TEHDAS2 publishes guidance on handling significant findings from secondary use of health data
TEHDAS2 has published a guideline for health data access bodies on handling significant findings arising from the secondary use of electronic health data under the European Health Data Space (EHDS). It sets out how such findings should be managed securely, transparently and in line with national rules.
The guideline makes clear that health data access bodies are not responsible for clinical validation or for contacting individuals directly. Their role is to receive notifications from authorised data users and securely forward the information to the relevant health data holder, while clinical assessment and decisions on whether and how to inform a person remain within national frameworks.
“The guideline supports health data access bodies in implementing procedures for managing significant findings in a secure, transparent and legally compliant manner. It clarifies the roles of data users, HDABs and data holders, helping to ensure a consistent and rights-respecting approach across Member States,” said János Misek, Senior Expert at the National Directorate General for Hospitals – OKFŐ, Hungary and lead author of the document.
Building trust in the secondary use of health data
As cross-border secondary use expands and AI-driven analysis becomes more common, the guideline highlights the need for traceable processes, clear accountability and secure transmission pathways, especially where re-identification is required under national law and governance arrangements.
Co-author and Expert at the National Directorate General for Hospitals Gergely Mikesy highlighted the link between responsible handling of findings and public confidence in the EHDS: “Behind every data point, there is a human story. If we want patients to continue sharing their data, they need to see the tangible benefits of research. Where appropriate and in line with individual preferences and national frameworks, findings from secondary data use that may affect patients’ lives can be shared back with them. This transparency is a vital step towards building public trust in the EHDS framework.”
Supporting implementation across Member States
The guideline helps health data access bodies translate EHDS obligations into practice, including documenting notifications, avoiding duplication through record-keeping and securely routing information to the appropriate data holder. Detailed workflows and communication with individuals remain to be defined at national level.
This non-binding guideline reflects expert input from TEHDAS2 partners and feedback from a public consultation. It is part of TEHDAS2’s wider set of guidance supporting EHDS implementation across Member States.
Download the guideline: Guideline for health data access bodies on implementing the obligation of notifying the natural person on a significant finding from the secondary use of health data
A summary of the comments received during the public consultation and how they were addressed is available in the annex.
Key recommendations stemming from the work
For Member States
- Establish clear and trusted pathways to assess, validate and communicate significant findings to individuals, so that the potential value of those findings can be realised in practice.
For the European Commission
- Support a common procedural backbone at EU level, while leaving clinical interpretation and the setting of thresholds to national contexts to support a balanced approach to significant findings.
Share away!