TEHDAS2 publishes a guideline to support decision-making on access to health data in the EHDS
TEHDAS2 has published a new guideline to help health data access bodies (HDABs) across Member States assess more consistently when the secondary use of electronic health data may or may not be allowed under the European Health Data Space (EHDS).
The document translates a complex legal framework into practical guidance for day-to-day assessment work, including how to handle questions around prohibited uses and commercially sensitive information such as trade secrets.
In practice, this means assessing not only the stated purpose of a data application, but also whether the request is necessary, proportionate and aligned with the applicant’s mandate.
“This guideline gives HDABs a practical starting point for assessing applications, especially in areas where the regulation leaves room for interpretation,” said Ann Gustafsson of the Swedish eHealth Agency, who coordinated the work. “Our aim is to support shared learning as Member States build their assessment practices.”
The guideline focuses on practical questions such as:
- how the six allowed purposes for secondary use can be understood in real assessment situations;
- how to identify possible signs of prohibited secondary use, without assuming intent;
- how issues related to intellectual property and trade secrets may arise, and what safeguards can be considered;
- when additional information from applicants may be needed to support decision‑making;
- how borderline cases, such as relating to AI development, innovation activities or sensitive populations, may benefit from additional scrutiny or cross‑border discussion.
It also makes clear that several of these themes will continue to evolve as Member States begin applying the EHDS in practice, underlining the need for continued dialogue and shared learning.
“Real cases will inevitably raise new questions,” said Jenina Soimala, lawyer at the Finnish Institute for Health and Welfare and one of the authors. “This guideline is intended to support that learning process and help Member States move towards more harmonised implementation while practical and governance questions are still being worked through.”
The non-binding guideline is part of TEHDAS2’s wider work to support Member State preparedness for the EHDS and to encourage more consistent interpretation as implementation moves forward.
Download the guideline: Guideline for common policies for health data access bodies on minimum categories of electronic data for secondary use purposes according to the EHDS and on limitations in further processing 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
- Ensure HDABs are supported by strong multidisciplinary expertise and clear internal assessment procedures.
- Establish clear national guidance for mandate verification and purpose classification under the EHDS.
- Apply risk-based screening and monitoring mechanisms to identify prohibited uses and post-permit misuse.
- Improve national procedures for IPR, trade secret handling and applicant transparency, including cross-border cases.
For the European Commission
- Support EU-level alignment of HDAB assessments through guidance, coordination structures and common tools.
- Provide practical EU-wide guidance on IPR, trade secrets and safeguarding measures for secondary data use.
- Clarify high-impact concepts, such as scientific research, public interest, harmful products and AI-related uses.
- Facilitate cross-border coordination on ethics and misuse monitoring to support consistent EHDS implementation.
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