The EU AIA – Recital 67 states, “High-quality data and access to high-quality data plays a vital role in providing structure and in ensuring the performance of many AI systems, especially when techniques involving the training of models are used, with a view to ensure that the high-risk AI system performs as intended and safely and it does not become a source of discrimination prohibited by Union law.

High-quality data sets for training, validation and testing require the implementation of appropriate data governance and management practices. [ For medical device entities, the QMS should address data lifecycle. ]

Data sets for training, validation and testing, including the labels, should be:

• relevant,
• sufficiently representative, and
• to the best extent possible free of errors and complete in view of the intended purpose of the system.

In order to facilitate compliance with Union data protection law, such as Regulation (EU) 2016/679, data governance and management practices should include, in the case of personal data, transparency about the original purpose of the data collection.

The data sets should also have the appropriate statistical properties, including as regards the persons or groups of persons in relation to whom the high-risk AI system is intended to be used, with specific attention to the mitigation of possible biases in the data sets, 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 (feedback loops).

Biases can for example be inherent in underlying data sets, especially when historical data is being used, or generated when the systems are implemented in real world settings. Results provided by AI systems could be influenced by such inherent biases that are inclined to gradually increase and thereby perpetuate and amplify existing discrimination, in particular for persons belonging to certain vulnerable groups, including racial or ethnic groups. The requirement for the data sets to be to the best extent possible complete and free of errors should not affect the use of privacy-preserving techniques in the context of the development and testing of AI systems. In particular, data sets should take into account, to the extent required by their intended purpose, the features, characteristics or elements that are particular to the specific geographical, contextual, behavioural or functional setting which the AI system is intended to be used. The requirements related to data governance can be complied with by having recourse to third parties that offer certified compliance services including verification of data governance, data set integrity, and data training, validation and testing practices, as far as compliance with the data requirements of this Regulation are ensured.”