EHDS, Article 62, EU

1. Health data access bodies, including the Union health data access service, or trusted health data holders referred to in Article 72 may charge fees for making electronic health data available for secondary use.

The fees shall be in proportion to the cost of making the data available and they shall not restrict competition.

The fees shall cover all or part of the costs related to the procedure for assessing a health data access application or a health data request, for issuing, refusing or amending a data permit pursuant to Articles 67 and 68 or for providing a response to a health data request submitted pursuant to Article 69, including costs related to the consolidation, preparation, pseudonymisation, anonymisation and provision of the electronic health data.

Member States may establish reduced fees for certain types of health data users located in the Union, such as public sector bodies or Union institutions, bodies, offices and agencies with a legal mandate in the field of public health, university researchers or microenterprises.

2. The fees referred to in paragraph 1 of this Article may include compensation for the costs incurred by the health data holder for compiling and preparing the electronic health data to be made available for secondary use. In such cases, the health data holder shall provide an estimate of such costs to the health data access body. Where the health data holder is a public sector body, Article 6 of Regulation (EU) 2022/868 shall not apply. The part of the fees linked to the health data holder’s costs shall be paid to the health data holder.

3. Any fees charged to health data users pursuant to this Article shall be transparent and non-discriminatory.

4. Where health data holders and health data users do not agree on the level of the fees within one month of the data permit being issued, the health data access body may set the fees in proportion to the cost of making electronic health data available for secondary use. Where health data holders or health data users disagree with the fee set by the health data access body, they shall have access to dispute settlement bodies in accordance with Article 10 of Regulation (EU) 2023/2854.

5. Before issuing a data permit pursuant to Article 68 or providing a response to a health data request submitted pursuant to Article 69, the health data access body shall inform the health data applicant of the estimated fees. The health data applicant shall be informed about the option to withdraw the health data access application or health data request. If the health data applicant withdraws its application or request, the health data applicant shall only be charged the costs that have already been incurred.

6. The Commission shall, by means of implementing acts, lay down principles for the fee policies and fee structures, including deductions for the entities referred to in paragraph 1, fourth subparagraph, of this Article in order to support consistency and transparency between Member States regarding such fee policies and fee structures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).

Official source

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