AI for healthcare and pharmaceutical organisations.

The constraint

Healthcare AI sits at the intersection of three regulators: GDPR (patient data is special-category personal data under Art. 9), the EU AI Act (clinical AI often qualifies as high-risk under Annex III), and the Medical Device Regulation (MDR) for anything that crosses into device territory. Public AI APIs aren’t just risky — they’re usually disqualified.

What we deliver here

• Private AI architectures — on-prem LLMs for clinical document search, patient intake summarisation, prior-authorization drafting, research literature review. Data stays on hospital infrastructure.
• EU AI Act compliance for clinical AI — Annex III risk classification, Annex IV documentation, conformity declaration, Art. 4 literacy. See our EU AI Act page.
• MDR-aware tooling guidance — advice on when an AI feature triggers MDR classification and what that means for your documentation burden.
• RAG over your own clinical corpora — protocols, SOPs, regulatory submissions, internal research, literature subscriptions. With proper data lineage and citation.
• GDPR + ePrivacy compliance for any patient-facing AI — consent flows, data minimisation, retention periods, DPIA.

Where to start

For healthcare organisations we typically suggest one of: AI Readiness Assessment if you’re evaluating the landscape; Private AI & Infrastructure Package if you’re ready to design an on-prem stack; or our broader AI Compliance service if the regulatory side is what’s holding you up.