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AI compliance

AI compliance & EU AI Act

Assess risk classes, meet documentation duties, stay compliant — pragmatic rather than bureaucratic.

The has been in force since 2024. The first prohibitions apply from February 2025, the duties for high-risk systems from August 2026. Anyone deploying or developing needs to classify their systems — and know which duties concretely follow.

is more than just the : GDPR remains applicable in parallel, industry-specific regulations (BaFin/, , healthcare) stack on top, copyright and liability questions too. Treating these in separate departments creates duplicate work and gaps at the same time.

The goal isn't a 200-page manual no one reads. The goal is a pragmatic framework that gets built into existing processes — templates, checklists, clearly assigned responsibilities and a risk register that actually gets maintained.

Process5 steps at a glance
  1. Inventory

    inventory incl. , data flows, responsibilities — as an record of processing.

  2. Risk classification

    Prohibited, high-risk, limited, minimal — documented per system with reasoning.

  3. Gap analysis

    Thinking + GDPR + industry rules together. Gap list with effort and priority.

  4. framework

    Policy, onboarding checklist, templates, roles, audit trail — built in pragmatically.

  5. Training & upkeep

    Staff awareness, update discipline, semi-annual self-check, incident process.

From AI Act status quo to a pragmatic compliance framework

Inventory

Before any compliance question comes an honest inventory. In most companies there's significantly more AI in use than management is aware of — shadow AI in marketing tools, translation apps, browser plugins, in the ChatGPT tabs employees keep open.

What we capture together:

  • Purchased AI software — CRM with AI features, marketing tools, HR software, translation services, automatic document recognition
  • Cloud AI APIs — where are OpenAI, Anthropic, Google Vertex, Azure OpenAI called directly? From which systems, with which data?
  • In-house AI — internal models, RAG systems, automated workflows with AI components
  • Shadow AI — what do staff use privately in a work context? ChatGPT tab in the browser, AI plugins in Word/Excel, image generators for presentations
  • Data flows — which personal data ends up where? Which systems leave the EU or go to US providers?
  • Responsibilities — who introduced which system? Who maintains it? Who decides on changes?

The result is an AI record of processing activities that reflects reality — not the wish list. Shadow AI becomes visible without being blanket-banned. Often the first value emerges right here: clarity about what the company actually works with.

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Industry

From the inventory and classification, a set of duties emerges per system. Now we compare what is already in place and what is missing — the classic gap analysis, applied to AI.

AI Act requirements per risk class:

  • Technical documentation (what does the system do, trained on which data, with which limits)
  • Risk management system (ongoing, not one-off)
  • Data governance (representativeness, bias checks, data provenance)
  • Logging and record-keeping duties (for high-risk systems)
  • Human oversight with clearly defined intervention points
  • Transparency and informing the people affected
  • Cybersecurity and robustness

GDPR overlap:

  • Legal basis for every processing — especially interesting for AI training data
  • DPIA at high risk, especially with profiling or automated decisions (Art. 22 GDPR)
  • DPA with every external AI processor that handles personal data
  • Document TOMs — encryption, access control, deletion concept, backups
  • Update the record of processing — enter AI processing cleanly
  • Check third-country transfers — Schrems II, Standard Contractual Clauses, Transfer Impact Assessment if needed

Industry-specific regulations:

  • Banks & financial services — MaRisk, BAIT, BAIT outsourcing module, MiFID II for investment recommendations
  • Healthcare professions — confidentiality (§ 203 StGB), patient data protection, MPG/MDR for medical devices
  • Law firms — professional secrecy, client protection, BRAO
  • KRITIS — extended IT security and reporting duties, penetration tests, contingency plans

From the comparison comes a concrete gap list per system: what's missing (documentation, process, technical measure), who's responsible, by when it must be in place, what it costs. Not a blanket “everything must be compliant” list, but prioritised by risk and effort.

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GDPRHigh-risk AIDPARecord of processingCompliance framework

Sounds interesting?

Let's talk it through in a free intro call and see how this would work for you.

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