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Article 1

Subject matter and scope

1.   This Regulation lays down harmonised rules, inter alia, on:

(a)

the making available of product data and related_service data to the user of the connected_product or related_service;

(b)

the making available of data by data holders to data recipients;

(c)

the making available of data by data holders to public sector bodies, the Commission, the European Central Bank and Union_bodies, where there is an exceptional need for those data for the performance of a specific task carried out in the public interest;

(d)

facilitating switching between data processing services;

(e)

introducing safeguards against unlawful third-party access to non-personal data; and

(f)

the development of interoperability standards for data to be accessed, transferred and used.

2.   This Regulation covers personal and non-personal data, including the following types of data, in the following contexts:

(a)

Chapter II applies to data, with the exception of content, concerning the performance, use and environment of connected_products and related_services;

(b)

Chapter III applies to any private sector data that is subject to statutory data sharing obligations;

(c)

Chapter IV applies to any private sector data accessed and used on the basis of contract between enterprises;

(d)

Chapter V applies to any private sector data with a focus on non-personal data;

(e)

Chapter VI applies to any data and services processed by providers of data processing services;

(f)

Chapter VII applies to any non-personal data held in the Union by providers of data processing services.

3.   This Regulation applies to:

(a)

manufacturers of connected_products placed on the market in the Union and providers of related_services, irrespective of the place of establishment of those manufacturers and providers;

(b)

users in the Union of connected_products or related_services as referred to in point (a);

(c)

data holders, irrespective of their place of establishment, that make data available to data recipients in the Union;

(d)

data recipients in the Union to whom data are made available;

(e)

public sector bodies, the Commission, the European Central Bank and Union_bodies that request data holders to make data available where there is an exceptional need for those data for the performance of a specific task carried out in the public interest and to the data holders that provide those data in response to such request;

(f)

providers of data processing services, irrespective of their place of establishment, providing such services to customers in the Union;

(g)

participants in data spaces and vendors of applications using smart_contracts and persons whose trade, business or profession involves the deployment of smart_contracts for others in the context of executing an agreement.

4.   Where this Regulation refers to connected_products or related_services, such references are also understood to include virtual_assistants insofar as they interact with a connected_product or related_service.

5.   This Regulation is without prejudice to Union and national law on the protection of personal data, privacy and confidentiality of communications and integrity of terminal equipment, which shall apply to personal data processed in connection with the rights and obligations laid down herein, in particular Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive 2002/58/EC, including the powers and competences of supervisory authorities and the rights of data subjects. Insofar as users are data subjects, the rights laid down in Chapter II of this Regulation shall complement the rights of access by data subjects and rights to data portability under Articles 15 and 20 of Regulation (EU) 2016/679. In the event of a conflict between this Regulation and Union law on the protection of personal data or privacy, or national legislation adopted in accordance with such Union law, the relevant Union or national law on the protection of personal data or privacy shall prevail.

6.   This Regulation does not apply to or pre-empt voluntary arrangements for the exchange of data between private and public entities, in particular voluntary arrangements for data sharing.

This Regulation does not affect Union or 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, in particular Regulations (EU) 2021/784, (EU) 2022/2065 and (EU) 2023/1543 and Directive (EU) 2023/1544, or international cooperation in that area. This Regulation does not apply to the collection or sharing of, access to or the use of data under Regulation (EU) 2015/847 and Directive (EU) 2015/849. 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, regardless of the type of entity entrusted by the Member States to carry out tasks in relation to those competences, or their power to safeguard other essential State functions, including ensuring the territorial integrity of the State and the maintenance of law and order. This Regulation does not affect the competences of the Member States concerning customs and tax administration or the health and safety of citizens.

7.   This Regulation complements the self-regulatory approach of Regulation (EU) 2018/1807 by adding generally applicable obligations on cloud switching.

8.   This Regulation is without prejudice to Union and national legal acts providing for the protection of intellectual property rights, in particular Directives 2001/29/EC, 2004/48/EC and (EU) 2019/790.

9.   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 Directives 93/13/EEC, 2005/29/EC and 2011/83/EU.

10.   This Regulation does not preclude the conclusion of voluntary lawful data sharing contracts, including contracts concluded on a reciprocal basis, which comply with the requirements laid down in this Regulation.

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

(1)

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

(2)

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

(3)

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

(4)

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

(5)

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

(6)

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

(7)

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

(8)

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

(9)

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

(10)

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

(11)

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

(12)

user’ means a natural or legal person that owns a connected_product or to whom temporary rights to use that connected_product have been contractually transferred, or that receives related_services;

(13)

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

(14)

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

(15)

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

(16)

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

(17)

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

(18)

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

(19)

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

(20)

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

(21)

making_available_on_the_market’ means any supply of a connected_product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(22)

placing_on_the_market’ means the first making available of a connected_product on the Union market;

(23)

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

(24)

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

(25)

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

(26)

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

(27)

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

(28)

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

(29)

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

(30)

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

(31)

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

(32)

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

(33)

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

(34)

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

(35)

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

(36)

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

(37)

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

(38)

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

(39)

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

(40)

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

(41)

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

(42)

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

(43)

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

CHAPTER II

BUSINESS TO CONSUMER AND BUSINESS TO BUSINESS DATA SHARING

Article 3

Obligation to make product data and related_service data accessible to the user

1.   Connected products shall be designed and manufactured, and related_services shall be designed and provided, in such a manner that product data and related_service data, including the relevant meta data necessary to interpret and use those data, are, by default, easily, securely, free of charge, in a comprehensive, structured, commonly used and machine-readable format, and, where relevant and technically feasible, directly accessible to the user.

2.   Before concluding a contract for the purchase, rent or lease of a connected_product, the seller, rentor or lessor, which may be the manufacturer, shall provide at least the following information to the user, in a clear and comprehensible manner:

(a)

the type, format and estimated volume of product data which the connected_product is capable of generating;

(b)

whether the connected_product is capable of generating data continuously and in real-time;

(c)

whether the connected_product is capable of storing data on-device or on a remote server, including, where applicable, the intended duration of retention;

(d)

how the user may access, retrieve or, where relevant, erase the data, including the technical means to do so, as well as their terms of use and quality of service.

3.   Before concluding a contract for the provision of a related_service, the provider of such related_service shall provide at least the following information to the user, in a clear and comprehensible manner:

(a)

the nature, estimated volume and collection frequency of product data that the prospective data holder is expected to obtain and, where relevant, the arrangements for the user to access or retrieve such data, including the prospective data holder’s data storage arrangements and the duration of retention;

(b)

the nature and estimated volume of related_service data to be generated, as well as the arrangements for the user to access or retrieve such data, including the prospective data holder’s data storage arrangements and the duration of retention;

(c)

whether the prospective data holder expects to use readily available data itself and the purposes for which those data are to be used, and whether it intends to allow one or more third parties to use the data for purposes agreed upon with the user;

(d)

the identity of the prospective data holder, such as its trading name and the geographical address at which it is established and, where applicable, of other data processing parties;

(e)

the means of communication which make it possible to contact the prospective data holder quickly and communicate with that data holder efficiently;

(f)

how the user can request that the data are shared with a third party and, where applicable, end the data sharing;

(g)

the user’s right to lodge a complaint alleging an infringement of any of the provisions of this Chapter with the competent authority designated pursuant to Article 37;

(h)

whether a prospective data holder is the holder of trade_secrets contained in the data that is accessible from the connected_product or generated during the provision of a related_service, and, where the prospective data holder is not the trade_secret holder, the identity of the trade_secret holder;

(i)

the duration of the contract between the user and the prospective data holder, as well as the arrangements for terminating such a contract.

Article 4

The rights and obligations of users and data holders with regard to access, use and making available product data and related_service data

1.   Where data cannot be directly accessed by the user from the connected_product or related_service, data holders shall make readily available data, as well as the relevant meta data necessary to interpret and use those data, accessible to the user without undue delay, of the same quality as is available to the data holder, easily, securely, free of charge, in a comprehensive, structured, commonly used and machine-readable format and, where relevant and technically feasible, continuously and in real-time. This shall be done on the basis of a simple request through electronic means where technically feasible.

2.   users and data holders may contractually restrict or prohibit accessing, using or further sharing data, if such processing could undermine security requirements of the connected_product, as laid down by Union or national law, resulting in a serious adverse effect on the health, safety or security of natural persons. Sectoral authorities may provide users and data holders with technical expertise in that context. Where the data holder refuses to share data pursuant to this Article, it shall notify the competent authority designated pursuant to Article 37.

3.   Without prejudice to the user’s right to seek redress at any stage before a court or tribunal of a Member State, the user may, in relation to any dispute with the data holder concerning the contractual restrictions or prohibitions referred to in paragraph 2:

(a)

lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority; or

(b)

agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

4.   Data holders shall not make the exercise of choices or rights under this Article by the user unduly difficult, including by offering choices to the user in a non-neutral manner or by subverting or impairing the autonomy, decision-making or choices of the user via the structure, design, function or manner of operation of a user digital interface or a part thereof.

5.   For the purpose of verifying whether a natural or legal person qualifies as a user for the purposes of paragraph 1, a data holder shall not require that person to provide any information beyond what is necessary. Data holders shall not keep any information, in particular log data, on the user’s access to the data requested beyond what is necessary for the sound execution of the user’s access request and for the security and maintenance of the data infrastructure.

6.   Trade secrets shall be preserved and shall be disclosed only where the data holder and the user take all necessary measures prior to the disclosure to preserve their confidentiality in particular regarding third parties. The data holder or, where they are not the same person, the trade_secret holder shall identify the data which are protected as trade_secrets, including in the relevant meta data, and shall agree with the user proportionate technical and organisational measures necessary to preserve the confidentiality of the shared data, in particular in relation to third parties, such as model contractual terms, confidentiality agreements, strict access protocols, technical standards and the application of codes of conduct.

7.   Where there is no agreement on the necessary measures referred to in paragraph 6, or if the user fails to implement the measures agreed pursuant to paragraph 6 or undermines the confidentiality of the trade_secrets, the data holder may withhold or, as the case may be, suspend the sharing of data identified as trade_secrets. The decision of the data holder shall be duly substantiated and provided in writing to the user without undue delay. In such cases, the data holder shall notify the competent authority designated pursuant to Article 37 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.

8.   In exceptional circumstances, where the data holder who is a trade_secret holder is able to demonstrate that it is highly likely to suffer serious economic damage from the disclosure of trade_secrets, despite the technical and organisational measures taken by the user pursuant to paragraph 6 of this Article, that data holder may refuse on a case-by-case basis a request for access to the specific data in question. That demonstration shall be duly substantiated on the basis of objective elements, in particular the enforceability of trade_secrets protection in third countries, the nature and level of confidentiality of the data requested, and the uniqueness and novelty of the connected_product, and shall be provided in writing to the user without undue delay. Where the data holder refuses to share data pursuant to this paragraph, it shall notify the competent authority designated pursuant to Article 37.

9.   Without prejudice to a user’s right to seek redress at any stage before a court or tribunal of a Member State, a user wishing to challenge a data holder’s decision to refuse or to withhold or suspend data sharing pursuant to paragraphs 7 and 8 may:

(a)

lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority, which shall, without undue delay, decide whether and under which conditions data sharing is to start or resume; or

(b)

agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

10.   The user shall not use the data obtained pursuant to a request referred to in paragraph 1 to develop a connected_product that competes with the connected_product from which the data originate, nor share the data with a third party with that intent and shall not use such data to derive insights about the economic situation, assets and production methods of the manufacturer or, where applicable the data holder.

11.   The user shall not use coercive means or abuse gaps in the technical infrastructure of a data holder which is designed to protect the data in order to obtain access to data.

12.   Where the user is not the data subject whose personal data is requested, any personal data generated by the use of a connected_product or related_service shall be made available by the data holder to the user only where there is 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 are fulfilled.

13.   A data holder shall only use any readily available data that is non-personal data on the basis of a contract with the user. A data holder shall not use such data to derive insights about the economic situation, assets and production methods of, or the use by, the user in any other manner that could undermine the commercial position of that user on the markets in which the user is active.

14.   Data holders shall 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. Where relevant, data holders shall contractually bind third parties not to further share data received from them.

Article 5

Right of the user to share data with third parties

1.   Upon request by a user, or by a party acting on behalf of a user, the data holder shall make available readily available data, as well as the relevant meta data necessary to interpret and use those data, to a third party without undue delay, of the same quality as is available to the data holder, easily, securely, free of charge to the user, in a comprehensive, structured, commonly used and machine-readable format and, where relevant and technically feasible, continuously and in real-time. The data shall be made available by the data holder to the third party in accordance with Articles 8 and 9.

2.   Paragraph 1 shall not apply to readily available data in the context of the testing of new connected_products, substances or processes that are not yet placed on the market unless their use by a third party is contractually permitted.

3.   Any undertaking designated as a gatekeeper, pursuant to Article 3 of Regulation (EU) 2022/1925, shall not be an eligible third party under this Article and therefore shall not:

(a)

solicit or commercially incentivise a user in any manner, including by providing monetary or any other compensation, to make data available to one of its services that the user has obtained pursuant to a request under Article 4(1);

(b)

solicit or commercially incentivise a user to request the data holder to make data available to one of its services pursuant to paragraph 1 of this Article;

(c)

receive data from a user that the user has obtained pursuant to a request under Article 4(1).

4.   For the purpose of verifying whether a natural or legal person qualifies as a user or as a third party for the purposes of paragraph 1, the user or the third party shall not be required to provide any information beyond what is necessary. Data holders shall not keep any information on the third party’s access to the data requested beyond what is necessary for the sound execution of the third party’s access request and for the security and maintenance of the data infrastructure.

5.   The third party shall not use coercive means or abuse gaps in the technical infrastructure of a data holder which is designed to protect the data in order to obtain access to data.

6.   A data holder shall not use any readily available data to derive insights about the economic situation, assets and 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, unless the third party has given permission to such use and has the technical possibility to easily withdraw that permission at any time.

7.   Where the user is not the data subject whose personal data is requested, any personal data generated by the use of a connected_product or related_service shall be made available by the data holder to the third party only where there is 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 are fulfilled.

8.   Any failure on the part of the data holder and the third party to agree on arrangements for transmitting the data shall not hinder, prevent or interfere with the exercise of the rights of the data subject under Regulation (EU) 2016/679 and, in particular, with the right to data portability under Article 20 of that Regulation.

9.   Trade secrets shall be preserved and shall be disclosed to third parties only to the extent that such disclosure is strictly necessary to fulfil the purpose agreed between the user and the third party. The data holder or, where they are not the same person, the trade_secret holder shall identify the data which are protected as trade_secrets, including in the relevant meta data, and shall agree with the third party all proportionate technical and organisational measures necessary to preserve the confidentiality of the shared data, such as model contractual terms, confidentiality agreements, strict access protocols, technical standards and the application of codes of conduct.

10.   Where there is no agreement on the necessary measures referred to in paragraph 9 of this Article or if the third party fails to implement the measures agreed pursuant to paragraph 9 of this Article or undermines the confidentiality of the trade_secrets, the data holder may withhold or, as the case may be, suspend the sharing of data identified as trade_secrets. The decision of the data holder shall be duly substantiated and provided in writing to the third party without undue delay. In such cases, the data holder shall notify the competent authority designated pursuant to Article 37 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.

11.   In exceptional circumstances, where the data holder who is a trade_secret holder is able to demonstrate that it is highly likely to suffer serious economic damage from the disclosure of trade_secrets, despite the technical and organisational measures taken by the third party pursuant to paragraph 9 of this Article, that data holder may refuse on a case-by-case basis a request for access to the specific data in question. That demonstration shall be duly substantiated on the basis of objective elements, in particular the enforceability of trade_secrets protection in third countries, the nature and level of confidentiality of the data requested, and the uniqueness and novelty of the connected_product, and shall be provided in writing to the third party without undue delay. Where the data holder refuses to share data pursuant to this paragraph, it shall notify the competent authority designated pursuant to Article 37.

12.   Without prejudice to the third party’s right to seek redress at any stage before a court or tribunal of a Member State, a third party wishing to challenge a data holder’s decision to refuse or to withhold or suspend data sharing pursuant to paragraphs 10 and 11 may:

(a)

lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority, which shall, without undue delay, decide whether and under which conditions the data sharing is to start or resume; or

(b)

agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

13.   The right referred to in paragraph 1 shall not adversely affect the rights of data subjects pursuant to the applicable Union and national law on the protection of personal data.

Article 6

Obligations of third parties receiving data at the request of the user

1.   A third party shall process the data made available to it pursuant to Article 5 only for the purposes and under the conditions agreed with the user and subject to Union and national law on the protection of personal data including the rights of the data subject insofar as personal data are concerned. The third party shall erase the data when they are no longer necessary for the agreed purpose, unless otherwise agreed with the user in relation to non-personal data.

2.   The third party shall not:

(a)

make the exercise of choices or rights under Article 5 and this Article 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;

(b)

notwithstanding Article 22(2), points (a) and (c), of Regulation (EU) 2016/679, use the data it receives for the profiling, unless it is necessary to provide the service requested by the user;

(c)

make the data it receives available to another third party, unless the data is made available on the basis of a contract with the user, and provided that the other third party takes all necessary measures agreed between the data holder and the third party to preserve the confidentiality of trade_secrets;

(d)

make the data it receives available to an undertaking designated as a gatekeeper pursuant to Article 3 of Regulation (EU) 2022/1925;

(e)

use the data it receives to develop a product that competes with the connected_product from which the accessed data originate or share the data with another third party for that purpose; third parties shall also not use any non-personal product data or related_service data made available to them to derive insights about the economic situation, assets and production methods of, or use by, the data holder;

(f)

use the data it receives in a manner that has an adverse impact on the security of the connected_product or related_service;

(g)

disregard the specific measures agreed with a data holder or with the trade_secrets holder pursuant to Article 5(9) and undermine the confidentiality of trade_secrets;

(h)

prevent the user that is a consumer, including on the basis of a contract, from making the data it receives available to other parties.

Article 7

Scope of business-to- consumer and business-to-business data sharing obligations

1.   The obligations of this Chapter shall not apply to data generated through the use of connected_products manufactured or designed or related_services provided by a micro enterprise or a small enterprise, provided that that enterprise does not have 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 micro enterprise or a small enterprise and where the micro enterprise and small enterprise is not subcontracted to manufacture or design a connected_product or to provide a related_service.

The same shall apply to data generated through the use of connected_products manufactured by or related_services provided by an enterprise that has qualified as a medium-sized enterprise under Article 2 of the Annex to Recommendation 2003/361/EC 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.

2.   Any contractual term which, to the detriment of the user, excludes the application of, derogates from or varies the effect of the user’s rights under this Chapter shall not be binding on the user.

CHAPTER III

OBLIGATIONS FOR DATA HOLDERS OBLIGED TO MAKE DATA AVAILABLE PURSUANT TO UNION LAW

Article 8

Conditions under which data holders make data available to data recipients

1.   Where, in business-to-business relations, a data holder is obliged to make data available to a data recipient under Article 5 or under other applicable Union law or national legislation adopted in accordance with Union law, it shall agree with a data recipient the arrangements for making the data available and shall do so under fair, reasonable and non-discriminatory terms and conditions and in a transparent manner in accordance with this Chapter and Chapter IV.

2.   A contractual term concerning access to and the use of data, or liability and remedies for the breach or termination of data-related obligations, shall not be binding if it constitutes an unfair contractual term within the meaning of Article 13 or if, to the detriment of the user, it excludes the application of, derogates from or varies the effect of the user’s rights under Chapter II.

3.   A data holder shall not discriminate regarding the arrangements for making data available between comparable categories of data recipients, including partner enterprises or linked enterprises of the data holder when making data available. Where a data recipient considers that the conditions under which data has been made available to it are discriminatory, the data holder shall without undue delay provide the data recipient, upon its reasoned request, with information showing that there has been no discrimination.

4.   A data holder shall not make data available to a data recipient, including on an exclusive basis, unless requested to do so by the user under Chapter II.

5.   Data holders and data recipients shall not be required to provide any information beyond what is necessary to verify compliance with the contractual terms agreed for making data available or with their obligations under this Regulation or other applicable Union law or national legislation adopted in accordance with Union law.

6.   Unless otherwise provided for in Union law, including Article 4(6) and Article 5(9) of this Regulation, or by national legislation adopted in accordance with Union law, an obligation to make data available to a data recipient shall not oblige the disclosure of trade_secrets.

Article 10

Dispute settlement

1.   users, data holders and data recipients shall have access to a dispute settlement body, certified in accordance with paragraph 5 of this Article, to settle disputes pursuant to Article 4(3) and (9) and Article 5(12) as well as disputes relating to the fair, reasonable and non-discriminatory terms and conditions for, and transparent manner of, making data available in accordance with this Chapter and Chapter IV.

2.   Dispute settlement bodies shall make the fees, or the mechanisms used to determine the fees, known to the parties concerned before those parties request a decision.

3.   For disputes referred to a dispute settlement body pursuant to Article 4(3) and (9) and Article 5(12), where the dispute settlement body decides a dispute in favour of the user or of the data recipient, the data holder shall bear all the fees charged by the dispute settlement body and shall reimburse that user or that data recipient for any other reasonable expenses that it has incurred in relation to the dispute settlement. If the dispute settlement body decides a dispute in favour of the data holder, the user or the data recipient shall not be required to reimburse any fees or other expenses that the data holder paid or is to pay in relation to the dispute settlement, unless the dispute settlement body finds that the user or the data recipient manifestly acted in bad faith.

4.   Customers and providers of data processing services shall have access to a dispute settlement body, certified in accordance with paragraph 5 of this Article, to settle disputes relating to breaches of the rights of customers and the obligations of providers of data processing services, in accordance with Articles 23 to 31.

5.   The Member State where the dispute settlement body is established shall, at the request of that body, certify that body where it has demonstrated that it meets all of the following conditions:

(a)

it is impartial and independent, and it is to issue its decisions in accordance with clear, non-discriminatory and fair rules of procedure;

(b)

it has the necessary expertise, in particular in relation to fair, reasonable and non-discriminatory terms and conditions, including compensation, and on making data available in a transparent manner, allowing the body to effectively determine those terms and conditions;

(c)

it is easily accessible through electronic communication technology;

(d)

it is capable of adopting its decisions in a swift, efficient and cost-effective manner in at least one official language of the Union.

6.   Member States shall notify to the Commission the dispute settlement bodies certified in accordance with paragraph 5. The Commission shall publish a list of those bodies on a dedicated website and keep it updated.

7.   A dispute settlement body shall 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.

8.   A dispute settlement body shall grant parties the possibility, within a reasonable period of time, to express their points of view on the matters those parties have brought before that body. In that context, each party to a dispute shall be provided with the submissions of the other party to their dispute and any statements made by experts. The parties shall be given the possibility to comment on those submissions and statements.

9.   A dispute settlement body shall adopt its decision on a matter referred to it within 90 days of receipt of a request pursuant to paragraphs 1 and 4. That decision shall be in writing or on a durable medium and shall be supported by a statement of reasons.

10.   Dispute settlement bodies shall draw up and make publicly available annual activity reports. Such annual reports shall include, in particular, the following general information:

(a)

an aggregation of the outcomes of disputes;

(b)

the average time taken to resolve disputes;

(c)

the most common reasons for disputes.

11.   In order to facilitate the exchange of information and best practices, a dispute settlement body may decide to include recommendations in the report referred to in paragraph 10 as to how problems can be avoided or resolved.

12.   The decision of a dispute settlement body shall be binding on the parties only if the parties have explicitly consented to its binding nature prior to the start of the dispute settlement proceedings.

13.   This Article does not affect the right of parties to seek an effective remedy before a court or tribunal of a Member State.

Article 11

Technical protection measures on the unauthorised use or disclosure of data

1.   A data holder may apply appropriate technical protection measures, including smart_contracts and encryption, to prevent unauthorised access to data, including meta data, and to ensure compliance with Articles 4, 5, 6, 8 and 9, as well as with the agreed contractual terms for making data available. Such technical protection measures shall not discriminate between data recipients or hinder a user’s right to obtain a copy of, retrieve, use or access data, to provide data to third parties pursuant to Article 5 or any right of a third party under Union law or national legislation adopted in accordance with Union law. users, third parties and data recipients shall not alter or remove such technical protection measures unless agreed by the data holder.

2.   In the circumstances referred to in paragraph 3, the third party or data recipient shall comply, without undue delay, with the requests of the data holder and, where applicable and where they are not the same person, the trade_secret holder or the user:

(a)

to erase the data made available by the data holder and any copies thereof;

(b)

to end the production, offering or placing_on_the_market or use of goods, derivative data or services produced on the basis of knowledge obtained through such data, or the importation, export or storage of infringing goods for those purposes, and destroy any infringing goods, where there is a serious risk that the unlawful use of those data will cause significant harm to the data holder, the trade_secret holder or the user or where such a measure would not be disproportionate in light of the interests of the data holder, the trade_secret holder or the user;

(c)

to inform the user of the unauthorised use or disclosure of the data and of the measures taken to put an end to the unauthorised use or disclosure of the data;

(d)

to compensate the party suffering from the misuse or disclosure of such unlawfully accessed or used data.

3.   Paragraph 2 shall apply where a third party or a data recipient has:

(a)

for the purposes of obtaining data, provided false information to a data holder, deployed deceptive or coercive means or abused gaps in the technical infrastructure of the data holder designed to protect the data;

(b)

used the data made available for unauthorised purposes, including the development of a competing connected_product within the meaning of Article 6(2), point (e);

(c)

unlawfully disclosed data to another party;

(d)

not maintained the technical and organisational measures agreed pursuant to Article 5(9); or

(e)

altered or removed technical protection measures applied by the data holder pursuant to paragraph 1 of this Article without the agreement of the data holder.

4.   Paragraph 2 shall also apply where a user alters or removes technical protection measures applied by the data holder or does not maintain the technical and organisational measures taken by the user in agreement with the data holder or, where they are not the same person, the trade_secrets holder, in order to preserve trade_secrets, as well as in respect of any other party that receives the data from the user by means of an infringement of this Regulation.

5.   Where the data recipient infringes Article 6(2), point (a) or (b), users shall have the same rights as data holders under paragraph 2 of this Article.

Article 12

Scope of obligations for data holders obliged pursuant to Union law to make data available

1.   This Chapter shall apply where, in business-to-business relations, a data holder is obliged under Article 5 or under applicable Union law or national legislation adopted in accordance with Union law, to make data available to a data recipient.

2.   A contractual term in a data sharing agreement which, to the detriment of one party, or, where applicable, to the detriment of the user, excludes the application of this Chapter, derogates from it, or varies its effect, shall not be binding on that party.

CHAPTER IV

UNFAIR CONTRACTUAL TERMS RELATED TO DATA ACCESS AND USE BETWEEN ENTERPRISES

Article 37

Competent authorities and data coordinators

1.   Each Member State shall designate one or more competent authorities to be responsible for the application and enforcement of this Regulation (competent authorities). Member States may establish one or more new authorities or rely on existing authorities.

2.   Where a Member State designates more than one competent authority, it shall designate a data coordinator from among them to facilitate cooperation between the competent authorities and to assist entities within the scope of this Regulation on all matters related to its application and enforcement. Competent authorities shall, in the exercise of the tasks and powers assigned to them under paragraph 5, cooperate with each other.

3.   The supervisory authorities responsible for monitoring the application of Regulation (EU) 2016/679 shall be responsible for monitoring the application of this Regulation insofar as the protection of personal data is concerned. Chapters VI and VII of Regulation (EU) 2016/679 shall apply mutatis mutandis.

The European Data Protection Supervisor shall be responsible for monitoring the application of this Regulation insofar as it concerns the Commission, the European Central Bank or Union_bodies. Where relevant, Article 62 of Regulation (EU) 2018/1725 shall apply mutatis mutandis.

The tasks and powers of the supervisory authorities referred to in this paragraph shall be exercised with regard to the processing of personal data.

4.   Without prejudice to paragraph 1 of this Article:

(a)

for specific sectoral data access and use issues related to the application of this Regulation, the competence of sectoral authorities shall be respected;

(b)

the competent authority responsible for the application and enforcement of Articles 23 to 31 and Articles 34 and 35 shall have experience in the field of data and electronic communications services.

5.   Member States shall ensure that the tasks and powers of the competent authorities are clearly defined and include:

(a)

promoting data literacy and awareness among users and entities falling within the scope of this Regulation of the rights and obligations under this Regulation;

(b)

handling complaints arising from alleged infringements of this Regulation, including in relation to trade_secrets, and investigating, to the extent appropriate, the subject matter of complaints and regularly informing complainants, where relevant in accordance with national law, of the progress and the outcome of the investigation within a reasonable period, in particular if further investigation or coordination with another competent authority is necessary;

(c)

conducting investigations into matters that concern the application of this Regulation, including on the basis of information received from another competent authority or other public authority;

(d)

imposing effective, proportionate and dissuasive financial penalties which may include periodic penalties and penalties with retroactive effect, or initiating legal proceedings for the imposition of fines;

(e)

monitoring technological and relevant commercial developments of relevance for the making available and use of data;

(f)

cooperating with competent authorities of other Member States and, where relevant, with the Commission or the EDIB, to ensure the consistent and efficient application of this Regulation, including the exchange of all relevant information by electronic means, without undue delay, including regarding paragraph 10 of this Article;

(g)

cooperating with the relevant competent authorities responsible for the implementation of other Union or national legal acts, including with authorities competent in the field of data and electronic communication services, with the supervisory authority responsible for monitoring the application of Regulation (EU) 2016/679 or with sectoral authorities to ensure that this Regulation is enforced consistently with other Union and national law;

(h)

cooperating with the relevant competent authorities to ensure that Articles 23 to 31 and Articles 34 and 35 are enforced consistently with other Union law and self-regulation applicable to providers of data processing services;

(i)

ensuring that switching charges are withdrawn in accordance with Article 29;

(j)

examining the requests for data made pursuant to Chapter V.

Where designated, the data coordinator shall facilitate the cooperation referred to in points (f), (g) and (h) of the first subparagraph and shall assist the competent authorities upon their request.

6.   The data coordinator, where such competent authority has been designated, shall:

(a)

act as the single point of contact for all issues related to the application of this Regulation;

(b)

ensure the online public availability of requests to make data available made by public sector bodies in the case of exceptional need under Chapter V and promote voluntary data sharing agreements between public sector bodies and data holders;

(c)

inform the Commission, on an annual basis, of the refusals notified under Article 4(2) and (8) and Article 5(11).

7.   Member States shall notify the Commission of the names of the competent authorities and of their tasks and powers and, where applicable, the name of the data coordinator. The Commission shall maintain a public register of those authorities.

8.   When carrying out their tasks and exercising their powers in accordance with this Regulation, competent authorities shall remain impartial and free from any external influence, whether direct or indirect, and shall neither seek nor take instructions for individual cases from any other public authority or any private party.

9.   Member States shall ensure that the competent authorities are provided with sufficient human and technical resources and relevant expertise to effectively carry out their tasks in accordance with this Regulation.

10.   Entities falling within the scope of this Regulation shall be subject to the competence of the Member State where the entity is established. Where the entity is established in more than one Member State, it shall be considered to be under the competence of the Member State in which it has its main establishment, that is, where the entity has its head office or registered office from which the principal financial functions and operational control are exercised.

11.   Any entity falling within the scope of this Regulation that makes connected_products available or offers services in the Union, and which is not established in the Union, shall designate a legal representative in one of the Member States.

12.   For the purpose of ensuring compliance with this Regulation, a legal representative shall be mandated by an entity falling within the scope of this Regulation that makes connected_products available or offers services in the Union to be addressed in addition to or instead of it by competent authorities with regard to all issues related to that entity. That legal representative shall cooperate with and comprehensively demonstrate to the competent authorities, upon request, the actions taken and provisions put in place by the entity falling within the scope of this Regulation that makes connected_products available or offers services in the Union to ensure compliance with this Regulation.

13.   An entity falling within the scope of this Regulation that makes connected_products available or offers services in the Union, shall be considered to be under the competence of the Member State in which its legal representative is located. The designation of a legal representative by such an entity shall be without prejudice to the liability of, and any legal action that could be initiated against, such an entity. Until such time as an entity designates a legal representative in accordance with this Article, it shall be under the competence of all Member States, where applicable, for the purposes of ensuring the application and enforcement of this Regulation. Any competent authority may exercise its competence, including by imposing effective, proportionate and dissuasive penalties, provided that the entity is not subject to enforcement proceedings under this Regulation regarding the same facts by another competent authority.

14.   Competent authorities shall have the power to request from users, data holders, or data recipients, or their legal representatives, falling under the competence of their Member State all information necessary to verify compliance with this Regulation. Any request for information shall be proportionate to the performance of the underlying task and shall be reasoned.

15.   Where a competent authority in one Member State requests assistance or enforcement measures from a competent authority in another Member State, it shall submit a reasoned request. A competent authority shall, upon receiving such a request, provide a response, detailing the actions that have been taken or which are intended to be taken, without undue delay.

16.   Competent authorities shall respect the principles of confidentiality and of professional and commercial secrecy and shall protect personal data in accordance with Union or national law. Any information exchanged in the context of a request for assistance and provided pursuant to this Article shall be used only in respect of the matter for which it was requested.

Article 44

Other Union legal acts governing rights and obligations on data access and use

1.   The specific obligations for the making available of data between businesses, between businesses and consumers, and on exceptional basis between businesses and public bodies, in Union legal acts that entered into force on or before 11 January 2024, and delegated or implementing acts pursuant thereto, shall remain unaffected.

2.   This Regulation is without prejudice to Union law specifying, in light of the needs of a sector, a common European data space, or an area of public interest, further requirements, in particular in relation to:

(a)

technical aspects of data access;

(b)

limits on the rights of data holders to access or use certain data provided by users;

(c)

aspects going beyond data access and use.

3.   This Regulation, with the exception of Chapter V, is without prejudice to Union and national law providing for access to and authorising the use of data for scientific research purposes.

Article 49

Evaluation and review

1.   By 12 September 2028, the Commission shall carry out an evaluation of this Regulation and submit a report on its main findings to the European Parliament and to the Council, and to the European Economic and Social Committee. That evaluation shall assess, in particular:

(a)

situations to be considered to be situations of exceptional need for the purpose of Article 15 of this Regulation and the application of Chapter V of this Regulation in practice, in particular the experience in the application of Chapter V of this Regulation by public sector bodies, the Commission, the European Central Bank and Union_bodies; the number and outcome of the proceedings brought to the competent authority under Article 18(5) on the application of Chapter V of this Regulation, as reported by the competent authorities; the impact of other obligations laid down in Union or national law for the purposes of complying with requests for access to information; the impact of voluntary data-sharing mechanisms, such as those put in place by data altruism organisations recognised under Regulation (EU) 2022/868, on meeting the objectives of Chapter V of this Regulation, and the role of personal data in the context of Article 15 of this Regulation, including the evolution of privacy-enhancing technologies;

(b)

the impact of this Regulation on the use of data in the economy, including on data innovation, data monetisation practices and data intermediation services, as well as on data sharing within the common European data spaces;

(c)

the accessibility and use of different categories and types of data;

(d)

the exclusion of certain categories of enterprises as beneficiaries under Article 5;

(e)

the absence of any impact on intellectual property rights;

(f)

the impact on trade_secrets, including on the protection against their unlawful acquisition, use and disclosure, as well as the impact of the mechanism allowing the data holder to refuse the user’s request under Article 4(8) and Article 5(11), taking into account, to the extent possible, any revision of Directive (EU) 2016/943;

(g)

whether the list of unfair contractual terms referred to in Article 13 is up-to-date in light of new business practices and the rapid pace of market innovation;

(h)

changes in the contractual practices of providers of data processing services and whether this results in sufficient compliance with Article 25;

(i)

the diminution of charges imposed by providers of data processing services for the switching process, in line with the gradual withdrawal of switching charges pursuant to Article 29;

(j)

the interplay of this Regulation with other Union legal acts of relevance to the data economy;

(k)

the prevention of unlawful governmental access to non-personal data;

(l)

the efficacy of the enforcement regime required under Article 37;

(m)

the impact of this Regulation on SMEs with regard to their capacity to innovate and to the availability of data processing services for users in the Union and the burden of complying with new obligations.

2.   By 12 September 2028, the Commission shall carry out an evaluation of this Regulation and submit a report on its main findings to the European Parliament and to the Council, and to the European Economic and Social Committee. That evaluation shall assess the impact of Articles 23 to 31 and Articles 34 and 35, in particular regarding pricing and the diversity of data processing services offered within the Union, with a special focus on SME providers.

3.   Member States shall provide the Commission with the information necessary for the preparation of the reports referred to in paragraphs 1 and 2.

4.   On the basis of the reports referred to in paragraphs 1 and 2, the Commission may, where appropriate, submit a legislative proposal to the European Parliament and to the Council to amend this Regulation.


whereas









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