EHDS Resource Index
The list below contains EHDS articles, recitals, glossary elements and other relevant resources.The focus of these pages lies on the impact of EHDS legislation on EHRs in support of ongoing care, which means that EHDS content related to the secondary use of data has been either minimized or omitted.
EHDS
PREAMBLE
Recital 25 Gradual improvement of interoperability and data sharing
Recital 38 Self-certification of general purpose software
CHAPTER I - General Provisions
Article 2 Definitions
CHAPTER II - Primary Use
Article 3 Right of natural persons to access their personal electronic health data
Article 4 Electronic health data access services for natural persons and their representatives
Article 5 Right of natural persons to insert information in their own EHR
Article 6 Right of natural persons to rectification
Article 7 Right to data portability for natural persons
Article 8 Right of natural persons to restrict access
Article 9 Right to obtain information on accessing data
Article 10 Right of natural persons to opt out in primary use
Article 11 Access by health professionals to personal electronic health data
Article 12 Health professional access services
Article 13 Registration of personal electronic health data
Article 14 Priority categories of personal electronic health data for primary use
Article 15 European electronic health record exchange format
Article 16 Identification management
Article 17 Requirements for technical implementation
Article 18 Compensation for making personal electronic health data available
Article 19 Digital health authorities
Article 23 Central interoperability platform for digital health (MyHealth@EU)
Article 24 Supplementary cross-border digital health services and infrastructures
CHAPTER III - EHR Systems and Wellness Applications
Article 25 Harmonised software components of EHR systems
Article 26 Placing EHRs on the market and putting into service
Article 27 Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
Article 28 Claims related to the functionality of the EHR System
Article 29 Procurement, reimbursement and financing of EHR Systems
Article 30 Obligations of manufacturers of EHR systems
Article 31 Authorised representatives
Article 32 Obligations of importers
Article 33 Obligations of distributors
Article 34 Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals
Article 35 Identification of economic operators
Article 36 Conformity of the harmonised software components of EHR systems - Common specifications
Article 37 Technical Documentation
Article 38 Information sheet accompanying the EHR system
Article 39 EU declaration of conformity
Article 40 European digital testing environment
Article 41 CE marking of conformity
Article 42 National EHR requirements and reporting to the Commission
Article 47 Labelling of wellness applications
Article 48 Interoperability of wellness applications with EHR systems
Article 49 EU database for registration of EHR systems and wellness applications
CHAPTER IV - Secondary Use
This chapter has been purposefully omitted
CHAPTER V - Additional Actions
Article 83 Training programmes and information for health professionals
Article 84 Support digital health literacy of patients
CHAPTER VI - European Governance and Coordination
Article 92 European Health Data Space Board
Article 93 Stakeholder Forum
Article 94 Tasks of the EHDS Board
Article 96 Roles and responsibilities of the Commission regarding the functioning of the EHDS
CHAPTER VII - Delegation of Powers and Committee Procedure
Article 97 Exercise of the delegation
Article 98 Committee procedure
CHAPTER VIII - Miscellaneous
Article 99 Penalties
Article 102 Evaluation, review and progress report
CHAPTER IX - Deferred Application, Transitional and Final provisions
Article 105 Entry into force and application
ANNEXES
Annex I Main characteristics of priority categories of personal electronic health data for primary use
Annex II Essential requirements for the harmonised software components of EHR systems.
Annex III Technical documentation
Annex IV EU declaration of conformity
Implementing- and Delegated Acts
13(4) Implementing Act Implementing Act related to EHDS Article 13(4)
14(2) Delegated Act Delegated Act related to EHDS Article 14(2)
15(1) Implementing Act Implementing Act related to EHDS Article 15(1)
16(2) Implementing Act Implementing Act related to EHDS Article 16(2)
17 Implementing Act Implementing Act related to EHDS Article 17
23 Implementing Act Implementing Act related to EHDS Articles 23(4) and 23(8)
36(1) Implementing Act Implementing Act related to EHDS Article 36(1)
4(4) Implementing Act Implementing Act related to EHDS Article 4(4)
40(4) Implementing Act Implementing Act related to EHDS Article 40(4)
Glossary
AI System AI System
Access Service An online service that enables persons to access electronic health data
Data Space Data Space
Delegated Act Delegated Act
EHR Electronic Health Record
GDPR General Data Protection Regulation
Harmonized Component Standarized functionality of EHR systems to enable the EHDS goals
Implementing Act Implementing Act
In Vitro Medical Device In Vitro Medical device
Interoperability Profile Interoperability Profile
Medical Device Medical device
Member State Obligations EHDS requirements for member states
NCP National Contact Point
NCPeH National Contact Point for eHealth
Priority Category Categories of personal electronic health data to be accessed and exchanged for primary use
Proxy Service An online service that enables natural persons to provide an authorisation to other natural persons of their choice
Wellness Application Wellness Application
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