AI Act & Ethics Help Desk

The AI Act is Regulation (EU) 2024/1689, the European Union’s law on artificial intelligence. It entered into force on 1 August 2024, and its obligations apply in stages.

It sets rules according to risk: it bans AI practices that pose an unacceptable risk, sets strict requirements for high-risk systems and transparency obligations for some systems such as chatbots. It adds no rules for minimal-risk systems. General-purpose AI models have their own rules.

That depends on your role. The Act covers providers that place AI systems on the EU market, organisations that use them in the EU (deployers), importers and distributors.

A company established outside the EU, for example in Türkiye, can also be covered if it places its system on the EU market or if the system’s output is used in the EU. The Commission’s Compliance Checker gives you a first indication.

If your AI system processes personal data, GDPR applies alongside the AI Act; the AI Act does not replace it. Health data is a special category under GDPR and is subject to stricter conditions.

Organisations established in Türkiye are subject to Law No. 6698 on the Protection of Personal Data (KVKK). If you offer goods or services to people in the EU or monitor their behaviour, GDPR may also apply.

There are two groups. The first covers AI systems that are products, or safety components of products, under EU product legislation such as the medical device rules and that need a third-party conformity assessment. The second covers systems used in the areas listed in Annex III of the Act, such as biometrics, education, employment, access to essential public and private services or emergency patient triage.

These systems must meet requirements such as risk management, data governance, technical documentation, human oversight, accuracy and cybersecurity. Classification depends on the system’s intended purpose; the Commission’s guidelines on high-risk systems explain it with examples.

Testing and Experimentation Facilities (TEFs) are EU co-funded sites where AI solutions are tested in real or near-real conditions. There are four TEFs, for agri-food, healthcare, manufacturing and smart cities. TEF-Health offers testing, validation and regulatory compliance services for healthcare; you request its services through its own website.

AI Factories give access to AI-optimised supercomputing, with priority for start-ups and SMEs.

No. This page provides initial information only; DIGI4AGE does not give legal opinions, issue certificates or approve conformity.

For a legal assessment you need a lawyer; if your product needs a third-party conformity assessment, you need a notified body.

You can send questions about the AI Act to the European Commission’s AI Act Service Desk through its online form. The form requires an EU Login account; questions are written in one of the official EU languages, such as English, and are answered by experts working closely with the AI Office.

For personal data matters you can contact the data protection authority. For general questions to DIGI4AGE, please use our Contact page.