Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
EHDS 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).
Relevant Recitals for this Article
Access to electronic health data for health data users established in third countries or for international organisations should take place only on the basis of the reciprocity principle. Making electronic health data available to a third country should be allowed to take place only where the Commission has established, by means of an implementing act, that the third country concerned allows access to electronic health data originating from that third country by Union entities under the same conditions and with the same safeguards as would be the case if they were accessing electronic health data within the Union. The Commission should monitor and carry out a periodic review of the situation in those third countries and for international organisations and list those implementing acts. Where the Commission finds that a third country no longer ensures access on the same terms, it should revoke the corresponding implementing act.