Preamble 1 to 76.
Preamble 1 to 10, European Health Data Space (EHDS) (Proposal 3.5.2022).
Preamble 11 to 20, European Health Data Space (EHDS) (Proposal 3.5.2022).
Preamble 21 to 30, European Health Data Space (EHDS) (Proposal 3.5.2022).
Preamble 31 to 40, European Health Data Space (EHDS) (Proposal 3.5.2022).
Preamble 41 to 50, European Health Data Space (EHDS) (Proposal 3.5.2022).
Preamble 51 to 60, European Health Data Space (EHDS) (Proposal 3.5.2022).
Preamble 61 to 76, European Health Data Space (EHDS) (Proposal 3.5.2022).
Chapter I, General provisions.
Article 1, Subject matter and scope, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 2, Definitions, European Health Data Space (EHDS) (Proposal 3.5.2022).
Chapter II, Primary use of electronic health data.
Section 1, Access to and transmission of personal electronic health data for primary use.
Article 3, Rights of natural persons in relation to the primary use of their personal electronic health data, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 4, Access by health professionals to personal electronic health data, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 5, Priority categories of personal electronic health data for primary use, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 6, European electronic health record exchange format, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 7, Registration of personal electronic health data, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 8, Telemedicine in the context of cross-border healthcare, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 9, Identification management, European Health Data Space (EHDS) Directive (Proposal 3.5.2022).
Article 10, Digital health authority, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 11, Right to lodge a complaint with a digital health authority, European Health Data Space (EHDS) (Proposal 3.5.2022).
Section 2, Cross-border infrastructure for primary use of electronic health data.
Article 12, MyHealth@EU, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 13, Supplementary cross-border digital health services and infrastructures, European Health Data Space (EHDS) (Proposal 3.5.2022).
CHAPTER III, EHR systems and wellness applications
Section 1, General provisions for EHR systems
Article 14, Interplay with legislation governing medical devices and AI systems, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 15, Placing on the market and putting into service, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 16, Claims, European Health Data Space (EHDS) (Proposal 3.5.2022).
Section 2, Obligations of economic operators with regard to EHR systems.
Article 17, Obligations of manufacturers of EHR systems, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 18, Authorised representatives, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 19, Obligations of importers, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 20, Obligations of distributors, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 21, Cases in which obligations of manufacturers of an EHR system apply to importers and distributors, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 22, Identification of economic operators, European Health Data Space (EHDS) (Proposal 3.5.2022).
Section 3, Conformity of the EHR system.
Article 23, Common specifications, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 24, Technical documentation, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 25, Information sheet accompanying the EHR system, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 26, EU declaration of conformity, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 27, CE marking, European Health Data Space (EHDS) (Proposal 3.5.2022).
Section 4, Market surveillance of EHR systems.
Article 28, Market surveillance authorities, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 29, Handling of risks posed by EHR systems and of serious incidents, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 30, Handling of non-compliance, European Health Data Space (EHDS) (Proposal 3.5.2022).
Section 5, Other provisions on interoperability.
Article 31, Voluntary labelling of wellness applications, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 32, Registration of EHR systems and wellness applications, European Health Data Space (EHDS) (Proposal 3.5.2022).
CHAPTER IV, Secondary use of electronic health data.
Section 1, General conditions with regard to the secondary use of electronic health data.
Article 33, Minimum categories of electronic data for secondary use, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 34, Purposes for which electronic health data can be processed for secondary use, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 35, Prohibited secondary use of electronic health data, European Health Data Space (EHDS) (Proposal 3.5.2022).
Section 2, Governance and mechanisms for the secondary use of electronic health data
Article 36, Health data access bodies, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 37, Tasks of health data access bodies, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 38, Obligations of health data access bodies towards natural persons, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 39, Reporting by health data access bodies, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 40, Data altruism in health, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 41, Duties of data holders, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 42, Fees, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 43, Penalties by health data access bodies, European Health Data Space (EHDS) (Proposal 3.5.2022).
Section 3, Data permit for the secondary use of electronic health data.
Article 44, Data minimisation and purpose limitation, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 45, Data access applications, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 46, Data permit, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 47, Data request, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 48, Making data available for public sector bodies and Union institutions, bodies, offices and agencies without a data permit, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 49, Access to electronic health data from a single data holder, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 50, Secure processing environment, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 51, Joint controllers, European Health Data Space (EHDS) (Proposal 3.5.2022).
Section 4, Cross-Border access to electronic health data for secondary use.
Article 52, Cross-border infrastructure for secondary use of electronic health data (HealthData@EU), European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 53, Access to cross-border sources of electronic health data for secondary use, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 54, Mutual recognition, European Health Data Space (EHDS) (Proposal 3.5.2022).
Section 5, Health data quality and utility for secondary use.
Article 55, Dataset description, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 56, Data quality and utility label, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 57, EU Datasets Catalogue, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 58, Minimum dataset specifications, European Health Data Space (EHDS) (Proposal 3.5.2022).
Chapter V, Additional actions.
Article 59, Capacity building, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 60, Additional requirements for public procurement and Union funding, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 61, Third country transfer of non-personal electronic data, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 62, International access and transfer of non-personal electronic health data, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 63, International access and transfer of personal electronic health data, European Health Data Space (EHDS) (Proposal 3.5.2022).
Chapter VI, European governance and coordination.
Article 64, European Health Data Space Board (EHDS Board), European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 65, Tasks of the EHDS Board, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 66, Joint controllership groups for Union infrastructures, European Health Data Space (EHDS) (Proposal 3.5.2022).
CHAPTER VII, Delegation and Committee.
Article 67, Exercise of the delegation, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 68, Committee procedure, European Health Data Space (EHDS) (Proposal 3.5.2022).
Chapter VIII, Miscellaneous.
Article 69, Penalties, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 70, Evaluation and review, European Health Data Space (EHDS) (Proposal 3.5.2022).
Article 71, Amendment to Directive 2011/24/EU, European Health Data Space (EHDS) (Proposal 3.5.2022).
Chapter IX, Deferred application and final provisions.
Article 72, Entry into force and application, European Health Data Space (EHDS) (Proposal 3.5.2022).
Note: This is not the final text of the European Health Data Space (EHDS). This is the text of the European Health Data Space Proposal of 3.5.2022.