Healthcare = high-risk AI + NIS2 essential entity

AI in healthcare saves lives.
Without rules, it endangers them.

Diagnostic AI, patient triage, predictive analytics — all classified as high-risk under AI Act. You are also an essential entity under NIS2, processing health data protected by GDPR Art. 9. We help you establish governance, documentation, and training in 2–3 weeks.

Book a free call → Check where you stand (5 min) ▷

77 % of hospitals lack AI governance

54 % of cyberattacks are ransomware

€300k median incident cost

2–3 weeks to full compliance

Healthcare Challenges

Four regulations at once.
One wrong answer is enough.

Hospitals and healthcare organisations are under pressure from AI Act, NIS2, GDPR, and MDR simultaneously. Each regulation has different deadlines, different requirements — and penalties for non-compliance reach millions of euros.

Diagnostic AI is high-risk

AI Act Annex III classifies diagnostic AI, triage, and predictive analytics as high-risk. You need CE marking, DPIA, human oversight, and complete technical documentation. Deadline: August 2026.

AI Act — Annex III, Art. 6

Patient data under GDPR Art. 9

Health data is a special category with stricter processing rules. Audit trails, explicit consent, DSAR within 30 days — and fines up to 4% of turnover. The average healthcare data breach costs over $10 million.

GDPR — Art. 9, Art. 35

NIS2: essential entity with proactive oversight

Hospitals are essential entities under NIS2. That means regular audits, security scans, and incident reporting to the national authority within 24 hours — even without a specific incident. Ransomware accounts for 54% of attacks on healthcare.

NIS2 — Annex I, Sector 5

MDR + AI Act = dual classification

If your AI system qualifies as a medical device, it falls under the Medical Device Regulation and AI Act simultaneously. Dual compliance, dual documentation — and only 13% of providers have tested crisis procedures for AI.

MDR 2017/745 + AI Act Art. 6

What We Deliver

Governance as patient protection,
not bureaucratic overhead.

We prepare complete documentation and policies tailored to your healthcare organisation. You invest 2–3 hours of your time, we handle the rest.

AI Policy tailored for healthcare

Acceptable Use Policy, AI system classification per Annex III, rules for clinical and administrative AI.

DPIA for health data

Data Protection Impact Assessment for AI systems processing patient data per GDPR Art. 35 and AI Act.

Training AI literacy for clinical staff

AI Act requires AI literacy (Art. 4). We prepare training for doctors, nurses, and admin staff — with certificates.

Audit Trail ready for inspection

Complete documentation for regulators. Only 22% of hospitals can produce an audit trail within 30 days — you will be able to.

NIS2 Gap Analysis for essential entities

We map your cybersecurity gaps against NIS2 requirements. Incident response, network segmentation, supply chain.

AI System Registry inventory and classification

We map all AI systems in clinical and administrative operations. Classify risks according to AI Act Annex III.

How It Works

Three steps. In 2–3 weeks, your AI will be under control.

You do not need to read hundreds of pages of regulations. We do it for you.

We assess your status

We conduct an inventory of AI systems in clinical and administrative operations. Identify high-risk systems, map patient data flows, and assess NIS2 gaps. It takes one introductory call and a questionnaire.

We prepare documentation

AI policy tailored to your healthcare organisation, DPIA for systems handling health data, risk classification per Annex III, training materials for clinical staff. You invest 2–3 hours of review.

We train and hand over

We train your staff (doctors, nurses, administration), deliver complete documentation, and leave you audit-ready for regulators. With certificates for every participant.

Further Perspectives