Article 41, Duties of data holders, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. Where a data holder is obliged to make electronic health data available under Article 33 or under other Union law or national legislation implementing Union law, it shall cooperate in good faith with the health data access bodies, where relevant.
2. The data holder shall communicate to the health data access body a general description of the dataset it holds in accordance with Article 55.
3. Where a data quality and utility label accompanies the dataset pursuant to Article 56, the data holder shall provide sufficient documentation to the health data access body for that body to confirm the accuracy of the label.
4. The data holder shall put the electronic health data at the disposal of the health data access body within 2 months from receiving the request from the health data access body. In exceptional cases, that period may be extended by the health data access body for an additional period of 2 months.
5. Where a data holder has received enriched datasets following a processing based on a data permit, it shall make available the new dataset, unless it considers it unsuitable and notifies the health data access body in this respect.
6. Data holders of non-personal electronic health data shall ensure access to data through trusted open databases to ensure unrestricted access for all users and data storage and preservation. Trusted open public databases shall have in place a robust, transparent and sustainable governance and a transparent model of user access.
7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the duties of the data holders in this Article, to reflect the evolution of activities performed by data holders.