Europe's new AI regulations are reshaping healthcare. HARR guides primary sector providers through every step — from risk classification to full EHDS readiness — so you can adopt AI with confidence and legal clarity.
The EU AI Act, the European Health Data Space regulation, and updated MDR/IVDR requirements are converging. For primary care providers, the obligations are real — and the guidance is scattered.
AI tools used in clinical settings fall under high-risk categories requiring conformity assessments and ongoing monitoring.
Obligations span the EU AI Act, EHDS, GDPR, and MDR — with overlapping timelines and no single roadmap for GPs and clinics.
High-risk AI system rules begin applying in 2026. Many providers are unaware of what they already need to document today.
We turn regulatory complexity into a clear, actionable path — built specifically for primary healthcare providers, not large hospital systems.
We audit your current and planned AI tools, classify them under EU AI Act risk tiers, and identify your exposure before regulators do.
A prioritised, practice-specific action plan covering documentation requirements, governance structures, and staff obligations.
Continuous monitoring, regulatory update tracking, and incident-ready templates so your practice stays compliant as the landscape evolves.
We're a small team building with primary care providers, not just for them. Here's what's next.
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