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 72. Simplified procedure for access to electronic health data from a trusted health data holder
- 1.Where a health data access body receives a health data access application pursuant to Article 67 or a health data request pursuant to Article 69 that only covers electronic health data held by a trusted health data holder designated in accordance with paragraph 2 of this Article, the procedure set out in paragraphs 4 to 6 of this Article shall apply.
- 2.Member States may establish a procedure whereby health data holders can apply to be designated as trusted health data holders, provided the health data holders meet the following conditions:
- (a)they are able to provide access to health data through a secure processing environment that complies with Article 73;
- (b)they have the necessary expertise to assess health data access applications and health data requests;
- (c)they provide the necessary guarantees to ensure compliance with this Regulation.
Member States shall designate trusted health data holders following an assessment of the fulfilment of those conditions by the relevant health data access body. Member States shall establish a procedure to regularly review whether the trusted health data holder continues to fulfil those conditions. Health data access bodies shall indicate the trusted health data holders in the dataset catalogue referred to in Article 77.
- 3.Health data access applications and health data requests referred to in paragraph 1 shall be submitted to the health data access body, which may forward them to the relevant trusted health data holder.
- 4.Following receipt of a health data access application or health data request pursuant to paragraph 3 of this Article, the trusted health data holder shall assess the health data access application or health data request against the criteria listed in Article 68(1) and (2) or Article 69(2) and (3), as applicable.
- 5.The trusted health data holder shall submit the assessment it carries out pursuant to paragraph 4, accompanied by a proposal for decision, to the health data access body within two months of receipt of the health data access application or health data request from the health data access body. Within two months of receipt of the assessment, the health data access body shall issue a decision on the health data access application or health data request. The health data access body shall not be bound by the proposal submitted by the trusted health data holder.
- 6.Following the health data access body’s decision to issue the data permit or to approve the health data request, the trusted health data holder shall carry out the tasks referred to in Article 57(1), points (a)(i) and (b).
- 7.The Union health data access service referred to in Article 56 may designate health data holders that are Union institutions, bodies, offices or agencies which comply with the conditions laid down in paragraph 2, first subparagraph, points (a), (b) and (c), of this Article as trusted health data holders. Where it does so, paragraph 2, third and fourth subparagraphs, and paragraphs 3 to 6 of this Article shall apply mutatis mutandis.
Relevant Recitals for this Article
Member States should be able to designate trusted health data holders for which the data permit issuing procedure can be performed in a simplified manner, in order to alleviate the administrative burden for health data access bodies of managing requests for the data processed by them. Trusted health data holders should be allowed to assess the health data access applications submitted under this simplified procedure, based on their expertise in dealing with the type of health data they are processing, and issue a recommendation regarding a data permit. The health data access body should remain responsible for issuing the final data permit and should not be bound by the recommendation provided by the trusted health data holder. Health data intermediation entities should not be designated as trusted health data holders.