art_68__para_12

12. A data permit shall be issued for the duration necessary to fulfil the requested purposes and that duration shall not exceed 10 years. That duration may be extended once, for a period which does not exceed 10 years, at the request of the health data user, based on arguments and documents to justify that extension which shall be provided one month before the expiry of the data permit. The health data access body may charge fees which increase to reflect the costs and risks of storing electronic health data for a period exceeding the initial period. In order to reduce such costs and fees, the health data access body may also propose to the health data user to store the dataset in a storage system with reduced capabilities. Such reduced capabilities shall not affect the security of the processed dataset. The electronic health data within the secure processing environment shall be deleted within six months of the expiry of the data permit. At the request of the health data user, the formula for the creation of the requested dataset may be stored by 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.