Data in the draft EU regulation on Artificial Intelligence

A draft Regulation on Artificial Intelligence has recently been made public as part of the European Commission's initiative in this area. It is directly linked to the proposal on data governance, the Directive on the re-use of public sector information and open data, as well as other initiatives in the framework of the European Data Strategy.

This measure is an important step forward in that it means that the European Union will have a uniform regulatory framework that will make it possible to go beyond the individual initiatives adopted by each of the Member States which, as in the case of Spain, have approved their own strategy under a Coordinated Plan that has recently been updated with the aim of promoting the global leadership of the European Union in the commitment to a reliable Artificial Intelligence model.

Why a Regulation?

Unlike the Directive, the EU Regulation is directly applicable in all Member States, and therefore does not need to be transposed through each Member State's own legislation. Although the national strategies served to identify the most relevant sectors and to promote debate and reflection on the priorities and objectives to be considered, the fact is that there was a risk of fragmentation in the regulatory framework given the possibility that each of the States to establish different requirements and guarantees. Ultimately, this potential diversity could negatively affect the legal certainty required by Artificial Intelligence systems and, above all, impede the objective of pursuing a balanced approach that would make the articulation of a reliable regulatory framework possible, based on the fundamental values and rights of the European Union in a global social and technological scenario. 

The importance of data

The White Paper on Artificial Intelligence graphically highlighted the importance of data in relation to the viability of this technology by stating categorically that "without data, there is no Artificial Intelligence". This is precisely one of the reasons why a draft Regulation on data governance was promoted at the end of 2020, which, among other measures, attempts to address the main legal challenges that hinder access to and reuse of data.

In this regard, as emphasised in the aforementioned Coordinated Plan, an essential precondition for the proper functioning of Artificial Intelligence systems is the availability of high-quality data, especially in terms of their diversity and respect for fundamental rights. Specifically, based on this elementary premise, it is necessary to ensure that:

• Artificial Intelligence systems are trained on sufficiently large datasets, both in terms of quantity and diversity.
• The datasets to be processed do not generate discriminatory or unlawful situations that may affect rights and freedoms.
• The requirements and conditions of the regulations on personal data protection are considered, not only from the perspective of their strict compliance, but also from the perspective of the principle of proactive responsibility, which requires the ability to demonstrate compliance with the regulations in this area.

The importance of access to and use of high-quality datasets has been particularly emphasised in the draft regulation, in particular with regard to the so-called Common European Data Spaces established by the Commission. The European regulation aims to ensure reliable, responsible and non-discriminatory access to enable, above all, the development of high-risk Artificial Intelligence systems with appropriate safeguards. This premise is particularly important in certain areas such as health, so that the training of AI algorithms can be carried out on the basis of high ethical and legal standards. Ultimately, the aim is to establish optimal conditions in terms of guarantees of privacy, security, transparency and, above all, to ensure adequate institutional governance as a basis for trust in their correct design and operation. 

Risk classification at the heart of regulatory obligations 

The Regulation is based on the classification of Artificial Intelligence systems considering their level of risk, distinguishing between those that pose an unacceptable risk, those that entail a minimal risk and those that, on the contrary, are considered to be of a high level. Thus, apart from the exceptional prohibition of the former, the draft establishes that those that are classified as high risk must comply with certain specific guarantees, which will be voluntary in the case of system providers that do not have this consideration. What are these guarantees?

• Firstly, it establishes the obligation to implement a data quality management model to be documented in a systematic and orderly manner, one of the main aspects of which refers to data management systems and procedures, including data collection, analysis, filtering, aggregation, labelling.
• Where techniques involving the training of models with data are used, system development is required to take place on the basis of training, validation and test datasets that meet certain quality standards. Specifically, they must be relevant, representative, error-free and complete, taking into account, to the extent required for the intended purpose, the characteristics or elements of the specific geographical, behavioural or functional environment in which the Artificial Intelligence system is intended to be used.
• These include the need for a prior assessment of the availability, quantity and adequacy of the required datasets, as well as an analysis of possible biases and gaps in terms of data gaps, in which case it will be necessary to establish how such gaps can be addressed.

In short, in the event that the Regulation continues to be processed and is finally approved, we will have a regulatory framework at European level which, based on the requirements of respect for rights and freedoms, could contribute to the consolidation and future development of Artificial Intelligence not only from the perspective of industrial competitiveness but also in accordance with legal standards in line with the values and principles on which the European Union is based.

Content prepared by Julián Valero, Professor at the University of Murcia and Coordinator of the Research Group "Innovation, Law and Technology" (iDerTec).

The contents and views expressed in this publication are the sole responsibility of the author.