EHDS, Article 57, DE

1. Health data access bodies shall carry out the following tasks:

(a)

deciding on health data access applications pursuant to Article 67 of this Regulation, authorising and issuing data permits pursuant to Article 68 of this Regulation to access electronic health data falling within their remit for secondary use and deciding on health data requests submitted pursuant to Article 69 of this Regulation in accordance with this Chapter and Chapter II of Regulation (EU) 2022/868, including with regard to:

(i)

providing access to electronic health data to health data users pursuant to a data permit in a secure processing environment in accordance with Article 73;

(ii)

monitoring and supervising compliance by health data users and health data holders with the requirements laid down in this Regulation;

(iii)

requesting electronic health data referred to in Article 51 from relevant health data holders pursuant to a data permit issued or a health data request approved;

(b)

processing electronic health data referred to in Article 51 such as by receiving, combining, preparing and compiling such data when requested from health data holders and the pseudonymisation or anonymisation of those data;

(c)

taking all measures necessary to preserve the confidentiality of intellectual property rights, for regulatory data protection and to preserve the confidentiality of trade secrets as provided for in Article 52, taking into account the relevant rights of both the health data holder and health data user;

(d)

Official source

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