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 16. Identification management
- 1.Where natural persons use electronic health data access services referred to in Article 4, those natural persons shall have the right to identify themselves electronically using any electronic identification means which are recognised pursuant to Article 6 of Regulation (EU) No 910/2014. Member States may provide complementary mechanisms to ensure appropriate identity matching in cross-border situations.
- 2.The Commission shall, by means of implementing acts, determine the requirements for the interoperable, cross-border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014. That mechanism shall facilitate the transferability of personal electronic health data in a cross-border context. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
- 3.The Commission, in cooperation with Member States, shall implement services required by the interoperable, cross-border identification and authentication mechanism referred to in paragraph 2 of this Article at Union level, as part of the cross-border infrastructure referred to in Article 23.
- 4.The Member States’ competent authorities and the Commission shall implement the interoperable, cross-border identification and authentication mechanism at Member State and Union level, respectively.
Relevant Recitals for this Article
Regulation (EU) No 910/2014 lays down the conditions under which Member States perform identification of natural persons in cross-border situations using identification means issued by another Member State, establishing rules for the mutual recognition of such electronic identification means. The EHDS requires secure access to electronic health data, including in cross-border situations. Electronic health data access services and telemedicine services should enable natural persons to exercise their rights regardless of their Member State of affiliation, and should therefore support the identification of natural persons using any electronic identification means recognised pursuant to Regulation (EU) No 910/2014. Given the possibility of challenges regarding identity matching in cross-border situations, it might be necessary for Member States of treatment to provide complementary access mechanisms such as tokens or codes to natural persons who arrive from other Member States and receive healthcare. The Commission should be empowered to adopt implementing acts to determine the requirements for the interoperable and cross-border identification and authentication of natural persons and health professionals, including any complementary mechanisms that are necessary to ensure that natural persons can exercise their rights related to personal electronic health data in cross-border situations.