art_68__para_4

4. By way of derogation from Regulation (EU) 2022/868, the health data access body shall issue or refuse a data permit within three months of receiving a complete health data access application. If the health data access body finds that the health data access application is incomplete, it shall notify the health data applicant, which shall be given the possibility of completing that application. If the health data applicant does not complete the health data access application within four weeks, the data permit shall not be issued. The health data access body may extend the period for responding to a health data access application by three additional months where necessary, taking into account the urgency and complexity of the health data access application and the volume of health data access applications submitted for decision. In such cases, the health data access body shall notify the health data applicant as soon as possible that more time is needed for examining the health data access application, together with the reasons for the delay.

← art_68__para_3__para · All articles · art_68__para_4__para →

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