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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 9

Procedure for requests for re-use

1.   Unless shorter time limits have been established in accordance with national law, the competent public sector bodies or the competent bodies referred to in Article 7(1) shall adopt a decision on the request for the re-use of the categories of data referred to in Article 3(1) within two months of the date of receipt of the request.

In the case of exceptionally extensive and complex requests for re-use, that two-month period may be extended by up to 30 days. In such cases the competent public sector bodies or the competent bodies referred to in Article 7(1) shall notify the applicant as soon as possible that more time is needed for conducting the procedure, together with the reasons for the delay.

2.   Any natural or legal person directly affected by a decision as referred to in paragraph 1 shall have an effective right of redress in the Member State where the relevant body is located. Such a right of redress shall be laid down in national law and shall include the possibility of review by an impartial body with the appropriate expertise, such as the national competition authority, the relevant access-to-documents authority, the supervisory authority established in accordance with Regulation (EU) 2016/679 or a national judicial authority, whose decisions are binding upon the public_sector_body or the competent body concerned.

CHAPTER III

Requirements applicable to data intermediation services

Article 11

Notification by data intermediation services providers

1.   Any data intermediation services provider who intends to provide the data intermediation services referred to in Article 10 shall submit a notification to the competent authority for data intermediation services.

2.   For the purposes of this Regulation, a data intermediation services provider with establishments in more than one Member State shall be deemed to be under the jurisdiction of the Member State in which it has its main_establishment, without prejudice to Union law regulating cross-border actions for damages and related proceedings.

3.   A data intermediation services provider that is not established in the Union, but which offers the data intermediation services referred to in Article 10 within the Union, shall designate a legal_representative in one of the Member States in which those services are offered.

For the purpose of ensuring compliance with this Regulation, the legal_representative shall be mandated by the data intermediation services provider to be addressed in addition to or instead of it by competent authorities for data intermediation services or data subjects and data holders, with regard to all issues related to the data intermediation services provided. The legal_representative shall cooperate with and comprehensively demonstrate to the competent authorities for data intermediation services, upon request, the actions taken and provisions put in place by the data intermediation services provider to ensure compliance with this Regulation.

The data intermediation services provider shall be deemed to be under the jurisdiction of the Member State in which the legal_representative is located. The designation of a legal_representative by the data intermediation services provider shall be without prejudice to any legal actions which could be initiated against the data intermediation services provider.

4.   After having submitted a notification in accordance with paragraph 1, the data intermediation services provider may start the activity subject to the conditions laid down in this Chapter.

5.   The notification referred to in paragraph 1 shall entitle the data intermediation services provider to provide data intermediation services in all Member States.

6.   The notification referred to in paragraph 1 shall include the following information:

(a)

the name of the data intermediation services provider;

(b)

the data intermediation services provider’s legal status, form, ownership structure, relevant subsidiaries and, where the data intermediation services provider is registered in a trade or other similar public national register, registration number;

(c)

the address of the data intermediation services provider’s main_establishment in the Union, if any, and, where applicable, of any secondary branch in another Member State or that of the legal_representative;

(d)

a public website where complete and up-to-date information on the data intermediation services provider and the activities can be found, including as a minimum the information referred to in points (a), (b), (c) and (f);

(e)

the data intermediation services provider’s contact persons and contact details;

(f)

a description of the data intermediation service the data intermediation services provider intends to provide, and an indication of the categories listed in Article 10 under which such data intermediation service falls;

(g)

the estimated date for starting the activity, if different from the date of the notification.

7.   The competent authority for data intermediation services shall ensure that the notification procedure is non-discriminatory and does not distort the competition.

8.   At the request of the data intermediation services provider, the competent authority for data intermediation services shall, within one week of a duly and fully completed notification, issue a standardised declaration, confirming that the data intermediation services provider has submitted the notification referred to in paragraph 1 and that the notification contains the information referred to in paragraph 6.

9.   At the request of the data intermediation services provider, the competent authority for data intermediation services shall confirm that the data intermediation services provider complies with this Article and Article 12. Upon receipt of such a confirmation, that data intermediation services provider may use the label ‘ data intermediation services provider recognised in the Union’ in its written and spoken communication, as well as a common logo.

In order to ensure that data intermediation services providers recognised in the Union are easily identifiable throughout the Union, the Commission shall, by means of implementing acts, establish a design for the common logo. Data intermediation services providers recognised in the Union shall display the common logo clearly on every online and offline publication that relates to their data intermediation activities.

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 33(2).

10.   The competent authority for data intermediation services shall notify the Commission of each new notification by electronic means without delay. The Commission shall keep and regularly update a public register of all data intermediation services providers providing their services in the Union. The information referred to in paragraph 6, points (a), (b), (c), (d), (f) and (g), shall be published in the public register.

11.   The competent authority for data intermediation services may charge fees for the notification in accordance with national law. Such fees shall be proportionate and objective and be based on the administrative costs related to the monitoring of compliance and other market control activities of the competent authority for data intermediation services in relation to notifications of data intermediation services providers. In the case of SMEs and start-ups, the competent authority for data intermediation services may charge a discounted fee or waive the fee.

12.   Data intermediation services providers shall notify the competent authority for data intermediation services of any changes to the information provided pursuant to paragraph 6 within 14 days of the date of the change.

13.   Where a data intermediation services provider ceases its activities, it shall notify the relevant competent authority for data intermediation services determined pursuant to paragraphs 1, 2 and 3 within 15 days.

14.   The competent authority for data intermediation services shall notify the Commission of each notification referred to in paragraphs 12 and 13 by electronic means without delay. The Commission shall update the public register of the data intermediation services providers in the Union accordingly.

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 14

Monitoring of compliance

1.   The competent authorities for data intermediation services shall monitor and supervise compliance of data intermediation services providers with the requirements of this Chapter. The competent authorities for data intermediation services may also monitor and supervise the compliance of data intermediation services providers, on the basis of a request by a natural or legal person.

2.   The competent authorities for data intermediation services shall have the power to request from data intermediation services providers or their legal_representatives all the information that is necessary to verify compliance with the requirements of this Chapter. Any request for information shall be proportionate to the performance of the task and shall be reasoned.

3.   Where the competent authority for data intermediation services finds that a data intermediation services provider does not comply with one or more of the requirements of this Chapter, it shall notify that data intermediation services provider of those findings and give it the opportunity to state its views, within 30 days of the receipt of the notification.

4.   The competent authority for data intermediation services shall have the power to require the cessation of the infringement referred to in paragraph 3 within a reasonable time limit or immediately in the case of a serious infringement and shall take appropriate and proportionate measures with the aim of ensuring compliance. In that regard, the competent authority for data intermediation services shall have the power, where appropriate:

(a)

to impose, through administrative procedures, dissuasive financial penalties, which may include periodic penalties and penalties with retroactive effect, to initiate legal proceedings for the imposition of fines, or both;

(b)

to require a postponement of the commencement or a suspension of the provision of the data intermediation service until any changes to the conditions requested by the competent authority for data intermediation services have been made; or

(c)

to require the cessation of the provision of the data intermediation service in the event that serious or repeated infringements have not been remedied despite prior notification in accordance with paragraph 3.

The competent authority for data intermediation services shall request the Commission to remove the data intermediation services provider from the register of data intermediation services providers once it has ordered the cessation of the provision of the data intermediation service in accordance with the first subparagraph, point (c).

If a data intermediation services provider remedies infringements, that data intermediation services provider shall re-notify the competent authority for data intermediation services. The competent authority for data intermediation services shall notify the Commission of each new re-notification.

5.   Where a data intermediation services provider that is not established in the Union fails to designate a legal_representative or the legal_representative fails, upon request of the competent authority for data intermediation services, to provide the necessary information that comprehensively demonstrates compliance with this Regulation, the competent authority for data intermediation services shall have the power to postpone the commencement of or to suspend the provision of the data intermediation service until the legal_representative is designated or the necessary information is provided.

6.   The competent authorities for data intermediation services shall notify the data intermediation services provider concerned of the measures imposed pursuant to paragraphs 4 and 5 and the reasons on which they are based, as well as the necessary steps to be taken to rectify the relevant shortcomings, without delay, and shall stipulate a reasonable period, which shall not be longer than 30 days, for the data intermediation services provider to comply with those measures.

7.   If a data intermediation services provider has its main_establishment or its legal_representative in a Member State but provides services in other Member States, the competent authority for data intermediation services of the Member State of the main_establishment or where the legal_representative is located and the competent authorities for data intermediation services of those other Member States shall cooperate and assist each other. Such assistance and cooperation may cover information exchanges between the competent authorities for data intermediation services concerned for the purposes of their tasks under this Regulation and reasoned requests to take the measures referred to in this Article.

Where a competent authority for data intermediation services in one Member State requests assistance from a competent authority for data intermediation services in another Member State, it shall submit a reasoned request. The competent authority for data intermediation services shall, upon such a request, provide a response without delay and within a timeframe proportionate to the urgency of the request.

Any information exchanged in the context of assistance requested and provided under this paragraph shall be used only in respect of the matter for which it was requested.

Article 18

General requirements for registration

In order to qualify for registration in a public national register of recognised data altruism organisations, an entity shall:

(a)

carry out data altruism activities;

(b)

be a legal person established pursuant to national law to meet objectives of general interest as provided for in national law, where applicable;

(c)

operate on a not-for-profit basis and be legally independent from any entity that operates on a for-profit basis;

(d)

carry out its data altruism activities through a structure that is functionally separate from its other activities;

(e)

comply with the rulebook referred to Article 22(1), at the latest 18 months after the date of entry into force of the delegated acts referred to in that paragraph.

Article 19

Registration of recognised data altruism organisations

1.   An entity which meets the requirements of Article 18 may submit an application for registration in the public national register of recognised data altruism organisations in the Member State in which it is established.

2.   An entity which meets the requirements of Article 18 and has establishments in more than one Member State may submit an application for registration in the public national register of recognised data altruism organisations in the Member State in which it has its main_establishment.

3.   An entity which meets the requirements of Article 18 but which is not established in the Union shall designate a legal_representative in one of the Member States in which the data altruism services are offered.

For the purpose of ensuring compliance with this Regulation, the legal_representative shall be mandated by the entity to be addressed in addition to or instead of it by competent authorities for the registration of data altruism organisations or data subjects and data holders, with regard to all issues related to that entity. The legal_representative shall cooperate with and comprehensively demonstrate to the competent authorities for the registration of data altruism organisations, upon request, the actions taken and provisions put in place by the entity to ensure compliance with this Regulation.

The entity shall be deemed to be under the jurisdiction of the Member State in which the legal_representative is located. Such an entity may submit an application for registration in the public national register of recognised data altruism organisations in that Member State. The designation of a legal_representative by the entity shall be without prejudice to any legal actions which could be initiated against the entity.

4.   Applications for registration referred to in paragraphs 1, 2 and 3 shall contain the following information:

(a)

the name of the entity;

(b)

the entity’s legal status, form and, where the entity is registered in a public national register, registration number;

(c)

the statutes of the entity, where appropriate;

(d)

the entity’s sources of income;

(e)

the address of the entity’s main_establishment in the Union, if any, and, where applicable, any secondary branch in another Member State or that of the legal_representative;

(f)

a public website where complete and up-to-date information on the entity and the activities can be found, including as a minimum the information referred to in points (a), (b), (d), (e) and (h);

(g)

the entity’s contact persons and contact details;

(h)

the objectives of general interest it intends to promote when collecting data;

(i)

the nature of the data that the entity intends to control or process, and, in the case of personal data, an indication of the categories of personal data;

(j)

any other documents which demonstrate that the requirements of Article 18 are met.

5.   Where the entity has submitted all necessary information pursuant to paragraph 4 and after the competent authority for the registration of data altruism organisations has evaluated the application for registration and found that the entity complies with the requirements of Article 18, it shall register the entity in the public national register of recognised data altruism organisations within 12 weeks after the receipt of the application for registration. The registration shall be valid in all Member States.

The competent authority for the registration of data altruism organisations shall notify the Commission of any registration. The Commission shall include that registration in the public Union register of recognised data altruism organisations.

6.   The information referred to in paragraph 4, points (a), (b), (f), (g) and (h), shall be published in the relevant public national register of recognised data altruism organisations.

7.   A recognised data altruism organisation shall notify the relevant competent authority for the registration of data altruism organisations of any changes to the information provided pursuant to paragraph 4 within 14 days of the date of the change.

The competent authority for the registration of data altruism organisations shall notify the Commission of each such notification by electronic means without delay. Based on such a notification, the Commission shall update the public Union register of recognised data altruism organisations without delay.

Article 34

Penalties

1.   Member States shall lay down the rules on penalties applicable to infringements of the obligations regarding transfers of non-personal data to third countries pursuant to Article 5(14) and Article 31, the notification obligation of data intermediation services providers pursuant to Article 11, the conditions for providing data intermediation services pursuant to Article 12 and the conditions for the registration as a recognised data altruism organisation pursuant to Articles 18, 20, 21 and 22, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. In their rules on penalties, Member States shall take into account the recommendations of the European Data Innovation Board. Member States shall, by 24 September 2023, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

2.   Member States shall take into account the following non-exhaustive and indicative criteria for the imposition of penalties on data intermediation services providers and recognised data altruism organisations for infringements of this Regulation, where appropriate:

(a)

the nature, gravity, scale and duration of the infringement;

(b)

any action taken by the data intermediation services provider or recognised data altruism organisation to mitigate or remedy the damage caused by the infringement;

(c)

any previous infringements by the data intermediation services provider or recognised data altruism organisation;

(d)

the financial benefits gained or losses avoided by the data intermediation services provider or recognised data altruism organisation due to the infringement, insofar as such benefits or losses can be reliably established;

(e)

any other aggravating or mitigating factors applicable to the circumstances of the case.

Article 35

Evaluation and review

By 24 September 2025, 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 as well as to the European Economic and Social Committee. The report shall be accompanied, where necessary, by legislative proposals.

The report shall assess, in particular:

(a)

the application and functioning of the rules on penalties laid down by the Member States pursuant to Article 34;

(b)

the level of compliance of the legal_representatives of data intermediation services providers and recognised data altruism organisations that are not established in the Union with this Regulation and the level of enforceability of penalties imposed on those providers and organisations;

(c)

the type of data altruism organisations registered under Chapter IV and an overview of the objectives of general interests for which data are shared in view of establishing clear criteria in that respect.

Member States shall provide the Commission with the information necessary for the preparation of that report.


whereas









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