Updated on April 10^th 2024 based on the version and article numbering approved by the EU Parliament on March 13^th 2024.

1. High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5 whenever such data sets are used.

2. Training, validation and testing data sets shall be subject to data governance and management practices appropriate for the intended purpose of the high-risk AI system. Those practices shall concern in particular:

1. the relevant design choices;
2. data collection processes and the origin of data, and in the case of personal data, the original purpose of the data collection;‍
3. relevant data-preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;
4. the formulation of assumptions, in particular with respect to the information that the data are supposed to measure and represent;‍
5. an assessment of the availability, quantity and suitability of the data sets that are needed;
6. examination in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;‍
7. appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);‍
8. the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those gaps and shortcomings can be addressed.
   

3. Training, validation and testing data sets shall be relevant, sufficiently representative, and to the best extent possible, free of errors and complete in view of the intended purpose. They shall have the appropriate statistical properties, including, where applicable, as regards the persons or groups of persons in relation to whom the high-risk AI system is intended to be used. Those characteristics of the data sets may be met at the level of individual data sets or at the level of a combination thereof.

4. Data sets shall take into account, to the extent required by the intended purpose, the characteristics or elements that are particular to the specific geographical, contextual, behavioural or functional setting within which the high-risk AI system is intended to be used.

5. To the extent that it is strictly necessary for the purpose of ensuring bias ▌ detection and correction in relation to the high-risk AI systems in accordance with paragraph (2), points

(f) and (g) of this Article, the providers of such systems may exceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. In addition to the provisions set out in Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725, all the following conditions shall apply in order for such processing to occur:

1. ‍the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data;
2. the special categories of personal data are subject to technical limitations on the re-use of the personal data, and state of the art security and privacy-preserving measures, including pseudonymisation;
3. the special categories of personal data are subject to measures to ensure that the personal data processed are secured, protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and ensure that only authorised persons with appropriate confidentiality obligations have access to those personal data;
4. the personal data in the special categories of personal data are not to be transmitted, transferred or otherwise accessed by other parties;
5. the personal data in the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whichever comes first;
6. the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680include the reasons why the processing of special categories of personal data was strictly necessary to detect and correct biases, and why that objective could not be achieved by processing other data.
   

6. For the development of high-risk AI systems not using techniques involving the training of AI models, paragraphs 2 to 5 apply only to the testing data sets.

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[Previous version]

‍Updated on Feb 6^th 2024 based on the version endorsed by the Coreper I on Feb 2^nd‍

1. High-risk AI systems which make use of techniques involving the training of models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5 whenever such datasets are used.

2. Training, validation and testing data sets shall be subject to appropriate data governance and management practices appropriate for the intended purpose of the AI system. Those practices shall concern in particular:

(a) the relevant design choices;

(aa) data collection processes and origin of data, and in the case of personal data, the original purpose of data collection;

(c) relevant data preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;

(d) the formulation of assumptions, notably with respect to the information that the data are supposed to measure and represent;

(e) an assessment of the availability, quantity and suitability of the data sets that are needed;

(f) examination in view of possible biases that are likely to affect the health and safety of persons, negatively impact fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;

(fa) appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);

(g) the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those gaps and shortcomings can be addressed.

3. Training, validation and testing datasets shall be relevant, sufficiently representative, and to the best extent possible, free of errors and complete in view of the intended purpose. They shall have the appropriate statistical properties, including, where applicable, as regards the persons or groups of persons in relation to whom the high-risk AI system is intended to be used. These characteristics of the data sets may be met at the level of individual data sets or a combination thereof.

4. Datasets shall take into account, to the extent required by the intended purpose, the characteristics or elements that are particular to the specific geographical, contextual, behavioural or functional setting within which the high-risk AI system is intended to be used.

5. To the extent that it is strictly necessary for the purposes of ensuring bias detection and correction in relation to the high-risk AI systems in accordance with the second paragraph, point f and fa, the providers of such systems may exceptionally process special categories of personal data referred to in Article 9(1) of Regulation (EU) 2016/679, Article 10 of Directive (EU) 2016/680 and Article 10(1) of Regulation (EU) 2018/1725, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. In addition to provisions set out in the Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725, all the following conditions shall apply in order for such processing to occur:

(a) the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data;

(b) the special categories of personal data processed for the purpose of this paragraph are subject to technical limitations on the re-use of the personal data and state of the art security and privacy-preserving measures, including pseudonymisation;

(c) the special categories of personal data processed for the purpose of this paragraph are subject to measures to ensure that the personal data processed are se

subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and ensure only authorised persons have access to those personal data with appropriate confidentiality obligations;

(d) the special categories of personal data processed for the purpose of this paragraph are not to be transmitted, transferred or otherwise accessed by other parties;

(e) the special categories of personal data processed for the purpose of this paragraph are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whatever comes first;

(f) the records of processing activities pursuant to Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725 includes justification why the processing of special categories of personal data was strictly necessary to detect and correct biases and this objective could not be achieved by processing other data.

6. For the development of high-risk AI systems not using techniques involving the training of models, paragraphs 2 to 5 shall apply only to the testing data sets.