· Yves Thorrez · Tutorials · 4 min read
What are Trusted Data Holders?
As a Health Data Holder, can you demonstrate robust expertise in data management, governance and security?
🎤 Honoured to take the stage at the Microsoft HealthTech Exec Summit 3.0 in Brussels last week!
Together with Tom Bouten (element61) I presented TREzure — a Secure Processing Environment for Health Data that helps hospitals share their data with authorized researchers + become trusted data holders in the European Health Data Space (EHDS). With TREzure, researchers can 🔍 discover datasets, 🤝 engage with health data holders and the Belgian Health Data Agency (HDA) to prepare a data permit, and 🛠️ analyse datasets in a safe & governed Azure-based workspace.
Big shout-out to 🔹 Microsoft for gathering so many healthcare executives under one roof; 🔹 our implementation partners element61 and KPMG for co-building the platform; 🔹 the hospital teams involved in the SPECTRE-HD data capabilities project who keep pushing boundaries every day.
Together we’re proving that secondary use of health data in a safe and scalable will build trust and create more value for patients and health systems throughout Belgium and the EU.
More news about TREzure coming soon, including our new website.
#TREzure #HealthTech #EHDS #SecureProcessingEnvironment #Azure #PowerPlatform #DataGovernance #UZBrussel #UZA #CUSL #ZOL #element61 #KPMG #Microsoft
While the EHDS aims to make available data from a broad range of health data holders, it is also true that some health data holders have more experience and relevant skills than others. The concept of trusted health data holders in Article 72 acknowledges this. Trusted health data holders are entities that have been designated by Member States based on their ability to provide a secure processing environment, demonstrate expertise in data management, and meet specific guarantees related to the handling of health data. Following designation, trusted health data holders may receive data permit applications forwarded by the Health Data Access Body (HDAB). The trusted health data holder is then responsible for assessing these applications and providing recommendations to the HDAB. However, the HDAB still retains the final authority to approve or refuse the applications. If a permit is granted, the trusted health data holder may also take on additional tasks, such as preparing the data for secure access by the health data user.
In the European Health Data Space (EHDS), a “trusted health data holder” is a health-data holder (e.g., a hospital, registry, research institute or company) that a Member State has formally designated because it can meet higher-level guarantees for managing secondary-use data.
Key points:
| What it is | Details |
|---|---|
| Special status | Designated by the competent national authority under Article 72 EHDS after demonstrating robust expertise in data management, governance and security. |
| Own secure processing environment | Must operate a secure, privacy-preserving environment where authorised users can analyse the data (instead of relying on the Health Data Access Body’s platform). |
| “Simplified” single-holder pathway | When an access request concerns data from that one holder only, the Health Data Access Body (HDAB) can forward the application to the trusted holder, which reviews the request and prepares the data. The HDAB still issues or refuses the permit, so legal oversight is retained. |
| Why opt in? | Suitable for organisations that already have mature governance processes and wish to keep end-to-end control of how their datasets are prepared, pseudonymised and accessed. It can shorten turnaround times for routine requests and reduce double handling of large or sensitive datasets. |
| Duties remain | Trusted holders must still: • describe their datasets for the EU-wide catalogue; • comply with FAIR and quality-label rules; • log all user activity; • charge only cost-based fees allowed under EHDS. They may also be asked to help the HDAB with dataset preparation once a permit is granted. |
In short: a trusted data holder is a recognised “centre of excellence” that can let authorised users work with its data directly, under HDAB supervision, through a secure environment it controls.
