Knowledge base

EHDS glossary

All statutory definitions of the EHDS Regulation — verbatim from Article 2, with their source and links to the articles on this site that discuss each term.

care

a professional service the purpose of which is to address the specific needs of a natural person who, on account of impairment or other physical or mental conditions, requires assistance, including preventive and supportive measures, to carry out essential activities of daily living in order to support his or her personal autonomy

CE marking of conformity

a marking by which the manufacturer indicates that the EHR system is in conformity with the applicable requirements set out in this Regulation and other applicable Union law providing for its affixing pursuant to Regulation (EC) No 765/2008 of the European Parliament and of the Council (30)

data permit

Also known as: data permit · datavergunning

an administrative decision issued to a health data user by a health data access body to process certain electronic health data specified in the data permit for specific secondary use purposes, based on conditions laid down in Chapter IV of this Regulation

data quality

the degree to which the elements of electronic health data are suitable for their intended primary use and secondary use

data quality and utility label

a graphic diagram, including a scale, describing the data quality and conditions of use of a dataset

dataset

a structured collection of electronic health data

dataset catalogue

a collection of dataset descriptions, arranged in a systematic manner and including a user-oriented public part, in which information concerning individual dataset parameters is accessible by electronic means through an online portal

dataset of high impact for secondary use

a dataset the re-use of which is associated with significant benefits due to its relevance for health research

EHR

Also known as: EPD · elektronisch patientendossier · elektronisch patiëntendossier · electronic health record

a collection of electronic health data related to a natural person and collected in the health system, processed for the purpose of the provision of healthcare

EHR system

Also known as: EPD-systeem · EPD-systemen · EHR-systeem · EHR system · EHR systems

any system whereby the software, or a combination of the hardware and the software of that system, allows personal electronic health data that belong to the priority categories of personal electronic health data established under this Regulation to be stored, intermediated, exported, imported, converted, edited or viewed, and intended by the manufacturer to be used by healthcare providers when providing patient care or by patients when accessing their electronic health data

electronic health data

personal or non-personal electronic health data

electronic health data access service

an online service, such as a portal or an application for mobile devices, that enables natural persons not acting in a professional capacity to access their own electronic health data or the electronic health data of those natural persons whose electronic health data they are legally authorised to access

European interoperability software component for EHR systems

a software component of the EHR system which provides and receives personal electronic health data under a priority category for primary use established under this Regulation in the European electronic health record exchange format provided for in this Regulation and which is independent of the European logging software component for EHR systems

European logging software component for EHR systems

a software component of the EHR system which provides logging information related to access by health professionals or other individuals to priority categories of personal electronic health data established under this Regulation, in the format defined in point 3.2. of Annex II thereto, and which is independent of the European interoperability software component for EHR systems

Health Data Access Body (HDAB)

Also known as: HDAB · Health Data Access Body · instantie voor toegang tot gezondheidsgegevens · instanties voor toegang tot gezondheidsgegevens · GDA · Gezondheidsdata-autoriteit

the body each Member State designates under Article 55 EHDS, responsible for granting access to electronic health data for secondary use, including assessing applications and issuing data permits (Articles 57, 58 and 59 EHDS). In the Netherlands this role is assigned to the Gezondheidsdata-autoriteit (GDA) under the proposed Wet GIS

health data holder

Also known as: datahouder · gegevenshouder · health data holder

any 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, in accordance with applicable Union or national law and in its capacity as a controller or joint controller, to process personal electronic health data for the provision of healthcare or care or for the purposes of public health, reimbursement, research, innovation, policymaking, official statistics or patient safety or for regulatory purposes; or (ii) the ability to make available non-personal electronic health data through the control of the technical design of a product and related services, including by registering, providing, restricting access to or exchanging such data

health data user

Also known as: datagebruiker · 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 pursuant to a data permit, a health data request approval or an access approval by an authorised participant in HealthData@EU

health professional access service

a service, supported by an EHR system, that enables health professionals to access data of natural persons under their treatment

HealthData@EU

the cross-border infrastructure for the secondary use of electronic health data, in which each Member State designates a single national contact point acting as gateway

interoperability

the ability of organisations, as well as of software applications or devices from the same manufacturer or different manufacturers, to interact through the processes they support, involving the exchange of information and knowledge, without changing the content of the data, between those organisations, software applications or devices

MyHealth@EU

the central interoperability platform for digital health established by the Commission to support the exchange of personal electronic health data between Member States for primary use

non-personal electronic health data

electronic health data other than personal electronic health data, including both data that have been anonymised so that they no longer relate to an identified or identifiable natural person (the ‘data subject’) and data that have never related to a data subject

Opt-out (secondary use)

Also known as: opt-out · opt-outrecht · opt-out-recht · bezwaar secundair gebruik

the right of natural persons to object, at any time and without stating reasons, to the processing of personal electronic health data relating to them for secondary use

personal electronic health data

data concerning health and genetic data, processed in an electronic form

primary use

Also known as: primary use

the processing of electronic health data for the provision of healthcare, in order to assess, maintain or restore the state of health of the natural person to whom those data relate, including the prescription, dispensation and provision of medicinal products and medical devices, as well as for relevant social, administrative or reimbursement services

putting into service

the first use, for its intended purpose, in the Union of an EHR system covered by this Regulation

registration of electronic health data

the recording of health data in an electronic format, through the manual entry of such data, through the collection of such data by a device, or through the conversion of non-electronic health data into an electronic format, to be processed in an EHR system or a wellness application

risk

the combination of the probability of an occurrence of a hazard causing harm to health, safety or information security and the degree of severity of such harm

secondary use

Also known as: secondary use · hergebruik van gezondheidsdata

the processing of electronic health data for the purposes set out in Chapter IV of this Regulation, other than the initial purposes for which they were collected or produced

serious incident

any malfunction or deterioration in the characteristics or performance of an EHR system made available on the market that directly or indirectly leads, might have led or might lead to any of the following: (i) the death of a natural person or serious harm to a natural person’s health; (ii) serious prejudice to a natural person’s rights; (iii) serious disruption of the management and operation of critical infrastructure in the health sector; (30) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). 32/96 ELI: http://data.europa.eu/eli/reg/2025/327/oj

software component

a discrete part of software which provides a specific functionality or performs specific functions or procedures and which can operate independently or in conjunction with other components

wellness application

Also known as: wellness-app · wellness applicatie

any software, or any combination of hardware and software, intended by the manufacturer to be used by a natural person, for the processing of electronic health data, specifically for providing information on the health of natural persons, or the delivery of care for purposes other than the provision of healthcare.

The definitions are taken verbatim from Article 2 of Regulation (EU) 2025/327; the full text of the Regulation is available on this site, in Dutch and English.