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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 5

Conditions for re-use

1.   Public sector bodies which are competent under national law to grant or refuse access for the re-use of one or more of the categories of data referred to in Article 3(1) shall make publicly available the conditions for allowing such re-use and the procedure to request the re-use via the single information point referred to in Article 8. Where they grant or refuse access for re-use, they may be assisted by the competent bodies referred to in Article 7(1).

Member States shall ensure that public sector bodies are equipped with the necessary resources to comply with this Article.

2.   Conditions for re-use shall be non-discriminatory, transparent, proportionate and objectively justified with regard to the categories of data and the purposes of re-use and the nature of the data for which re-use is allowed. Those conditions shall not be used to restrict competition.

3.   Public sector bodies shall, in accordance with Union and national law, ensure that the protected nature of data is preserved. They may provide for the following requirements:

(a)

to grant access for the re-use of data only where the public_sector_body or the competent body, following the request for re-use, has ensured that data has been:

(i)

anonymised, in the case of personal data; and

(ii)

modified, aggregated or treated by any other method of disclosure control, in the case of commercially confidential information, including trade secrets or content protected by intellectual property rights;

(b)

to access and re-use the data remotely within a secure processing environment that is provided or controlled by the public_sector_body;

(c)

to access and re-use the data within the physical premises in which the secure processing environment is located in accordance with high security standards, provided that remote access cannot be allowed without jeopardising the rights and interests of third parties.

4.   In the case of re-use allowed in accordance with paragraph 3, points (b) and (c), the public sector bodies shall impose conditions that preserve the integrity of the functioning of the technical systems of the secure processing environment used. The public_sector_body shall reserve the right to verify the process, the means and any results of processing of data undertaken by the re-user to preserve the integrity of the protection of the data and reserve the right to prohibit the use of results that contain information jeopardising the rights and interests of third parties. The decision to prohibit the use of the results shall be comprehensible and transparent to the re-user.

5.   Unless national law provides for specific safeguards on applicable confidentiality obligations relating to the re-use of data referred to in Article 3(1), the public_sector_body shall make the re-use of data provided in accordance with paragraph 3 of this Article conditional on the adherence by the re-user to a confidentiality obligation that prohibits the disclosure of any information that jeopardises the rights and interests of third parties that the re-user may have acquired despite the safeguards put in place. Re-users shall be prohibited from re-identifying any data subject to whom the data relates and shall take technical and operational measures to prevent re-identification and to notify any data breach resulting in the re-identification of the data subjects concerned to the public_sector_body. In the event of the unauthorised re-use of non-personal data, the re-user shall, without delay, where appropriate with the assistance of the public_sector_body, inform the legal persons whose rights and interests may be affected.

6.   Where the re-use of data cannot be allowed in accordance with the obligations laid down in paragraphs 3 and 4 of this Article and there is no legal basis for transmitting the data under Regulation (EU) 2016/679, the public_sector_body shall make best efforts, in accordance with Union and national law, to provide assistance to potential re-users in seeking consent of the data subjects or permission from the data holders whose rights and interests may be affected by such re-use, where it is feasible without a disproportionate burden on the public_sector_body. Where it provides such assistance, the public_sector_body may be assisted by the competent bodies referred to in Article 7(1).

7.   Re-use of data shall be allowed only in compliance with intellectual property rights. The right of the maker of a database as provided for in Article 7(1) of Directive 96/9/EC shall not be exercised by public sector bodies in order to prevent the re-use of data or to restrict re-use beyond the limits set by this Regulation.

8.   Where data requested is considered to be confidential, in accordance with Union or national law on commercial or statistical confidentiality, the public sector bodies shall ensure that the confidential data is not disclosed as a result of allowing re-use, unless such re-use is allowed in accordance with paragraph 6.

9.   Where a re-user intends to transfer non-personal data protected on the grounds set out in Article 3(1) to a third country, it shall inform the public_sector_body of its intention to transfer such data and the purpose of such transfer at the time of requesting the re-use of such data. In the case of re-use in accordance with paragraph 6 of this Article, the re-user shall, where appropriate with the assistance of the public_sector_body, inform the legal person whose rights and interests may be affected of that intention, purpose and the appropriate safeguards. The public_sector_body shall not allow the re-use unless the legal person gives permission for the transfer.

10.   Public sector bodies shall transmit non-personal confidential data or data protected by intellectual property rights to a re-user which intends to transfer those data to a third country other than a country designated in accordance with paragraph 12 only if the re-user contractually commits to:

(a)

complying with the obligations imposed in accordance with paragraphs 7 and 8 even after the data is transferred to the third country; and

(b)

accepting the jurisdiction of the courts or tribunals of the Member State of the transmitting public_sector_body with regard to any dispute related to compliance with paragraphs 7 and 8.

11.   Public sector bodies shall, where relevant and to the extent of their capabilities, provide guidance and assistance to re-users in complying with the obligations referred to in paragraph 10 of this Article.

In order to assist public sector bodies and re-users, the Commission may adopt implementing acts establishing model contractual clauses for complying with the obligations referred to in paragraph 10 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(3).

12.   Where justified because of the substantial number of requests across the Union concerning the re-use of non-personal data in specific third countries, the Commission may adopt implementing acts declaring that the legal, supervisory and enforcement arrangements of a third country:

(a)

ensure protection of intellectual property and trade secrets in a way that is essentially equivalent to the protection ensured under Union law;

(b)

are being effectively applied and enforced; and

(c)

provide effective judicial redress.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(3).

13.   Specific Union legislative acts may deem certain non-personal data categories held by public sector bodies to be highly sensitive for the purposes of this Article where their transfer to third countries may put at risk Union public policy objectives, such as safety and public health or may lead to the risk of re-identification of non-personal, anonymised data. Where such an act is adopted, the Commission shall adopt delegated acts in accordance with Article 32 supplementing this Regulation by laying down special conditions applicable to the transfers of such data to third countries.

Those special conditions shall be based on the nature of the non-personal data categories identified in the specific Union legislative act and on the grounds for deeming those categories to be highly sensitive, taking into account the risks of re-identification of non-personal, anonymised data. They shall be non-discriminatory and limited to what is necessary to achieve the Union public policy objectives identified in that act, in accordance with the Union’s international obligations.

If required by specific Union legislative acts as referred to in the first subparagraph, such special conditions may include terms applicable for the transfer or technical arrangements in this regard, limitations with regard to the re-use of data in third countries or categories of persons entitled to transfer such data to third countries or, in exceptional cases, restrictions with regard to transfers to third countries.

14.   The natural or legal person to which the right to re-use non-personal data was granted may transfer the data only to those third countries for which the requirements in paragraphs 10, 12 and 13 are met.

Article 6

Fees

1.   Public sector bodies which allow re-use of the categories of data referred to in Article 3(1) may charge fees for allowing the re-use of such data.

2.   Any fees charged pursuant to paragraph 1 shall be transparent, non-discriminatory, proportionate and objectively justified and shall not restrict competition.

3.   Public sector bodies shall ensure that any fees can also be paid online through widely available cross-border payment services, without discrimination based on the place of establishment of the payment service provider, the place of issue of the payment instrument or the location of the payment account within the Union.

4.   Where public sector bodies charge fees, they shall take measures to provide incentives for the re-use of the categories of data referred to in Article 3(1) for non-commercial purposes, such as scientific research purposes, and by SMEs and start-ups in accordance with State aid rules. In that regard, public sector bodies may also make the data available at a discounted fee or free of charge, in particular to SMEs and start-ups, civil society and educational establishments. To that end, public sector bodies may establish a list of categories of re-users to which data for re-use is made available at a discounted fee or free of charge. That list, together with the criteria used to establish it, shall be made public.

5.   Any fees shall be derived from the costs related to conducting the procedure for requests for the re-use of the categories of data referred to in Article 3(1) and limited to the necessary costs in relation to:

(a)

the reproduction, provision and dissemination of data;

(b)

the clearance of rights;

(c)

anonymisation or other forms of preparation of personal data and commercially confidential data as provided for in Article 5(3);

(d)

the maintenance of the secure processing environment;

(e)

the acquisition of the right to allow re-use in accordance with this Chapter by third parties outside the public sector; and

(f)

assisting re-users in seeking consent from data subjects and permission from data holders whose rights and interests may be affected by such re-use.

6.   The criteria and methodology for calculating fees shall be laid down by the Member States and published. The public_sector_body shall publish a description of the main categories of costs and the rules used for the allocation of costs.

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 15

Exceptions

This Chapter shall not apply to recognised data altruism organisations or other not-for-profit entities insofar as their activities consist of seeking to collect data for objectives of general interest, made available by natural or legal persons on the basis of data altruism, unless those organisations and entities aim to establish commercial relationships between an undetermined number of data subjects and data holders on the one hand and data users on the other.

CHAPTER IV

Data altruism

Article 16

National arrangements for data altruism

Member States may have in place organisational or technical arrangements, or both, to facilitate data altruism. To that end, Member States may establish national policies for data altruism. Those national policies may, in particular, assist data subjects in making personal data related to them held by public sector bodies available voluntarily for data altruism, and set out the necessary information that is required to be provided to data subjects concerning the re-use of their data in the general interest.

If a Member State develops such national policies, it shall notify the Commission thereof.

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 20

Transparency requirements

1.   A recognised data altruism organisation shall keep full and accurate records concerning:

(a)

all natural or legal persons that were given the possibility to process data held by that recognised data altruism organisation, and their contact details;

(b)

the date or duration of the processing of personal data or use of non-personal data;

(c)

the purpose of the processing as declared by the natural or legal person that was given the possibility of processing;

(d)

the fees paid by natural or legal persons processing the data, if any.

2.   A recognised data altruism organisation shall draw up and transmit to the relevant competent authority for the registration of data altruism organisations an annual activity report which shall contain at least the following:

(a)

information on the activities of the recognised data altruism organisation;

(b)

a description of the way in which the objectives of general interest for which data was collected have been promoted during the given financial year;

(c)

a list of all natural and legal persons that were allowed to process data it holds, including a summary description of the objectives of general interest pursued by such data processing and the description of the technical means used for it, including a description of the techniques used to preserve privacy and data protection;

(d)

a summary of the results of the data processing allowed by the recognised data altruism organisation, where applicable;

(e)

information on sources of revenue of the recognised data altruism organisation, in particular all revenue from allowing access to the data, and on expenditure.

Article 21

Specific requirements to safeguard rights and interests of data subjects and data holders with regard to their data

1.   A recognised data altruism organisation shall inform data subjects or data holders prior to any processing of their data in a clear and easily comprehensible manner of:

(a)

the objectives of general interest and, if applicable, the specified, explicit and legitimate purpose for which personal data is to be processed, and for which it permits the processing of their data by a data user;

(b)

the location of and the objectives of general interest for which it permits any processing carried out in a third country, where the processing is carried out by the recognised data altruism organisation.

2.   The recognised data altruism organisation shall not use the data for other objectives than those of general interest for which the data subject or data holder allows the processing. The recognised data altruism organisation shall not use misleading marketing practices to solicit the provision of data.

3.   The recognised data altruism organisation shall provide tools for obtaining consent from data subjects or permissions to process data made available by data holders. The recognised data altruism organisation shall also provide tools for easy withdrawal of such consent or  permission.

4.   The recognised data altruism organisation shall take measures to ensure an appropriate level of security for the storage and processing of non-personal data that it has collected based on data altruism.

5.   The recognised data altruism organisation shall, without delay, inform data holders in the event of any unauthorised transfer, access or use of the non-personal data that it has shared.

6.   Where the recognised data altruism organisation facilitates data processing by third parties, including by providing 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.

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 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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