The European Health Data Space (EHDS) has been in force since 26 March 2025, but most obligations will only apply in two to six years’ time. What does this mean in practice for healthcare providers in the Netherlands? The EHDS promises improved access to health data, including within national borders. To make this tangible, we explore a (fictitious) case: a patient at a small mental healthcare practice who sees multiple care providers. How did this work before the EHDS, and what changes now? In this blog, we compare the legal position using concrete examples.
The case: Ms De Jong
Ms De Jong, aged 38, receives therapy for burnout at a small mental healthcare practice in Arnhem. Her psychologist uses an electronic exchange system to share data. In addition, an occupational health expert engaged by her employer requests access to her medical record for a reintegration programme. This is an external party outside direct care. How does this work without and with the EHDS?
Without the EHDS
The psychologist uses the electronic exchange system to request Ms De Jong’s record from her general practitioner, for example previous diagnoses and medication. Although presumed consent applies to data sharing within the direct treatment relationship, explicit opt-in consent from the patient is required for inclusion in the electronic exchange system. Separate consent is required for the occupational health expert, as this party is not a direct care provider. Ms De Jong checks her personal health environment (PHE) but only sees data from her GP. Mental healthcare notes are missing due to limited connectivity. The occupational health expert must wait.
Legal considerations:
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The electronic exchange system meets security requirements, such as NEN 7510, but sharing with an external party like the occupational health expert falls outside the treatment relationship. Explicit consent is required for the occupational health expert under Articles 6 and 9 GDPR, as this party has no role in direct care delivery.
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The electronic exchange system required opt-in consent. Ms De Jong has given this consent, but she must give separate approval for the occupational health expert. This process is cumbersome and causes delays.
With the EHDS
Using an EHDS-compliant electronic exchange system, the psychologist can immediately view Ms De Jong’s GP data, including diagnoses and medication, thanks to an internationally accepted format. The EHDS introduces an opt-out system. Health data is available by default to care providers within the electronic exchange system, unless the patient actively opts out. Ms De Jong has not done so, so exchange within the healthcare system is immediately possible. The Dutch Act on Electronic Data Exchange in Healthcare (Wegiz) ensures seamless alignment within the Netherlands.
For the external occupational health expert, opt-out is not sufficient. Ms De Jong logs into her PHE, sees her full record, including GP data and therapy reports, and gives specific consent via the EHDS, for example diagnosis only and no session notes. This is arranged immediately.
Legal benefits and points of attention
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The EHDS and the Wegiz provide for a secure, encrypted electronic exchange system. Opt-out applies within healthcare, but explicit consent via the PHE is required for external parties such as occupational health experts.
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Opt-out simplifies data exchange within healthcare. Ms De Jong does not need to take any action unless she opts out. For the occupational health expert, the EHDS enables digital and granular consent management.
Other obligations for healthcare providers
Interoperability
Under the EHDS, ICT service providers must adapt their systems to the EEHRxF format and self-certify compliance with technical standards. For small mental healthcare practices, this may require a costly upgrade.
Patient information
The GDPR requires healthcare providers to inform patients about their rights. This information must be provided actively and in a clear and understandable way.
Data registration at source
The EHDS promotes the principle of record once, use many times. Mental healthcare practices must ensure that data is recorded correctly and in full at the point of entry.
The EHDS changes how small mental healthcare providers like Mr Bakker’s practice exchange data. The process becomes more efficient and secure, with greater control for the patient. This does require action. We are ready to support you with legal checks and practical guidance. Would you like to work hands-on with data availability and implementation? Follow our Healthcare & ICT training programme, where we provide practical tools and insights to address this transition. Together, we ensure your practice is ready for the future.
