Articles of the European Health Data Space (EHDS), Article 42, Fees

Article 42, Fees, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

1. Health data access bodies and single data holders may charge fees for making electronic health data available for secondary use. Any fees shall include and be derived from the costs related to conducting the procedure for requests, including for assessing a data application or a data request, granting, refusing or amending a data permit pursuant to Articles 45 and 46 or providing an answer to a data request pursuant to Article 47, in accordance with Article 6 of Regulation […] [Data Governance Act COM/2020/767 final]

2. Where the data in question are not held by the data access body or a public sector body, the fees may also include compensation for part of the costs for collecting the electronic health data specifically under this Regulation in addition to the fees that may be charged pursuant to paragraph 1. The part of the fees linked to the data holder’s costs shall be paid to the data holder.

3. The electronic health data referred to in Article 33(1), point (o), shall be made available to a new user free of charge or against a fee matching the compensation for the costs of the human and technical resources used to enrich the electronic health data. That fee shall be paid to the entity that enriched the electronic health data.

4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The support received by the data holder from donations, public national or Union funds, to set up, develop or update tat dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.

5. Where data holders and data users do not agree on the level of the fees within 1 month of the data permit being granted, the health data access body may set the fees in proportion to the cost of making available electronic health data for secondary use. Where the data holder or the data user disagree with the fee set out by the health data access body, they shall have access to dispute settlement bodies set out in accordance with Article 10 of the Regulation […] [Data Act COM/2022/68 final].

6. The Commission may, by means of implementing acts, lay down principles and rules for the fee policies and fee structures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).