TEHDAS2 provides guidance on implementing the EHDS right to opt-out
TEHDAS2 has published a guideline to support health data access bodies in implementing the European Health Data Space (EHDS) opt-out right for secondary use of electronic health data. The guideline outlines key requirements for managing opt-out choices and where Member States have flexibility in organising technical and operational arrangements.
The document provides practical guidance on how individuals should be informed about the opt-out, how their choices can be recorded and managed, and how those choices should be respected when health data is made available for purposes such as research, innovation and policymaking. It also outlines the respective roles of health data access bodies, data holders and supervisory authorities in supporting implementation.
“Health data access bodies across Europe are preparing for the practical implementation of the EHDS opt-out,” said lead author János Misek, Senior Expert at the Hungarian National Directorate General for Hospitals (OKFŐ). “This guidance brings together the main requirements and supports national authorities in translating them into everyday practice.”
Rather than prescribing a single technical solution, the guidance identifies the key requirements that should be addressed at national level and highlights areas where Member States may exercise discretion. It emphasises that opt-out mechanisms should be accessible, reversible at any time and supported by clear and understandable information, while national authorities can determine the technical model and level of granularity best suited to their context.
“Our aim was to provide a clear and practical reference on what the EHDS opt-out requires and where Member States retain flexibility in implementation,” said task lead András Pethő, Project Manager at the Hungarian National Directorate General for Hospitals (OKFŐ).
The guidance further underlines the importance of transparency, usability and consistent application of individuals’ choices in strengthening public trust in the secondary use of health data under the EHDS.
This non-binding guideline reflects expert input from TEHDAS2 partners and feedback from a public consultation. It is part of TEHDAS2’s wider guidance supporting EHDS preparedness and provides a high-level framework for national implementation ahead of future implementing acts and operational experience.
Download the guideline: Guideline for health data access bodies: how to implement opt-out from secondary use of electronic 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
- Integrate the opt-out into health data ecosystems in a transparent and enforceable way, ensuring that individuals can easily exercise their rights.
For the European Commission
- Support alignment at EU level on core opt-out aspects (such as recognition, timing and interoperability), while allowing for different national approaches, to help ensure a coherent and trusted framework.
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