European Health Data Space Regulation
Navigation log
Table of Contents
Chapter I – General provisions
Chapter II – Primary use
Chapter III – Ehr systems and wellness applications
Chapter IV – Secondary use
Chapter V – Additional actions
Chapter VI – European governance and coordination
Chapter VII – Delegation of powers and committee procedure
Chapter VIII – Miscellaneous
Chapter IX – Deferred application, transitional and final provisions
Recitals (115)
Annexes
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 General Data Protection Regulation (GDPR) or Article 5(1) and Article 10(2) of EU Institutions Data Protection Regulation (EUDPR);
(g) where the health data applicant intends to make use of an exception under Article 71(4), the justification required in that regard by national law pursuant to that Article.
3. The health data access body shall assess if the health data request is complete and take into account the risks referred to in Article 68(2).
4. The health data access body shall assess the health data request within three months of receipt of the request and, where possible, subsequently provide the response to the health data user within a further three months.