With the proposal for the Digital Omnibus Regulation, the European Commission is opening a new phase of European digital policy. The goal is to make central laws more coherent, comprehensible and practical. Our new study shows how the simplification of the AI Act can succeed without jeopardizing protection and trust.

In August 2024, the AI Act entered into force as one of the European Union’s most recent digital regulatory frameworks and has since been moving step by step into its implementation phase. Yet even before the first provisions take full effect, it has become clear that implementation in practice faces significant hurdles. The development of key standards, technical guidelines and cross-sectoral interpretations needed for consistent application is progressing slowly. In many member states, the establishment of national enforcement authorities is delayed, and coordination between national and European levels remains unclear in several areas. These practical challenges not only jeopardize smooth implementation but also risk fragmentation and inconsistency within the European legal framework.

Implementation Meets Competitive Pressure

At the same time, the debate about the future of European competitiveness and regulation gained a new political dimension with the publication of the Draghi Report in September 2024. Mario Draghi emphasizes that Europe’s economic strength crucially depends on how well innovation and regulation are aligned. His main objective is to streamline and harmonize existing legal frameworks to create the foundation for sustainable competitiveness. A year later, in his reflections on the report, Draghi highlighted the growing strategic importance of digital regulation and artificial intelligence, while also pointing to persistent barriers in implementation and enforcement and the need for more practical and effective approaches. This debate has also gained urgency considering growing geopolitical pressure on Europe to secure its digital and economic sovereignty. As a result, the discussion surrounding the AI Act and other digital laws is once again not merely technical or legal but a deep political debate about Europe’s economic, technological and democratic future.

Simplification as a Political Priority

With the Omnibus Agenda, the European Commission is seeking to address these challenges. The initiative covers six thematic packages, ranging from sustainability and investment to agriculture, security and industry. It aims to modernize the European legal framework by 2030, reduce bureaucracy and eliminate contradictions between existing regulations.
The Digital Package, part of Omnibus IV within this agenda, focuses particularly on simplifying existing digital acts. The goal is to avoid overlaps and redundancies, harmonize reporting requirements and make the regulatory framework more practical. For the first time, key digital laws are being jointly reviewed for coherence, clarity and applicability.

How the AI Act Can Be Simplified

Our study “Simplifying European AI Regulation – An Evidence-Based Study,” authored by Prof. Dr. Philipp Hacker, Dr. Robert Kilian and Prof. Dr. Jana Costas and supported by the German AI Association, shows how the AI Act itself offers opportunities for simplification and how these could be implemented in practice. Based on 15 semi-structured interviews and a stakeholder workshop with companies, start-ups, associations and civil society organizations from across Europe, the study analyzes where the main practical and structural challenges in implementation lie and formulates recommendations for achieving simplification, coherence and legal certainty without weakening the protective purpose of the law.

The authors recommend, for example:

  1. Sharpening risk classification and governance: Apply more sector-specific approaches for high-risk systems, avoid duplicate checks and establish clear rules for General Purpose AI (GPAI) and fine-tuning.
  2. Reducing technical and procedural burdens: Streamline overlapping obligations, make documentation more risk-based, harmonize technical standards and improve access to them.
  3. Strengthening accountability, oversight and support: Clarify liability along the value chain, consolidate supervisory structures and build targeted support for small and medium-sized enterprises (SMEs) and civil society actors.

Simplification does not mean deregulation but rather more precise regulation with clear responsibilities, comprehensible requirements and consistent procedures that strengthen trust, efficiency and competitiveness alike.

Recalibrating Europe’s Digital Regulation

Our study comes at a decisive moment. On November 19, 2025, the European Commission published its Digital Omnibus Regulation Proposal as part of the Digital Package, which includes the AI Act, the Data Act, the General Data Protection Regulation (GDPR) and cybersecurity directives such as NIS2, thereby laying the foundation for the ongoing negotiations. The European Union is at a stage where the guardrails of digital policy are being redrawn and where it will be decided whether regulation can be simplified without losing clarity, protection and value orientation.

What is decided in the upcoming negotiations on the Digital Omnibus Regulation deserves particular attention. Simplification should not become a political measure that creates unintended loopholes or new uncertainties. It must not weaken trust and institutional structures but instead contribute to strengthening them. At the same time, the process offers the opportunity to make European digital policy more modern and effective.

Properly implemented, simplification can foster innovation, facilitate market access for small and medium-sized enterprises and make cooperation between supervisory authorities and businesses more efficient. It offers the possibility of making the European legal framework clearer, more transparent and easier to apply, strengthening the link between protection, trust and competitiveness. In this way, Europe can reliably anchor its values of transparency, fairness and democratic participation in the next phase of digital regulation.

This requires clear, fair and workable rules that provide orientation for European start-ups and SMEs while safeguarding fundamental and digital rights, the core of Europe’s existing regulatory framework. These foundations must not be lightly put at risk during the Digital Omnibus process.

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