art_72__para_2

2. Member States may establish a procedure whereby health data holders can apply to be designated as trusted health data holders, provided the health data holders meet the following conditions: they are able to provide access to health data through a secure processing environment that complies with Article 73; they have the necessary expertise to assess health data access applications and health data requests; they provide the necessary guarantees to ensure compliance with this Regulation. Member States shall designate trusted health data holders following an assessment of the fulfilment of those conditions by the relevant health data access body. Member States shall establish a procedure to regularly review whether the trusted health data holder continues to fulfil those conditions. Health data access bodies shall indicate the trusted health data holders in the dataset catalogue referred to in Article 77.

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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.