available to a third party and should not be understood as conferring any new right on the data holder to use personal data generated by the use of a connected product or related service. In those cases, it could be in the interest of the user to facilitate meeting the requirements of Article 6 of Regulation (EU) 2016/679. As this Regulation should not adversely affect the data protection rights of data subjects, the data holder can comply with requests in those cases, inter alia, by anonymising personal data or, where the readily available data contains personal data of several data subjects, transmitting only personal data relating to the user.

(8) The principles of data minimisation and data protection by design and by default are essential when processing involves significant risks to the fundamental rights of individuals. Taking into account the state of the art, all parties to data sharing, including data sharing falling within scope of this Regulation, should implement technical and organisational measures to protect those rights. Such measures include not only pseudonymisation and encryption, but also the use of increasingly available technology that permits algorithms to be brought to the data and allow valuable insights to be derived without the transmission between parties or unnecessary copying of the raw or structured data themselves.

(9) Unless otherwise provided for in this Regulation, it does not affect national contract law, including rules on the formation, validity or effect of contracts, or the consequences of the termination of a contract. This Regulation complements and is without prejudice to Union law which aims to promote the interests of consumers and ensure a high level of consumer protection, and to protect their health, safety and economic interests, in particular Council Directive 93/13/EEC (9) and Directives 2005/29/EC (10) and 2011/83/EU (11) of the European Parliament and of the Council.

(10) This Regulation is without prejudice to Union and national legal acts providing for the sharing of, access to and the use of data for the purpose of the prevention, investigation, detection or prosecution of criminal offences or for the execution of criminal penalties, or for customs and taxation purposes, irrespective of the legal basis under the Treaty on the Functioning of the European Union (TFEU) on which such Union legal acts were adopted, as well as to international cooperation in that area, in particular on the basis of the Council of Europe Convention on Cybercrime, (ETS No 185), done at Budapest on 23 November 2001. Such acts include Regulations (EU) 2021/784 (12), (EU) 2022/2065 (13) and (EU) 2023/1543 (14) of the European Parliament and of the Council and Directive (EU) 2023/1544 of the European Parliament and of the Council (15). This Regulation does not apply to the collection or sharing of, access to or the use of data under Regulation (EU) 2015/847 of the European Parliament and of the Council (16) and Directive (EU) 2015/849 of the European Parliament and of the Council (17). This Regulation does not apply to areas that fall outside the scope of Union law and in any event does not affect the competences of the Member States concerning public security, defence or national security, customs and tax administration or the health and safety of citizens, regardless of the type of entidadEntidad Persona física o jurídica creada y reconocida como tal en virtud de la legislación nacional de su lugar de establecimiento, que puede, actuando en nombre propio, ejercer derechos y estar sujeta a obligaciones -. Definición según el artículo 6 de la Directiva (UE) 2022/2555 (Directiva NIS2) entrusted by the Member States to carry out tasks in relation to those competences.

(11) Union law establishing physical design and data requirements for products to be placed on the Union market should not be affected unless specifically provided for by this Regulation.

(12) This Regulation complements and is without prejudice to Union law aiming to establish accessibility requirements on certain products and services, in particular Directive (EU) 2019/882 of the European Parliament and of the Council (18).

(13) This Regulation is without prejudice to Union and national legal acts providing for the protection of intellectual property rights, including Directives 2001/29/EC (19), 2004/48/EC (20) and (EU) 2019/790 (21) of the European Parliament and of the Council.

(14) Connected products that obtain, generate or collect, by means of their components or operating systems, data concerning their performance, use or environment and that are able to communicate those data via an servicio de comunicaciones electrónicasServicio de comunicaciones electrónicas Significa un servicio prestado normalmente a cambio de una remuneración a través de redes de comunicaciones electrónicas, que engloba, con excepción de los servicios que proporcionan contenidos transmitidos utilizando redes y servicios de comunicaciones electrónicas o ejercen un control editorial sobre ellos, los siguientes tipos de servicios: a) "servicio de acceso a internet", tal como se define en el artículo 2, párrafo segundo, punto 2, del Reglamento (UE) 2015/2120; b) servicio de comunicaciones interpersonales; y c) servicios consistentes, en su totalidad o principalmente, en el transporte de señales, como los servicios de transmisión utilizados para la prestación de servicios de máquina a máquina y para la radiodifusión. - Definición según el artículo 2, punto (4), de la Directiva (UE) 2018/1972, a physical connection, or on-device access, often referred to as the Internet of Things, should fall within the scope of this Regulation, with the exception of prototypes. Examples of such electronic communications services include, in particular, land-based telephone networks, television cable networks, satellite-based networks and near-field communication networks. Connected products are found in all aspects of the economy and society, including in private, civil or commercial infrastructure, vehicles, health and lifestyle equipment, ships, aircraft, home equipment and consumer goods, medical and health devices or agricultural and industrial machinery. Manufacturers’ design choices, and, where relevant, Union or national law that addresses sector-specific needs and objectives or relevant decisions of competent authorities, should determine which data a connected product is capable of making available.

(15) The data represent the digitisation of user actions and events and should accordingly be accessible to the user. The rules for access to and the use of data from connected products and related services under this Regulation address both product data and related service data. Product data refers to data generated by the use of a connected product that the manufacturer designed to be retrievable from the connected product by a user, data holder or a third party, including, where relevant, the manufacturer. Related service data refers to data, which also represent the digitisation of user actions or events related to the connected product which are generated during the provision of a related service by the provider. Data generated by the use of a connected product or related service should be understood to cover data recorded intentionally or data which result indirectly from the user’s action, such as data about the connected product’s environment or interactions. This should include data on the use of a connected product generated by a user interface or via a related service, and should not be limited to the information that such use took place, but should include all data that the connected product generates as a result of such use, such as data generated automatically by sensors and data recorded by embedded applications, including applications indicating hardware status and malfunctions. This should also include data generated by the connected product or related service during times of inaction by the user, such as when the user chooses not to use a connected product for a given period of time and instead to keep it in stand-by mode or even switched off, as the status of a connected product or its components, for example its batteries, can vary when the connected product is in stand-by mode or switched off. Data which are not substantially modified, meaning data in raw form, also known as source or primary data which refer to data points that are automatically generated without any further form of processing, as well as data which have been pre-processed for the purpose of making them understandable and useable prior to subsequent processing and analysis fall within the scope of this Regulation. Such data includes data collected from a single sensor or a connected group of sensors for the purpose of making the collected data comprehensible for wider use-cases by determining a physical quantity or quality or the change in a physical quantity, such as temperature, pressure, flow rate, audio, pH value, liquid level, position, acceleration or speed. The term ‘pre-processed data’ should not be interpreted in such a manner as to impose an obligation on the data holder to make substantial investments in cleaning and transforming the data. The data to be made available should include the relevant metadata, including its basic context and timestamp, to make the data usable, combined with other data, such as data sorted and classified with other data points relating to them, or re-formatted into a commonly used format. Such data are potentially valuable to the user and support innovation and the development of digital and other services to protect the environment, health and the circular economy, including through facilitating the maintenance and repair of the connected products in question. By contrast, information inferred or derived from such data, which is the outcome of additional investments into assigning values or insights from the data, in particular by means of proprietary, complex algorithms, including those that are a part of proprietary software, should not be considered to fall within the scope of this Regulation and consequently should not be subject to the obligation of a data holder to make it available to a user or a data recipient, unless otherwise agreed between the user and the data holder. Such data could include, in particular, information derived by means of sensor fusion, which infers or derives data from multiple sensors, collected in the connected product, using proprietary, complex algorithms and which could be subject to intellectual property rights.

(16) This Regulation enables users of connected products to benefit from aftermarket, ancillary and other services based on data collected by sensors embedded in such products, the collection of those data being of potential value in improving the performance of the connected products. It is important to delineate between, on the one hand, markets for the provision of such sensor-equipped connected products and related services and, on the other, markets for unrelated software and content such as textual, audio or audiovisual content often covered by intellectual property rights. As a result, data that such sensor-equipped connected products generate when the user records, transmits, displays or plays content, as well as the content itself, which is often covered by intellectual property rights, inter alia for use by an online service, should not be covered by this Regulation. This Regulation should also not cover data which was obtained, generated or accessed from the connected product, or which was transmitted to it, for the purpose of storage or other processing operations on behalf of other parties, who are not the user, such as may be the case with regard to servers or cloud infrastructure operated by their owners entirely on behalf of third parties, inter alia for use by an online service.

(17) It is necessary to lay down rules regarding products that are connected to a related service 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 or adapt the functionality of the connected product. Such related services involve the exchange of data between the connected product and the service provider and should be understood to be explicitly linked to the operation of the connected product’s functions, such as services that, where applicable, transmit commands to the connected product that are able to have an impact on its action or behaviour. Services which do not have an impact on the operation of the connected product and which do not involve the transmitting of data or commands to the connected product by the service provider should not be considered to be related services. Such services could include, for example, auxiliary consulting, analytics or financial services, or regular repair and maintenance. Related services can be offered as part of the purchase, rent or lease contract. Related services could also be provided for products of the same type and users could reasonably expect them to be provided taking into account the nature of the connected product and any public statement made by or on behalf of the seller, rentor, lessor or other persons in previous links of the chain of transactions, including the manufacturer. Those related services may themselves generate data of value to the user independently of the data collection capabilities of the connected product with which they are interconnected. This Regulation should also apply to a related service that is not supplied by the seller, rentor or lessor itself, but which is provided by a third party. In the event of doubt as to whether the service is provided as part of the purchase, rent or lease contract, this Regulation should apply. Neither the power supply, nor the supply of the connectivity are to be interpreted as related services under this Regulation.

(18) The user of a connected product should be understood to be a natural or legal person, such as a business, a consumer or a public sector body, that owns a connected product, has received certain temporary rights, for example by means of a rental or lease agreement, to access or use data obtained from the connected product, or receives related services for the connected product. Those access rights should in no way alter or interfere with the rights of data subjects who may be interacting with a connected product or a related service regarding personal data generated by the connected product or during the provision of the related service. The user bears the risks and enjoys the benefits of using the connected product and should also enjoy access to the data it generates. The user should therefore be entitled to derive benefit from data generated by that connected product and any related service. An owner, renter or lessee should also be considered to be a user, including where several entities can be considered to be users. In the context of multiple users, each user may contribute in a different manner to the data generation and have an interest in several forms of use, such as fleet management for a leasing enterprise, or mobility solutions for individuals using a car sharing service.

(19) Data literacy refers to the skills, knowledge and understanding that allows users, consumers and businesses, in particular SMEs falling within the scope of this Regulation, to gain awareness of the potential value of the data they generate, produce and share and that they are motivated to offer and provide access to in accordance with relevant legal rules. Data literacy should go beyond learning about tools and technologies and aim to equip and empower citizens and businesses with the ability to benefit from an inclusive and fair data market. The spread of data literacy measures and the introduction of appropriate follow-up actions could contribute to improving working conditions and ultimately sustain the consolidation, and innovation path of, the data economy in the Union. Competent authorities should promote tools and adopt measures to advance data literacy among users and entities falling within the scope of this Regulation and an awareness of their rights and obligations thereunder.

(20) In practice, not all data generated by connected products or related services are easily accessible to their users and there are often limited possibilities regarding the portability of data generated by products connected to the internet. Users are unable to obtain the data necessary to make use of providers of repair and other services and businesses are unable to launch innovative, convenient and more efficient services. In many sectors, manufacturers are able to determine, through their control of the technical design of the connected products or related services, what data are generated and how they can be accessed, despite having no legal right to those data. It is therefore necessary to ensure that connected products are designed and manufactured, and related services are designed and provided, in such a manner that product data and related service data, including the relevant metadata necessary to interpret and use those data, including for the purpose of retrieving, using or sharing them, are always easily and securely accessible to a user, free of charge, in a comprehensive, structured, commonly used and machine-readable format. Product data and related service data that a data holder lawfully obtains or can lawfully obtain from the connected product or related service, such as by means of the connected product design, the data holder’s contract with the user for the provision of related services, and its technical means of data access, without disproportionate effort, are referred to as ‘readily available data’. Readily available data does not include data generated by the use of a connected product where the design of the connected product does not provide for such data being stored or transmitted outside the component in which they are generated or the connected product as a whole. This Regulation should therefore not be understood to impose an obligation to store data on the central computing unit of a connected product. The absence of such an obligation should not prevent the manufacturer or data holder from voluntarily agreeing with the user on the making of such adaptations. The design obligations in this Regulation are also without prejudice to the data minimisation principle laid down in Article 5(1), point (c), of Regulation (EU) 2016/679 and should not be understood as imposing an obligation to design connected products and related services in such a way that they store or otherwise process any personal data other than the personal data necessary in relation to the purposes for which they are processed. Union or national law could be introduced to outline further specificities, such as the product data that should be accessible from connected products or related services, given that such data may be essential for the efficient operation, repair or maintenance of those connected products or related services. Where subsequent updates or alterations to a connected product or a related service, by the manufacturer or another party, lead to additional accessible data or a restriction of initially accessible data, such changes should be communicated to the user in the context of the update or alteration.

(21) Where several persons or entities are considered to be users, for example in the case of co-ownership or where an owner, renter or lessee shares rights of data access or use, the design of the connected product or related service, or the relevant interface, should enable each user to have access to the data they generate. Use of connected products that generate data typically requires a user account to be set up. Such an account allows the user to be identified by the data holder, which may be the manufacturer. It can also be used as a means of communication and to submit and process data access requests. Where several manufacturers or related services providers have sold, rented or leased connected products or provided related services, integrated together, to the same user, the user should turn to each of the parties with which it has a contract. Manufacturers or designers of a connected product that is typically used by several persons should put in place the necessary mechanisms to allow separate user accounts for individual persons, where relevant, or for the possibility of several persons using the same user account. Account solutions should allow users to delete their accounts and erase the data related to them and could allow users to terminate data access, use or sharing, or submit requests to terminate, in particular taking into account situations in which the ownership or usage of the connected product changes. Access should be granted to the user on the basis of simple request mechanism granting automatic execution and not requiring examination or clearance by the manufacturer or data holder. This means that the data should be made available only when the user actually wants access. Where automated execution of the data access request is not possible, for example via a user account or accompanying mobile application provided with the connected product or related service, the manufacturer should inform the user as to how the data may be accessed.

(22) Connected products may be designed to make certain data directly accessible from on-device data storage or from a remote server to which the data are communicated. Access to on-device data storage may be enabled via cable-based or wireless local area networks connected to a publicly available electronic communications service or mobile network. The server may be the manufacturer’s own local server capacity or that of a third party or a cloud service provider. Processors as defined in Article 4, point (8), of Regulation (EU) 2016/679 are not considered to act as data holders. However, they can be specifically tasked with making data available by the controller as defined in Article 4, point (7), of Regulation (EU) 2016/679. Connected products may be designed to permit the user or a third party to process the data on the connected product, on a computing instance of the manufacturer or within an information and communications technology (ICT) environment chosen by the user or the third party.

(23) Virtual assistants play an increasing role in digitising consumer and professional environments and serve as an easy-to-use interface to play content, obtain information, or activate products connected to the internet. Virtual assistants can act as a single gateway in, for example, a smart home environment and record significant amounts of relevant data on how users interact with products connected to the internet, including those manufactured by other parties, and can replace the use of manufacturer-provided interfaces such as touch screens or smartphone apps. The user may wish to make available such data to third party manufacturers and enable novel smart services. Virtual assistants should be covered by the data access rights provided for in this Regulation. Data generated when a user interacts with a connected product via a virtual assistant provided by an entity other than the manufacturer of the connected product should also be covered by the data access rights provided for in this Regulation. However, only the data arising from the interaction between the user and a connected product or related service through the virtual assistant should be covered by this Regulation. Data produced by the virtual assistant which are unrelated to the use of a connected product or related service are not covered by this Regulation.

(24) Before concluding a contract for the purchase, rent, or lease of a connected product, the seller, rentor or lessor, which may be the manufacturer, should provide to the user information regarding the product data which the connected product is capable of generating, including the type, format and the estimated volume of such data, in a clear and comprehensible manner. This could include information on data structures, data formats, vocabularies, classification schemes, taxonomies and code lists, where available, as well as clear and sufficient information relevant for the exercise of the user’s rights on how the data may be stored, retrieved or accessed, including the terms of use and quality of service of application programming interfaces or, where applicable, the provision of software development kits. That obligation provides transparency over the product data generated and enhances easy access for the user. The information obligation could be fulfilled, for example by maintaining a stable uniform resource locator (URL) on the web, which can be distributed as a web link or QR code, pointing to the relevant information, which could be provided by the seller, rentor or lessor, which may be the manufacturer, to the user before concluding the contract for the purchase, rent or lease of a connected product. It is, in any case, necessary that the user is able to store the information in a way that is accessible for future reference and that allows the unchanged reproduction of the information stored. The data holder cannot be expected to store the data indefinitely in view of the needs of the user of the connected product, but should implement a reasonable data retention policy, where applicable, in line with storage limitation principle pursuant Article 5(1), point (e), of Regulation (EU) 2016/679, that allows for the effective application of the data access rights provided for in this Regulation. The obligation to provide information does not affect the obligation of the controller to provide information to the data subject pursuant to Articles 12, 13 and 14 of Regulation (EU) 2016/679. The obligation to provide information before concluding a contract for the provision of a related service should lie with the prospective data holder, independently of whether the data holder concludes a contract for the purchase, rent or lease of a connected product. Where information changes during the lifetime of the connected product or the contract period for the related service, including where the purpose for which those data are to be used changes from the originally specified purpose, it should also be provided to the user.

(25) This Regulation should not be understood to confer any new right on data holders to use product data or related service data. Where the manufacturer of a connected product is a data holder, the basis for the manufacturer to use non-personal data should be a contract between the manufacturer and the user. Such a contract could be part of an agreement for the provision of the related service, which could be concluded together with the purchase, rent or lease agreement relating to the connected product. Any contractual term stipulating that the data holder may use product data or related service data should be transparent to the user, including regarding the purposes for which the data holder intends to use the data. Such purposes could include improving the functioning of the connected product or related services, developing new products or services, or aggregating data with the aim of making available the resulting derived data to third parties, provided that such derived data do not allow the identification of specific data transmitted to the data holder from the connected product, or allow a third party to derive those data from the dataset. Any change of the contract should depend on the informed agreement of the user. This Regulation does not prevent parties from agreeing on contractual terms the effect of which is to exclude or limit the use of non-personal data, or certain categories of non-personal data, by a data holder. Neither does it prevent parties from agreeing to make product data or related service data available to third parties, directly or indirectly, including, where applicable, via another data holder. Moreover, this Regulation does not prevent sector-specific regulatory requirements under Union law, or national law compatible with Union law, which would exclude or limit the use of certain such data by the data holder on well-defined public policy grounds. This Regulation does not prevent users, in the case of business-to-business relations, from making data available to third parties or data holders under any lawful contractual term, including by agreeing to limit or restrict further sharing of such data, or from being compensated proportionately, for example in exchange for waiving their right to use or share such data. While the notion of ‘data holder’ generally does not include public sector bodies, it may include public undertakings.

(26) To foster the emergence of liquid, fair and efficient markets for non-personal data, users of connected products should be able to share data with others, including for commercial purposes, with minimal legal and technical effort. It is currently often difficult for businesses to justify the personnel or computing costs that are necessary for preparing non-personal datasets or data products and to offer them to potential counterparties via data intermediation services, including data marketplaces. A substantial hurdle to the sharing of non-personal data by businesses therefore results from the lack of predictability of economic returns from investing in the curation and making available of datasets or data products. In order to allow for the emergence of liquid, fair and efficient markets for non-personal data in the Union, the party that has the right to offer such data on a market must be clarified. Users should therefore have the right to share non-personal data with data recipients for commercial and non-commercial purposes. Such data sharing could be performed directly by the user, upon the request of the user via a data holder, or through data intermediation services. Data intermediation services, as regulated by Regulation (EU) 2022/868 of the European Parliament and of the Council (22) could facilitate a data economy by establishing commercial relationships between users, data recipients and third parties and may support users in exercising their right to use data, such as ensuring the anonymisation of personal data or aggregation of access to data from multiple individual users. Where data are excluded from a data holder’s obligation to make them available to users or third parties, the scope of such data could be specified in the contract between the user and the data holder for the provision of a related service so that users can easily determine which data are available to them for sharing with data recipients or third parties. Data holders should not make available non-personal product data to third parties for commercial or non-commercial purposes other than the fulfilment of their contract with the user, without prejudice to legal requirements pursuant to Union or national law for a data holder to make data available. Where relevant, data holders should contractually bind third parties not to further share data received from them.

(27) In sectors characterised by the concentration of a small number of manufacturers supplying connected products to end users, there may only be limited options available to users for the access to and the use and sharing of data. In such circumstances, contracts may be insufficient to achieve the objective of user empowerment, making it difficult for users to obtain value from the data generated by the connected product they purchase, rent or lease. Consequently, there is limited potential for innovative smaller businesses to offer data-based solutions in a competitive manner and for a diverse data economy in the Union. This Regulation should therefore build on recent developments in specific sectors, such as the Code of Conduct on agricultural data sharing by contract. Union or national law may be adopted to address sector-specific needs and objectives. Furthermore, data holders should not use any readily available data that is non-personal data in order to derive insights about the economic situation of the user or its assets or production methods or about such use by the user in any other manner that could undermine the commercial position of that user on the markets in which it is active. This could include using knowledge about the overall performance of a business or a farm in contractual negotiations with the user on the potential acquisition of the user’s products or agricultural produce to the user’s detriment, or using such information to feed into larger databases on certain markets in the aggregate, for example databases on crop yields for the upcoming harvesting season, as such use could affect the user negatively in an indirect manner. The user should be given the necessary technical interface to manage permissions, preferably with granular permission options such as ‘allow once’ or ‘allow while using this app or service’, including the option to withdraw such permissions.

(28) In contracts between a data holder and a consumer as user of a connected product or related service generating data, Union consumer law, in particular Directives 93/13/EEC and 2005/29/EC, applies to ensure that a consumer is not subject to unfair contractual terms. For the purposes of this Regulation, unfair contractual terms unilaterally imposed on an enterprise should not be binding on that enterprise.

(29) Data holders may require appropriate user identification to verify a user’s entitlement to access the data. In the case of personal data processed by a processor on behalf of the controller, data holders should ensure that the access request is received and handled by the processor.

(30) The user should be free to use the data for any lawful purpose. This includes providing the data the user has received while exercising its rights under this Regulation to a third party offering an aftermarket service that may be in competition with a service provided by a data holder, or to instruct the data holder to do so. The request should be submitted by the user or by an authorised third party acting on a user’s behalf, including a provider of a data intermediation service. Data holders should ensure that the data made available to the third party is as accurate, complete, reliable, relevant and up-to-date as the data the data holder itself may be able or entitled to access from the use of the connected product or related service. Any intellectual property rights should be respected in the handling of the data. It is important to preserve incentives to invest in products with functionalities based on the use of data from sensors built into those products.

(31) Directive (EU) 2016/943 of the European Parliament and of the Council (23) provides that the acquisition, use or disclosure of a trade secret shall be considered to be lawful, inter alia, where such acquisition, use or disclosure is required or allowed by Union or national law. While this Regulation requires data holders to disclose certain data to users, or third parties of a user’s choice, even when such data qualify for protection as trade secrets, it should be interpreted in such a manner as to preserve the protection afforded to trade secrets under Directive (EU) 2016/943. In this context, data holders should be able to require users, or third parties of a user’s choice, to preserve the confidentiality of data considered to be trade secrets. To that end, data holders should identify trade secrets prior to the disclosure, and should have the possibility to agree with users, or third parties of a user’s choice, on necessary measures to preserve their confidentiality, including by the use of model contractual terms, confidentiality agreements, strict access protocols, technical standards and the application of codes of conduct. In addition to the use of model contractual terms to be developed and recommended by the Commission, the establishment of codes of conduct and technical standards related to the protection of trade secrets in handling the data could help achieve the aim of this Regulation and should be encouraged. Where there is no agreement on the necessary measures or where a user, or third parties of the user’s choice, fail to implement agreed measures or undermine the confidentiality of the trade secrets, the data holder should be able to withhold or suspend the sharing of data identified as trade secrets. In such cases, the data holder should provide the decision in writing to the user or to the third party without undue delay and notify the competent authority of the Member State in which the data holder is established that it has withheld or suspended data sharing and identify which measures have not been agreed or implemented and, where relevant, which trade secrets have had their confidentiality undermined. Data holders cannot, in principle, refuse a data access request under this Regulation solely on the basis that certain data is considered to be a trade secret, as this would subvert the intended effects of this Regulation. However, in exceptional circumstances, a data holder who is a trade secret holder should be able, on a case-by-case basis, to refuse a request for the specific data in question if it is able to demonstrate to the user or to the third party that, despite the technical and organisational measures taken by the user or by the third party, serious economic damage is highly likely to result from the disclosure of that trade secret. Serious economic damage implies serious and irreparable economic loss. The data holder should duly substantiate its refusal in writing without undue delay to the user or to the third party and notify the competent authority. Such a substantiation should be based on objective elements, demonstrating the concrete riesgoRiesgo Se refiere al potencial de pérdida o perturbación causado por un incidente y debe expresarse como una combinación de la magnitud de dicha pérdida o perturbación y la probabilidad de que se produzca el incidente. Definición según el artículo 6 de la Directiva (UE) 2022/2555 (Directiva NIS2) of serious economic damage expected to result from a specific data disclosure and the reasons why the measures taken to safeguard the requested data are not considered to be sufficient. A possible negative impact on ciberseguridadCiberseguridad "ciberseguridad": la ciberseguridad definida en el artículo 2, punto 1, del Reglamento (UE) 2019/881; - Definición según el artículo 6 de la Directiva (UE) 2022/2555 (Directiva NIS2) "ciberseguridad": las actividades necesarias para proteger las redes y los sistemas de información, a los usuarios de dichos sistemas y a otras personas afectadas por las ciberamenazas; - Definición según el artículo 2, punto (1), del Reglamento (UE) 2019/881; can be taken into account in that context. Without prejudice to the right to seek redress before a court or tribunal of a Member State, where the user or a third party wishes to challenge the data holder’s decision to refuse or to withhold or suspend data sharing, the user or the third party can lodge a complaint with the competent authority, which should, without undue delay, decide whether and under which conditions data sharing should start or resume, or can agree with the data holder to refer the matter to a dispute settlement body. The exceptions to data access rights in this Regulation should not in any case limit the right of access and right to data portability of data subjects under Regulation (EU) 2016/679.

(32) The aim of this Regulation is not only to foster the development of new, innovative connected products or related services, stimulate innovation on aftermarkets, but also to stimulate the development of entirely novel services making use of the data concerned, including based on data from a variety of connected products or related services. At the same time, this Regulations aims to avoid undermining the investment incentives for the type of connected product from which the data are obtained, for instance, by the use of data to develop a competing connected product which is considered to be interchangeable or substitutable by users, in particular on the basis of the connected product’s characteristics, its price and intended use. This Regulation provides for no prohibition on the development of a related service using data obtained under this Regulation as this would have an undesirable discouraging effect on innovation. Prohibiting the use of data accessed under this Regulation for developing a competing connected product protects data holders’ innovation efforts. Whether a connected product competes with the connected product from which the data originates depends on whether the two connected products are in competition on the same product market. This is to be determined on the basis of the established principles of Union competition law for defining the relevant product market. However, lawful purposes for the use of the data could include reverse engineering, provided that it complies with the requirements laid down in this Regulation and in Union or national law. This may be the case for the purposes of repairing or prolonging the lifetime of a connected product or for the provision of aftermarket services to connected products.

(33) A third party to whom data is made available may be a natural or legal person, such as a consumer, an enterprise, a organización de la investigaciónOrganización de la investigación Se refiere a una entidad que tiene como objetivo principal llevar a cabo investigación aplicada o desarrollo experimental con vistas a explotar los resultados de dicha investigación con fines comerciales, pero que no incluye a las instituciones educativas -. Definición según el artículo 6 de la Directiva (UE) 2022/2555 (Directiva NIS2), a not-for-profit organisation or an entity acting in a professional capacity. In making the data available to the third party, a data holder should not abuse its position to seek a competitive advantage in markets where the data holder and the third party may be in direct competition. The data holder should not therefore use any readily available data in order to derive insights about the economic situation, assets or production methods of, or the use by, the third party in any other manner that could undermine the commercial position of the third party on the markets in which the third party is active. The user should be able to share non-personal data with third parties for commercial purposes. Upon the agreement with the user, and subject to the provisions of this Regulation, third parties should be able to transfer the data access rights granted by the user to other third parties, including in exchange for compensation. Business-to-business data intermediaries and personal information management systems (PIMS), referred to as data intermediation services in Regulation (EU) 2022/868, may support users or third parties in establishing commercial relations with an undetermined number of potential counterparties for any lawful purpose falling within the scope of this Regulation. They could play an instrumental role in aggregating access to data so that big data analyses or machine learning can be facilitated, provided that users remain in full control of whether to provide their data to such aggregation and the commercial terms under which their data are to be used.

(34) The use of a connected product or related service may, in particular when the user is a natural person, generate data that relates to the data subject. Processing of such data is subject to the rules established under Regulation (EU) 2016/679, including where personal and non-personal data in a dataset are inextricably linked. The data subject may be the user or another natural person. Personal data may only be requested by a controller or a data subject. A user who is the data subject is, under certain circumstances, entitled under Regulation (EU) 2016/679 to access personal data concerning that user and such rights are unaffected by this Regulation. Under this Regulation, the user who is a natural person is further entitled to access all data generated by the use of a connected product, whether personal or non-personal. Where the user is not the data subject but an enterprise, including a sole trader, and not in cases of shared household use of the connected product, the user is considered to be a controller. Accordingly, such a user who as controller intends to request personal data generated by the use of a connected product or related service is required to have a legal basis for processing the data as required by Article 6(1) of Regulation (EU) 2016/679, such as the consent of the data subject or the performance of a contract to which the data subject is a party. Such user should ensure that the data subject is appropriately informed of the specified, explicit and legitimate purposes for processing those data, and of how the data subject may exercise their rights effectively. Where the data holder and the user are joint controllers within the meaning of Article 26 of Regulation (EU) 2016/679, they are required to determine, in a transparent manner by means of an arrangement between them, their respective responsibilities for compliance with that Regulation. It should be understood that such a user, once data has been made available, may in turn become a data holder if that user meets the criteria under this Regulation and thus becomes subject to the obligations to make data available under this Regulation.

(35) Product data or related service data should only be made available to a third party at the request of the user. This Regulation complements accordingly the right, provided for in Article 20 of Regulation (EU) 2016/679, of data subjects to receive personal data concerning them in a structured, commonly used and machine-readable format, as well as to port those data to another controller, where those data are processed by automated means on the basis of Article 6(1), point (a), or Article 9(2), point (a), or of a contract pursuant to Article 6(1), point (b) of that Regulation. Data subjects also have the right to have the personal data transmitted directly from one controller to another, but only where that is technically feasible. Article 20 of Regulation (EU) 2016/679 specifies that it pertains to data provided by the data subject but does not specify whether this necessitates active behaviour on the side of the data subject or whether it also applies to situations where a connected product or related service, by its design, observes the behaviour of a data subject or other information in relation to a data subject in a passive manner. The rights provided for under this Regulation complement the right to receive and port personal data under Article 20 of Regulation (EU) 2016/679 in a number of ways. This Regulation grants users the right to access and make available to a third party any product data or related service data, irrespective of their nature as personal data, of the distinction between actively provided or passively observed data, and irrespective of the legal basis of processing. Unlike Article 20 of Regulation (EU) 2016/679, this Regulation mandates and ensures the technical feasibility of third party access for all types of data falling within its scope, whether personal or non-personal, thereby ensuring that technical obstacles no longer hinder or prevent access to such data. It also allows data holders to set reasonable compensation to be met by third parties, but not by the user, for costs incurred in providing direct access to the data generated by the user’s connected product. If a data holder and a third party are unable to agree on terms for such direct access, the data subject should in no way be prevented from exercising the rights laid down in Regulation (EU) 2016/679, including the right to data portability, by seeking remedies in accordance with that Regulation. It is to be understood in this context that, in accordance with Regulation (EU) 2016/679, a contract does not allow for the processing of special categories of personal data by the data holder or the third party.

(36) Access to any data stored in and accessed from terminal equipment is subject to Directive 2002/58/EC and requires the consent of the subscriber or user within the meaning of that Directive unless it is strictly necessary for the provision of an information society service explicitly requested by the user or by the subscriber or for the sole purpose of the transmission of a communication. Directive 2002/58/EC protects the integrity of a user’s terminal equipment regarding the use of processing and storage capabilities and the collection of information. Internet of Things equipment is considered to be terminal equipment if it is directly or indirectly connected to a public communications network.

(37) In order to prevent the exploitation of users, third parties to whom data has been made available at the request of the user should process those data only for the purposes agreed with the user and share them with another third party only with the agreement of the user to such data sharing.

(38) In line with the data minimisation principle, third parties should access only information that is necessary for the provision of the service requested by the user. Having received access to data, the third party should process it for the purposes agreed with the user without interference from the data holder. It should be as easy for the user to refuse or discontinue access by the third party to the data as it is for the user to authorise access. Neither third parties nor data holders should make the exercise of choices or rights by the user unduly difficult, including by offering choices to the user in a non-neutral manner, or by coercing, deceiving or manipulating the user, or by subverting or impairing the autonomy, decision-making or choices of the user, including by means of a user digital interface or a part thereof. In that context, third parties or data holders should not rely on so-called ‘dark patterns’ in designing their digital interfaces. Dark patterns are design techniques that push or deceive consumers into decisions that have negative consequences for them. Those manipulative techniques can be used to persuade users, in particular vulnerable consumers, to engage in unwanted behaviour, to deceive users by nudging them into decisions on data disclosure transactions or to unreasonably bias the decision-making of the users of the service in such a way as to subvert or impair their autonomy, decision-making and choice. Common and legitimate commercial practices that comply with Union law should not in themselves be regarded as constituting dark patterns. Third parties and data holders should comply with their obligations under relevant Union law, in particular the requirements laid down in Directives 98/6/EC (24) and 2000/31/EC (25) of the European Parliament and of the Council and in Directives 2005/29/EC and 2011/83/EU.

(39) Third parties should also refrain from using data falling within the scope of this Regulation to profile individuals unless such processing activities are strictly necessary to provide the service requested by the user, including in the context of automated decision-making. The requirement to erase data when no longer required for the purpose agreed with the user, unless otherwise agreed in relation to non-personal data, complements the data subject’s right to erasure pursuant to Article 17 of Regulation (EU) 2016/679. Where a third party is a provider of a data intermediation service, the safeguards for the data subject provided for by Regulation (EU) 2022/868 apply. The third party may use the data to develop a new and innovative connected product or related service but not to develop a competing connected product.

(40) Start-ups, small enterprises, enterprises that qualify as a medium-sized enterprises under Article 2 of the Annex to Recommendation 2003/361/EC and enterprises from traditional sectors with less-developed digital capabilities struggle to obtain access to relevant data. This Regulation aims to facilitate access to data for those entities, while ensuring that the corresponding obligations are as proportionate as possible to avoid overreach. At the same time, a small number of very large enterprises have emerged with considerable economic power in the digital economy through the accumulation and aggregation of vast volumes of data and the technological infrastructure for monetising them. Those very large enterprises include undertakings that provide core platform services controlling whole platform ecosystems in the digital economy and which existing or new market operators are unable to challenge or contest. Regulation (EU) 2022/1925 of the European Parliament and of the Council (26) aims to redress those inefficiencies and imbalances by allowing the Commission to designate an undertaking as a ‘gatekeeper’, and imposes a number of obligations on such gatekeepers, including a prohibition to combine certain data without consent and an obligation to ensure effective rights to data portability under Article 20 of Regulation (EU) 2016/679. In accordance with Regulation (EU) 2022/1925, and given the unrivalled ability of those undertakings to acquire data, it is not necessary to achieve the objective of this Regulation, and would therefore be disproportionate for data holders made subject to such obligations, to include gatekeeper as beneficiaries of the data access right. Such inclusion would also likely limit the benefits of this Regulation for SMEs, linked to the fairness of the distribution of data value across market actors. This means that an undertaking that provides core platform services that has been designated as a gatekeeper cannot request or be granted access to users’ data generated by the use of a connected product or related service or by a virtual assistant pursuant to this Regulation. Furthermore, third parties to whom data are made available at the request of the user may not make the data available to a gatekeeper. For instance, the third party may not subcontract the service provision to a gatekeeper. However, this does not prevent third parties from using data processing services offered by a gatekeeper. Nor does it prevent those undertakings from obtaining and using the same data through other lawful means. The access rights provided for in this Regulation contribute to a wider choice of services for consumers. As voluntary agreements between gatekeepers and data holders remain unaffected, the limitation on granting access to gatekeepers would not exclude them from the market or prevent them from offering their services.

(41) Given the current state of technology, it would be overly burdensome on microenterprises and small enterprises to impose further design obligations in relation to connected products manufactured or designed, or the related services provided, by them. That is not the case, however, where a microenterprise or a small enterprise has a partner enterprise or a linked enterprise within the meaning of Article 3 of the Annex to Recommendation 2003/361/EC that does not qualify as a microenterprise or a small enterprise and where it is subcontracted to manufacture or design a connected product or to provide a related service. In such situations, the enterprise which has subcontracted the manufacturing or design to a microenterprise or a small enterprise is able to compensate the subcontractor appropriately. A microenterprise or a small enterprise may nevertheless be subject to the requirements laid down by this Regulation as data holder where it is not the manufacturer of the connected product or a provider of related services. A transitional period should apply to an enterprise that has qualified as a medium-sized enterprise for less than one year and to connected products for one year after the date on which they were placed on the market by a medium-sized enterprise. Such a one-year period allows such a medium-sized enterprise to adjust and prepare before facing competition in the market for services for the connected products that it manufactures on the basis of the access rights provided by this Regulation. Such a transitional period does not apply where such a medium-sized enterprise has a partner enterprise or a linked enterprise that does not qualify as a microenterprise or a small enterprise or where such a medium-sized enterprise was subcontracted to manufacture or design the connected product or to provide the related service.

(42) Taking into account the variety of connected products producing data of different nature, volume and frequency, presenting different levels of data and cybersecurity risks and providing economic opportunities of different value, and for the purpose of ensuring consistency of data sharing practices in the internal market, including across sectors, and to encourage and promote fair data sharing practices even in areas where no such right to data access is provided for, this Regulation provides for horizontal rules on the arrangements for access to data whenever a data holder is obliged by Union law or national legislation adopted in accordance with Union law to make data available to a data recipient. Such access should be based on fair, reasonable, non-discriminatory and transparent terms and conditions. Those general access rules do not apply to obligations to make data available under Regulation (EU) 2016/679. Voluntary data sharing remains unaffected by those rules. The non-binding model contractual terms for business-to-business data sharing to be developed and recommended by the Commission may help parties to conclude contracts which include fair, reasonable and non-discriminatory terms and conditions and which are to be implemented in a transparent way. The conclusion of contracts, which may include the non-binding model contractual terms, should not mean that the right to share data with third parties is in any way conditional upon the existence of such a contract. Should parties be unable to conclude a contract on data sharing, including with the support of dispute settlement bodies, the right to share data with third parties is enforceable in national courts or tribunals.

(43) On the basis of the principle of contractual freedom, parties should remain free to negotiate the precise conditions for making data available in their contracts within the framework for the general access rules for making data available. Terms of such contracts could include technical and organisational measures, including in relation to data security.

(44) In order to ensure that the conditions for mandatory data access are fair for both parties to a contract, the general rules on data access rights should refer to the rule on avoiding unfair contractual terms.

(45) Any agreement concluded in business-to-business relations for making data available should be non-discriminatory between comparable categories of data recipients, independently of whether the parties are large enterprises or SMEs. In order to compensate for the lack of information on the conditions contained in different contracts, which makes it difficult for the data recipient to assess whether the terms for making the data available are non-discriminatory, it should be the responsibility of data holders to demonstrate that a contractual term is not discriminatory. It is not unlawful discrimination where a data holder uses different contractual terms for making data available if those differences are justified by objective reasons. Those obligations are without prejudice to Regulation (EU) 2016/679.

(46) In order to promote continued investment in generating and making available valuable data, including investments in relevant technical tools, while at the same time avoiding excessive burdens on access to and the use of data which make data sharing no longer commercially viable, this Regulation contains the principle that in business-to-business relations data holders may request reasonable compensation when obliged pursuant to Union law or national legislation adopted in accordance with Union law to make data available to a data recipient. Such compensation should not be understood to constitute payment for the data itself. The Commission should adopt guidelines on the calculation of reasonable compensation in the data economy.

(47) First, reasonable compensation for meeting the obligation pursuant to Union law or national legislation adopted in accordance with Union law to comply with a request to make data available may include compensation for the costs incurred in making the data available. Those costs may be technical costs, such as the costs necessary for data reproduction, dissemination via electronic means and storage, but not for data collection or production. Such technical costs may also include the costs for processing, necessary to make data available, including costs associated with the formatting of data. Costs related to making the data available may also include the costs of facilitating concrete data sharing requests. They may also vary depending on the volume of the data as well as the arrangements taken for making the data available. Long-term arrangements between data holders and data recipients, for instance via a subscription model or the use of smart contracts, may reduce the costs in regular or repetitive transactions in a business relationship. Costs related to making data available are either specific to a particular request or shared with other requests. In the latter case, a single data recipient should not pay the full costs of making the data available. Second, reasonable compensation may also include a margin, except regarding SMEs and not-for-profit research organisations. A margin may vary depending on factors related to the data itself, such as volume, format or nature of the data. It may consider the costs for collecting the data. A margin may therefore decrease where the data holder has collected the data for its own business without significant investments or may increase where the investments in the data collection for the purposes of the data holder’s business are high. It may be limited or even excluded in situations where the use of the data by the data recipient does not affect the data holder’s own activities. The fact that the data is co-generated by a connected product owned, rented or leased by the user could also reduce the amount of the compensation in comparison to other situations where the data are generated by the data holder for example during the provision of a related service.

(48) It is not necessary to intervene in the case of data sharing between large enterprises, or where the data holder is a small enterprise or a medium-sized enterprise and the data recipient is a large enterprise. In such cases, the enterprises are considered to be capable of negotiating the compensation within the limits of what is reasonable and non-discriminatory.

(49) To protect SMEs from excessive economic burdens which would make it commercially too difficult for them to develop and run innovative business models, the reasonable compensation for making data available to be paid by them should not exceed the costs directly related to making the data available. Directly related costs are those costs which are attributable to individual requests, taking into account that the necessary technical interfaces or related software and connectivity is to be established on a permanent basis by the data holder. The same regime should apply to not-for-profit research organisations.

(50) In duly justified cases, including where there is a need to safeguard consumer participation and competition or to promote innovation in certain markets, regulated compensation for making available specific data types may be provided for in Union law or national legislation adopted in accordance with Union law.

(51) Transparency is an important principle for ensuring that the compensation requested by a data holder is reasonable, or, if the data recipient is an SME or a not-for-profit research organisation, that the compensation does not exceed the costs directly related to making the data available to the data recipient and is attributable to the individual request concerned. In order to put data recipients in a position to assess and verify that the compensation complies with the requirements of this Regulation, the data holder should provide to the data recipient sufficiently detailed information for the calculation of the compensation.

(52) Ensuring access to alternative ways of resolving domestic and cross-border disputes that arise in connection with making data available should benefit data holders and data recipients and therefore strengthen trust in data sharing. Where parties cannot agree on fair, reasonable and non-discriminatory terms and conditions of making data available, dispute settlement bodies should offer a simple, fast and low-cost solution to the parties. While this Regulation only lays down the conditions that dispute settlement bodies need to fulfil to be certified, Member States are free to adopt any specific rules for the certification procedure, including the expiry or revocation of certification. The provisions of this Regulation on dispute settlement should not require Member States to establish dispute settlement bodies.

(53) The dispute settlement procedure under this Regulation is a voluntary procedure that enables users, data holders and data recipients to agree to bring their disputes before dispute settlement bodies. Therefore, the parties should be free to address a dispute settlement body of their choice, be it within or outside of the Member States in which those parties are established.

(54) To avoid cases in which two or more dispute settlement bodies are seized for the same dispute, in particular in a cross-border situation, a dispute settlement body should be able to refuse to deal with a request to resolve a dispute that has already been brought before another dispute settlement body or before a court or tribunal of a Member State.

(55) In order to ensure the uniform application of this Regulation, the dispute settlement bodies should take into account the non-binding model contractual terms to be developed and recommended by the Commission as well as Union or national law specifying data sharing obligations or guidelines issued by sectoral authorities for the application of such law.

(56) Parties to dispute settlement proceedings should not be prevented from exercising their fundamental rights to an effective remedy and a fair trial. Therefore, the decision to submit a dispute to a dispute settlement body should not deprive those parties of their right to seek redress before a court or tribunal of a Member State. Dispute settlement bodies should make annual activity reports publicly available.

(57) Data holders may apply appropriate technical protection measures to prevent the unlawful disclosure of or access to data. However, those measures should neither discriminate between data recipients, nor hinder access to or the use of data for users or data recipients. In the case of abusive practices on the part of a data recipient, such as misleading the data holder by providing false information with the intent to use the data for unlawful purposes, including developing a competing connected product on the basis of the data, the data holder and, where applicable and where they are not the same person, the trade secret holder or the user can request the third party or data recipient to implement corrective or remedial measures without undue delay. Any such requests, and in particular requests to end the production, offering or placing on the market of goods, derivative data or services, as well as those to end importation, export, storage of infringing goods or their destruction, should be assessed in the light of their proportionality in relation to the interests of the data holder, the trade secret holder or the user.

(58) Where one party is in a stronger bargaining position, there is a risk that that party could leverage such a position to the detriment of the other contracting party when negotiating access to data with the result that access to data is commercially less viable and sometimes economically prohibitive. Such contractual imbalances harm all enterprises without a meaningful ability to negotiate the conditions for access to data, and which may have no choice but to accept take-it-or-leave-it contractual terms. Therefore, unfair contractual terms regulating access to and the use of data, or liability and remedies for the breach or the termination of data related obligations, should not be binding on enterprises when those terms have been unilaterally imposed on those enterprises.

(59) Rules on contractual terms should take into account the principle of contractual freedom as an essential concept in business-to-business relationships. Therefore, not all contractual terms should be subject to an unfairness test, but only those terms that are unilaterally imposed. This concerns take-it-or-leave-it situations where one party supplies a certain contractual term and the other enterprise cannot influence the content of that term despite an attempt to negotiate it. A contractual term that is simply provided by one party and accepted by the other enterprise or a term that is negotiated and subsequently agreed in an amended form between contracting parties should not be considered to have been unilaterally imposed.

(60) Furthermore, the rules on unfair contractual terms should apply only to those elements of a contract that are related to making data available, that is contractual terms concerning access to and use of the data as well as liability or remedies for breach and termination of data related obligations. Other parts of the same contract, unrelated to making data available, should not be subject to the unfairness test laid down in this Regulation.

(61) Criteria for identifying unfair contractual terms should be applied only to excessive contractual terms where a stronger bargaining position has been abused. The vast majority of contractual terms that are commercially more favourable to one party than to the other, including those that are normal in business-to-business contracts, are a normal expression of the principle of contractual freedom and continue to apply. For the purposes of this Regulation, grossly deviating from good commercial practice would include, inter alia, objectively impairing the ability of the party upon whom the term has been unilaterally imposed to protect its legitimate commercial interest in the data in question.

(62) In order to ensure legal certainty, this Regulation establishes a list of clauses that are always considered unfair and a list of clauses that are presumed to be unfair. In the latter case, the enterprise that imposes the contractual term should be able to rebut the presumption of unfairness by demonstrating that the contractual term listed in this Regulation is not unfair in the specific case in question. If a contractual term is not included in the list of terms that are always considered unfair or that are presumed to be unfair, the general unfairness provision applies. In that regard, the terms listed as unfair contractual terms in this Regulation should serve as a yardstick to interpret the general unfairness provision. Finally, non-binding model contractual terms for business-to-business data sharing contracts to be developed and recommended by the Commission may also be helpful to commercial parties when negotiating contracts. If a contractual term is declared to be unfair, the contract concerned should continue to apply without that term, unless the unfair contractual term is not severable from the other terms of the contract.

(63) In situations of exceptional need, it may be necessary for public sector bodies, the Commission, the European Central Bank or Union bodies to use in the performance of their statutory duties in the public interest existing data, including, where relevant, accompanying metadata, to respond to public emergencies or in other exceptional cases. Exceptional needs are circumstances which are unforeseeable and limited in time, in contrast to other circumstances which might be planned, scheduled, periodic or frequent. While the notion of ‘data holder’ does not, generally, include public sector bodies, it may include public undertakings. Research-performing organisations and research-funding organisations could also be organised as public sector bodies or bodies governed by public law. To limit the burden on businesses, microenterprises and small enterprises should only be under the obligation to provide data to public sector bodies, the Commission, the European Central Bank or Union bodies in situations of exceptional need where such data is required to respond to a public emergency and the public sector body, the Commission, the European Central Bank or the Union body is unable to obtain such data by alternative means in a timely and effective manner under equivalent conditions.

(64) In the case of public emergencies, such as public health emergencies, emergencies resulting from natural disasters including those aggravated by climate change and environmental degradation, as well as human-induced major disasters, such as major cybersecurity incidents, the public interest resulting from the use of the data will outweigh the interests of the data holders to dispose freely of the data they hold. In such a case, data holders should be placed under an obligation to make the data available to public sector bodies, the Commission, the European Central Bank or Union bodies upon their request. The existence of a public emergency should be determined or declared in accordance with Union or national law and based on the relevant procedures, including those of the relevant international organisations. In such cases, the public sector body should demonstrate that the data in scope of the request could not otherwise be obtained in a timely and effective manner and under equivalent conditions, for instance by way of the voluntary provision of data by another enterprise or the consultation of a public database.

(65) An exceptional need may also arise from non-emergency situations. In such cases, a public sector body, the Commission, the European Central Bank or a Union body should be allowed to request only non-personal data. The public sector body should demonstrate that the data are necessary for the fulfilment of a specific task carried out in the public interest that has been explicitly provided for by law, such as the production of official statistics or the mitigation of or recovery from a public emergency. In addition, such a request can be made only when the public sector body, the Commission, the European Central Bank or a Union body has identified specific data that could not otherwise be obtained in a timely and effective manner and under equivalent conditions and only if it has exhausted all other means at its disposal to obtain such data, such as obtaining the data through voluntary agreements, including purchasing of non-personal data on the market by offering market rates, or by relying on existing obligations to make data available or the adoption of new legislative measures which could guarantee the timely availability of data. The conditions and principles governing requests, such as those related to purpose limitation, proportionality, transparency and time limitation, should also apply. In cases of requests for data necessary for the production of official statistics, the requesting public sector body should also demonstrate whether the national law allows it to purchase non-personal data on the market.

(66) This Regulation should not apply to, or pre-empt, voluntary arrangements for the exchange of data between private and public entities, including the provision of data by SMEs, and is without prejudice to Union legal acts providing for mandatory information requests by public entities to private entities. Obligations placed on data holders to provide data that are motivated by needs of a non-exceptional nature, in particular where the range of data and of data holders is known or where data use can take place on a regular basis, as in the case of reporting obligations and internal market obligations, should not be affected by this Regulation. Requirements to access data to verify compliance with applicable rules, including where public sector bodies assign the task of the verification of compliance to entities other than public sector bodies, should also not be affected by this Regulation.

(67) This Regulation complements and is without prejudice to the Union and national law providing for access to and the use of data for statistical purposes, in particular Regulation (EC) No 223/2009 of the European Parliament and of the Council (27) as well as national legal acts related to official statistics.

(68) For the exercise of their tasks in the areas of prevention, investigation, detection or prosecution of criminal or administrative offences or the execution of criminal and administrative penalties, as well as the collection of data for taxation or customs purposes, public sector bodies, the Commission, the European Central Bank or Union bodies should rely on their powers under Union or national law. This Regulation accordingly does not affect legislative acts on the sharing, access to and use of data in those areas.

(69) In accordance with Article 6(1) and (3) of Regulation (EU) 2016/679, a proportionate, limited and predictable framework at Union level is necessary when providing for the legal basis for the making available of data by data holders, in cases of exceptional needs, to public sector bodies, the Commission, the European Central Bank or Union bodies, both to ensure legal certainty and to minimise the administrative burdens placed on businesses. To that end, data requests from public sector bodies, the Commission, the European Central Bank or Union bodies to data holders should be specific, transparent and proportionate in their scope of content and their granularity. The purpose of the request and the intended use of the data requested should be specific and clearly explained, while allowing appropriate flexibility for the requesting entity to carry out its specific tasks in the public interest. The request should also respect the legitimate interests of the data holder to whom the request is made. The burden on data holders should be minimised by obliging requesting entities to respect the once-only principle, which prevents the same data from being requested more than once by more than one public sector body or the Commission, the European Central Bank or Union bodies. To ensure transparency, data requests made by the Commission, the European Central Bank or Union bodies should be made public without undue delay by the entity requesting the data. The European Central Bank and Union bodies should inform the Commission of their requests. If the data request has been made by a public sector body, that body should also notify the data coordinator of the Member State where the public sector body is established. Online public availability of all requests should be ensured. Upon the receipt of a notification of a data request, the competent authority can decide to assess the lawfulness of the request and exercise its functions in relation to the enforcement and application of this Regulation. Online public availability of all requests made by public sector bodies should be ensured by the data coordinator.

(70) The objective of the obligation to provide the data is to ensure that public sector bodies, the Commission, the European Central Bank or Union bodies have the necessary knowledge to respond to, prevent or recover from public emergencies or to maintain the capacity to fulfil specific tasks explicitly provided for by law. The data obtained by those entities may be commercially sensitive. Therefore, neither Regulation (EU) 2022/868 nor Directive (EU) 2019/1024 of the European Parliament and of the Council (28) should apply to data made available under this Regulation and should not be considered as open data available for reuse by third parties. This however should not affect the applicability of Directive (EU) 2019/1024 to the reuse of official statistics for the production of which data obtained pursuant to this Regulation was used, provided the reuse does not include the underlying data. In addition, provided the conditions laid down in this Regulation are met, the possibility of sharing the data for conducting research or for the development, production and dissemination of official statistics should not be affected. Public sector bodies should also be allowed to exchange data obtained pursuant to this Regulation with other public sector bodies, the Commission, the European Central Bank or Union bodies in order to address the exceptional needs for which the data has been requested.

(71) Data holders should have the possibility to either decline a request made by a public sector body, the Commission, the European Central Bank or a Union body or seek its modification without undue delay and, in any event, no later than within a period of five or 30 working days, depending on the nature of the exceptional need invoked in the request. Where relevant, the data holder should have this possibility where it does not have control over the data requested, namely where it does not have immediate access to the data and cannot determine its availability. A valid reason not to make the data available should exist if it can be shown that the request is similar to a previously submitted request for the same purpose by another public sector body or the Commission, the European Central Bank or a Union body and the data holder has not been notified of the erasure of the data pursuant to this Regulation. A data holder declining the request or seeking its modification should communicate the underlying justification to the public sector body, the Commission, the European Central Bank or a Union body requesting the data. Where the sui generis database rights under Directive 96/9/EC of the European Parliament and of the Council (29) apply in relation to the requested datasets, data holders should exercise their rights in such a way that does not prevent the public sector body, the Commission, the European Central Bank or Union body from obtaining the data, or from sharing it, in accordance with this Regulation.

(72) In the case of an exceptional need related to a public emergency response, public sector bodies should use non-personal data wherever possible. In the case of requests on the basis of an exceptional need not related to a public emergency, personal data cannot be requested. Where personal data fall within the scope of the request, the data holder should anonymise the data. Where it is strictly necessary to include personal data in the data to be made available to a public sector body, the Commission, the European Central Bank or a Union body or where anonymisation proves impossible, the entity requesting the data should demonstrate the strict necessity and the specific and limited purposes for processing. The applicable rules on personal data protection should be complied with. The making available of the data and their subsequent use should be accompanied by safeguards for the rights and interests of individuals concerned by those data.

(73) Data made available to public sector bodies, the Commission, the European Central Bank or Union bodies on the basis of an exceptional need should be used only for the purposes for which they were requested, unless the data holder that made the data available has expressly agreed for the data to be used for other purposes. The data should be erased once it is no longer necessary for the purposes stated in the request, unless agreed otherwise, and the data holder should be informed thereof. This Regulation builds on the existing access regimes in the Union and the Member States and does not change the national law on public access to documents in the context of transparency obligations. Data should be erased once it is no longer needed to comply with such transparency obligations.

(74) When reusing data provided by data holders, public sector bodies, the Commission, the European Central Bank or Union bodies should respect both existing applicable Union or national law and contractual obligations to which the data holder is subject. They should refrain from developing or enhancing a connected product or related service that compete with the connected product or related service of the data holder as well as from sharing the data with a third party for those purposes. They should likewise provide public acknowledgement to the data holders upon their request and should be responsible for maintaining the security of the data received. Where the disclosure of trade secrets of the data holder to public sector bodies, the Commission, the European Central Bank or Union bodies is strictly necessary to fulfil the purpose for which the data has been requested, confidentiality of such disclosure should be guaranteed prior to the disclosure of data.

(75) When the safeguarding of a significant public good is at stake, such as responding to public emergencies, the public sector body, the Commission, the European Central Bank or the Union body concerned should not be expected to compensate enterprises for the data obtained. Public emergencies are rare events and not all such emergencies require the use of data held by enterprises. At the same time, the obligation to provide data might constitute a considerable burden on microenterprises and small enterprises. They should therefore be allowed to claim compensation even in the context of a public emergency response. The business activities of the data holders are therefore not likely to be negatively affected as a consequence of the public sector bodies, the Commission, the European Central Bank or Union bodies having recourse to this Regulation. However, as cases of an exceptional need, other than cases of responding to public emergencies, might be more frequent, data holders should in such cases be entitled to a reasonable compensation which should not exceed the technical and organisational costs incurred in complying with the request and the reasonable margin required for making the data available to the public sector body, the Commission, the European Central Bank or the Union body. The compensation should not be understood as constituting payment for the data itself or as being compulsory. Data holders should not be able to claim compensation where national law prevents national statistical institutes or other national authorities responsible for the production of statistics from compensating data holders for making data available. The public sector body, the Commission, the European Central Bank or the Union body concerned should be able to challenge the level of compensation requested by the data holder by bringing the matter to the competent authority of the Member State where the data holder is established.

(76) A public sector body, the Commission, the European Central Bank or a Union body should be entitled to share the data it has obtained pursuant to the request with other entities or persons when this is necessary to carry out scientific research activities or analytical activities it cannot perform itself, provided that those activities are compatible with the purpose for which the data was requested. It should inform the data holder of such sharing in a timely manner. Such data may also be shared under the same circumstances with the national statistical institutes and Eurostat for the development, production and dissemination of official statistics. Such research activities should, however, be compatible with the purpose for which the data was requested and the data holder should be informed about the further sharing of the data it has provided. Individuals conducting research or research organisations with whom those data may be shared should act either on a not-for-profit basis or in the context of a public-interest mission recognised by the State. Organisations upon which commercial undertakings have a significant influence, allowing such undertakings to exercise control due to structural situations which could result in preferential access to the results of the research, should not be considered to be research organisations for the purposes of this Regulation.

(77) In order to handle a cross-border public emergency or another exceptional need, data requests may be addressed to data holders in Member States other than that of the requesting public sector body. In such a case, the requesting public sector body should notify the competent authority of the Member State where the data holder is established in order to allow it to examine the request against the criteria established in this Regulation. The same should apply to requests made by the Commission, the European Central Bank or a Union body. Where personal data are requested, the public sector body should notify the supervisory authority responsible for monitoring the application of Regulation (EU) 2016/679 in the Member State where the public sector body is established. The competent authority concerned should be entitled to advise the public sector body, the Commission, the European Central Bank or the Union body to cooperate with the public sector bodies of the Member State in which the data holder is established on the need to ensure a minimised administrative burden on the data holder. When the competent authority has substantiated objections as regards the compliance of the request with this Regulation, it should reject the request of the public sector body, the Commission, the European Central Bank or the Union body, which should take those objections into account before taking any further action, including resubmitting the request.

(78) The ability of customers of data processing services, including cloud and edge services, to switch from one data processing service to another while maintaining a minimum functionality of service and without downtime of services, or to use the services of several providers simultaneously without undue obstacles and data transfer costs, is a key condition for a more competitive market with lower entry barriers for new providers of data processing services, and for ensuring further resilience for the users of those services. Customers benefiting from free-tier offerings should also benefit from the provisions for switching that are laid down in this Regulation, so that those offerings do not result in a lock-in situation for customers.

(79) Regulation (EU) 2018/1807 of the European Parliament and of the Council (30) encourages providers of data processing services to develop and effectively implement self-regulatory codes of conduct covering best practices for, inter alia, facilitating the switching of providers of data processing services and the porting of data. Given the limited uptake of the self-regulatory frameworks developed in response, and the general unavailability of open standards and interfaces, it is necessary to adopt a set of minimum regulatory obligations for providers of data processing services to eliminate pre-commercial, commercial, technical, contractual and organisational obstacles, which are not limited to reduced speed of data transfer at the customer’s exit, which hamper effective switching between data processing services.

(80) Data processing services should cover services that allow ubiquitous and on-demand network access to a configurable, scalable and elastic shared pool of distributed computing resources. Those computing resources include resources such as networks, servers or other virtual or physical infrastructure, software, including software development tools, storage, applications and services. The capability of the customer of the data processing service to unilaterally self-provision computing capabilities, such as server time or network storage, without any human interaction by the provider of data processing services could be described as requiring minimal management effort and as entailing minimal interaction between provider and customer. The term ‘ubiquitous’ is used to describe the computing capabilities provided over the network and accessed through mechanisms promoting the use of heterogeneous thin or thick client platforms (from web browsers to mobile devices and workstations). The term ‘scalable’ refers to computing resources that are flexibly allocated by the provider of data processing services, irrespective of the geographical location of the resources, in order to handle fluctuations in demand. The term ‘elastic’ is used to describe those computing resources that are provisioned and released according to demand in order to rapidly increase or decrease resources available depending on workload. The term ‘shared pool’ is used to describe those computing resources that are provided to multiple users who share a common access to the service, but where the processing is carried out separately for each user, although the service is provided from the same electronic equipment. The term ‘distributed’ is used to describe those computing resources that are located on different networked computers or devices and which communicate and coordinate among themselves by message passing. The term ‘highly distributed’ is used to describe data processing services that involve data processing closer to where data are being generated or collected, for instance in a connected data processing device. Edge computing, which is a form of such highly distributed data processing, is expected to generate new business models and cloud service delivery models, which should be open and interoperable from the outset.

(81) The generic concept ‘data processing services’ covers a substantial number of services with a very broad range of different purposes, functionalities and technical set-ups. As commonly understood by providers and users and in line with broadly used standards, data processing services fall into one or more of the following three data processing service delivery models, namely Infrastructure as a Service (IaaS), Platform as a service (PaaS) and Software as a Service (SaaS). Those service delivery models represent a specific, pre-packaged combination of ICT resources offered by a provider of data processing service. Those three fundamental data processing delivery models are further complemented by emerging variations, each comprised of a distinct combination of ICT resources, such as Storage as a Service and Database as a Service. Data processing services can be categorised in a more granular way and divided into a non-exhaustive list of sets of data processing services that share the same primary objective and main functionalities as well as the same type of data processing models, that are not related to the service’s operational characteristics (same service type). Services falling under the same service type may share the same data processing service model, however, two databases might appear to share the same primary objective, but after considering their data processing model, distribution model and the use cases that they are targeted at, such databases could fall into a more granular subcategory of similar services. Services of the same service type may have different and competing characteristics such as performance, security, resilience, and quality of service.

(82) Undermining the extraction of the exportable data that belongs to the customer from the source provider of data processing services can impede the restoration of the service functionalities in the infrastructure of the destination provider of data processing services. In order to facilitate the customer’s exit strategy, avoid unnecessary and burdensome tasks and to ensure that the customer does not lose any of their data as a consequence of the switching process, the source provider of data processing services should inform the customer in advance of the scope of the data that can be exported once that customer decides to switch to a different service provided by a different provider of data processing services or to move to an on-premises ICT infrastructure. The scope of exportable data should include, at a minimum, 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 of the provider of data processing services or a third party. The exportable data should exclude any assets or data of the provider of data processing services or of the third party that are protected by intellectual property rights or constituting trade secrets of that provider or of that third party, or data related to the integrity and security of the service, the export of which will expose the providers of data processing services to cybersecurity vulnerabilities. Those exemptions should not impede or delay the switching process.

(83) Digital assets refer to elements in digital form for which the customer has the right of use, including applications and metadata related to the configuration of settings, security, and access and control rights management, and other elements such as manifestations of virtualisation technologies, including virtual machines and containers. Digital assets can be transferred where the customer has the right of use independent of the contractual relationship with the data processing service it intends to switch from. Those other elements are essential for the effective use of the customer’s data and applications in the environment of the destination provider of data processing services.

(84) This Regulation aims to facilitate switching between data processing services, which encompasses conditions and actions that are necessary for a customer to terminate a contract for a data processing service, to conclude one or more new contracts with different providers of data processing services, to port its exportable data and digital assets, and where applicable, benefit from functional equivalence.

(85) Switching is a customer-driven operation consisting of several steps, including data extraction, which refers to the downloading of data from the ecosystem of the source provider of data processing services; transformation, where the data is structured in a way that does not match the schema of the target location; and the uploading of the data in a new destination location. In a specific situation outlined in this Regulation, unbundling of a particular service from the contract and moving it to a different provider should also be considered to be switching. The switching process is sometimes managed on behalf of the customer by a third-party entity. Accordingly, all rights and obligations of the customer established by this Regulation, including the obligation to cooperate in good faith, should be understood to apply to such a third-party entity in those circumstances. Providers of data processing services and customers have different levels of responsibilities, depending on the steps of the process referred to. For instance, the source provider of data processing services is responsible for extracting the data to a machine-readable format, but it is the customer and the destination provider of data processing services who are to upload the data to the new environment, unless a specific professional transition service has been obtained. A customer who intends to exercise rights related to switching, which are provided for in this Regulation, should inform the source provider of data processing services of the decision to either switch to a different provider of data processing services, switch to an on-premises ICT infrastructure or to delete that customer’s assets and erase its exportable data.

(86) 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 switching, 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. Providers of data processing services can only be expected to facilitate functional equivalence for the features that both the source and destination data processing services offer independently. This Regulation does not constitute an obligation to facilitate functional equivalence for providers of data processing services other than those offering services of the IaaS delivery model.

(87) Data processing services are used across sectors and vary in complexity and service type. This is an important consideration with regard to the porting process and timeframes. Nonetheless, an extension of the transitional period on the grounds of technical unfeasibility to allow the finalisation of the switching process in the given timeframe should be invoked only in duly justified cases. The burden of proof in that regard should fall fully on the provider of the data processing service concerned. This is without prejudice to the exclusive right of the customer to extend the transitional period once for a period that the customer considers to be more appropriate for its own purposes. The customer may evoke that right to an extension prior to or during the transitional period, taking into account that the contract remains applicable during the transitional period.

(88) Switching charges are charges imposed by providers of data processing services on the customers for the switching process. Typically, those charges are intended to pass on costs which the source provider of data processing services may incur because of the switching process to the customer who wishes to switch. Common examples of switching charges are costs related to the transit of data from one provider of data processing services to another or to an on-premises ICT infrastructure (data egress charges) or the costs incurred for specific support actions during the switching process. Unnecessarily high data egress charges and other unjustified charges unrelated to actual switching costs inhibit customers from switching, restrict the free flow of data, have the potential to limit competition and cause lock-in effects for the customers by reducing incentives to choose a different or additional service provider. Switching charges should therefore be abolished after three years from the date of entry into force of this Regulation. Providers of data processing services should be able to impose reduced switching charges up to that date.

(89) A source provider of data processing services should be able to outsource certain tasks and compensate third-party entities in order to comply with the obligations provided for in this Regulation. A customer should not bear the costs arising from the outsourcing of services concluded by the source provider of data processing services during the switching process and such costs should be considered to be unjustified unless they cover work undertaken by the provider of data processing services at the customer’s request for additional support in the switching process which goes beyond the switching obligations of the provider as expressly provided for in this Regulation. Nothing in this Regulation prevents a customer from compensating third-party entities for support in the migration process or parties from agreeing on contracts for data processing services of a fixed duration, including proportionate early termination penalties to cover the early termination of such contracts, in accordance with Union or national law. In order to foster competition, the gradual withdrawal of the charges associated with switching between different providers of data processing services should specifically include data egress charges imposed by a provider of data processing services on a customer. EstándarEstándar Especificación técnica, adoptada por un organismo de normalización reconocido, de aplicación repetida o continua, cuyo cumplimiento no es obligatorio y que es una de las siguientes (a) "norma internacional": norma adoptada por un organismo internacional de normalización; b) "norma europea": norma adoptada por un organismo europeo de normalización; c) "norma armonizada": norma europea adoptada sobre la base de una solicitud formulada por la Comisión para la aplicación de la legislación de armonización de la Unión; d) "norma nacional": norma adoptada por un organismo nacional de normalización - Definición según el artículo 2, punto 1, delReglamento (UE) nº 1025/2012 del Parlamento Europeo y del Consejo. service fees for the provision of the data processing services themselves are not switching charges. Those standard service fees are not subject to withdrawal and remain applicable until the contract for the provision of the relevant services ceases to apply. This Regulation allows the customer to request the provision of additional services that go beyond the provider’s switching obligations under this Regulation. Those additional services, can be performed and charged for by the provider when they are performed at the customer’s request and the customer agrees to the price of those services in advance.

(90) An ambitious and innovation-inspiring regulatory approach to interoperability is needed to overcome vendor lock-in, which undermines competition and the development of new services. Interoperability between data processing services involves multiple interfaces and layers of infrastructure and software and is rarely confined to a binary test of being achievable or not. Instead, the building of such interoperability is subject to a cost-benefit analysis which is necessary to establish whether it is worthwhile to pursue reasonably predictable results. The ISO/IEC 19941:2017 is an important international standard constituting a reference for the achievement of the objectives of this Regulation, as it contains technical considerations clarifying the complexity of such a process.

(91) Where providers of data processing services are in turn customers of data processing services provided by a third-party provider, they will benefit from more effective switching themselves while simultaneously remaining bound by this Regulation’s obligations regarding their own service offerings.

(92) Providers of data processing services should be required to offer all the assistance and support within their capacity, proportionate to their respective obligations, that is required to make the switching process to a service of a different provider of data processing services successful, effective and secure. This Regulation does not require providers of data processing services to develop new categories of data processing services, including within, or on the basis of, the ICT infrastructure of different providers of data processing services in order to guarantee functional equivalence in an environment other than their own systems. A source provider of data processing services does not have access to or insights into the environment of the destination provider of data processing services. Functional equivalence should not be understood to oblige the source provider of data processing services to rebuild the service in question within the infrastructure of the destination provider of data processing services. Instead, the source provider of data processing services should take all reasonable measures within its power to facilitate the process of achieving functional equivalence through the provision of capabilities, adequate information, documentation, technical support and, where appropriate, the necessary tools.

(93) Providers of data processing services should also be required to remove existing obstacles and not impose new ones, including for customers wishing to switch to an on-premises ICT infrastructure. Obstacles can, inter alia, be of a pre-commercial, commercial, technical, contractual or organisational nature. Providers of data processing services should also be required to remove obstacles to unbundling a specific individual service from other data processing services provided under a contract and make the relevant service available for switching, in the absence of major and demonstrated technical obstacles that prevent such unbundling.

(94) Throughout the switching process, a high level of security should be maintained. This means that the source provider of data processing services should extend the level of security to which it committed for the service to all technical arrangements for which such provider is responsible during the switching process, such as network connections or physical devices. Existing rights relating to the termination of contracts, including those introduced by Regulation (EU) 2016/679 and Directive (EU) 2019/770 of the European Parliament and of the Council (31) should not be affected. This Regulation should not be understood to prevent a provider of data processing services from providing to customers new and improved services, features and functionalities or from competing with other providers of data processing services on that basis.

(95) The information to be provided by providers of data processing services to the customer could support the customer’s exit strategy. That information should include procedures for initiating switching from the data processing service; the machine-readable data formats to which the user’s data can be exported; the tools intended to export data, including open interfaces as well as information on compatibility with harmonised standards or common specifications based on open interoperability specifications; information on known technical restrictions and limitations that could have an impact on the switching process; and the estimated time necessary to complete the switching process.

(96) To facilitate interoperability and switching between data processing services, users and providers of data processing services should consider the use of implementation and compliance tools, in particular those published by the Commission in the form of an EU Cloud Rulebook and a Guidance on public procurement of data processing services. In particular, standard contractual clauses are beneficial because they increase confidence in data processing services, create a more balanced relationship between users and providers of data processing services and improve legal certainty with regard to the conditions that apply for switching to other data processing services. In that context, users and providers of data processing services should consider the use of standard contractual clauses or other self-regulatory compliance tools provided that they fully comply with this Regulation, developed by relevant bodies or expert groups established under Union law.

(97) In order to facilitate switching between data processing services, all parties involved, including both source and destination providers of data processing services, should cooperate in good faith to make the switching process effective, enable the secure and timely transfer of necessary data in a commonly used, machine-readable format, and by means of open interfaces, while avoiding service disruptions and maintaining continuity of the service.

(98) Data processing services which concern services of which the majority of main features has been custom-built to respond to the specific demands of an individual customer or where all components have been developed for the purposes of an individual customer should be exempted from some of the obligations applicable to data processing service switching. This should not include services which the provider of data processing services offers at a broad commercial scale via its service catalogue. It is among the obligations of the provider of data processing services to duly inform prospective customers of such services, prior to the conclusion of a contract, of the obligations laid down in this Regulation that do not apply to the relevant services. Nothing prevents the provider of data processing services from eventually deploying such services at scale, in which case that provider would have to comply with all obligations for switching laid down in this Regulation.

(99) In line with the minimum requirement allowing switching between providers of data processing services, this Regulation also aims to improve interoperability for in-parallel use of multiple data processing services with complementary functionalities. This relates to situations in which customers do not terminate a contract to switch to a different provider of data processing services, but where multiple services of different providers are used in parallel, in an interoperable manner, to benefit from the complementary functionalities of the different services in the set-up of the customer’s system. However, it is recognised that the egress of data from one provider of data processing services to another in order to facilitate the in-parallel use of services can be an ongoing activity, in contrast with the one-off egress required as part of the switching process. Providers of data processing services should therefore continue to be able to impose data egress charges, not exceeding the costs incurred, for the purposes of in-parallel use after three years from the date of entry into force of this Regulation. This is important, inter alia, for the successful deployment of multi-cloud strategies, which allow customers to implement future-proof ICT strategies and which decrease dependence on individual providers of data processing services. Facilitating a multi-cloud approach for customers of data processing services can also contribute to increasing their digital operational resilience, as recognised for financial service institutions in Regulation (EU) 2022/2554 of the European Parliament and of the Council (32).

(100) Open interoperability specifications and standards developed in accordance with Annex II to Regulation (EU) No 1025/2012 of the European Parliament and of the Council (33) in the field of interoperability and portability are expected to enable a multi-vendor cloud environment, which is a key requirement for open innovation in the European data economy. As the market adoption of identified standards under the cloud standardisation coordination (CSC) initiative concluded in 2016 has been limited, it is also necessary that the Commission relies on parties in the market to develop relevant open interoperability specifications to keep up with the fast pace of technological development in this industry. Such open interoperability specifications can then be adopted by the Commission in the form of common specifications. In addition, where market-driven processes have not demonstrated a capacity to establish common specifications or standards that facilitate effective cloud interoperability at the PaaS and SaaS levels, the Commission should be able, on the basis of this Regulation and in accordance with Regulation (EU) No 1025/2012, to request European standardisation bodies to develop such standards for specific service types where such standards do not yet exist. In addition to this, the Commission will encourage parties in the market to develop relevant open interoperability specifications. After consulting stakeholders, the Commission, by means of implementing acts, should be able to mandate the use of harmonised standards for interoperability or common specifications for specific service types through a reference in a central Union standards repository for the interoperability of data processing services. Providers of data processing services should ensure compatibility with those harmonised standards and common specifications based on open interoperability specifications, which should not have an adverse impact on the security or integrity of data. Harmonised standards for the interoperability of data processing services and common specifications based on open interoperability specifications will be referenced only if they comply with the criteria specified in this Regulation, which have the same meaning as the requirements in Annex II to Regulation (EU) No 1025/2012 and the interoperability facets defined under the international standard ISO/IEC 19941:2017. In addition, standardisation should take into account the needs of SMEs.

(101) Third countries may adopt laws, regulations and other legal acts that aim to directly transfer or provide governmental access to non-personal data located outside their borders, including in the Union. Judgments of courts or tribunals or decisions of other judicial or administrative authorities, including law enforcement authorities in third countries requiring such transfer or access to non-personal data should be enforceable when based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or a Member State. In other cases, situations may arise where a request to transfer or provide access to non-personal data arising from a third country law conflicts with an obligation to protect such data under Union law or under the national law of the relevant Member State, in particular regarding the protection of fundamental rights of the individual, such as the right to security and the right to an effective remedy, or the fundamental interests of a Member State related to national security or defence, as well as the protection of commercially sensitive data, including the protection of trade secrets, and the protection of intellectual property rights, including its contractual undertakings regarding confidentiality in accordance with such law. In the absence of international agreements regulating such matters, transfer of or access to non-personal data should be allowed only if it has been verified that the third country’s legal system requires the reasons and proportionality of the decision to be set out, that the court order or the decision is specific in character, and that the reasoned objection of the addressee is subject to a review by a competent third-country court or tribunal which is empowered to take duly into account the relevant legal interests of the provider of such data. Wherever possible under the terms of the data access request of the third country’s authority, the provider of data processing services should be able to inform the customer whose data are being requested before granting access to those data in order to verify the presence of a potential conflict of such access with Union or national law, such as that on the protection of commercially sensitive data, including the protection of trade secrets and intellectual property rights and the contractual undertakings regarding confidentiality.

(102) To foster further trust in data, it is important that safeguards to ensure control of their data by Union citizens, the public sector bodies and businesses are implemented to the extent possible. In addition, Union law, values and standards regarding, inter alia, security, data protection and privacy, and consumer protection should be upheld. In order to prevent unlawful governmental access to non-personal data by third-country authorities, providers of data processing services subject to this Regulation, such as cloud and edge services, should take all reasonable measures to prevent access to systems on which non-personal data are stored, including, where relevant, through the encryption of data, frequent submission to audits, verified adherence to relevant security reassurance certification schemes, and by the modification of corporate policies.

(103) Standardisation and semantic interoperability should play a key role to provide technical solutions to ensure interoperability within and among common European data spaces which are purpose or sector specific or cross-sectoral interoperable frameworks for common standards and practices to share or jointly process data for, inter alia, the development of new products and services, scientific research or civil society initiatives. This Regulation lays down certain essential requirements for interoperability. Participants in data spaces that offer data or data services to other participants, which are entities facilitating or engaging in data sharing within common European data spaces, including data holders, should comply with those requirements insofar as elements under their control are concerned. Compliance with those rules can be ensured by adhering to the essential requirements laid down in this Regulation, or presumed by complying with harmonised standards or common specifications via a presumption of conformity. In order to facilitate conformity with the requirements for interoperability, it is necessary to provide for a presumption of conformity of interoperability solutions that meet harmonised standards or parts thereof in accordance with Regulation (EU) No 1025/2012, which represents the framework by default to elaborate standards that provide for such presumptions. The Commission should assess barriers to interoperability and prioritise standardisation needs, on the basis of which it may request one or more European standardisation organisations, pursuant to Regulation (EU) No 1025/2012, to draft harmonised standards which satisfy the essential requirements laid down in this Regulation. Where such requests do not result in harmonised standards or such harmonised standards are insufficient to ensure conformity with the essential requirements of this Regulation, the Commission should be able to adopt common specifications in those areas provided that in so doing it duly respects the role and functions of standardisation organisations. Common specification should be adopted only as an exceptional fall-back solution to facilitate compliance with the essential requirements of this Regulation, or when the standardisation process is blocked, or when there are delays in the establishment of appropriate harmonised standards. Where a delay is due to the technical complexity of the standard in question, this should be considered by the Commission before contemplating the establishment of common specifications. Common specifications should be developed in an open and inclusive manner and take into account, where relevant, the advice of the European Data Innovation Board (EDIB) established by Regulation (EU) 2022/868. Additionally, common specifications in different sectors could be adopted, in accordance with Union or national law, on the basis of specific needs of those sectors. Furthermore, the Commission should be enabled to mandate the development of harmonised standards for the interoperability of data processing services.

(104) To promote the interoperability of tools for the automated execution of data sharing agreements, it is necessary to lay down essential requirements for smart contracts which professionals create for others or integrate in applications that support the implementation of agreements for data sharing. In order to facilitate the conformity of such smart contracts with those essential requirements, it is necessary to provide for a presumption of conformity of smart contracts that meet harmonised standards or parts thereof in accordance with Regulation (EU) No 1025/2012. The notion of ‘smart contract’ in this Regulation is technologically neutral. Smart contracts can, for example, be connected to an electronic ledger. The essential requirements should apply only to the vendors of smart contracts, although not where they develop smart contracts in-house exclusively for internal use. The essential requirement to ensure that smart contracts can be interrupted and terminated implies mutual consent by the parties to the data sharing agreement. The applicability of the relevant rules of civil, contractual and consumer protection law to data sharing agreements remains or should remain unaffected by the use of smart contracts for the automated execution of such agreements.

(105) To demonstrate fulfilment of the essential requirements of this Regulation, the vendor of a smart contract, or in the absence thereof, the person whose trade, business or profession involves the deployment of smart contracts for others in the context of executing an agreement or part of it, to make data available in the context of this Regulation, should perform a conformity assessment and issue an EU declaration of conformity. Such a conformity assessment should be subject to the general principles set out in Regulation (EC) No 765/2008 of the European Parliament and of the Council (34) and Decision No 768/2008/EC of the European Parliament and of the Council (35).

(106) Besides the obligation on professional developers of smart contracts to comply with essential requirements, it is also important to encourage those participants within data spaces that offer data or data-based services to other participants within and across common European data spaces to support interoperability of tools for data sharing including smart contracts.

(107) In order to ensure the application and enforcement of this Regulation, Member States should designate one or more competent authorities. If a Member State designates more than one competent authority, it should also designate from among them a data coordinator. Competent authorities should cooperate with each other. Through the exercise of their powers of investigation in accordance with applicable national procedures, competent authorities should be able to search for and obtain information, in particular in relation to the activities of entities within their competence and, including in the context of joint investigations, with due regard to the fact that oversight and enforcement measures concerning an entity under the competence of another Member State should be adopted by the competent authority of that other Member State, where relevant, in accordance with the procedures relating to cross-border cooperation. Competent authorities should assist each other in a timely manner, in particular when a competent authority in a Member State holds relevant information for an investigation carried out by the competent authorities in other Member States, or is able to gather such information to which the competent authorities in the Member State where the entity is established do not have access. Competent authorities and data coordinators should be identified in a public register maintained by the Commission. The data coordinator could be an additional means for facilitating cooperation in cross-border situations, such as when a competent authority from a given Member State does not know which authority it should approach in the data coordinator’s Member State, for example where the case is related to more than one competent authority or sector. The data coordinator should act, inter alia, as a single point of contact for all issues related to the application of this Regulation. Where no data coordinator has been designated, the competent authority should assume the tasks assigned to the data coordinator under this Regulation. The authorities responsible for the supervision of compliance with data protection law and competent authorities designated under Union or national law should be responsible for the application of this Regulation in their areas of competence. In order to avoid conflicts of interest, the competent authorities responsible for the application and enforcement of this Regulation in the area of making data available following a request on the basis of an exceptional need should not benefit from the right to submit such a request.

(108) In order to enforce their rights under this Regulation, natural and legal persons should be entitled to seek redress for infringements of their rights under this Regulation by lodging complaints. The data coordinator should, upon request, provide all the necessary information to natural and legal persons for the lodging of their complaints with the appropriate competent authority. Those authorities should be obliged to cooperate to ensure a complaint is appropriately handled and resolved effectively and in a timely manner. In order to make use of the consumer protection cooperation network mechanism and to enable representanteRepresentante Persona física o jurídica establecida en la Unión designada explícitamente para actuar en nombre de un proveedor de servicios DNS, un registro de nombres TLD, una entidad que preste servicios de registro de nombres de dominio, un proveedor de servicios de computación en nube, un proveedor de servicios de centros de datos, un proveedor de redes de suministro de contenidos, un proveedor de servicios gestionados, un proveedor de servicios de seguridad gestionados o un proveedor de un mercado en línea, de un motor de búsqueda en línea o de una plataforma de servicios de redes sociales que no esté establecido en la Unión, a la que pueda dirigirse una autoridad competente o un CSIRT en lugar de la propia entidad en lo que respecta a las obligaciones que incumben a dicha entidad en virtud de la presente Directiva. - Definición según el artículo 6 de la Directiva (UE) 2022/2555 (Directiva NIS2) actions, this Regulation amends the Annexes to Regulation (EU) 2017/2394 of the European Parliament and of the Council (36) and Directive (EU) 2020/1828 of the European Parliament and of the Council (37).

(109) Competent authorities should ensure that infringements of the obligations laid down in this Regulation are subject to penalties. Such penalties could include financial penalties, warnings, reprimands or orders to bring business practices into compliance with the obligations imposed by this Regulation. Penalties established by the Member States should be effective, proportionate and dissuasive, and should take into account the recommendations of the EDIB, thus contributing to achieving the greatest possible level of consistency in the establishment and application of penalties. Where appropriate, competent authorities should make use of interim measures to limit the effects of an alleged infringement while the investigation of that infringement is ongoing. In so doing, they should take into account, inter alia the nature, gravity, scale and duration of the infringement in view of the public interest at stake, the scope and kind of activities carried out, and the economic capacity of the infringing party. They should also take into account whether the infringing party systematically or recurrently fails to comply with its obligations under this Regulation. In order to ensure that the principle of ne bis in idem is respected, and in particular to avoid that the same infringement of the obligations laid down in this Regulation is penalised more than once, a Member State that intends to exercise its competence in relation to an infringing party that is not established and has not designated a legal representative in the Union should, without undue delay, inform all data coordinators as well as the Commission.

(110) The EDIB should advise and assist the Commission in coordinating national practices and policies on the topics covered by this Regulation as well as in delivering on its objectives in relation to technical standardisation to enhance interoperability. It should also play a key role in facilitating comprehensive discussions between competent authorities concerning the application and enforcement of this Regulation. That exchange of information is designed to increase effective access to justice as well as enforcement and judicial cooperation across the Union. Among other functions, the competent authorities should make use of the EDIB as a platform to evaluate, coordinate and adopt recommendations on the setting of penalties for infringements of this Regulation. It should allow for competent authorities, with the assistance of the Commission, to coordinate the optimal approach to determining and imposing such penalties. That approach prevents fragmentation while allowing for Member State’s flexibility and should lead to effective recommendations that support the consistent application of this Regulation. The EDIB should also have an advisory role in the standardisation processes and the adoption of common specifications by means of implementing acts, in the adoption of delegated acts to establish a monitoring mechanism for switching charges, imposed by providers of data processing services and to further specify the essential requirements for the interoperability of data, of data sharing mechanisms and services, as well as of the common European data spaces. It should also advise and assist the Commission in the adoption of the guidelines laying down interoperability specifications for the functioning of the common European data spaces.

(111) In order to help enterprises to draft and negotiate contracts, the Commission should develop and recommend non-binding model contractual terms for business-to-business data sharing contracts, where necessary taking into account the conditions in specific sectors and the existing practices with voluntary data sharing mechanisms. Those model contractual terms should be primarily a practical tool to help in particular SMEs to conclude a contract. When used widely and integrally, those model contractual terms should also have the beneficial effect of influencing the design of contracts regarding access to and the use of data and therefore lead more broadly towards fairer contractual relations when accessing and sharing data.

(112) In order to eliminate the risk that holders of data in databases obtained or generated by means of physical components, such as sensors, of a connected product and a related service or other machine-generated data, claim the sui generis right under Article 7 of Directive 96/9/EC, and in so doing hinder, in particular, the effective exercise of the right of users to access and use data and the right to share data with third parties under this Regulation, it should be clarified that the sui generis right does not apply to such databases. That does not affect the possible application of the sui generis right under Article 7 of Directive 96/9/EC to databases containing data falling outside the scope of this Regulation, provided that the requirements for protection pursuant to paragraph 1 of that Article are fulfilled.

(113) In order to take account of technical aspects of data processing services, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of supplementing this Regulation in order to establish a monitoring mechanism on switching charges imposed by providers of data processing services on the market, and to further specify the essential requirements in respect of interoperability for participants in data spaces that offer data or data services to other participants. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (38). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(114) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of the adoption of common specifications to ensure the interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces, common specifications on the interoperability of data processing services, and common specifications on the interoperability of smart contracts. Implementing powers should also be conferred on the Commission for the purpose of publishing the references of harmonised standards and common specifications for the interoperability of data processing services in a central Union standards repository for the interoperability of data processing services. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (39).

(115) This Regulation should be without prejudice to rules addressing needs specific to individual sectors or areas of public interest. Such rules may include additional requirements on the technical aspects of data access, such as interfaces for data access, or how data access could be provided, for example directly from the product or via data intermediation services. Such rules may also include limits on the rights of data holders to access or use user data, or other aspects beyond data access and use, such as governance aspects or security requirements, including cybersecurity requirements. This Regulation should also be without prejudice to more specific rules in the context of the development of common European data spaces or, subject to the exceptions provided for in this Regulation, to Union and national law providing for access to and authorising the use of data for scientific research purposes.

(116) This Regulation should not affect the application of the rules of competition, in particular Articles 101 and 102 TFEU. The measures provided for in this Regulation should not be used to restrict competition in a manner contrary to the TFEU.

(117) In order to allow actors within the scope of this Regulation to adapt to the new rules provided for herein, and to make the necessary technical arrangements, those rules should apply from 12 September 2025.

(118) The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42(1) and (2) of Regulation (EU) 2018/1725 and delivered their opinion on 4 May 2022.

(119) Since the objectives of this Regulation, namely ensuring fairness in the allocation of value from data among actors in the data economy and fostering fair access to and use of data in order to contribute to establishing a genuine internal market for data, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action and cross-border use of data, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,

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