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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 audiovisual recording;

(2)

re-use’ means the use by natural or legal persons of data held by public sector bodies, for commercial or non-commercial purposes other than the initial purpose within the public task for which the data were produced, except for the exchange of data between public sector bodies purely in pursuit of their public tasks;

(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)

consent’ means consent as defined in Article 4, point (11), of Regulation (EU) 2016/679;

(6)

permission’ means giving data users the right to the processing of non-personal data;

(7)

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

(8)

data holder’ means a legal person, including public sector bodies and international organisations, or a natural person who is not a data subject with respect to the specific data in question, which, in accordance with applicable Union or national law, has the right to grant access to or to share certain personal data or non-personal data;

(9)

data user’ means a natural or legal person who has lawful access to certain personal or non-personal data and has the right, including under Regulation (EU) 2016/679 in the case of personal data, to use that data for commercial or non-commercial purposes;

(10)

data sharing’ means the provision of data by a data subject or a data holder to a data user for the purpose of the joint or individual use of such data, based on voluntary agreements or Union or national law, directly or through an intermediary, for example under open or commercial licences subject to a fee or free of charge;

(11)

data intermediation service’ means a service which aims to establish commercial relationships for the purposes of data sharing between an undetermined number of data subjects and data holders on the one hand and data users on the other, through technical, legal or other means, including for the purpose of exercising the rights of data subjects in relation to personal data, excluding at least the following:

(a)

services that obtain data from data holders and aggregate, enrich or transform the data for the purpose of adding substantial value to it and license the use of the resulting data to data users, without establishing a commercial relationship between data holders and data users;

(b)

services that focus on the intermediation of copyright-protected content;

(c)

services that are exclusively used by one data holder in order to enable the use of the data held by that data holder, or that are used by multiple legal persons in a closed group, including supplier or customer relationships or collaborations established by contract, in particular those that have as a main objective to ensure the functionalities of objects and devices connected to the Internet of Things;

(d)

data sharing services offered by public sector bodies that do not aim to establish commercial relationships;

(12)

processing’ means processing as defined in Article 4, point (2), of Regulation (EU) 2016/679 with regard to personal data or Article 3, point (2), of Regulation (EU) 2018/1807 with regard to non-personal data;

(13)

access’ means data use, in accordance with specific technical, legal or organisational requirements, without necessarily implying the transmission or downloading of data;

(14)

main_establishment’ of a legal person means the place of its central administration in the Union;

(15)

‘services of data cooperatives’ means data intermediation services offered by an organisational structure constituted by data subjects, one-person undertakings or SMEs who are members of that structure, having as its main objectives to support its members in the exercise of their rights with respect to certain data, including with regard to making informed choices before they consent to data processing, to exchange views on data processing purposes and conditions that would best represent the interests of its members in relation to their data, and to negotiate terms and conditions for data processing on behalf of its members before giving permission to the processing of non-personal data or before they consent to the processing of personal data;

(16)

data altruism’ means the voluntary sharing of data on the basis of the consent of data subjects to process personal data pertaining to them, or permissions of data holders to allow the use of their non-personal data without seeking or receiving a reward that goes beyond compensation related to the costs that they incur where they make their data available for objectives of general interest as provided for in national law, where applicable, such as healthcare, combating climate change, improving mobility, facilitating the development, production and dissemination of official statistics, improving the provision of public services, public policy making or scientific research purposes in the general interest;

(17)

public_sector_body’ means the State, regional or local authorities, bodies_governed_by_public_law or associations formed by one or more such authorities, or one or more such bodies_governed_by_public_law;

(18)

bodies_governed_by_public_law’ means bodies that have the following characteristics:

(a)

they are established for the specific purpose of meeting needs in the general interest, and do not have an industrial or commercial character;

(b)

they have legal personality;

(c)

they are financed, for the most part, by the State, regional or local authorities, or other bodies_governed_by_public_law, are subject to management supervision by those authorities or bodies, or have an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities, or by other bodies_governed_by_public_law;

(19)

public_undertaking’ means any undertaking over which the public sector bodies may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it; for the purposes of this definition, a dominant influence on the part of the public sector bodies shall be presumed in any of the following cases in which those bodies, directly or indirectly:

(a)

hold the majority of the undertaking’s subscribed capital;

(b)

control the majority of the votes attaching to shares issued by the undertaking;

(c)

can appoint more than half of the undertaking’s administrative, management or supervisory body;

(20)

‘secure processing environment’ means the physical or virtual environment and organisational means to ensure compliance with Union law, such as Regulation (EU) 2016/679, in particular with regard to data subjects’ rights, intellectual property rights, and commercial and statistical confidentiality, integrity and accessibility, as well as with applicable national law, and to allow the entity providing the secure processing environment to determine and supervise all data processing actions, including the display, storage, download and export of data and the calculation of derivative data through computational algorithms;

(21)

legal_representative’ means a natural or legal person established in the Union explicitly designated to act on behalf of a data intermediation services provider or an entity that collects data for objectives of general interest made available by natural or legal persons on the basis of data altruism not established in the Union, which may be addressed by the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations in addition to or instead of the data intermediation services provider or entity with regard to the obligations under this Regulation, including with regard to initiating enforcement proceedings against a non-compliant data intermediation services provider or entity not established in the Union.

CHAPTER II

Re-use of certain categories of protected data held by public sector bodies

Article 4

Prohibition of exclusive arrangements

1.   Agreements or other practices pertaining to the re-use of data held by public sector bodies containing categories of data referred to in Article 3(1) which grant exclusive rights or which have as their objective or effect to grant such exclusive rights or to restrict the availability of data for re-use by entities other than the parties to such agreements or other practices shall be prohibited.

2.   By way of derogation from paragraph 1, an exclusive right to re-use data referred to in that paragraph may be granted to the extent necessary for the provision of a service or the supply of a product in the general interest that would not otherwise be possible.

3.   An exclusive right as referred to in paragraph 2 shall be granted through an administrative act or contractual arrangement in accordance with applicable Union or national law and in compliance with the principles of transparency, equal treatment and non-discrimination.

4.   The duration of an exclusive right to re-use data shall not exceed 12 months. Where a contract is concluded, the duration of the contract shall be the same as the duration of the exclusive right.

5.   The grant of an exclusive right pursuant to paragraphs 2, 3 and 4, including the reasons as to why it is necessary to grant such a right, shall be transparent and be made publicly available online, in a form that complies with relevant Union law on public procurement.

6.   Agreements or other practices falling within the scope of the prohibition referred to in paragraph 1 which do not meet the conditions laid down in paragraphs 2 and 3 and which were concluded before 23 June 2022 shall be terminated at the end of the applicable contract and in any event by 24 December 2024.

Article 12

Conditions for providing data intermediation services

The provision of data intermediation services referred in Article 10 shall be subject to the following conditions:

(a)

the data intermediation services provider shall not use the data for which it provides data intermediation services for purposes other than to put them at the disposal of data users and shall provide data intermediation services through a separate legal person;

(b)

the commercial terms, including pricing, for the provision of data intermediation services to a data holder or data user shall not be dependent upon whether the data holder or data user uses other services provided by the same data intermediation services provider or by a related entity, and if so to what degree the data holder or data user uses such other services;

(c)

the data collected with respect to any activity of a natural or legal person for the purpose of the provision of the data intermediation service, including the date, time and geolocation data, duration of activity and connections to other natural or legal persons established by the person who uses the data intermediation service, shall be used only for the development of that data intermediation service, which may entail the use of data for the detection of fraud or cybersecurity, and shall be made available to the data holders upon request;

(d)

the data intermediation services provider shall facilitate the exchange of the data in the format in which it receives it from a data subject or a data holder, shall convert the data into specific formats only to enhance interoperability within and across sectors or if requested by the data user or where mandated by Union law or to ensure harmonisation with international or European data standards and shall offer an opt-out possibility regarding those conversions to data subjects or data holders, unless the conversion is mandated by Union law;

(e)

data intermediation services may include offering additional specific tools and services to data holders or data subjects for the specific purpose of facilitating the exchange of data, such as temporary storage, curation, conversion, anonymisation and pseudonymisation, such tools being used only at the explicit request or approval of the data holder or data subject and third-party tools offered in that context not being used for other purposes;

(f)

the data intermediation services provider shall ensure that the procedure for access to its service is fair, transparent and non-discriminatory for both data subjects and data holders, as well as for data users, including with regard to prices and terms of service;

(g)

the data intermediation services provider shall have procedures in place to prevent fraudulent or abusive practices in relation to parties seeking access through its data intermediation services;

(h)

the data intermediation services provider shall, in the event of its insolvency, ensure a reasonable continuity of the provision of its data intermediation services and, where such data intermediation services ensure the storage of data, shall have mechanisms in place to allow data holders and data users to obtain access to, to transfer or to retrieve their data and, where such data intermediation services are provided between data subjects and data users, to allow data subjects to exercise their rights;

(i)

the data intermediation services provider shall take appropriate measures to ensure interoperability with other data intermediation services, inter alia, by means of commonly used open standards in the sector in which the data intermediation services provider operates;

(j)

the data intermediation services provider shall put in place adequate technical, legal and organisational measures in order to prevent the transfer of or access to non-personal data that is unlawful under Union law or the national law of the relevant Member State;

(k)

the data intermediation services provider shall without delay inform data holders in the event of an unauthorised transfer, access or use of the non-personal data that it has shared;

(l)

the data intermediation services provider shall take necessary measures to ensure an appropriate level of security for the storage, processing and transmission of non-personal data, and the data intermediation services provider shall further ensure the highest level of security for the storage and transmission of competitively sensitive information;

(m)

the data intermediation services provider offering services to data subjects shall act in the data subjects’ best interest where it facilitates the exercise of their rights, in particular by informing and, where appropriate, advising data subjects in a concise, transparent, intelligible and easily accessible manner about intended data uses by data users and standard terms and conditions attached to such uses before data subjects give consent;

(n)

where a data intermediation services provider provides tools for obtaining consent from data subjects or permissions to process data made available by data holders, it shall, where relevant, specify the third-country jurisdiction in which the data use is intended to take place and provide data subjects with tools to both give and withdraw consent and data holders with tools to both give and withdraw permissions to process data;

(o)

the data intermediation services provider shall maintain a log record of the data intermediation activity.

Article 22

Rulebook

1.   The Commission shall adopt delegated acts in accordance with Article 32, supplementing this Regulation by establishing a rulebook laying down:

(a)

appropriate information requirements to ensure that data subjects and data holders are provided, before a consent or permission for data altruism is given, with sufficiently detailed, clear and transparent information regarding the use of data, the tools for giving and withdrawing consent or permission, and the measures taken to avoid misuse of the data shared with the data altruism organisation;

(b)

appropriate technical and security requirements to ensure the appropriate level of security for the storage and processing of data, as well as for the tools for giving and withdrawing consent or permission;

(c)

communication roadmaps taking a multi-disciplinary approach to raise awareness of data altruism, of the designation as a ‘ data altruism organisation recognised in the Union’ and of the rulebook among relevant stakeholders, in particular data holders and data subjects that would potentially share their data;

(d)

recommendations on relevant interoperability standards.

2.   The rulebook referred to in paragraph 1 shall be prepared in close cooperation with data altruism organisations and relevant stakeholders.

Article 28

Right to an effective judicial remedy

1.   Notwithstanding any administrative or other non-judicial remedies, any affected natural and legal persons shall have the right to an effective judicial remedy with regard to legally binding decisions referred to in Article 14 taken by the competent authorities for data intermediation services in the management, control and enforcement of the notification regime for data intermediation services providers and legally binding decisions referred to in Articles 19 and 24 taken by the competent authorities for the registration of data altruism organisations in the monitoring of recognised data altruism organisations.

2.   Proceedings pursuant to this Article shall be brought before the courts or tribunals of the Member State of the competent authority for data intermediation services or the competent authority for the registration of data altruism organisations against which the judicial remedy is sought individually or, where relevant, collectively by the representatives of one or more natural or legal persons.

3.   Where a competent authority for data intermediation services or a competent authority for the registration of data altruism organisations fails to act on a complaint, any affected natural and legal persons shall, in accordance with national law, either have the right to an effective judicial remedy or access to review by an impartial body with the appropriate expertise.

CHAPTER VI

European Data Innovation Board

Article 31

International access and transfer

1.   The public_sector_body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider or the recognised data altruism organisation shall take all reasonable technical, legal and organisational measures, including contractual arrangements, in order to prevent international transfer or governmental access to non-personal data held in the Union where such transfer or access would create a conflict with Union law or the national law of the relevant Member State, without prejudice to paragraph 2 or 3.

2.   Any decision or judgment of a third-country court or tribunal and any decision of a third-country administrative authority requiring a public_sector_body, a natural or legal person to which the right to re-use data was granted under Chapter II, a data intermediation services provider or recognised data altruism organisation to transfer or give access to non-personal data within the scope of this Regulation held in the Union shall be recognised or enforceable in any manner only if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or any such agreement between the requesting third country and a Member State.

3.   In the absence of an international agreement as referred to in paragraph 2 of this Article, where a public_sector_body, a natural or legal person to which the right to re-use data was granted under Chapter II, a data intermediation services provider or recognised data altruism organisation is the addressee of a decision or judgment of a third-country court or tribunal or a decision of a third-country administrative authority to transfer or give access to non-personal data within the scope of this Regulation held in the Union and compliance with such a decision would risk putting the addressee in conflict with Union law or with the national law of the relevant Member State, transfer to or access to such data by that third-country authority shall take place only where:

(a)

the third-country system requires the reasons and proportionality of such a decision or judgment to be set out and requires such a decision or judgment to be specific in character, for instance by establishing a sufficient link to certain suspected persons or infringements;

(b)

the reasoned objection of the addressee is subject to a review by a competent third-country court or tribunal; and

(c)

the competent third-country court or tribunal issuing the decision or judgment or reviewing the decision of an administrative authority is empowered under the law of that third country to take duly into account the relevant legal interests of the provider of the data protected under Union law or the national law of the relevant Member State.

4.   If the conditions laid down in paragraph 2 or 3 are met, the public_sector_body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider or the recognised data altruism organisation shall provide the minimum amount of data permissible in response to a request, based on a reasonable interpretation of the request.

5.   The public_sector_body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider and the recognised data altruism organisation shall inform the data holder about the existence of a request of a third-country administrative authority to access its data before complying with that request, except where the request serves law enforcement purposes and for as long as this is necessary to preserve the effectiveness of the law enforcement activity.

CHAPTER VIII

Delegation and committee procedure

Article 32

Exercise of the delegation

1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.   The power to adopt delegated acts referred to in Article 5(13) and Article 22(1) shall be conferred on the Commission for an indeterminate period of time from 23 June 2022.

3.   The delegation of power referred to in Article 5(13) and Article 22(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.   before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.   A delegated act adopted pursuant to Article 5(13) or Article 22(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.


whereas









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