Digital Governance Act 2022/0868 EN

BG CS DA DE EL EN ES ET FI FR GA HR HU IT LV LT MT NL PL PT RO SK SL SV print pdf

2022/0868 EN cercato: 'commission' . Output generated live by software developed by IusOnDemand srl

expand index commission:

CHAPTER I

General provisions

CHAPTER II

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

CHAPTER III

Requirements applicable to data intermediation services

CHAPTER IV

Data altruism

CHAPTER V

Competent authorities and procedural provisions

CHAPTER VI

European Data Innovation Board

CHAPTER VII

International access and transfer

CHAPTER VIII

Delegation and committee procedure

CHAPTER IX

Final and transitional provisions

whereas commission:

definitions:

cloud tag:

and the number of total unique words without stopwords is: 1063

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 7

Competent bodies

1. For the purpose of carrying out the tasks referred to in this Article, each Member State shall designate one or more competent bodies, which may be competent for particular sectors, to assist the public sector bodies which grant or refuse access for the re-use of the categories of data referred to in Article 3(1). Member States may either establish one or more new competent bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions laid down in this Regulation.

2. The competent bodies may be empowered to grant access for the re-use of the categories of data referred to in Article 3(1) pursuant to Union or national law which provides for such access to be granted. Where they grant or refuse access for the re-use, Articles 4, 5, 6 and 9 shall apply to those competent bodies.

3. The competent bodies shall have adequate legal, financial, technical and human resources to carry out the tasks assigned to them, including the necessary technical knowledge to be able to comply with relevant Union or national law concerning the access regimes for the categories of data referred to in Article 3(1).

4. The assistance provided for in paragraph 1 shall include, where necessary:

(a)	providing technical support by making available a secure processing environment for providing access for the re-use of data;

(b)	providing guidance and technical support on how to best structure and store data to make that data easily accessible;

(c)

providing technical support for pseudonymisation and ensuring data processing in a manner that effectively preserves the privacy, confidentiality, integrity and accessibility of the information contained in the data for which re-use is allowed, including techniques for the anonymisation, generalisation, suppression and randomisation of personal data or other state-of-the-art privacy-preserving methods, and the deletion of commercially confidential information, including trade secrets or content protected by intellectual property rights;

(d)

assisting the public sector bodies, where relevant, to provide support to re-users in requesting consent for re-use from data subjects or permission from data holders in line with their specific decisions, including on the jurisdiction in which the data processing is intended to take place and assisting the public sector bodies in establishing technical mechanisms that allow the transmission of requests for consent or permission from re-users, where practically feasible;

(e)	providing public sector bodies with assistance in assessing the adequacy of contractual commitments made by a re-user pursuant to Article 5(10).

5. Each Member State shall notify the commission of the identity of the competent bodies designated pursuant to paragraph 1 by 24 September 2023. Each Member State shall also notify the commission of any subsequent change to the identity of those competent bodies.

Article 8

Single information points

1. Member States shall ensure that all relevant information concerning the application of Articles 5 and 6 is available and easily accessible through a single information point. Member States shall establish a new body or designate an existing body or structure as the single information point. The single information point may be linked to sectoral, regional or local information points. The functions of the single information point may be automated provided that the public_sector_body ensures adequate support.

2. The single information point shall be competent to receive enquiries or requests for the re-use of the categories of data referred to in Article 3(1) and shall transmit them, where possible and appropriate by automated means, to the competent public sector bodies, or the competent bodies referred to in Article 7(1), where relevant. The single information point shall make available by electronic means a searchable asset list containing an overview of all available data resources including, where relevant, those data resources that are available at sectoral, regional or local information points, with relevant information describing the available data, including at least the data format and size and the conditions for their re-use.

3. The single information point may establish a separate, simplified and well-documented information channel for SMEs and start-ups, addressing their needs and capabilities in requesting the re-use of the categories of data referred to in Article 3(1).

4. The commission shall establish a European single access point offering a searchable electronic register of data available in the national single information points and further information on how to request data via those national single information points.

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 13

Competent authorities for data intermediation services

1. Each Member State shall designate one or more competent authorities to carry out the tasks related to the notification procedure for data intermediation services and shall notify the commission of the identity of those competent authorities by 24 September 2023. Each Member State shall also notify the commission of any subsequent change to the identity of those competent authorities.

2. The competent authorities for data intermediation services shall comply with the requirements set out in Article 26.

3. The powers of the competent authorities for data intermediation services are without prejudice to the powers of the data protection authorities, national competition authorities, authorities in charge of cybersecurity and other relevant sectoral authorities. In accordance with their respective competences under Union and national law, those authorities shall establish strong cooperation and exchange information as is necessary for the exercise of their tasks in relation to data intermediation services providers, and shall aim to achieve consistency in the decisions taken in applying this Regulation.

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 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 17

Public registers of recognised data altruism organisations

1. Each competent authority for the registration of data altruism organisations shall keep and regularly update a public national register of recognised data altruism organisations.

2. The commission shall maintain a public Union register of recognised data altruism organisations for information purposes. Provided that an entity is registered in the public national register of recognised data altruism organisations in accordance with Article 18, it may use the label ‘ data altruism organisation recognised in the Union’ in its written and spoken communication, as well as a common logo.

In order to ensure that recognised data altruism organisations are easily identifiable throughout the Union, the commission shall, by means of implementing acts, establish a design for the common logo. Recognised data altruism organisations shall display the common logo clearly on every online and offline publication that relates to their data altruism activities. The common logo shall be accompanied by a QR code with a link to the public Union register of recognised data altruism organisations.

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

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 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 23

Competent authorities for the registration of data altruism organisations

1. Each Member State shall designate one or more competent authorities responsible for its public national register of recognised data altruism organisations.

The competent authorities for the registration of data altruism organisations shall comply with the requirements set out in Article 26.

2. Each Member State shall notify the commission of the identity of their competent authorities for the registration of data altruism organisations by 24 September 2023. Each Member State shall also notify the commission of any subsequent change to the identity of those competent authorities.

3. The competent authority for the registration of data altruism organisations of a Member State shall undertake its tasks in cooperation with the relevant data protection authority, where such tasks are related to processing of personal data, and with relevant sectoral authorities of that Member State.

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 26

Requirements relating to competent authorities

1. The competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall be legally distinct from, and functionally independent of, any data intermediation services provider or recognised data altruism organisation. The functions of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations may be carried out by the same authority. Member States may either establish one or more new authorities for those purposes or rely on existing ones.

2. Competent authorities for data intermediation services and competent authorities for the registration of data altruism organisations shall exercise their tasks in an impartial, transparent, consistent, reliable and timely manner. Where they exercise their tasks, they shall safeguard fair competition and non-discrimination.

3. The top-level management and personnel responsible for carrying out the relevant tasks of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the services which they evaluate, nor the authorised representative of any of those parties. This shall not preclude the use of evaluated services that are necessary for the operations of the competent authority for data intermediation services and the competent authority for the registration of data altruism organisations or the use of such services for personal purposes.

4. The top-level management and personnel of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall not engage in any activity that may conflict with their independence of judgment or integrity in relation to evaluation activities assigned to them.

5. The competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall have at their disposal the adequate financial and human resources to carry out the tasks assigned to them, including the necessary technical knowledge and resources.

6. The competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations of a Member State shall provide the commission and competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations from other Member States, on reasoned request and without delay, with the information necessary to carry out their tasks under this Regulation. Where a competent authority for data intermediation services or a competent authority for the registration of data altruism organisations considers the information requested to be confidential in accordance with Union and national law on commercial and professional confidentiality, the commission and any other competent authorities for data intermediation services or competent authorities for the registration of data altruism organisations concerned shall ensure such confidentiality.

Article 29

European Data Innovation Board

1. The commission shall establish a European Data Innovation Board in the form of an expert group, consisting of representatives of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations of all Member States, the European Data Protection Board, the European Data Protection Supervisor, ENISA, the commission, the EU SME Envoy or a representative appointed by the network of SME envoys, and other representatives of relevant bodies in specific sectors as well as bodies with specific expertise. In its appointments of individual experts, the commission shall aim to achieve gender and geographical balance among the members of the expert group.

2. The European Data Innovation Board shall consist of at least the following three subgroups:

(a)	a subgroup composed of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations, with a view to carrying out the tasks pursuant to Article 30, points (a), (c), (j) and (k);

(b)	a subgroup for technical discussions on standardisation, portability and interoperability pursuant to Article 30, points (f) and (g);

(c)

a subgroup for stakeholder involvement composed of relevant representatives from industry, research, academia, civil society, standardisation organisations, relevant common European data spaces and other relevant stakeholders and third parties advising the European Data Innovation Board on tasks pursuant to Article 30, points (d), (e), (f), (g) and (h).

3. The commission shall chair the meetings of the European Data Innovation Board.

4. The European Data Innovation Board shall be assisted by a secretariat provided by the commission.

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

Article 32

Exercise of the delegation

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

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

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

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

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

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

Article 33

Committee procedure

1. The commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

CHAPTER IX

Final and transitional provisions

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.

Article 38

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 24 September 2023.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 30 May 2022.

For the European Parliament

The President

R. METSOLA

For the Council

The President

B. LE MAIRE

(1) OJ C 286, 16.7.2021, p. 38.

(2) Position of the European Parliament of 6 April 2022 (not yet published in the Official Journal) and decision of the Council of 16 May 2022.

(3) commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

(4) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

(5) Regulation (EU) 2019/1239 of the European Parliament and of the Council of 20 June 2019 establishing a European Maritime Single Window environment and repealing Directive 2010/65/EU (OJ L 198, 25.7.2019, p. 64).

(6) Regulation (EU) 2020/1056 of the European Parliament and of the Council of 15 July 2020 on electronic freight transport information (OJ L 249, 31.7.2020, p. 33).

(7) Directive 2010/40/EU of the European Parliament and of the Council of 7 July 2010 on the framework for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with other modes of transport (OJ L 207, 6.8.2010, p. 1).

(8) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).

(9) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).

(10) Regulation (EU) 2018/1807 of the European Parliament and of the Council of 14 November 2018 on a framework for the free flow of non-personal data in the European Union (OJ L 303, 28.11.2018, p. 59).

(11) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1).

(12) Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 167, 22.6.2001, p. 10).

(13) Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, p. 45).

(14) Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1).

(15) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73).

(16) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).

(17) Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law (OJ L 169, 30.6.2017, p. 46).

(18) Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/EC (OJ L 130, 17.5.2019, p. 92).

(19) Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (OJ L 172, 26.6.2019, p. 56).

(20) Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 2004/18/EC (OJ L 216, 20.8.2009, p. 76).

(21) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

(22) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

(23) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).

(24) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89).

(25) commission Regulation (EU) No 557/2013 of 17 June 2013 implementing Regulation (EC) No 223/2009 of the European Parliament and of the Council on European Statistics as regards access to confidential data for scientific purposes and repealing commission Regulation (EC) No 831/2002 (OJ L 164, 18.6.2013, p. 16).

(26) Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases (OJ L 77, 27.3.1996, p. 20).

(27) Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84).

(28) Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (OJ L 337, 23.12.2015, p. 35).

(29) Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1).

(30) OJ L 123, 12.5.2016, p. 1.

(31) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

(32) Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1).

(33) Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70).

whereas

keyboard_tab Digital Governance Act 2022/0868 EN

Digital Governance Act 2022/0868 EN