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2023/2854 EN cercato: 'considers' . Output generated live by software developed by IusOnDemand srl


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Article 8

Conditions under which data holders make data available to data recipients

1.   Where, in business-to-business relations, a data holder is obliged to make data available to a data recipient under Article 5 or under other applicable Union law or national legislation adopted in accordance with Union law, it shall agree with a data recipient the arrangements for making the data available and shall do so under fair, reasonable and non-discriminatory terms and conditions and in a transparent manner in accordance with this Chapter and Chapter IV.

2.   A contractual term concerning access to and the use of data, or liability and remedies for the breach or termination of data-related obligations, shall not be binding if it constitutes an unfair contractual term within the meaning of Article 13 or if, to the detriment of the user, it excludes the application of, derogates from or varies the effect of the user’s rights under Chapter II.

3.   A data holder shall not discriminate regarding the arrangements for making data available between comparable categories of data recipients, including partner enterprises or linked enterprises of the data holder when making data available. Where a data recipient considers that the conditions under which data has been made available to it are discriminatory, the data holder shall without undue delay provide the data recipient, upon its reasoned request, with information showing that there has been no discrimination.

4.   A data holder shall not make data available to a data recipient, including on an exclusive basis, unless requested to do so by the user under Chapter II.

5.   Data holders and data recipients shall not be required to provide any information beyond what is necessary to verify compliance with the contractual terms agreed for making data available or with their obligations under this Regulation or other applicable Union law or national legislation adopted in accordance with Union law.

6.   Unless otherwise provided for in Union law, including Article 4(6) and Article 5(9) of this Regulation, or by national legislation adopted in accordance with Union law, an obligation to make data available to a data recipient shall not oblige the disclosure of trade_secrets.

Article 17

Requests for data to be made available

1.   When requesting data pursuant to Article 14, a public_sector_body, the Commission, the European Central Bank or a Union body shall:

(a)

specify the data required, including the relevant meta data necessary to interpret and use those data;

(b)

demonstrate that the conditions necessary for the existence of an exceptional need as referred to in Article 15 for the purpose of which the data are requested are met;

(c)

explain the purpose of the request, the intended use of the data requested, including, where applicable, by a third party in accordance with paragraph 4 of this Article, the duration of that use, and, where relevant, how the processing of personal data is to address the exceptional need;

(d)

specify, if possible, when the data are expected to be erased by all parties that have access to them;

(e)

justify the choice of data holder to which the request is addressed;

(f)

specify any other public sector bodies or the Commission, European Central Bank or Union_bodies and the third parties with which the data requested is expected to be shared with;

(g)

where personal data are requested, specify any technical and organisational measures necessary and proportionate to implement data protection principles and necessary safeguards, such as pseudonymisation, and whether anonymisation can be applied by the data holder before making the data available;

(h)

state the legal provision allocating to the requesting public_sector_body, the Commission, the European Central Bank or the Union body the specific task carried out in the public interest relevant for requesting the data;

(i)

specify the deadline by which the data are to be made available and the deadline referred to in Article 18(2) by which the data holder may decline or seek modification of the request;

(j)

make its best efforts to avoid compliance with the data request resulting in the data holders’ liability for infringement of Union or national law.

2.   A request for data made pursuant to paragraph 1 of this Article shall:

(a)

be made in writing and expressed in clear, concise and plain language understandable to the data holder;

(b)

be specific regarding the type of data requested and correspond to data which the data holder has control over at the time of the request;

(c)

be proportionate to the exceptional need and duly justified, regarding the granularity and volume of the data requested and frequency of access of the data requested;

(d)

respect the legitimate aims of the data holder, committing to ensuring the protection of trade_secrets in accordance with Article 19(3), and the cost and effort required to make the data available;

(e)

concern non-personal data, and only if this is demonstrated to be insufficient to respond to the exceptional need to use data, in accordance with Article 15(1), point (a), request personal data in pseudonymised form and establish the technical and organisational measures that are to be taken to protect the data;

(f)

inform the data holder of the penalties that are to be imposed pursuant to Article 40 by the competent authority designated pursuant to Article 37 in the event of non-compliance with the request;

(g)

where the request is made by a public_sector_body, be transmitted to the data coordinator referred to in Article 37 of the Member State where the requesting public_sector_body is established, who shall make the request publicly available online without undue delay unless the data coordinator considers that such publication would create a risk for public security;

(h)

where the request is made by the Commission, the European Central Bank or a Union body, be made available online without undue delay;

(i)

where personal data are requested, be notified without undue delay to the supervisory authority responsible for monitoring the application of Regulation (EU) 2016/679 in the Member State where the public_sector_body is established.

The European Central Bank and Union_bodies shall inform the Commission of their requests.

3.   A public_sector_body, the Commission, the European Central Bank or a Union body shall not make data obtained pursuant to this Chapter available for reuse as defined in Article 2, point (2), of Regulation (EU) 2022/868 or Article 2, point (11), of Directive (EU) 2019/1024. Regulation (EU) 2022/868 and Directive (EU) 2019/1024 shall not apply to the data held by public sector bodies obtained pursuant to this Chapter.

4.   Paragraph 3 of this Article does not preclude a public_sector_body, the Commission, the European Central Bank or a Union body to exchange data obtained pursuant to this Chapter with another public_sector_body or the Commission, the European Central Bank or a Union body in view of completing the tasks referred to in Article 15, as specified in the request in accordance with paragraph 1, point (f), of this Article or to make the data available to a third party where it has delegated, by means of a publicly available agreement, technical inspections or other functions to that third party. The obligations on public sector bodies pursuant to Article 19, in particular safeguards to preserve the confidentiality of trade_secrets, shall apply also to such third parties. Where a public_sector_body, the Commission, the European Central Bank or a Union body transmits or makes data available under this paragraph, it shall notify the data holder from whom the data was received without undue delay.

5.   Where the data holder considers that its rights under this Chapter have been infringed by the transmission or making available of data, it may lodge a complaint with the competent authority designated pursuant to Article 37 of the Member State where the data holder is established.

6.   The Commission shall develop a model template for requests pursuant to this Article.

Article 25

Contractual terms concerning switching

1.   The rights of the customer and the obligations of the provider of data processing services in relation to switching between providers of such services or, where applicable, to an on-premises_ICT_infrastructure shall be clearly set out in a written contract. The provider of data processing services shall make that contract available to the customer prior to signing the contract in a way that allows the customer to store and reproduce the contract.

2.   Without prejudice to Directive (EU) 2019/770, the contract referred to in paragraph 1 of this Article shall include at least the following:

(a)

clauses allowing the customer, upon request, to switch to a data processing service offered by a different provider of data processing services or to port all exportable data and digital_assets to an on-premises_ICT_infrastructure, without undue delay and in any event not after the mandatory maximum transitional period of 30 calendar days, to be initiated after the maximum notice period referred to in point (d), during which the service contract remains applicable and during which the provider of data processing services shall:

(i)

provide reasonable assistance to the customer and third parties authorised by the customer in the switching process;

(ii)

act with due care to maintain business continuity, and continue the provision of the functions or services under the contract;

(iii)

provide clear information concerning known risks to continuity in the provision of the functions or services on the part of the source provider of data processing services;

(iv)

ensure that a high level of security is maintained throughout the switching process, in particular the security of the data during their transfer and the continued security of the data during the retrieval period specified in point (g), in accordance with applicable Union or national law;

(b)

an obligation of the provider of data processing services to support the customer’s exit strategy relevant to the contracted services, including by providing all relevant information;

(c)

a clause specifying that the contract shall be considered to be terminated and the customer shall be notified of the termination, in one of the following cases:

(i)

where applicable, upon the successful completion of the switching process;

(ii)

at the end of the maximum notice period referred to in paragraph (d), where the customer does not wish to switch but to erase its exportable data and digital_assets upon service termination;

(d)

a maximum notice period for initiation of the switching process, which shall not exceed two months;

(e)

an exhaustive specification of all categories of data and digital_assets that can be ported during the switching process, including, at a minimum, all exportable data;

(f)

an exhaustive specification of categories of data specific to the internal functioning of the provider’s data processing service that are to be exempted from the exportable data under point (e) of this paragraph where a risk of breach of trade_secrets of the provider exists, provided that such exemptions do not impede or delay the switching process provided for in Article 23;

(g)

a minimum period for data retrieval of at least 30 calendar days, starting after the termination of the transitional period that was agreed between the customer and the provider of data processing services, in accordance with point (a) of this paragraph and paragraph 4;

(h)

a clause guaranteeing full erasure of all exportable data and digital_assets generated directly by the customer, or relating to the customer directly, after the expiry of the retrieval period referred to in point (g) or after the expiry of an alternative agreed period at a date later than the date of expiry of the retrieval period referred to in point (g), provided that the switching process has been completed successfully;

(i)

switching charges, that may be imposed by providers of data processing services in accordance with Article 29.

3.   The contract referred to in paragraph 1 shall include clauses providing that the customer may notify the provider of data processing services of its decision to perform one or more of the following actions upon termination of the maximum notice period referred to in paragraph 2, point (d):

(a)

switch to a different provider of data processing services, in which case the customer shall provide the necessary details of that provider;

(b)

switch to an on-premises_ICT_infrastructure;

(c)

erase its exportable data and digital_assets.

4.   Where the mandatory maximum transitional period as provided for in paragraph 2, point (a) is technically unfeasible, the provider of data processing services shall notify the customer within 14 working days of the making of the switching request, and shall duly justify the technical unfeasibility and indicate an alternative transitional period, which shall not exceed seven months. In accordance with paragraph 1, service continuity shall be ensured throughout the alternative transitional period.

5.   Without prejudice to paragraph 4, the contract referred to in paragraph 1 shall include clauses providing the customer with the right to extend the transitional period once for a period that the customer considers more appropriate for its own purposes.

Article 32

International governmental access and transfer

1.   Providers of data processing services shall take all adequate technical, organisational and legal measures, including contracts, in order to prevent international and third-country governmental access and transfer of non-personal data held in the Union where such transfer or access would create a conflict with Union law or with 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 provider of data processing services to transfer or give access to non-personal data falling 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, where a provider of data processing services 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 falling 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 by Union law or by the national law of the relevant Member State.

The addressee of the decision or judgment may ask the opinion of the relevant national body or authority competent for international cooperation in legal matters, in order to determine whether the conditions laid down in the first subparagraph are met, in particular when it considers that the decision may relate to trade_secrets and other commercially sensitive data as well as to content protected by intellectual property rights or the transfer may lead to re-identification. The relevant national body or authority may consult the Commission. If the addressee considers that the decision or judgment may impinge on the national security or defence interests of the Union or its Member States, it shall ask the opinion of the relevant national body or authority in order to determine whether the data requested concerns national security or defence interests of the Union or its Member States. If the addressee has not received a reply within one month, or if the opinion of such body or authority concludes that the conditions laid down in the first subparagraph are not met, the addressee may reject the request for transfer or access, to non-personal data, on those grounds.

The EDIB referred to in Article 42 shall advise and assist the Commission in developing guidelines on the assessment of whether the conditions laid down in the first subparagraph of this paragraph are met.

4.   If the conditions laid down in paragraph 2 or 3 are met, the provider of data processing services shall provide the minimum amount of data permissible in response to a request, on the basis of the reasonable interpretation of that request by the provider or relevant national body or authority referred to in paragraph 3, second subparagraph.

5.   The provider of data processing services shall inform the customer about the existence of a request of a third-country 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

INTEROPERABILITY

Article 33

Essential requirements regarding interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces

1.   Participants in data spaces that offer data or data services to other participants shall comply with the following essential requirements to facilitate the interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces which are purpose- or sector-specific or cross-sectoral interoperable frameworks for 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:

(a)

the dataset content, use restrictions, licences, data collection methodology, data quality and uncertainty shall be sufficiently described, where applicable, in a machine-readable format, to allow the recipient to find, access and use the data;

(b)

the data structures, data formats, vocabularies, classification schemes, taxonomies and code lists, where available, shall be described in a publicly available and consistent manner;

(c)

the technical means to access the data, such as application programming interfaces, and their terms of use and quality of service shall be sufficiently described to enable automatic access and transmission of data between parties, including continuously, in bulk download or in real-time in a machine-readable format where that is technically feasible and does not hamper the good functioning of the connected_product;

(d)

where applicable, the means to enable the interoperability of tools for automating the execution of data sharing agreements, such as smart_contracts shall be provided.

The requirements can have a generic nature or concern specific sectors, while taking fully into account the interrelation with requirements arising from other Union or national law.

2.   The Commission is empowered to adopt delegated acts, in accordance with Article 45 of this Regulation to supplement this Regulation by further specifying the essential requirements laid down in paragraph 1 of this Article, in relation to those requirements that, by their nature, cannot produce the intended effect unless they are further specified in binding Union legal acts and in order to properly reflect technological and market developments.

The Commission shall when adopting delegated acts take into account the advice of the EDIB in accordance with Article 42, point (c)(iii).

3.   The participants in data spaces that offer data or data services to other participants in data spaces which meet the harmonised_standards or parts thereof, the references of which are published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such harmonised_standards or parts thereof.

4.   The Commission shall, pursuant to Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised_standards that satisfy the essential requirements laid down in paragraph 1 of this Article.

5.   The Commission may, by means of implementing acts, adopt common_specifications covering any or all of the essential requirements laid down in paragraph 1 where the following conditions have been fulfilled:

(a)

the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised_standard that satisfies the essential requirements laid down in paragraph 1 of this Article and:

(i)

the request has not been accepted;

(ii)

the harmonised_standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or

(iii)

the harmonised_standards do not comply with the request; and

(b)

no reference to harmonised_standards covering the relevant essential requirements laid down in paragraph 1 of this Article is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(2).

6.   Before preparing a draft implementing act referred to in paragraph 5 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 5 of this Article have been fulfilled.

7.   When preparing the draft implementing act referred to in paragraph 5, the Commission shall take into account the advice of the EDIB and views of other relevant bodies or expert groups and shall duly consult all relevant stakeholders.

8.   The participants in data spaces that offer data or data services to other participants in data spaces that meet the common_specifications established by implementing acts referred to in paragraph 5 or parts thereof shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such common_specifications or parts thereof.

9.   Where a harmonised_standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the harmonised_standard in accordance with Regulation (EU) No 1025/2012. Where the reference of a harmonised_standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 5 of this Article, or parts thereof which cover the same essential requirements as those covered by that harmonised_standard.

10.   When a Member State considers that a common specification does not entirely satisfy the essential requirements laid down in paragraph 1, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

11.   The Commission may adopt guidelines taking into account the proposal of the EDIB in accordance with Article 30, point (h), of Regulation (EU) 2022/868 laying down interoperable frameworks for common standards and practices for the functioning of common European data spaces.

Article 35

Interoperability of data processing services

1.   Open interoperability specifications and harmonised_standards for the interoperability of data processing services shall:

(a)

achieve, where technically feasible, interoperability between different data processing services that cover the same_service_type;

(b)

enhance portability of digital_assets between different data processing services that cover the same_service_type;

(c)

facilitate, where technically feasible, functional_equivalence between different data processing services referred to in Article 30(1) that cover the same_service_type;

(d)

not have an adverse impact on the security and integrity of data processing services and data;

(e)

be designed in such a way so as to allow for technical advances and the inclusion of new functions and innovation in data processing services.

2.   Open interoperability specifications and harmonised_standards for the interoperability of data processing services shall adequately address:

(a)

the cloud interoperability aspects of transport interoperability, syntactic interoperability, semantic data interoperability, behavioural interoperability and policy interoperability;

(b)

the cloud data portability aspects of data syntactic portability, data semantic portability and data policy portability;

(c)

the cloud application aspects of application syntactic portability, application instruction portability, application meta data portability, application behaviour portability and application policy portability.

3.   Open interoperability specifications shall comply with Annex II to Regulation (EU) No 1025/2012.

4.   After taking into account relevant international and European standards and self-regulatory initiatives, the Commission may, in accordance with Article 10(1) of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised_standards that satisfy the essential requirements laid down in paragraphs 1 and 2 of this Article.

5.   The Commission may, by means of implementing acts, adopt common_specifications based on open interoperability specifications covering all of the essential requirements laid down in paragraphs 1 and 2.

6.   When preparing the draft implementing act referred to in paragraph 5 of this Article, the Commission shall take into account the views of the relevant competent authorities referred to in Article 37(5), point (h) and other relevant bodies or expert groups and shall duly consult all relevant stakeholders.

7.   When a Member State considers that a common specification does not entirely satisfy the essential requirements laid down in paragraphs 1 and 2, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

8.   For the purpose of Article 30(3), the Commission shall, by means of implementing acts, publish the references of harmonised_standards and common_specifications for the interoperability of data processing services in a central Union standards repository for the interoperability of data processing services.

9.   The implementing acts referred to in this Article shall be adopted in accordance with the examination procedure referred to in Article 46(2).

Article 36

Essential requirements regarding smart_contracts for executing data sharing agreements

1.   The vendor of an application using smart_contracts or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart_contracts for others in the context of executing an agreement or part of it, to make data available shall ensure that those smart_contracts comply with the following essential requirements of:

(a)

robustness and access control, to ensure that the smart_contract has been designed to offer access control mechanisms and a very high degree of robustness to avoid functional errors and to withstand manipulation by third parties;

(b)

safe termination and interruption, to ensure that a mechanism exists to terminate the continued execution of transactions and that the smart_contract includes internal functions which can reset or instruct the contract to stop or interrupt the operation, in particular to avoid future accidental executions;

(c)

data archiving and continuity, to ensure, in circumstances in which a smart_contract must be terminated or deactivated, there is a possibility to archive the transactional data, smart_contract logic and code in order to keep the record of operations performed on the data in the past (auditability);

(d)

access control, to ensure that a smart_contract is protected through rigorous access control mechanisms at the governance and smart_contract layers; and

(e)

consistency, to ensure consistency with the terms of the data sharing agreement that the smart_contract executes.

2.   The vendor of a smart_contract or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart_contracts for others in the context of executing an agreement or part of it, to make data available shall perform a conformity assessment with a view to fulfilling the essential requirements laid down in paragraph 1 and, on the fulfilment of those requirements, issue an EU declaration of conformity.

3.   By drawing up the EU declaration of conformity, the vendor of an application using smart_contracts or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart_contracts for others in the context of executing an agreement or part of it, to make data available shall be responsible for compliance with the essential requirements laid down in paragraph 1.

4.   A smart_contract that meets the harmonised_standards or the relevant parts thereof, the references of which are published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such harmonised_standards or parts thereof.

5.   The Commission shall, pursuant to Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised_standards that satisfy the essential requirements laid down in paragraph 1 of this Article.

6.   The Commission may, by means of implementing acts, adopt common_specifications covering any or all of the essential requirements laid down in paragraph 1 where the following conditions have been fulfilled:

(a)

the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised_standard that satisfies the essential requirements laid down in paragraph 1 of this Article and:

(i)

the request has not been accepted;

(ii)

the harmonised_standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or

(iii)

the harmonised_standards do not comply with the request; and

(b)

no reference to harmonised_standards covering the relevant essential requirements laid down in paragraph 1 of this Article is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(2).

7.   Before preparing a draft implementing act referred to in paragraph 6 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 6 of this Article have been fulfilled.

8.   When preparing the draft implementing act referred to in paragraph 6, the Commission shall take into account the advice of the EDIB and views of other relevant bodies or expert groups and shall duly consult all relevant stakeholders.

9.   The vendor of a smart_contract or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart_contracts for others in the context of executing an agreement or part of it, to make data available that meet the common_specifications established by implementing acts referred to in paragraph 6 or parts thereof shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such common_specifications or parts thereof.

10.   Where a harmonised_standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the harmonised_standard in accordance with Regulation (EU) No 1025/2012. Where the reference of a harmonised_standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 6 of this Article, or parts thereof which cover the same essential requirements as those covered by that harmonised_standard.

11.   When a Member State considers that a common specification does not entirely satisfy the essential requirements laid down in paragraph 1, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

CHAPTER IX

IMPLEMENTATION AND ENFORCEMENT


whereas









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