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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 13

Unfair contractual terms unilaterally imposed on another enterprise

1.   A contractual term concerning access to and the use of data or liability and remedies for the breach or the termination of data related obligations, which has been unilaterally imposed by an enterprise on another enterprise, shall not be binding on the latter enterprise if it is unfair.

2.   A contractual term which reflects mandatory provisions of Union law, or provisions of Union law which would apply if the contractual terms did not regulate the matter, shall not be considered to be unfair.

3.   A contractual term is unfair if it is of such a nature that its use grossly deviates from good commercial practice in data access and use, contrary to good faith and fair dealing.

4.   In particular, a contractual term shall be unfair for the purposes of paragraph 3, if its object or effect is to:

(a)

exclude or limit the liability of the party that unilaterally imposed the term for intentional acts or gross negligence;

(b)

exclude the remedies available to the party upon whom the term has been unilaterally imposed in the case of non-performance of contractual obligations, or the liability of the party that unilaterally imposed the term in the case of a breach of those obligations;

(c)

give the party that unilaterally imposed the term the exclusive right to determine whether the data supplied are in conformity with the contract or to interpret any contractual term.

5.   A contractual term shall be presumed to be unfair for the purposes of paragraph 3 if its object or effect is to:

(a)

inappropriately limit remedies in the case of non-performance of contractual obligations or liability in the case of a breach of those obligations, or extend the liability of the enterprise upon whom the term has been unilaterally imposed;

(b)

allow the party that unilaterally imposed the term to access and use the data of the other contracting party in a manner that is significantly detrimental to the legitimate interests of the other contracting party, in particular when such data contain commercially sensitive data or are protected by trade_secrets or by intellectual property rights;

(c)

prevent the party upon whom the term has been unilaterally imposed from using the data provided or generated by that party during the period of the contract, or to limit the use of such data to the extent that that party is not entitled to use, capture, access or control such data or exploit the value of such data in an adequate manner;

(d)

prevent the party upon whom the term has been unilaterally imposed from terminating the agreement within a reasonable period;

(e)

prevent the party upon whom the term has been unilaterally imposed from obtaining a copy of the data provided or generated by that party during the period of the contract or within a reasonable period after the termination thereof;

(f)

enable the party that unilaterally imposed the term to terminate the contract at unreasonably short notice, taking into consideration any reasonable possibility of the other contracting party to switch to an alternative and comparable service and the financial detriment caused by such termination, except where there are serious grounds for so doing;

(g)

enable the party that unilaterally imposed the term to substantially change the price specified in the contract or any other substantive condition related to the nature, format, quality or quantity of the data to be shared, where no valid reason and no right of the other party to terminate the contract in the case of such a change is specified in the contract.

Point (g) of the first subparagraph shall not affect terms by which the party that unilaterally imposed the term reserves the right to unilaterally change the terms of a contract of an indeterminate duration, provided that the contract specified a valid reason for such unilateral changes, that the party that unilaterally imposed the term is required to provide the other contracting party with reasonable notice of any such intended change, and that the other contracting party is free to terminate the contract at no cost in the case of a change.

6.   A contractual term shall be considered to be unilaterally imposed within the meaning of this Article if it has been supplied by one contracting party and the other contracting party has not been able to influence its content despite an attempt to negotiate it. The contracting party that supplied the contractual term bears the burden of proving that that term has not been unilaterally imposed. The contracting party that supplied the contested contractual term may not argue that the term is an unfair contractual term.

7.   Where the unfair contractual term is severable from the remaining terms of the contract, those remaining terms shall be binding.

8.   This Article does not apply to contractual terms defining the main subject matter of the contract or to the adequacy of the price, as against the data supplied in exchange.

9.   The parties to a contract covered by paragraph 1 shall not exclude the application of this Article, derogate from it, or vary its effects.

CHAPTER V

MAKING DATA AVAILABLE TO PUBLIC SECTOR BODIES, THE COMMISSION, THE EUROPEAN CENTRAL BANK AND UNION BODIES ON THE BASIS OF AN EXCEPTIONAL NEED

Article 17

Requests for data to be made available

1.   When requesting data pursuant to Article 14, a public_sector_body, the Commission, the European Central Bank or a Union body shall:

(a)

specify the data required, including the relevant meta data necessary to interpret and use those data;

(b)

demonstrate that the conditions necessary for the existence of an exceptional need as referred to in Article 15 for the purpose of which the data are requested are met;

(c)

explain the purpose of the request, the intended use of the data requested, including, where applicable, by a third party in accordance with paragraph 4 of this Article, the duration of that use, and, where relevant, how the processing of personal data is to address the exceptional need;

(d)

specify, if possible, when the data are expected to be erased by all parties that have access to them;

(e)

justify the choice of data holder to which the request is addressed;

(f)

specify any other public sector bodies or the Commission, European Central Bank or Union_bodies and the third parties with which the data requested is expected to be shared with;

(g)

where personal data are requested, specify any technical and organisational measures necessary and proportionate to implement data protection principles and necessary safeguards, such as pseudonymisation, and whether anonymisation can be applied by the data holder before making the data available;

(h)

state the legal provision allocating to the requesting public_sector_body, the Commission, the European Central Bank or the Union body the specific task carried out in the public interest relevant for requesting the data;

(i)

specify the deadline by which the data are to be made available and the deadline referred to in Article 18(2) by which the data holder may decline or seek modification of the request;

(j)

make its best efforts to avoid compliance with the data request resulting in the data holders’ liability for infringement of Union or national law.

2.   A request for data made pursuant to paragraph 1 of this Article shall:

(a)

be made in writing and expressed in clear, concise and plain language understandable to the data holder;

(b)

be specific regarding the type of data requested and correspond to data which the data holder has control over at the time of the request;

(c)

be proportionate to the exceptional need and duly justified, regarding the granularity and volume of the data requested and frequency of access of the data requested;

(d)

respect the legitimate aims of the data holder, committing to ensuring the protection of trade_secrets in accordance with Article 19(3), and the cost and effort required to make the data available;

(e)

concern non-personal data, and only if this is demonstrated to be insufficient to respond to the exceptional need to use data, in accordance with Article 15(1), point (a), request personal data in pseudonymised form and establish the technical and organisational measures that are to be taken to protect the data;

(f)

inform the data holder of the penalties that are to be imposed pursuant to Article 40 by the competent authority designated pursuant to Article 37 in the event of non-compliance with the request;

(g)

where the request is made by a public_sector_body, be transmitted to the data coordinator referred to in Article 37 of the Member State where the requesting public_sector_body is established, who shall make the request publicly available online without undue delay unless the data coordinator considers that such publication would create a risk for public security;

(h)

where the request is made by the Commission, the European Central Bank or a Union body, be made available online without undue delay;

(i)

where personal data are requested, be notified without undue delay to the supervisory authority responsible for monitoring the application of Regulation (EU) 2016/679 in the Member State where the public_sector_body is established.

The European Central Bank and Union_bodies shall inform the Commission of their requests.

3.   A public_sector_body, the Commission, the European Central Bank or a Union body shall not make data obtained pursuant to this Chapter available for reuse as defined in Article 2, point (2), of Regulation (EU) 2022/868 or Article 2, point (11), of Directive (EU) 2019/1024. Regulation (EU) 2022/868 and Directive (EU) 2019/1024 shall not apply to the data held by public sector bodies obtained pursuant to this Chapter.

4.   Paragraph 3 of this Article does not preclude a public_sector_body, the Commission, the European Central Bank or a Union body to exchange data obtained pursuant to this Chapter with another public_sector_body or the Commission, the European Central Bank or a Union body in view of completing the tasks referred to in Article 15, as specified in the request in accordance with paragraph 1, point (f), of this Article or to make the data available to a third party where it has delegated, by means of a publicly available agreement, technical inspections or other functions to that third party. The obligations on public sector bodies pursuant to Article 19, in particular safeguards to preserve the confidentiality of trade_secrets, shall apply also to such third parties. Where a public_sector_body, the Commission, the European Central Bank or a Union body transmits or makes data available under this paragraph, it shall notify the data holder from whom the data was received without undue delay.

5.   Where the data holder considers that its rights under this Chapter have been infringed by the transmission or making available of data, it may lodge a complaint with the competent authority designated pursuant to Article 37 of the Member State where the data holder is established.

6.   The Commission shall develop a model template for requests pursuant to this Article.

Article 19

Obligations of public sector bodies, the Commission, the European Central Bank and Union_bodies

1.   A public_sector_body, the Commission, the European Central Bank or a Union body receiving data pursuant to a request made under Article 14 shall:

(a)

not use the data in a manner incompatible with the purpose for which they were requested;

(b)

have implemented technical and organisational measures that preserve the confidentiality and integrity of the requested data and the security of the data transfers, in particular personal data, and safeguard the rights and freedoms of data subjects;

(c)

erase the data as soon as they are no longer necessary for the stated purpose and inform the data holder and individuals or organisations that received the data pursuant to Article 21(1) without undue delay that the data have been erased, unless archiving of the data is required in accordance with Union or national law on public access to documents in the context of transparency obligations.

2.   A public_sector_body, the Commission, the European Central Bank, a Union body or a third party receiving data under this Chapter shall not:

(a)

use the data or insights about the economic situation, assets and production or operation methods of the data holder to develop or enhance a connected_product or related_service that competes with the connected_product or related_service of the data holder;

(b)

share the data with another third party for any of the purposes referred to in point (a).

3.   Disclosure of trade_secrets to a public_sector_body, the Commission, the European Central Bank or a Union body shall be required only to the extent that it is strictly necessary to achieve the purpose of a request under Article 15. In such a case, 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. The public_sector_body, the Commission, the European Central Bank or the Union body shall, prior to the disclosure of trade_secrets, take all necessary and appropriate technical and organisational measures to preserve the confidentiality of the trade_secrets, including, as appropriate, the use of model contractual terms, technical standards and the application of codes of conduct.

4.   A public_sector_body, the Commission, the European Central Bank or a Union body shall be responsible for the security of the data it receives.

Article 21

Sharing of data obtained in the context of an exceptional need with research organisations or statistical bodies

1.   A public_sector_body, the Commission, the European Central Bank or a Union body shall be entitled to share data received under this Chapter:

(a)

with individuals or organisations in view of carrying out scientific research or analytics compatible with the purpose for which the data was requested; or

(b)

with national statistical institutes and Eurostat for the production of official statistics.

2.   Individuals or organisations receiving the data pursuant to paragraph 1 shall act on a not-for-profit basis or in the context of a public-interest mission recognised in Union or national law. They shall not include organisations upon which commercial undertakings have a significant influence which is likely to result in preferential access to the results of the research.

3.   Individuals or organisations receiving the data pursuant to paragraph 1 of this Article shall comply with the same obligations that are applicable to the public sector bodies, the Commission, the European Central Bank or Union_bodies pursuant to Article 17(3) and Article 19.

4.   Notwithstanding Article 19(1), point (c), individuals or organisations receiving the data pursuant to paragraph 1 of this Article may keep the data received for the purpose for which the data was requested for up to six months following erasure of the data by the public sector bodies, the Commission, the European Central Bank and Union_bodies.

5.   Where a public_sector_body, the Commission, the European Central Bank or a Union body intends to transmit or make data available under paragraph 1 of this Article, it shall notify without undue delay the data holder from whom the data was received, stating the identity and contact details of the organisation or the individual receiving the data, the purpose of the transmission or making available of the data, the period for which the data is to be used and the technical protection and organisational measures taken, including where personal data or trade_secrets are involved. Where the data holder disagrees with the transmission or making available of data, it may lodge a complaint with the competent authority designated pursuant to Article 37 of the Member State where the data holder is established.

Article 33

Essential requirements regarding interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces

1.   Participants in data spaces that offer data or data services to other participants shall comply with the following essential requirements to facilitate the interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces which are purpose- or sector-specific or cross-sectoral interoperable frameworks for common standards and practices to share or jointly process data for, inter alia, the development of new products and services, scientific research or civil society initiatives:

(a)

the dataset content, use restrictions, licences, data collection methodology, data quality and uncertainty shall be sufficiently described, where applicable, in a machine-readable format, to allow the recipient to find, access and use the data;

(b)

the data structures, data formats, vocabularies, classification schemes, taxonomies and code lists, where available, shall be described in a publicly available and consistent manner;

(c)

the technical means to access the data, such as application programming interfaces, and their terms of use and quality of service shall be sufficiently described to enable automatic access and transmission of data between parties, including continuously, in bulk download or in real-time in a machine-readable format where that is technically feasible and does not hamper the good functioning of the connected_product;

(d)

where applicable, the means to enable the interoperability of tools for automating the execution of data sharing agreements, such as smart_contracts shall be provided.

The requirements can have a generic nature or concern specific sectors, while taking fully into account the interrelation with requirements arising from other Union or national law.

2.   The Commission is empowered to adopt delegated acts, in accordance with Article 45 of this Regulation to supplement this Regulation by further specifying the essential requirements laid down in paragraph 1 of this Article, in relation to those requirements that, by their nature, cannot produce the intended effect unless they are further specified in binding Union legal acts and in order to properly reflect technological and market developments.

The Commission shall when adopting delegated acts take into account the advice of the EDIB in accordance with Article 42, point (c)(iii).

3.   The participants in data spaces that offer data or data services to other participants in data spaces which meet the harmonised_standards or parts thereof, the references of which are published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such harmonised_standards or parts thereof.

4.   The Commission shall, pursuant to Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised_standards that satisfy the essential requirements laid down in paragraph 1 of this Article.

5.   The Commission may, by means of implementing acts, adopt common_specifications covering any or all of the essential requirements laid down in paragraph 1 where the following conditions have been fulfilled:

(a)

the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised_standard that satisfies the essential requirements laid down in paragraph 1 of this Article and:

(i)

the request has not been accepted;

(ii)

the harmonised_standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or

(iii)

the harmonised_standards do not comply with the request; and

(b)

no reference to harmonised_standards covering the relevant essential requirements laid down in paragraph 1 of this Article is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(2).

6.   Before preparing a draft implementing act referred to in paragraph 5 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 5 of this Article have been fulfilled.

7.   When preparing the draft implementing act referred to in paragraph 5, the Commission shall take into account the advice of the EDIB and views of other relevant bodies or expert groups and shall duly consult all relevant stakeholders.

8.   The participants in data spaces that offer data or data services to other participants in data spaces that meet the common_specifications established by implementing acts referred to in paragraph 5 or parts thereof shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such common_specifications or parts thereof.

9.   Where a harmonised_standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the harmonised_standard in accordance with Regulation (EU) No 1025/2012. Where the reference of a harmonised_standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 5 of this Article, or parts thereof which cover the same essential requirements as those covered by that harmonised_standard.

10.   When a Member State considers that a common specification does not entirely satisfy the essential requirements laid down in paragraph 1, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

11.   The Commission may adopt guidelines taking into account the proposal of the EDIB in accordance with Article 30, point (h), of Regulation (EU) 2022/868 laying down interoperable frameworks for common standards and practices for the functioning of common European data spaces.


whereas









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