Regulation (EU) 2023/2854 of the European Parliament and of the Council of 13 December 2023 on harmonised rules on fair access to and use of data and amending Regulation (EU) 2017/2394 and Directive (EU) 2020/1828 (Data Act) (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Central Bank (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Having regard to the opinion of the Committee of the Regions (3),

Acting in accordance with the ordinary legislative procedure (4),

Whereas:

(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 entity 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 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.

(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.