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S02 · EU Compliance

Healthcare / Hospital — compliance

Healthcare organisations handle the most sensitive personal data in the EU. NEN7510, NIS2, AVG and BIG certification create a complex compliance stack — with patient safety directly at stake.

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Relevant roles: CIO · CISO · CFO · CEO

What keeps compliance officers awake

// SECTOR REALITY

A ransomware attack on a hospital is no longer just an IT problem — it is a patient safety incident under NIS2. NEN7510 requires a certified ISMS. BIG registration demands proven competency frameworks. AVG applies to every patient record.

Applicable EU frameworks

NEN7510
NEN 7510:2 — Healthcare Information Security
Dutch standard for ISMS in healthcare. ISO 27001 equivalent, healthcare-specific controls.
NIS2
Network & Information Security Directive 2
Hospitals are essential entities: 24h incident reporting, strict supply chain oversight.
AVG/GDPR
Algemene Verordening Gegevensbescherming
Patient data = special category data. DPA required, consent management, breach notification.
BIG
Beroepen in de Individuele Gezondheidszorg
Healthcare professional registration. Compliance competency requirements.
Free · 30 minutes

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