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The European Commission publishes the draft delegated act on high-risk AI systems — consultation open until 30 April 2026.

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RAGFebruary 17, 202615 min read

Secure RAG architecture for regulated sectors: 2026 technical guide

How to deploy an AI Act-compliant RAG (Retrieval-Augmented Generation) system in a banking, medical or industrial environment? Data sovereignty, traceability, robustness.

Why RAG is particularly sensitive in regulated sectors

A RAG (Retrieval-Augmented Generation) architecture combines a language model with a proprietary knowledge base. In regulated sectors, this base contains sensitive data: client files, medical data, contracts, financial data. The question of sovereignty, traceability and robustness is therefore central.

The 4 pillars of an AI Act-compliant secure RAG

1. Data sovereignty — Training and context data do not leave your infrastructure. On-premise or sovereign cloud deployment (SecNumCloud, EUCS). No client data transmitted to third-party models.

2. Full traceability — Every query, every source mobilised, every generated response is logged (Art. 12). Logs are retained according to regulatory timeframes and accessible to auditors.

3. Robustness and adversarial testing — Resistance testing against prompt injection attacks, hallucinations and biases. Compliance with Art. 15 on accuracy and robustness.

4. Human oversight — Any high-impact decision (credit, diagnosis, recruitment) involves documented human validation before execution (Art. 14).

Valyence™ reference architecture

Our reference RAG architecture for regulated sectors is based on: an open-source LLM deployed on-premise (Mistral, LLaMA), an isolated vector database (Qdrant, Weaviate), an auditable RAG pipeline, a human oversight module and a compliant logging system.

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