EHDS, Artikkel 69, DE

1. The health data applicant may submit a health data request for the purposes referred to in Article 53 with the aim of obtaining a response only in an anonymised statistical format. A health data access body shall not provide a response to a health data request in any other format and the health data user shall have no access to the electronic health data used to provide that response.

2. A health data request as referred to in paragraph 1 shall include the following information:

(a)

the identity of the health data applicant and a description of that health data applicant’s professional functions and activities;

(b)

a detailed explanation of the intended use of the electronic health data, including the purposes referred to in Article 53(1) for which the health data request is submitted;

(c)

a description of the requested electronic health data, their format and the sources of those data, where possible;

(d)

a description of the statistical content;

(e)

a description of the safeguards planned to prevent any misuse of the requested electronic health data;

(f)

a description of how the processing would comply with Article 6(1) of Regulation (EU) 2016/679 or Article 5(1) and Article 10(2) of Regulation (EU) 2018/1725;

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