(a)

the relevant design choices;

(b)

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

(c)

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

(d)

the formulation of assumptions, in particular 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, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;

(g)

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

(h)

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

(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 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 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 have access to those personal data with appropriate confidentiality obligations;

(d)

the special categories of personal data are not to be transmitted, transferred or otherwise accessed by other parties;

(e)

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;

(f)

the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 include 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.

(a)

a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;

(b)

techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;

(c)

techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;

(d)

examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system, and the frequency with which they have to be carried out;

(e)

technical specifications, including standards, to be applied and, where the relevant harmonised standards are not applied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that the high-risk AI system complies with those requirements;

(f)

systems and procedures for data management, including data acquisition, data collection, data analysis, data labelling, data storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data that is performed before and for the purpose of the placing on the market or the putting into service of high-risk AI systems;

(g)

the risk management system referred to in Article 9;

(h)

the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with Article 72;

(i)

procedures related to the reporting of a serious incident in accordance with Article 73;

(j)

the handling of communication with national competent authorities, other relevant authorities, including those providing or supporting the access to data, notified bodies, other operators, customers or other interested parties;

(k)

systems and procedures for record-keeping of all relevant documentation and information;

(l)

resource management, including security-of-supply related measures;

(m)

an accountability framework setting out the responsibilities of the management and other staff with regard to all the aspects listed in this paragraph.