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 74. Controllership
- 1.The health data holder shall be deemed controller for the making available of personal electronic health data requested pursuant to Article 60(1) to the health data access body. The health data access body shall be deemed controller for the processing of the personal electronic health data when fulfilling its tasks pursuant to this Regulation. Notwithstanding the second subparagraph of this paragraph, the health data access body shall be deemed to act as a processor on behalf of the health data user acting as a controller for the processing of the personal electronic health data pursuant to a data permit issued under Article 68 in the secure processing environment when providing data through such environment or for the processing of such data pursuant to a health data request approved under Article 69 for a response to be generated.
- 2.In situations referred to in Article 72(6), the trusted health data holder shall be deemed controller for its processing of personal electronic health data related to the provision of electronic health data to the health data user pursuant to a data permit or a health data request. The trusted health data holder shall be deemed to act as a processor on behalf of the health data user when providing data through a secure processing environment.
- 3.The Commission may, by means of implementing acts, establish a template for agreements between controllers and processors under paragraphs (1) and (2) of this Article. Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 98(2).
Relevant Recitals for this Article
For the processing of electronic health data in the scope of a data permit or a health data request, health data holders, including trusted health data holders, health data access bodies and health data users should be deemed each of them, in turn, controllers for a specific part of the process and according to their respective roles therein. Health data holders should be deemed controllers for the disclosure of the requested personal electronic health data to the health data access bodies, while the health data access bodies should in turn be deemed controllers for the processing of the personal electronic health data when preparing the data and making them available to the health data users. Health data users should be deemed controllers for the processing of personal electronic health data in pseudonymised form in the secure processing environment pursuant to their data permits. Health data access bodies should be deemed processors on behalf of the health data user for the processing carried out by the health data user pursuant to a data permit in the secure processing environment as well as for the processing to generate a response to a health data request. Similarly, trusted health data holders should be deemed controllers for their processing of personal electronic health data related to the provision of electronic health data to the health data user pursuant to a data permit or a health data request. The trusted health data holders should be deemed processors for the health data user when providing data through a secure processing environment.