NEN 7510, GDPR, NIS2, WGBO, NIS2 — the Dutch healthcare sector is one of the most regulated markets in Europe. The right product with the wrong regulatory story doesn't get past procurement. We know both sides of that equation.
| Requirement | What it means for your product |
|---|---|
NEN 7510 Information security in healthcare |
Mandatory for all healthcare organisations. Your product must fit within a NEN 7510-certified environment or hold certification itself. Audit trail: 4-9 months to certification. |
GDPR / AVG Patient data processing |
DPA appointment, DPIA required, verwerkersovereenkomst mandatory before any pilot. EU hosting required — no exceptions for patient data. |
NIS2 Network & information security |
In force 2025. Healthcare organisations must demonstrate security controls for all vendors with system access. Your compliance status is a procurement criterion. |
WGBO Medical treatment contracts |
Patient information obligations. Any product touching patient communication must demonstrate WGBO alignment — relevant for education, discharge, consent tools. |
EU AI Act AI classification |
AI-assisted medical tools may be classified as high-risk or prohibited. Classification must be determined before market entry — not after. |
Direct C-level introductions across all major healthcare segments. Not cold outreach — warm connections built over 30 years.
Following the Zivver/Kiteworks acquisition and the Dutch cabinet's official confirmation that CLOUD Act applies to Zivver data — even stored on European servers — approximately 40% of Dutch hospitals began actively evaluating alternatives.
HCI identified a fully European compliance communications platform — email, chat, video and file sharing — as the optimal fit. Assessment: market timing optimal, NEN 7510 roadmap achievable in 4-9 months, Office365 drop-in differentiator.
SSC-ICT (9 Dutch ministries, 58,000 civil servants) has already migrated away from Zivver. The Ministry of Justice switched to SecuMailer. Hospital CISOs and boards are asking the same question: what now? HCI is positioning the answer before the procurement round begins in 2026.
Three structural forces are creating demand for technology in Dutch healthcare that didn't exist five years ago.
Ready to Enter Dutch Healthcare?
The EU Healthcare Readiness Scan assesses your NEN 7510, GDPR, NIS2 and WGBO position. Seven minutes. No sales call required.