+CHAPTER IV SECONDARY USE
---+SECTION 1 General conditions with regard to secondary use
------+Article 50 Applicability to health data holders
---------+Article 50 1
---------+Article 50 2
---------+Article 50 3
---------+Article 50 4
------+Article 51 Minimum categories of electronic health data for secondary use
---------+Article 51 1
---------+Article 51 2
---------+Article 51 3
---------+Article 51 4
------+Article 52 Intellectual property rights and trade secrets
---------+Article 52 1
---------+Article 52 2
---------+Article 52 3
---------+Article 52 4
---------+Article 52 5
------+Article 53 Purposes for which electronic health data can be processed for secondary use
---------+Article 53 1
---------+Article 53 2
------+Article 54 Prohibited secondary use
---------+Article 54 2
---------+Article 54 (a)
---------+Article 54 (b)
---------+Article 54 (c)
---------+Article 54 (d)
---------+Article 54 (e)
---+SECTION 2 Governance and mechanisms for secondary use
------+Article 55 Health data access bodies
---------+Article 55 1
---------+Article 55 2
---------+Article 55 3
---------+Article 55 4
---------+Article 55 5
---------+Article 55 6
------+Article 56 Union health data access service
---------+Article 56 1
---------+Article 56 2
---------+Article 56 3
------+Article 57 Tasks of health data access bodies
---------+Article 57 1
---------+Article 57 2
---------+Article 57 3
---------+Article 57 4
------+Article 58 Obligations of health data access bodies towards natural persons
---------+Article 58 1
---------+Article 58 2
---------+Article 58 3
---------+Article 58 4
------+Article 59 Reporting by health data access bodies
---------+Article 59 1
---------+Article 59 2
------+Article 60 Duties of health data holders
---------+Article 60 1
---------+Article 60 2
---------+Article 60 3
---------+Article 60 4
---------+Article 60 5
------+Article 61 Duties of health data users
---------+Article 61 1
---------+Article 61 2
---------+Article 61 3
---------+Article 61 4
---------+Article 61 5
---------+Article 61 6
------+Article 62 Fees
---------+Article 62 1
---------+Article 62 2
---------+Article 62 3
---------+Article 62 4
---------+Article 62 5
---------+Article 62 6
------+Article 63 Enforcement by health data access bodies
---------+Article 63 1
---------+Article 63 2
---------+Article 63 3
---------+Article 63 4
---------+Article 63 5
---------+Article 63 6
---------+Article 63 7
---------+Article 63 8
------+Article 64 General conditions for the imposition of administrative fines by health data access bodies
---------+Article 64 1
---------+Article 64 2
---------+Article 64 3
---------+Article 64 4
---------+Article 64 5
---------+Article 64 6
---------+Article 64 7
---------+Article 64 8
------+Article 65 Relationship with supervisory authorities under Regulation (EU) 2016/679
---+SECTION 3 Access to electronic health data for secondary use
------+Article 66 Data minimisation and purpose limitation
---------+Article 66 1
---------+Article 66 2
---------+Article 66 3
------+Article 67 Health data access applications
---------+Article 67 1
---------+Article 67 2
---------+Article 67 3
---------+Article 67 4
---------+Article 67 5
------+Article 68 Data permit
---------+Article 68 1
---------+Article 68 2
---------+Article 68 3
---------+Article 68 4
---------+Article 68 5
---------+Article 68 6
---------+Article 68 7
---------+Article 68 8
---------+Article 68 9
---------+Article 68 10
---------+Article 68 11
---------+Article 68 12
---------+Article 68 13
---------+Article 68 14
------+Article 69 Health data request
---------+Article 69 1
---------+Article 69 2
---------+Article 69 3
---------+Article 69 4
------+Article 70 Templates to support access to electronic health data for secondary use
------+Article 71 Right to opt out from the processing of personal electronic health data for secondary use
---------+Article 71 1
---------+Article 71 2
---------+Article 71 3
---------+Article 71 4
---------+Article 71 5
---------+Article 71 6
---------+Article 71 7
---------+Article 71 8
------+Article 72 Simplified procedure for access to electronic health data from a trusted health data holder
---------+Article 72 1
---------+Article 72 2
---------+Article 72 3
---------+Article 72 4
---------+Article 72 5
---------+Article 72 6
---------+Article 72 7
------+Article 73 Secure processing environment
---------+Article 73 1
---------+Article 73 2
---------+Article 73 3
---------+Article 73 4
---------+Article 73 5
------+Article 74 Controllership
---------+Article 74 1
---------+Article 74 2
---------+Article 74 3
---+SECTION 4 Cross-border infrastructure for secondary use
------+Article 75 HealthData@EU
---------+Article 75 1
---------+Article 75 2
---------+Article 75 3
---------+Article 75 4
---------+Article 75 5
---------+Article 75 6
---------+Article 75 7
---------+Article 75 8
---------+Article 75 9
---------+Article 75 10
---------+Article 75 11
---------+Article 75 12
---------+Article 75 13
------+Article 76 Access to cross-border registries or databases of electronic health data for secondary use
---------+Article 76 1
---------+Article 76 2
---+SECTION 5 Health data quality and utility for secondary use
------+Article 77 Dataset description and dataset catalogue
---------+Article 77 1
---------+Article 77 2
---------+Article 77 3
---------+Article 77 4
------+Article 78 Data quality and utility label
---------+Article 78 1
---------+Article 78 2
---------+Article 78 3
---------+Article 78 4
---------+Article 78 5
---------+Article 78 6
------+Article 79 EU dataset catalogue
---------+Article 79 1
---------+Article 79 2
------+Article 80 Minimum specifications for datasets of high impact
---+SECTION 6 Complaints
------+Article 81 Right to lodge a complaint with a health data access body
---------+Article 81 1
---------+Article 81 2
---------+Article 81 3
---------+Article 81 4

CHAPTER IV SECONDARY USE

CHAPTER IV SECONDARY USE

1. Overview

,
SECTION 1 General conditions with regard to secondary use SECTION 1 General conditions with regard to secondary use
SECTION 2 Governance and mechanisms for secondary use SECTION 2 Governance and mechanisms for secondary use
SECTION 3 Access to electronic health data for secondary use SECTION 3 Access to electronic health data for secondary use
SECTION 4 Cross-border infrastructure for secondary use SECTION 4 Cross-border infrastructure for secondary use
SECTION 5 Health data quality and utility for secondary use SECTION 5 Health data quality and utility for secondary use
SECTION 6 Complaints SECTION 6 Complaints

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements

3. Related Standards

Standards
  • Builddate: 05.03.2025 00:00:00 -Doknr: CELEX:32025R0327
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