art_52__para_2
2. Health data holders shall inform the health data access body of any electronic health data containing content or information protected by intellectual property rights, trade secrets or covered by 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. Health data holders shall identify which parts of the datasets are concerned and justify the need for the specific protection of the data. Health data holders shall provide that information when communicating to the health data access body the description of the dataset they hold pursuant to Article 60(3) of this Regulation or, at the latest, following a request received from the health data access body.
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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.