art_62__para_1

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.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.