Process data with SPE FAQs

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SPE and EHDs FAQs

A Secure Processing Environment (SPE) is a controlled and isolated (virtual) environment designed to protect sensitive data against unauthorized access, modification, or disclosure. Privacy-sensitive data is processed in this highly secure environment, such as in the context of data analysis for health research. 

Synonyms for an SPE are Beveiligde Verwerkingsomgeving (BVO) and Trusted Research Environment (TRE). 

The main characteristics of an SPE can be summarized under four points: 

  • Isolation: the SPE is separated from other environments to prevent unauthorized access or interference. 
  • Access control: strict controls are implemented to limit who has access to the SPE and what actions they can perform.  
  • Data protection and integrity protection: sensitive data is encrypted and protected throughout its entire lifecycle within the SPE. Measures have been taken to ensure that data and processes within the SPE are not manipulated or damaged. 
  • Monitoring and logging: activity within the SPE is monitored and recorded to detect suspicious or unauthorized behavior. 

Currently, there are multiple providers of SPEs (such as SURF, CBS, and myDRE) that handle the technical and organizational management. Within the development of the EHDS, existing solutions are being tested and further developed. Ultimately, the HDAB will play a central role in offering SPEs that meet the EHDS requirements. The offered SPEs can be existing systems that have been adapted to European requirements. 

The European Health Data Space (EHDS) stipulates that health data may only be made available within a secure environment. A Secure Processing Environment (SPE) ensures that sensitive health data remains well protected and that the privacy of citizens is guaranteed. In the Netherlands, the use of an SPE is currently not mandatory, but SPEs are already widely used for sharing data between research groups. 

Working in an SPE has the following advantages: 

  1. In an SPE, data remains within a controlled environment. This reduces the chance that data is copied, shared, or ends up outside the secure environment. Only authorized users have access, and results may only be exported in aggregated, non-identifiable form. 
  2. Additionally, an SPE unburdens the researcher. By working within this environment, you automatically comply with applicable laws and regulations and with the guidelines for the use of sensitive data. This reduces the risk of errors and potential liability. 

In short: an SPE protects the privacy of citizens and helps researchers work safely and in accordance with applicable legislation and guidelines. 

Currently, cross-border data exchange is complex, but international research collaborations are possible. Foreign researchers can often gain access to a Dutch SPE without data leaving the country. 

With the introduction of the EHDS, it will be possible to securely share and analyze health data within the EU via the HealthData@EU infrastructure, provided that all EHDS rules are met. 

Certified or recognized SPEs are technically configured so that data cannot leave the environment. Users cannot download or copy datasets. Only verified and approved output may be exported. The configuration of the SPE, including security measures, ensures compliance with the guidelines. Under the EHDS, additional and harmonized requirements will apply to the SPE. 

A data user is responsible for the careful and ethical use of the data. This means, among other things, that they: 

  • Do not attempt to identify individuals 
  • Only perform necessary analyses 
  • Do not copy, photograph, or otherwise take data outside the SPE 
  • Only request approved, anonymous output for export 

Each SPE establishes clear terms of use that the data user must adhere to. 

In the current situation, the data holder is usually the controller. This means, among other things, that data holders control who is granted access, oversee the correct use of the data, and assess output for export.