art_68__para_10

10. When issuing a data permit, the health data access body shall set out in that data permit the general conditions applicable to the health data user. The data permit shall contain the following: the categories, specification and format of the electronic health data to be accessed, which are covered by the data permit, including their sources and an indication of whether the electronic health data are to be accessed in a pseudonymised format in the secure processing environment; a detailed description of the purpose for which the electronic health data are made available; where a mechanism to implement an exception is provided for and applicable under Article 71(4), information on whether it has been applied and the reason for the related decision; the identity of authorised persons, in particular the identity of the principal investigator, with access rights to the electronic health data in the secure processing environment; the duration of the data permit; information about the technical characteristics and tools available to the health data user within the secure processing environment; the fees to be paid by the health data user; any specific conditions.

← art_68__para_9 · All articles · (a) →

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