SECTION 1: GENERAL CONDITIONS WITH REGARD TO SECONDARY USE |
Applicability to health data holders |
Minimum categories of electronic health data for secondary use |
Intellectual property rights and trade secrets |
Purposes for which electronic health data can be processed for secondary use |
Prohibited secondary use |
SECTION 2: GOVERNANCE AND MECHANISMS FOR SECONDARY USE |
Health data access bodies |
Union health data access service |
Tasks of health data access bodies |
Obligations of health data access bodies towards natural persons |
Reporting by health data access bodies |
Duties of health data holders |
Duties of health data users |
Fees |
Enforcement by health data access bodies |
General conditions for the imposition of administrative fines by health data access bodies |
Relationship with supervisory authorities under Regulation (EU) 2016/679 |
SECTION 3: ACCESS TO ELECTRONIC HEALTH DATA FOR SECONDARY USE |
Data minimisation and purpose limitation |
Data permit |
Health data request |
Templates to support access to electronic health data for secondary use |
Right to opt out from the processing of personal electronic health data for secondary use |
Simplified procedure for access to electronic health data
from a trusted health data holder |
Secure processing environment |
Controllership |
SECTION 4: CROSS-BORDER INFRASTRUCTURE FOR SECONDARY USE |
HealthData@EU |
Access to cross-border registries or databases of electronic health data for secondary use |
SECTION 5: HEALTH DATA QUALITY AND UTILITY FOR SECONDARY USE |
Dataset description and dataset catalogue |
Data quality and utility label |
EU dataset catalogue |
Minimum specifications for datasets of high impact |
SECTION 6: COMPLAINTS |
Right to lodge a complaint with a health data access body |