EHDS Entity Types

The following entity types are mapped from the official European Health Data Space (EHDS) Regulation as published in the Official Journal:

Health data holder: A natural or legal person, public authority, agency or other body in the healthcare or the care sectors, including reimbursement services where necessary, as well as any natural or legal person developing products or services intended for the health, healthcare or care sectors, developing or manufacturing wellness applications, performing research in relation to the healthcare or care sectors or acting as a mortality registry, as well as any Union institution, body, office or agency, that has either: (i) the right or obligation to process personal electronic health data; or (ii) the ability to make available non-personal electronic health data. [EHDS Art. 2(2)(t)]
Health data user: A natural or legal person, including Union institutions, bodies, offices or agencies, which has been granted lawful access to electronic health data for secondary use. [EHDS Art. 2(2)(u)]
Health data access body: Entity responsible for granting access to health data for secondary use. [EHDS Art. 55]
Digital health authority: Entity responsible for implementation and enforcement of primary use provisions. [EHDS Art. 19]
Healthcare provider: Healthcare organizations/professionals providing healthcare services. [EHDS Art. 2(1)(b)]
Health professional: Doctor, nurse, dental practitioner, midwife, pharmacist or other healthcare professional. [EHDS Art. 2(1)(b)]
EHR system manufacturer: Manufacturer of electronic health record systems. [EHDS Art. 30]
EHR system importer: Importer of electronic health record systems. [EHDS Art. 32]
EHR system distributor: Distributor of electronic health record systems. [EHDS Art. 33]
Wellness app manufacturer: Manufacturer of wellness applications. [EHDS Art. 47]
Market surveillance authority: Authority responsible for EHR systems market surveillance. [EHDS Art. 43]
Economic operator: Any manufacturer, authorized representative, importer, or distributor. [EHDS Art. 2(1)(d)]
National contact point for digital health: Gateway for cross-border exchange of personal electronic health data. [EHDS Art. 23(2)]
National contact point for secondary use: Gateway for cross-border secondary use of health data. [EHDS Art. 75(1)]
Trusted health data holder: Designated health data holder meeting conditions for simplified data access. [EHDS Art. 72]
EHDS Board: EU-level coordination body for EHDS implementation. [EHDS Art. 92]
Authorized participants in HealthData@EU: Entities authorized to participate in cross-border infrastructure. [EHDS Art. 75]
Union health data access service: Contact point for EU institutions for secondary use. [EHDS Art. 56]
Data permit issuer: Body authorized to issue data permits for secondary use. [EHDS Art. 68]
Medical device manufacturer: Manufacturer of medical devices claiming EHR interoperability. [EHDS Art. 27]
AI system provider: Provider of AI systems claiming EHR interoperability. [EHDS Art. 27]
Research infrastructure: Health-related research infrastructures providing support for data use. [EHDS Art. 75(4)]
Supervisory authorities: Authorities monitoring GDPR compliance. [EHDS Art. 22]
Ethics bodies: Bodies performing ethical assessments for data access. [EHDS Art. 73(2)]

Update EHDS extension with practical concepts #238

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