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
Article 91
Health data access applications and health data requests from third countries
1. Without prejudice to Articles 67, 68 and 69, health data access applications and health data requests submitted by a health data applicant established in a third country shall be considered eligible by health data access bodies and the Union health data access service if the third country concerned:
(a) is an authorised participant on the basis of having a national contact point for secondary use covered by an implementing act referred to in Article 75(5); or
(b) allows Union health data applicants access to electronic health data in that third country under conditions that are not more restrictive than those provided for in this Regulation, and therefore such access is covered by an implementing act referred to in paragraph 2 of this Article.
2. By means of implementing acts, the Commission may determine that a third country meets the requirement set out in paragraph 1, point (b), of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available.
3. The Commission shall monitor developments in third countries and international organisations that could affect the application of the implementing acts adopted pursuant to paragraph 2, and shall provide for a periodic review of the application of this Article.
Where the Commission considers that a third country no longer meets the requirement laid down in paragraph 1, point (b), of this Article, it shall adopt an implementing act repealing the implementing act referred to in paragraph 2 of this Article relating to that third country that benefits from access. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).