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RetinaLyze System A/S (Copenhagen, DK); in NL via EyeVinci (Heemstede)

How safe is RetinaLyze for eye care?

GDPR profileOur summary of what the provider itself publishes about your data: whether the data is held in the EU (2 points), whether there is a certification or GDPR guarantee (1), and whether the provider is based in the NL or the EU (1). 3 or 4 points is Strong, 2 Good, 1 Limited, 0 Unknown. How we measure for eye careGood

RetinaLyze has a good GDPR profile. Usable in eye care, provided you use the business variant and follow the points of attention below.

Where does RetinaLyze stand in eye care?

Shared place 5 of 26 options for eye care (professional tools and general assistants) on the GDPR profile. 2 options, like RetinaLyze, have a profile rated Good. Each tile is an option we follow for this field; click for the check.

Strong4
Good2
Limited9
Unknown4
Caution7

Published safeguards

✓Provider based in NL/EUYes
–Data in the EU (according to provider)Not known
✓Publishes certification (ISO/NEN/GDPR)Yes

proprietary image model, not a language model. CE marking, ISO 13485; the provider cites GDPR and AI Act compliance. Hosting not public: ask about data location and sign a data processing agreement.

How to use RetinaLyze safely

  • Use the business variant and sign a data processing agreement (DPA).
  • Do not enter unnecessary personal data into prompts; anonymise where possible.
  • Enable EU data residency where the provider offers it.
  • Keep a professional in the loop: retinal images are health data and therefore special category personal data under the GDPR.

Stronger or equally strong in eye care

FittingboxFittingbox (Labège, FR)ClaudeAnthropicGeminiGoogleChatGPTOpenAILe Chat (Mistral)Mistral AI

Questions

How safe is RetinaLyze for eye care?
RetinaLyze has a good GDPR profile. Usable in eye care, provided you use the business version and follow the points of attention below. Good safeguards, but not on every point.
Does RetinaLyze train on my data?
proprietary image model, not a language model. CE marking, ISO 13485; the provider cites GDPR and AI Act compliance. Hosting not public: ask about data location and sign a data processing agreement.
What should I watch out for with AI in eye care?
Retinal images are health data and therefore special category personal data under the GDPR. Software that assesses images is a medical device: check the CE class under the MDR (usually IIa or IIb) and whether the algorithm has been validated for your camera or OCT device. Some tools are for 'research use only'. Choose a provider with a data processing agreement, ISO 27001 and ISO 13485, and clear data location (EU hosting or on-premise). Ask whether your images are used to train models. Opticians without a medical background may screen and refer, but not make a diagnosis. Explain in your client communication what an AI result does and does not mean. Under the EU AI Act, medical AI counts as high risk.

Source documents

retinalyze.comwww.deopticien.bizwww.eyevinci.nl

Everything about RetinaLyze Best AI for eye care

Summarised by the editorial team from provider documentation · not legal advice

Last checked: 5 October 2026 · How we check

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