Compliance & Security

NEN 7510 & GDPR compliance in healthcare technology: what you really need to know

Compliance is not an obstacle to digitalization — it is the prerequisite for trust. A practical guide to information security and privacy in the Dutch healthcare sector.

By PCD CareHub 7 min read
Context

Why compliance is the key to successful healthcare digitalization

Digitalization in healthcare offers enormous opportunities: less administrative burden, better collaboration between chain partners, and a more complete patient overview. However, the sensitivity of health data means that healthcare organizations cannot simply implement new systems. Information security and privacy are not secondary concerns — they form the foundation of every digitalization project.

Yet many healthcare organizations view compliance as a barrier. The regulations are complex, requirements change, and the consequences of non-compliance are severe: fines from the Dutch Data Protection Authority, reputational damage, and — most importantly — risks to patients. The result: postponement of essential digitalization.

This is a missed opportunity. Compliance does not have to be a brake on innovation. Organizations that proactively set up information security and privacy actually digitalize faster and more securely. In this article, we outline the most important standards — and show how an ecosystem approach makes the compliance burden manageable.

100%

Of healthcare software must be NEN 7510-compliant

Source: NEN, Information security in healthcare

72 hrs

Data breach notification requirement (GDPR)

Source: Dutch Data Protection Authority

2027

EHDS implementation deadline EU

Source: European Commission, EHDS Regulation

NEN 7510 in practice: what it really requires from healthcare software

NEN 7510 is the Dutch standard for information security in healthcare. It is not a voluntary guideline: every organization that processes health data — from hospitals to software vendors — must comply. The standard is based on ISO 27001 but contains additional requirements specific to the healthcare sector.

1. Risk assessment as the starting point

NEN 7510 requires a systematic risk assessment: what threats exist to the confidentiality, integrity, and availability of health data? Based on this analysis, appropriate measures are implemented. This is not a one-time exercise but a continuous process.

2. Access management and authorization

Only authorized personnel may access patient data, and only the data they need for their work. Role-based access control (RBAC), multi-factor authentication, and logging of all access are core requirements.

3. Encryption and data protection

Health data must be encrypted both in storage and in transit. This applies to data at rest (stored in databases) as well as data in transit (exchanged between systems). End-to-end encryption is the standard.

4. Logging, monitoring, and incident response

All access to and modifications of health data must be logged. Continuous monitoring detects anomalies early. In the event of an incident, a tested response plan must be in place — including the legal obligation to report data breaches.

NEN 7510 vs. ISO 27001: what is the difference?

ISO 27001 is the international standard for information security. NEN 7510 builds on this with healthcare-specific requirements: stricter rules for access management to patient records, specific requirements for logging medical data, and additional measures for the availability of healthcare systems. An organization that is ISO 27001-certified does not automatically comply with NEN 7510.

Privacy

GDPR in healthcare technology: more than a privacy checkbox

The General Data Protection Regulation (GDPR) protects the personal data of all EU citizens. Health data falls under the highest protection category: special categories of personal data. Processing such data is in principle prohibited, unless there is a legal basis.

01

Data Protection Impact Assessment (DPIA)

When introducing new healthcare software or integrations, a DPIA is mandatory when the processing is likely to result in a high risk to data subjects. The DPIA maps out risks and describes the measures to mitigate them — before the system goes live.

02

Data processing agreements in an ecosystem

In an ecosystem like the CareHub, multiple software parties collaborate. The GDPR requires that every processing of personal data is contractually defined through data processing agreements. Who is the data controller, who is the data processor, which data is shared, and for what purpose?

03

Privacy-by-Design as an architectural principle

The GDPR requires that data protection is incorporated from the design phase of a system — not as an afterthought. This means: data minimization (only processing what is necessary), pseudonymization where possible, and the highest privacy settings by default. In the CareHub ecosystem, privacy-by-design is not optional but a design principle.

04

Data breach notification obligation

In the event of a data breach involving health data, the Dutch Data Protection Authority must be notified within 72 hours. Depending on the severity, affected patients must also be informed. A robust incident response plan is not a luxury — it is a legal obligation.

Wegiz and EHDS: the next compliance wave

In addition to NEN 7510 and the GDPR, two new regulatory frameworks are on the horizon that will fundamentally change how healthcare systems communicate with each other — and what requirements apply.

Wegiz — Electronic Data Exchange in Healthcare Act

The Wegiz mandates healthcare providers to exchange data electronically via standardized interfaces. No faxes, no PDFs by email — but structured data exchange via open standards. This requires systems that are FHIR- and HL7-compatible, and vendors that facilitate interoperability.

EHDS — European Health Data Space

The EHDS creates a European framework for sharing and reusing health data. Patients gain the right to access their data in any EU country, and researchers gain access to anonymized datasets under strict conditions. The implementation deadline is 2027.

Both regulatory frameworks share a common denominator: interoperability via open standards. Healthcare systems must be capable of exchanging structured data via standards such as FHIR and HL7. Organizations that invest in interoperable architecture now will be compliant later without major overhaul operations.

The CareHub ecosystem is designed with these future requirements in mind. By connecting healthcare software via open standards rather than proprietary integrations, participating organizations anticipate Wegiz and EHDS — and avoid costly last-minute compliance sprints. Read more about our vision on interoperability in our insight on interoperability in Dutch healthcare.

Compliance is not a brake — it is an accelerator

Organizations that proactively embrace NEN 7510, GDPR, and the Wegiz build the trust needed for sustainable digitalization. In the CareHub ecosystem, compliance is not solved per organization but distributed across specialized partners — each certified, each responsible for their domain. This is how compliance becomes scalable.

Read our other insights

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