DA Article 2. Definitions

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 (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.

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.

The fundamental right to the protection of personal data is safeguarded, in particular, by Regulations (EU) 2016/679 and (EU) 2018/1725 of the European Parliament and of the Council. Directive 2002/58/EC of the European Parliament and of the Council 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.

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 electronic communications service, 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.

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.

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.

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.

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.

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 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.

Directive (EU) 2016/943 of the European Parliament and of the Council 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 risk 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 cybersecurity 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.

A third party to whom data is made available may be a natural or legal person, such as a consumer, an enterprise, a research organisation, 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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.