art_52__para_5

5. Where the granting of access to electronic health data for secondary use entails a serious risk of infringing intellectual property rights, trade secrets or the regulatory data protection right laid down in Article 10(1) of Directive 2001/83/EC or Article 14(11) of Regulation (EC) No 726/2004 which cannot be addressed in a satisfactory manner, the health data access body shall refuse access to the health data applicant to such data. The health data access body shall inform the health data applicant of, and provide to the health data applicant a justification for, that refusal. Health data holders and health data applicants shall have the right to lodge a complaint in accordance with Article 81 of this Regulation.

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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.