Simplifying with Responsibility: How Europe Can Make the AI Act More Practical

By publishing the proposal for the Digital Omnibus Regulation on 19 November 2025, the European Commission launched a new phase of European digital policy. The goal is to harmonize major legal acts such as the AI Act, the Data Act, the GDPR, and cybersecurity directives such as NIS2, and to make their implementation more practical. The regulation aims to reduce bureaucracy, strengthen legal certainty, and uphold Europe’s values of transparency, fairness, and democratic participation. The new study illustrates how the simplification of the AI Act can enhance both efficiency and trust in regulation.

Since the AI Act came into force in August 2024, Europe has faced the challenge of turning its complex legal framework into practice. Progress on key standards, technical guidelines, and cross-sectoral interpretations has been slow. Many Member States are experiencing delays in setting up national supervisory structures, and coordination between national and European levels remains unclear.

The publication of the Draghi Report in September 2024 has also revived the debate on Europe’s competitiveness and regulatory approach. Mario Draghi emphasizes that Europe’s economic strength depends on how successfully innovation and regulation can be balanced. His call for clearer and more harmonized legal frameworks is reflected in the European Union’s current agenda, particularly in the Omnibus Agenda, which seeks to modernize the European legal framework by 2030 and to eliminate inconsistencies between existing regulations.

Based on fifteen semi-structured interviews and a stakeholder workshop with companies, start-ups, associations, and civil society organizations from across Europe, the study, supported by the German AI Association, identifies the main practical and structural challenges in implementing the AI Act. It also provides concrete proposals on how to achieve simplification, coherence, and legal certainty without weakening the protective goals of the law.

The authors Prof. Dr. Philipp Hacker, Dr. Robert Kilian, and Prof. Dr. Jana Costas present the following recommendations:

1. Refine risk classification and governance. Apply more sector-specific approaches for high-risk systems, avoid duplicate assessments, and define clear rules for general-purpose AI and fine-tuning.
2. Simplify technical and procedural requirements. Streamline overlapping obligations, make documentation more risk-based, harmonize technical standards, and improve access to them.
3. Strengthen accountability, oversight, and support. Clarify liability along the value chain, consolidate supervisory structures, and provide targeted support for small and medium-sized enterprises and civil society organizations.

Simplification in this context does not mean reducing protection. It refers to a more precise form of regulation that creates clear responsibilities, understandable requirements, and consistent procedures. Such an approach builds trust and promotes efficiency and competitiveness at the same time.

The outcome of the upcoming negotiations on the Digital Omnibus Regulation will determine whether the planned simplification of European digital laws leads to greater coherence. Simplification should not turn into a political exercise that creates loopholes or new uncertainties. It can become an opportunity to make existing rules clearer, easier to understand, and more practical.

It is important that new structures promote trust and provide clear guidance for European start-ups as well as small and medium-sized enterprises. At the same time, the fundamental principles of the European digital governance framework such as transparency, fairness, and democratic participation must continue to be safeguarded under the Digital Omnibus Regulation.

For a concise introduction to the topic, the previously published white paper offers an initial overview.