NEN 7510 and AI: what to check before using an AI tool in healthcare

What is NEN 7510, and how does it differ from ISO 27001?

NEN 7510 is the Dutch standard for information security in healthcare, published by NEN, the Dutch standards body. It has two parts. NEN 7510-1:2024 sets the requirements for the management system and is the healthcare version of ISO 27001. NEN 7510-2 combines the controls of ISO 27002 with the healthcare controls of ISO 27799.

For Dutch law, NEN 7510-1:2024 and NEN 7510-2:2024+A1:2026 apply from 1 June 2026. Organisations certified to the old edition must move to the new one before 20 February 2027. NEN 7510, 7512 and 7513 are free to read on NEN Connect, under an agreement between the Dutch health ministry and NEN.

Outside the Netherlands NEN 7510 has no legal force. ISO 27001, with the controls of ISO 27799, is the usual equivalent; check your own country's rules for health data.

Who must comply with NEN 7510?

Every Dutch care provider that processes personal data in a care information system, including small practices and sole traders, according to the Health and Youth Care Inspectorate (IGJ). The legal basis is the Besluit elektronische gegevensverwerking door zorgaanbieders: Article 3 requires working to NEN 7510 and NEN 7512, and Article 5 requires logging to NEN 7513. Youth care providers use ISO 27001 instead.

The law does not require a certificate. You must show that you comply with the standard, and the IGJ expects an independent assessment at least once every three years. A supplier that works to NEN 7510 does not take that responsibility off you: the IGJ expects security requirements in your supplier contracts and an assessment of the supplier's service.

What does a vendor's NEN 7510 certificate cover?

It says that the vendor's information security management system, within a stated scope, was audited by a certification body that returns every year. Only organisations that process health data structurally can be certified; according to NEN, occasional access is not enough. A certificate does not cover:

• The software. Organisations are certified, products are not. NEN says the care organisation sets requirements and the supplier shows the software meets them.
• Anything outside the scope. The certified organisation sets its own scope, which can be one department or one service.
• Sub-processors. The language model often runs at a large provider such as OpenAI, Anthropic, Google or Microsoft, and the certificate does not certify it. Ask how the vendor assesses and controls that provider within its management system.
• The GDPR. NEN 7510 is about security. Whether you may process the data, and on what legal basis, is a separate question.
• Processing location. A certificate does not show where a question is processed, at the vendor or at the model provider.

What should you ask an AI vendor?

Trace one document and one question with patient data: what leaves when documents are indexed, what reaches the model, who stores it and for how long. Then ask:

What does the GDPR require when you use AI with health data?

Health data is special-category data. Article 9 GDPR prohibits processing it unless an exception applies, such as healthcare provided under professional secrecy, and you also need a lawful basis under Article 6. If the AI vendor processes the data on your instructions, agree Article 28 terms with it before use. A vendor that uses the data for its own purposes is not your processor.

A DPIA (Article 35) is required for large-scale processing of health data; in the Netherlands that is on the Dutch DPA's list. Recital 91 does not count an individual doctor's patient records as large-scale. New technology such as AI can still make a DPIA necessary because of the high risk. Either way, the AI tool belongs in the risk assessment that NEN 7510 already requires.

In August 2024 the Dutch DPA reported a breach at a GP practice, where an employee had entered patients' medical data into an AI chatbot against the practice's rules. A tool its maker intends for diagnosis or treatment can also be a medical device under the MDR, with its own requirements.

How does seef fit this checklist?

seef fits a care provider or other organisation with health data that wants AI to answer from its own documents and wants a vendor certified to NEN 7510. Timformatie, which runs seef and is the company you contract with, is certified to NEN 7510-1:2024 and ISO 27001:2022 by Brand Compliance, accredited by the RvA under C 548. The published scope covers data consultancy, including software development, implementation and the processing of personal health information, plus support for infrastructure and hosting.

With health data the choice of model matters, so with seef you choose the model with us, including models hosted in the EU. If processing must stay in the EU, we agree models and services that keep it there, and the data processing agreement records it. You get the processor list for your instance in writing. The AI providers in our standard setup state in their API terms that they do not train on your data by default. Files for part of your team can go in a knowledge base of their own, with its own access. The security page names each service that sees your data, where it processes it and how long data is kept.

Samergo, which advises on and guides partnerships across healthcare and social care, has used seef since mid-2025. Read how one of its advisers works with seef.