EHDS, Article 61, SE

1. Health data users may access and process the electronic health data referred to in Article 51 for secondary use only in accordance with a data permit issued pursuant to Article 68, a health data request approved pursuant to Article 69 or, in situations referred to in Article 67(3), an access approval from the relevant authorised participant in HealthData@EU referred to in Article 75.

2. When processing electronic health data within the secure processing environments referred to in Article 73, health data users shall not provide access to the electronic health data, or make those data available, to third parties not mentioned in the data permit.

3. Health data users shall not re-identify or attempt to re-identify the natural persons to whom the electronic health data obtained by the health data users on the basis of a data permit, a health data request or an access approval by an authorised participant in HealthData@EU relate.

4. Health data users shall make public the results or output of secondary use, including information relevant for the provision of healthcare, within 18 months of the completion of the processing of the electronic health data in the secure processing environment or of having received the response to the health data request referred to in Article 69.

In justified cases related to the permitted purposes of the processing of electronic health data, the period referred to in the first subparagraph may be extended by the health data access body, in particular in cases where the result is published in a scientific journal or other scientific publication.

The results or output of secondary use shall contain only anonymous data.

Health data users shall inform the health data access bodies from which a data permit was obtained about the results or output of secondary use and assist them to make that information public on health data access bodies’ websites. Such publication shall be without prejudice to publication rights in scientific journals or other scientific publications.

When health data users use electronic health data in accordance with this Chapter, they shall acknowledge the sources of the electronic health data and the fact that the electronic health data have been obtained in the framework of the EHDS.

5. Without prejudice to paragraph 2, health data users shall inform the health data access body of any significant finding related to the health of the natural person whose data are included in the dataset.

6. Health data users shall cooperate with health data access bodies in those bodies’ performance of their tasks.

Official source

Version: c864195e81209eea

SHA-256: sha256:c864195e81209eeae7bd6577a2d4ebe66f09dc5b86115d0be1aefb732b1e6100

• Article 1
• Article 2
• Article 3
• Article 4
• Article 5
• Article 6
• Article 7
• Article 8
• Article 9
• Article 10
• Article 11
• Article 12
• Article 13
• Article 14
• Article 15
• Article 16
• Article 17
• Article 18
• Article 19
• Article 20
• Article 21
• Article 22
• Article 23
• Article 24
• Article 25
• Article 26
• Article 27
• Article 28
• Article 29
• Article 30
• Article 31
• Article 32
• Article 33
• Article 34
• Article 35
• Article 36
• Article 37
• Article 38
• Article 39
• Article 40
• Article 41
• Article 42
• Article 43
• Article 44
• Article 45
• Article 46
• Article 47
• Article 48
• Article 49
• Article 50
• Article 51
• Article 52
• Article 53
• Article 54
• Article 55
• Article 56
• Article 57
• Article 58
• Article 59
• Article 60
• Article 62
• Article 63
• Article 64
• Article 65
• Article 66
• Article 67
• Article 68
• Article 69
• Article 70
• Article 71
• Article 72
• Article 73
• Article 74
• Article 75
• Article 76
• Article 77
• Article 78
• Article 79
• Article 80
• Article 81
• Article 82
• Article 83
• Article 84
• Article 85
• Article 86
• Article 87
• Article 88
• Article 89
• Article 90
• Article 91
• Article 92
• Article 93
• Article 94
• Article 95
• Article 96
• Article 97
• Article 98
• Article 99
• Article 100
• Article 101
• Article 102
• Article 103
• Article 104
• Article 105

Geographical article agents

Source: NovaCopilot