TEHDAS2 guidance clarifies fees and penalties under the EHDS
TEHDAS2 has published guidance to help health data access bodies (HDABs) organise data access fees and oversee compliance under the European Health Data Space (EHDS).The document provides a practical reference for Member States preparing for national implementation and early operational activities.
The guideline addresses two core operational needs of HDABs: organising transparent and coherent fees for secondary use of electronic health data, and applying proportionate and consistent enforcement actions across Member States. The document was developed with input from stakeholders across the health data community.
“This guideline aims to support the harmonisation of fee and penalty practices across Europe while reflecting the diverse perspectives of stakeholders, whom we warmly thank for their contributions,” said Julie Baussand, Strategic Advisor to General Management at Health Data Hub and TEHDAS2 task lead on fees. “It is the result of extensive engagement with the ecosystem, both prior to drafting and through the public consultation process.”
Organising data access fees
The guideline clarifies which costs can be included or must be excluded when charging fees for secondary use of electronic health data. It outlines core principles of transparency, proportionality, nondiscrimination and competition neutrality.
The document recommends a centralised single invoice model with conditional staged payments. In this model, HDABs consolidate relevant costs into one invoice for the data user, while allowing Member States to adapt the approach to their national administrative systems.
To support predictability, the guideline encourages HDABs to publish clear cost information and practical examples for applicants.
Compliance and enforcement
The guideline also describes how HDABs can fulfil their supervisory functions under the EHDS. It outlines how to identify and address non‑compliance, apply corrective measures and impose proportionate administrative fines.
The document emphasises coordinated and transparent procedures, including collaboration with national data protection authorities where EHDS-related breaches intersect with General Data Protection Regulation (GDPR) obligations.
The guideline aims to strengthen legal certainty and support more consistent implementation across Europe. The non-binding document forms part of a wider set of TEHDAS2 outputs supporting Member States in the implementation of the EHDS.
Download document: Guideline on fees and penalties for noncompliance related to the EHDS regulation
A summary of the comments received during the public consultation and how they were addressed is available in the annex.
View published TEHDAS2 results
Key recommendations stemming from the work
For Member States
- Establish centralised single‑invoice fee model, adaptable to national systems.
- Ensure transparent, public cost information so applicants can anticipate fees and build trust.
- Ensure clear, proportionate HDAB enforcement to support consistency while respecting national procedures.
For the European Commission
- Provide further guidance by the EHDS Board on revocation/exclusion criteria and periodic penalty payments (under Article 63(8)).
- Ensure EU‑level measures on fees and enforcement promote EU-wide consistency, while remaining practical and interoperable for national HDABs.
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