This TEHDAS2 expert guideline supports the implementation of the European Health Data Space (EHDS).This document provides comprehensive, non-binding guidance to health data access bodies (HDABs) on both the fee structure for accessing electronic health data for secondary use under Article 62 of the European Health Data Space (EHDS) Regulation and the exercise of their supervisory and enforcement powers under Articles 63 and 64. The EHDS establishes a common European framework for the lawful, transparent and trustworthy secondary use of electronic health data through the HealthData@EU infrastructure, and HDABs play a central role in ensuring its effective implementation. From a principles-based and operational perspective, the guidance clarifies which costs may be included in fees – focusing on operational and infrastructure costs directly linked to EHDS procedures such as data access applications and data requests – and which costs must be excluded, including data collection and processing carried out for medical purposes, the data discovery phase, costs related to informing natural persons of significant health findings, and costs already publicly funded. It addresses to whom and when fees should be paid, recommending in particular acentralised single-invoice model with conditional staged payments managed by the HDAB, while allowing sufficient flexibility for Member States to integrate the model into existing national systems and contractual arrangements. To promote transparency, fairness, non-discrimination, proportionality and competition neutrality across Member States, the document recommends EU-level safeguards to mitigate economic disparities, encourages a minimum baseline for any fee reductions applied to specific user categories, and calls for the proactive publication – via HDABs – of clear information such as price lists, illustrative examples, FAQs and cost simulators. In parallel, the guidance supports HDABs throughout the full supervisory lifecycle, from the early detection of potential non-compliance by data users or holders, through corrective measures such as permit revocation or exclusion from access, to the imposition and proportionate quantification of administrative fines that are effective, dissuasive and consistent with EU and national law. It also recommends that each HDAB make publicly available its national governance framework and dispute settlement procedures. This document should be regarded as a living instrument, subject to future updates in light ofimplementing and delegated acts adopted by the European Commission in cooperation with the EHDS Board.
Baussand et al. (Fri,) studied this question.