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The European AI Act, the Digital Omnibus and the reality Europe can no longer ignore

 

By Antonio Tejeda Encinas | CEO, META Channel Corporation | President, CEA Digital Law (Euro-American Committee of Digital Law)

I. A starting point that Europe has tried to disguise

In 2024, Europe celebrated the adoption of the AI Act as if it marked a turning point. The narrative was simple: ethical leadership, protection for citizens and a regulation the world would admire.

The reality has been different. While speeches were being made:

  • The EU attracted barely 10% of global investment in AI in 2024-2025.
  • The US accounted for 65%.
  • Asia, 25%.
  • European startups in critical sectors—healthcare, fintech, automation—moved straight to the US so they could operate without being held back.
  • Mistral AI, one of the few European-born companies with global ambitions, opened offices in San Francisco to grow.

It is not a question of “complying” or not complying. It is a design problem: the framework created to protect has raised a wall that only Big Tech can climb.

And this brings us to the second piece on the board.

II. Before sorting out the AI Act, Europe has already set another process in motion: the Digital Omnibus

In late 2025, the European Commission has been pushing forward what it calls the Digital Omnibus: a package of coordinated reforms to “simplify” the European digital ecosystem, including:

  • adjustments to the AI Act,
  • amendments to the GDPR,
  • ePrivacy review,
  • consistency with DORA,
  • and harmonisation with MiCA and the DMA.

The formal presentation is scheduled for 19 November 2025, although much of the content is already circulating in drafts and leaks.

The official message is “simplification”. The political effect is different: an admission that the current European digital framework does not work coherently. And this confirms what the market has sensed for a year.

III. Europe does not have a one-off problem: it has four simultaneous fractures

1. Regulatory fracture: too many rules without coordination

AI Act, GDPR, MiCA, DMA, DORA and sectoral regulation form a system that was never designed to coexist.

Clear examples:

Medical diagnosis with AI – The AI Act requires large, representative datasets. – The GDPR requires strict data minimisation. The company has to maximise and minimise at the same time.

Biometrics The same fingerprint may be ultra-sensitive data or not be “high risk,” depending on the use.

Finance – AI Act: high risk. – GDPR: mandatory human intervention. – DMA: interoperability. – Financial supervisors: statistical validation.

The European Parliament has already admitted it: “lack of coordination, duplication of costs and contradictory criteria”.

The Digital Omnibus tries to correct part of the problem, but it reveals a bigger one: Europe legislated before building an institutional architecture capable of sustaining that level of regulation.

2. Economic fracture: European costs that make it impossible to compete

  • Complying with the AI Act for high-risk systems costs €500,000 – 2 million.
  • EU 2025 aggregate impact: 10.9 billion.
  • Result: 90% of the European GPAI market in the hands of US companies.

The Digital Omnibus does not eliminate this imbalance. It only proposes partial and temporary relief for mid-caps and startups. It does not resolve the underlying asymmetry.

3. Timing fracture: timetables out of step with reality

  • High-risk obligations: August 2026.
  • Technical standards: Q2 2026, at best.
  • Notified bodies: most not yet designated.
  • Regulatory guidance arriving after entry into force.

The Digital Omnibus provides for delays and “clock-stops”. But not because Europe wants to be flexible: it is because it cannot get there in time.

4. Global fracture: Europe competes alone

  • US: light-touch regulation and rapid adaptation.
  • China: strict control + 50 billion in subsidies.
  • Europe: rigid regulation + zero equivalent subsidies.

Foundation models in 2025: – Europe: 3 – US: 40 – China: 15

It is not a cyclical problem: it is structural.

IV. The loosening of the AI Act reported in the press is not a reform: it is an admission

The leaks (FT, Reuters, Tech Policy Press) point to:

  • delayed penalties,
  • exemptions for mid-sized companies,
  • GPAI flexibility,
  • a clock-stop for high-risk systems.

The Digital Omnibus is the formal vehicle for introducing these adjustments. But its origin is clear: Europe has realised that the law, as it stands, is not sustainable in practice. Uncertainty, however, continues to grow: each leak generates paralysis. And the absence of clear political communication amplifies the feeling of improvisation.

V. What really works in 2025–2028?

  1. Smart defensive classification Prevent systems from “falling” into high risk by default.
  2. Avoid open-source without contractual traceability Especially until 2027.
  3. Document automation from CI/CD It’s not optional: it’s the only way to withstand simultaneous audits.
  4. Active use of national sandboxes Spain, Germany and France are acting as regulatory decompression zones.
  5. Honest communication to investors

“We are aligning evolving standards with traceable documentation from the pipeline”. In an unstable environment, this message builds trust.

VI. Who is executing, not improvising

This point is important.

Few organisations work at the real intersection of the legal, the technical and the operational. META Channel Corporation is one of them.

While others separate regulations by department, META Channel Corporation translates the AI Act, GDPR, MiCA, DORA and sectoral regulation into a single operating model.

This makes possible something most organisations would not even know where to start with: making five regulatory frameworks work as if they were one, without internal contradictions.

It is not theory or marketing. It is architecture. And it is what allows us to build while others continue to discuss interpretations.

VII. Europe needs clarity, not more layers of regulation

The AI Act was born of a legitimate political conviction. The Digital Omnibus is born of an urgent institutional need. But a continent cannot stand on principles alone. It needs consistent rules, realistic timetables and regulators that talk to each other.

If the Digital Omnibus stops at minor adjustments rather than fundamental reform, Europe will prolong its uncertainty until the end of the decade. Meanwhile, companies can’t wait for Brussels to get its act together.

The only sensible strategy is to prepare for the most realistic scenario: a partially corrected, partially watered-down AI Act, applied by authorities that will continue to interpret it unevenly for years.

Whoever adapts to that scenario will be able to compete. Whoever does not will be trapped between rules that don’t fit.

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