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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 3

Categories of data

1.   This Chapter applies to data held by public sector bodies which are protected on grounds of:

(a)

commercial confidentiality, including business, professional and company secrets;

(b)

statistical confidentiality;

(c)

the protection of intellectual property rights of third parties; or

(d)

the protection of personal data, insofar as such data fall outside the scope of Directive (EU) 2019/1024.

2.   This Chapter does not apply to:

(a)

data held by public_undertakings;

(b)

data held by public service broadcasters and their subsidiaries, and by other bodies or their subsidiaries for the fulfilment of a public service broadcasting remit;

(c)

data held by cultural establishments and educational establishments;

(d)

data held by public sector bodies which are protected for reasons of public security, defence or national security; or

(e)

data the supply of which is an activity falling outside the scope of the public task of the public sector bodies concerned as defined by law or by other binding rules in the Member State concerned, or, in the absence of such rules, as defined in accordance with common administrative practice in that Member State, provided that the scope of the public tasks is transparent and subject to review.

3.   This Chapter is without prejudice to:

(a)

Union and national law and international agreements to which the Union or Member States are party on the protection of categories of data referred to in paragraph 1; and

(b)

Union and national law on access to documents.

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 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 25

European data altruism consent form

1.   In order to facilitate the collection of data based on data altruism, the Commission shall adopt implementing acts establishing and developing a European data altruism consent form, after consulting the European Data Protection Board, taking into account the advice of the European Data Innovation Board and duly involving relevant stakeholders. The form shall allow the collection of consent or permission across Member States in a uniform format. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 33(2).

2.   The European data altruism consent form shall use a modular approach allowing customisation for specific sectors and for different purposes.

3.   Where personal data are provided, the European data altruism consent form shall ensure that data subjects are able to give consent to and withdraw consent from a specific data processing operation in compliance with the requirements of Regulation (EU) 2016/679.

4.   The form shall be available in a manner that can be printed on paper and is easily understandable as well as in an electronic, machine-readable form.

CHAPTER V

Competent authorities and procedural provisions

Article 30

Tasks of the European Data Innovation Board

The European Data Innovation Board shall have the following tasks:

(a)

to advise and assist the Commission with regard to developing a consistent practice of public sector bodies and competent bodies referred to in Article 7(1) in handling requests for the re-use of the categories of data referred to in Article 3(1);

(b)

to advise and assist the Commission with regard to developing a consistent practice for data altruism across the Union;

(c)

to advise and assist the Commission with regard to developing a consistent practice of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations in the application of requirements applicable to data intermediation services providers and recognised data altruism organisations;

(d)

to advise and assist the Commission with regard to developing consistent guidelines on how to best protect, in the context of this Regulation, commercially sensitive non-personal data, in particular trade secrets, but also non-personal data representing content protected by intellectual property rights from unlawful access that risks intellectual property theft or industrial espionage;

(e)

to advise and assist the Commission with regard to developing consistent guidelines for cybersecurity requirements for the exchange and storage of data;

(f)

to advise the Commission, in particular taking into account the input from standardisation organisations, on the prioritisation of cross-sector standards to be used and developed for data use and cross-sector data sharing between emerging common European data spaces, cross-sectoral comparison and exchange of best practices with regard to sectoral requirements for security and access procedures, taking into account sector-specific standardisation activities, in particular clarifying and distinguishing which standards and practices are cross-sectoral and which are sectoral;

(g)

to assist the Commission, in particular taking into account the input from standardisation organisations, in addressing fragmentation of the internal market and the data economy in the internal market by enhancing cross-border, cross-sector interoperability of data as well as data sharing services between different sectors and domains, building on existing European, international or national standards, inter alia with the aim of encouraging the creation of common European data spaces;

(h)

to propose guidelines for common European data spaces, namely purpose- or sector-specific or cross-sectoral interoperable frameworks of common standards and practices to share or jointly process data for, inter alia, the development of new products and services, scientific research or civil society initiatives, such common standards and practices taking into account existing standards, complying with the competition rules and ensuring non-discriminatory access to all participants, for the purpose of facilitating data sharing in the Union and reaping the potential of existing and future data spaces, addressing, inter alia:

(i)

cross-sectoral standards to be used and developed for data use and cross-sector data sharing, cross-sectoral comparison and exchange of best practices with regard to sectoral requirements for security and access procedures, taking into account sector-specific standardisation activities, in particular clarifying and distinguishing which standards and practices are cross-sectoral and which are sectoral;

(ii)

requirements to counter barriers to market entry and to avoid lock-in effects, for the purpose of ensuring fair competition and interoperability;

(iii)

adequate protection for lawful data transfers to third countries, including safeguards against any transfers prohibited by Union law;

(iv)

adequate and non-discriminatory representation of relevant stakeholders in the governance of common European data spaces;

(v)

adherence to cybersecurity requirements in accordance with Union law;

(i)

to facilitate cooperation between Member States with regard to setting harmonised conditions allowing for the re-use of the categories of data referred to in Article 3(1) held by public sector bodies across the internal market;

(j)

to facilitate cooperation between competent authorities for data intermediation services and competent authorities for the registration of data altruism organisations through capacity-building and the exchange of information, in particular by establishing methods for the efficient exchange of information relating to the notification procedure for data intermediation services providers and the registration and monitoring of recognised data altruism organisations, including coordination with regard to the setting of fees or penalties, as well as facilitate cooperation between competent authorities for data intermediation services and competent authorities for the registration of data altruism organisations with regard to international access and transfer of data;

(k)

to advise and assist the Commission with regard to evaluating whether the implementing acts referred to in Article 5(11) and (12) are to be adopted;

(l)

to advise and assist the Commission with regard to developing the European data altruism consent form in accordance with Article 25(1);

(m)

to advise the Commission on improving the international regulatory environment for non-personal data, including standardisation.

CHAPTER VII

International access and transfer


whereas
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