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 5. Right of natural persons to insert information in their own EHR
- Natural persons, or their representatives referred to in Article 4(2), shall have the right to insert information in the EHR of those natural persons through electronic health data access services or applications linked to those services as referred to in that Article. That information shall be clearly distinguishable as having been inserted by the natural person or by his or her representative. Natural persons, or their representatives referred to in Article 4(2), shall not be able to directly alter the electronic health data and related information inserted by health professionals.
Relevant Recitals for this Article
Regulation (EU) 2016/679 sets out specific provisions concerning the rights of natural persons in relation to the processing of their personal data. The EHDS builds upon those rights and complements some of them as applied to personal electronic health data. Those rights apply regardless of the Member State in which the personal electronic health data are processed, type of healthcare provider, sources of those data or Member State of affiliation of the natural person. The rights and rules related to the primary use of personal electronic health data under this Regulation concern all categories of those data, irrespective of how they have been collected or who has provided them, the legal ground for the processing under Regulation (EU) 2016/679 or the status of the controller as a public or private organisation. The additional rights of access and portability of personal electronic health data provided for in this Regulation should be without prejudice to the rights of access and portability as established under Regulation (EU) 2016/679. Natural persons continue to have those rights under the conditions set out in that Regulation.
In order to complement the information available to them, natural persons should be able to add electronic health data to their EHRs or to store additional information in their separate personal health record which could be accessed by health professionals. However, information inserted by natural persons might not be as reliable as electronic health data entered and verified by health professionals and does not have the same clinical or legal value as information provided by health professionals. Therefore, data added by natural persons in their EHR should be clearly distinguishable from data provided by health professionals. That possibility for natural persons to add and complement personal electronic health data should not entitle them to change personal electronic health data which have been provided by health professionals.