Feb 5, 2024

Are you ready for the new Artificial Intelligence Regulation?

Have you heard that there is a future European Regulation that is going to apply to artificial intelligence services and systems?

We will tell you the relevant key points:

1. Processing status

The final text of the Regulation has been agreed by the European institutions.

2. Subjects affected

In general, the Regulation will apply to:

  • Providers placing AI systems or general purpose AI models on the EU market irrespective of where they are located (inside or outside the EU).
  • Entities implementing AI systems that are established in the EU.
  • Service providers and entities implementing AI systems located outside the EU but where the output produced by the system is used in the EU.
  • Importers and distributors of AI systems.
  • Manufacturers placing on the market or operating AI systems together with their product and under their name and brand name.
  • Authorized representatives of providers not established in the EU.Persons affected by these systems located in the EU.

3. What is being regulated?

  • Sets harmonized rules for placing on the market, putting into operation and use of AI systems.
  • Sets prohibitions for certain practices with AI / AI systems.
  • Establishes specific requirements for high-risk systems and obligations to be met by operators of such systems.
  • Establishes harmonized and transparent rules for the placing on the market of so-called general-purpose AI models.
  • Establishes rules for supervision.
  • Sets out measures for the promotion of innovation with a special focus on SMEs and start-ups.

4. Typologies of AI systems

The following systems are essentially contemplated:

  • Systems / prohibited systems.
  • High-risk systems which will have to comply with a number of regulatory requirements (e.g., a risk management system or a design and implementation that enables human oversight, fundamental rights impact assessments, descriptive technical documentation, etc.).
  • Non-high-risk systems.
  • General purpose AI models.

5. Facilities for SMEs and Start-ups

The Regulation contemplates a series of measures aimed at facilitating the promotion of projects by this type of companies, such as, for example:

Priority access to the sandbox provided they meet the eligibility criteria.

  • Training activities on the application and obligations under the Regulation.
  • Use of existing communication channels and implementation of new channels with local public authorities to answer questions on the obligations to be fulfilled.
  • Encouragement of the participation of this type of companies in standardization processes.
  • Consideration of the size of this type of companies for the calculation of the fees to be paid for conformity assessments.
  • In the case of penalties, these should take into account the interests of this type of companies and their economic viability

6. Sandbox

Defined in the Regulation as a concrete and controlled framework set up by a competent authority offering potential AI system providers the possibility to develop, train, validate and test, if necessary under real conditions, an innovative AI system, according to a sandbox plan for a limited time under regulatory supervision.

7. The AESIA

On August 23, 2023, the Council of Ministers approved the Royal Decree approving the statute of the Agencia Española de Supervisión de la Inteligencia Artificial (Spanish Agency for the Supervision of Artificial Intelligence), becoming the first European country to have an organization with these characteristics.

Among their competencies, it is worth mentioning the following:

Within the scope of state competence, exercise of the functions of the authority responsible for the supervision and, where appropriate, sanctioning of artificial intelligence systems with the aim of eliminating or reducing risks to integrity, privacy, equal treatment and non-discrimination.

  • The promotion of the sandbox to reinforce the protection of users and avoid discriminatory biases.
  • The supervision of the implementation, use or commercialization of AI systems, especially those that may pose significant risks to health, safety, equal treatment and non-discrimination.

Further information

For questions related to the topic raised in this article, please contact Gonzalo Navarro.

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