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Glossary Highlights


Last updated:  Jul 20, 2018 18:00



FAQ



  1. Who is the Owner of the Glossary?

    The eHDSI Solution Provider (Business Analyst) is the Owner of the Glossary.

  2. How can someone request a change (new entry or entry update)?

    -New entry => Use "Page comment" (at the very bottom of this page)
    -Update entry => Use "Inline comment" (right click on the selected text)

  3. How do we manage releases?

    Every 6 months, an announcement e-mail will be sent to communicate the changes made to the new version (similarly as for OpenNCP Releases announcement).
    See also section "Glossary maintenance process"

  4. How do we track changes?

    Inline and page comments, consolidated in Changes Review page to be used in Review meeting and Release Notes

  5. How to visualise the changes made by the Glossary Owner (based on the requests for change) from the previous version of the Glossary?

    -Deprecated entry's => (strike through)
    -Request for change => highlighted in bold red (to avoid duplicate request)

Glossary maintenance process




Full details about this procedure can be found Glossary maintenance process page.




Glossary Key Terms


The following table presents an extract of the main terms used within eHDSI, from the eHDSI Complete Glossary presented below.

The key terms were selected from all the domains, with the purpose to help any type of audience better familiarize with the eHDSI context.

#

Term

AcronymDomain

Term Type/

Audience

Definition

1Building BlocksBBDigital Service InfrastructureTechnicalBasic digital service infrastructures, which are key enablers to be reused in more complex (e.g. eHealth) digital services.
2Connecting Europe Facility CEFDigital Service InfrastructurePolicyA key EU funding instrument supporting the development of high performing, sustainable and efficiently interconnected trans-European networks in the fields of transport, energy and digital services (telecom).
3Continuity of caren/aHealthcareClinical

Component of patient care quality consisting of the degree to which the care needed by a patient is coordinated among practitioners and across organizations and time.

4Core Services/Central Servicesn/aDigital Service InfrastructurePolicy, Technical

Central hubs of digital service infrastructures aiming to ensure trans-European connectivity, access and interoperability and which are open to Member States and may be open to other entities.

5Cross-border healthcaren/aHealthcarePolicy

Healthcare provided or prescribed in a Member State other than the Member State of affiliation.

6Deploying countryn/aDigital Service InfrastructurePolicy

EU Member State or nation participating in the set up and operation of services for cross-border health data exchange under the CEF eHealth Digital Service Infrastructure (eHDSI).

7

e-Dispensing/

eDispensation

eDHealthcare, ePrescriptionClinical

The act of electronically retrieving a prescription and giving the medicine to the patient. Once the medicine has been dispensed, a report on the items dispensed is sent to the prescribing Member State in a structured format.

8eHealth Digital Service InfrastructureeHDSIDigital Service InfrastructurePolicyTerm used for the generic and core services for the cross border services of eP and PS during CEF financing.
Source: Guideline on an Organisational Framework for eHealth National Contact Point
9Electronic identificationeIDIdentity and Access ManagementTechnicalThe process of using person identification data in electronic form uniquely representing either a natural or legal person, or a natural person representing a legal person.
10ePrescriptionePHealthcare, ePrescriptionClinical

A medicinal prescription issued and transmitted electronically.

Source: Commission Recommendation 2008/594/EC on cross-border interoperability of electronic health records - Point 3(f)PS/eP guidelines

The concept of the ePrescription service is understood as the ordering of a prescription in software, the electronic transmission of that prescription from the Prescription provider to a Dispense provider, the electronic dispensing of the medicine and the electronic transmission of the dispensed medicine information from the dispenser provider to the prescription provider.

The ePrescription service is made up of electronic prescribing and electronic dispensing:

  • ePrescribing is defined as prescribing of medicines in software by a health care professional legally authorized to do so, for dispensing once it has been electronically transmitted, at the pharmacy.
  • eDispensing is defined as the act of electronically retrieving a prescription and giving out the medicine to the patient as indicated in the corresponding ePrescription. Once the medicine is dispensed, the dispenser shall report via software the information about the dispensed medicine(s).
11eHDSI Servicen/aDigital Service InfrastructurePolicy, TechnicalThe Patient Summary and ePrescription services built on top of the NCPs (internal and external communications and processes).
12Friendly documentn/aHealthcareTechnicaleHDSI Friendly documents reflect the semantics and information scope as defined by the selected eHDSI semantic signifier and conform to the pivot schema and value sets of that semantic signifier.
13Functional RequirementFRBusiness Analysis and Requirements ManagementTechnical

Describes the capabilities that a solution must have in terms of the behavior and information that the solution will manage.

Source: BABOK®

eHDSI use: eHDSI Business Analysis and Requirements Management Approach

14

Generic services

n/aDigital Service InfrastructurePolicy, TechnicalThe generic services are the necessary implementation of data exchange at country level.
15Health ProfessionalHP/HCPHealthcareGenericA doctor of medicine, a nurse responsible for general care, a dental practitioner, a midwife or a pharmacist within the meaning of Directive 2005/36/EC, or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC, or a person considered to be a health professional according to the legislation of the Member State of treatment.
16Interoperabilityn/aGenericPolicy, TechnicalInteroperability, within the context of European public service delivery, is the ability of disparate and diverse organisations to interact towards mutually beneficial and agreed common goals, involving the sharing of information and knowledge between the organisations, through the business processes they support, by means of the exchange of data between their respective ICT systems.
17Master Value Sets CatalogueMVCHealthcareSemanticA collection of terms used within certain parts of the eHDSI pivot documents (either parts describing the patient demographics or the clinical problems for example) based on standardised code system such as ICD-10, SNOMED CT, ATC classification, EDQM Standard Tems, and UCUM.
18Member State of affiliationCountry AHealthcarePolicy
  • The Member State that is competent to grant to the insured person a prior authorization to receive appropriate treatment outside the Member State of residence according to Regulations (EC) No 883/2004 and (EC) No 987/2009;
  • The Member State that is competent to grant to the insured person a prior authorization to receive appropriate treatment in another Member State according to Regulation (EC) No 859/2003 or Regulation (EU) No 1231/2010.
19Member State of treatmentCountry BHealthcarePolicyThe country where cross-border healthcare is provided when the patient seeks care abroad. In the case of telemedicine, healthcare is considered to be provided in the Member State where the healthcare provider is established.
20National Contact PointNCPGenericPolicy, TechnicalOrganisations delegated by each participating Country, acting as a bidirectional way of interfacing between the existing different national functions provided by the national IT infrastructures and those provided by the common European infrastructure, created in eHDSI. The NCP takes care of external and internal national communication and functions in eHDSI and the semantic mapping (if necessary) between information on either side. The NCP also acts as a kind of mediator as far as the legal and regulatory aspects are concerned. The NCP creates the conditions (by supporting trust, data protection and privacy) for a trusted relationship with other countries’ NCPs.
21Non-repudiationn/aInformation SecurityPolicy, TechnicalThe security service by which the entities involved in a communication cannot deny having participated. Specifically the sending entity cannot deny having sent a message (non-repudiation with proof of origin) and the receiving entity cannot deny having received a message (non-repudiation with proof of delivery).
22OpenNCPn/aHealthcareTechnicaleHDSI NCP software publicly available under Open Source licensing.
23Patientn/aHealthcareClinicalAny natural person who receives or wishes to receive healthcare in a country.
24Patient SummaryPSHealthcareClinicalAn identifiable “dataset of essential and understandable health information” that is made available “at the point of care to deliver safe patient care during unscheduled care [and planned care] with its maximal impact in the unscheduled care”; it can also be defined at a high level as: “the minimum set of information need to assure Health Care Coordination and the continuity of care”.
25Personal datan/aData ProtectionPolicyAny information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.
26Pivot documentn/aHealthcareTechnicalA document whose structure allows for semantic interoperability between eHDSI Countries. Its structure is based on the data contained in the eHN Guidelines for ePrescription and Patient Summary and a commonly used syntax standard. If a country document is mapped onto this schema it ensures that the meaning of the concept transferred is commonly understood by the other countries. The schema tags are in English. The document structures sections necessary for the data presented such as "Allergies", "Medical Problems", etc.
27Point of CarePoCHealthcareClinicalA location where an EU citizen may seek healthcare services. This may be a hospital, pharmacy or any other facility in the healthcare system of Country B.
28Processing of personal datan/aData ProtectionPolicyAny operation or set of operations which is performed upon personal data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, blocking, erasure or destruction.
29Routine Operationn/aDigital Service InfrastructurePolicy, Technical

An NCPeH that has started the exchange of real patient data (after approval for going life). It runs on the Production/Operation (OP) environment (1 of the 3 environments that a country should establish for the NCP, that are DEV, PPT, OP).

30Semantic servicesn/aDigital Service InfrastructurePolicy, TechnicalA collection of services surrounding the exchange of the Patient Summary, ePrescription and eDispensation between deploying countries. The services address the syntax (structure), the terminology (or Value Sets), and the translation and transcoding services that might be needed, so that healthcare professionals can make informed decisions concerning patient care.


Complete Glossary



#

Term

AcronymDomain

Term Type/

Audience

Definition

1

Access control

n/aIdentity and Access Management
Technical

The process of ensuring that access to assets is authorized and restricted based on business and security requirements.

Source: ISO/IEC 27000:2018 - Terms and definitions

The process of granting or denying specific requests: 1) for obtaining and using information and related information processing services; and 2) to enter specific physical facilities.
eHDSI use: Identity Management Specification

2Active substance/ Active ingredient/ Active pharmaceutical ingredientActive pharmaceutical ingredient (API)

Healthcare, Patient Summary, ePrescription

Clinical

Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis.

Source: DIRECTIVE 2001_83_EC on the Community code relating to medicinal products for human use

eHDSI use: eHDSI Requirements Catalogue

3ADMET parametersADMETHealthcareClinical

Absorption, distribution, metabolism, excretion and toxicity parameters of a drug, which are important for the choice of drug and drug dosage.

Source: eP guidelines R2

4

Adverse Reaction

n/aHealthcare, Patient SummaryClinical

A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.

Source: DIRECTIVE 2001_83_EC on the Community code relating to medicinal products for human use

eHDSI use: eHDSI Requirements Catalogue

5

Alerts

n/a

Healthcare,

Patient Summary

Clinical

Any allergies, adverse reactions and alerts as part of the medical history of a patient.
Source: eHDSI Requirements Catalogue

6Allergenn/a

Healthcare, Patient Summary

Clinical

A usually harmless substance capable of triggering a response that starts in the immune system and results in an allergic reaction.

Example of allergens: pollen, dust mites, animal dander, mold, medications, insect venoms and various foods.

Source: http://www.aaaai.org/conditions-and-treatments/conditions-dictionary/Allergen

eHDSI use: eHDSI Requirements Catalogue

7Allergen Productn/aHealthcare, Patient SummaryClinical

Any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent.

Source: DIRECTIVE 2001_83_EC on the Community code relating to medicinal products for human use

8Assertionn/aIdentity and Access ManagementTechnical

A set of statements that can be evaluated by an authority (usually an Identity Provider) concerning an entity. The statements can be concerning identifying information (e.g. name) as well as attributes (e.g. role).

eHDSI use: Identity Management Specification

9Assurance levelsn/aIdentity and Access ManagementTechnical

Assurance levels characterize the degree of confidence in electronic identification means in establishing the identity of a person, thus providing assurance that the person claiming a particular identity is in fact the person to which that identity was assigned. The assurance level depends on the degree of confidence that electronic identification means provides in claimed or asserted identity of a person taking into account processes (for example, identity proofing and verification, and authentication), management activities (for example, the entity issuing electronic identification means and the procedure to issue such means) and technical controls implemented.

Source: Regulation (EU) No 910/2014

Assurance levels low, substantial and high for electronic identification means issued under a notified electronic identification scheme shall be determined with reference to the specifications and procedures set out in the Annex.

Source: Commission Implementing Regulation (EU) 2015/1502

10Attributen/aSoftware ArchitectureTechnical

A property or a characteristic of an entity.

eHDSI use: Identity Management Specification

11

Attribute based access

n/aIdentity and Access ManagementTechnical

An attributable role-based access that controls and limits the user access to the defined services based on his/her role/profile.

eHDSI use: Identity Management Specification

12Attribute providern/aIdentity and Access ManagementTechnical

The stakeholder that provides additional information related to the identity by providing a service that can be defined as “a service trusted by one or more entities that provides digital identity-related ‘attributes’ (i.e. specific data describing that identity that may be either a natural or a legal person)”.

Source: http://www.esens.eu/technical-solutions/e-sens-competence-clusters/e-identity/

13Auditn/aAuditPolicy

Independent review and examination of records and activities to assess the adequacy of system controls, to ensure compliance with established policies and operational procedures, and to recommend necessary changes in controls, policies, or procedures.

Source: Identity Management Specification

14

Authentication

n/aIdentity and Access ManagementTechnical

An electronic process that enables the electronic identification of a natural or legal person, or the origin and integrity of data in electronic form to be confirmed.
Source: Regulation (EU) No 910/2014 (eIDAS)

Formalized process to create a validated identity for a claimant, based on the value of one or more attributes of its identity.

Note: Authentication typically involves the use of a policy to specify a required level of assurance in the result after a successful completion of the process.

Source: Identity Management Specification

Process to verify the claimed identity before authorizing a particular action to be performed.
Source: eHDSI Requirements Catalogue

Note: Authentication should not be confused with Identification.

15

Authorisation

n/aIdentity and Access ManagementTechnical

Process to approve a temporary granting of a set of privileges to an entity. The privileges enable the entity to access to some sources or to use some services of a system. Authorization is based on policy rules for permitting an activity in a particular system.
Source: Identity Management Specification

Process by which entitlement of a requester, to access or use a given service, is determined.
Source: eHDSI Requirements Catalogue

16Availabilityn/aSoftware ArchitectureTechnical

The property of a system or a system resource being accessible, or usable or operational upon demand, by an authorized system entity, according to performance specifications for the system; i.e., a system is available if it provides services according to the system design whenever users request them.

Source: Identity Management Specification

17

Available prescriptions

n/aHealthcare, ePrescriptionClinical

The prescription that can be retrieved for the patient in the act of dispensing (at that specific or particular moment). This implicitly means that it is a time valid prescription.

Source: eHDSI Requirements Catalogue

18

Brand name or Name of the medicinal product

n/aHealthcare, ePrescriptionClinical

The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorization holder.

Source: DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending DIRECTIVE 2001_83_EC on the Community code relating to medicinal products for human use
eHDSI use: Identity Management Specification

19

Building Blocks

BBDigital Service InfrastructureTechnical

Basic digital service infrastructures, which are key enablers to be reused in more complex (e.g. eHealth) digital services.
Source: CEF Telecom guidelines Regulation (EU) N° 283/2014

20

Connect-a-thon

CATTestingTechnical

Connect-a-thon (organised by IHE)

Source: Test Framework

21

Cross-Border eHealth Information Services

CBeHISGenericPolicy

Cross-Border eHealth Information Services within the scope, namely Patient Summary and ePrescription (may include eDispensation).
Source: Guideline on an Organisational Framework for eHealth National Contact Point

The generic services are the necessary implementation of data exchange at country level, the core services at EU level. These together enable the provision of Cross Border eHealth Information Services (CBeHIS).

Source: eHN - Governance model (2016 version) adopted by the eHealth Network, Brussels, 21 November 2016.

22

Connecting Europe Facility eHealth Digital Service Infrastructure

CEF eHDSIDigital Service InfrastructurePolicy

The initial deployment and operation of services for cross-border health data exchange under the Connecting Europe Facility (CEF). eHDSI sets up and starts deploying the core and generic services, as defined in the CEF, for Patient Summary and ePrescription.
Source: eHN - Governance model (2016 version) for the eHDSI, adopted by the eHealth Network, Brussels, 21 November 2016.

EU financial mechanism (based on call for proposals) that was launched by November 2015 and used by MS to support CBeHIS provision (preparation, deployment and operation of NCPeH - meaning generic services in CEF).
Source: Guideline on an Organisational Framework for eHealth National Contact Point

23

Certificate for electronic signature

n/aIdentity and Access ManagementTechnical

An electronic attestation which links electronic signature validation data to a natural person and confirms at least the name or the pseudonym of that person.
Source: Regulation (EU) No 910/2014 (eIDAS)

24Claimantn/aIdentity and Access ManagementTechnical

Entity that initiates an authentication of its identity.

Source: Identity Management Specification

25Clinical Information Systemn/aHealthcareTechnicalSolutions of Primary Care Centers, General Practitioner’s for documentation and Prescription.
Source: Identity Management Specification
26Closed Problems/ Diagnosisn/aHealthcare, Patient SummaryClinicalProblems or diagnosis not included under the definition of ''Current problems or diagnosis''. This is a synonymous of inactive problems or resolved problems.
Source: eHDSI Requirements Catalogue
27Coding Systemn/aHealthcareSemantic

A scheme for representing concepts using (usually) short concept identifiers to denote the concepts that are members of the system; defines a set of unique concept codes. Examples of coding systems are ICD-9, LOINC and SNOMED.

Source: eHDSI Requirements Catalogue

28

Communication gateway

n/aGenericTechnical

Member States (MS) system that manages CBeHIS transactions with other MS and which connects to the National Infrastructure (NI).
This is an entry/exit point from the MS, acting on behalf of a HP and citizen (at a Point of Care), that ensures the exchange of the patient’s medical data in a controlled environment.

Source:  Guideline on an Organisational Framework for eHealth National Contact Point

29

Compliance establishment process

n/aGenericPolicy

A well-defined set of activities and evidence used to ensure that NCPeH compliance can be established, maintained and reinforced.

Source: Guideline on an Organisational Framework for eHealth National Contact Point

30Conceptn/aHealthcare, ePrescriptionTechnical

Unit of knowledge constructed through combining characteristics.

Source: eHDSI Requirements Catalogue

31Confidentialityn/aInformation Security, Data Protection

Technical,

Policy

The property that sensitive information is not disclosed to unauthorized individuals, entities or processes.

Source: Identity Management Specification, REGULATION 2016/679 (data protection)

32

Connecting Europe Facility

CEFDigital Service InfrastructurePolicy

A key EU funding instrument supporting the development of high performing, sustainable and efficiently interconnected trans-European networks in the fields of transport, energy and digital services (telecom).

Source: https://ec.europa.eu/inea/en/connecting-europe-facility

33

Consent

n/aData ProtectionPolicy

Any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her.

Source: REGULATION 2016/679 (data protection)

34Contextn/aSoftware ArchitectureTechnical

Property of an attribute that specifies the meaning and possible values of the attribute (the same attribute, e.g. a number can have different meaning in various contexts).

Source: Identity Management Specification

35Continuity of caren/aHealthcareClinical

Component of patient care quality consisting of the degree to which the care needed by a patient is coordinated among practitioners and across organizations and time.

Source: http://www.astm.org/Standards/E2369.htm
eHDSI use: eHDSI Requirements Catalogue

36

Controller

n/aData ProtectionPolicy

The natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State law.
Source: REGULATION 2016/679 (data protection), DIRECTIVE 95/46/EC (data protection)

37

Core Services/ Central Services

n/aDigital Service InfrastructurePolicy, Technical

Central hubs of digital service infrastructures aiming to ensure trans-European connectivity, access and interoperability and which are open to Member States and may be open to other entities.
Source: CEF Telecom guidelines Regulation (EU) N° 283/2014

The core services are the necessary implementation of data exchange at EU level.
Source: eHN - Governance model (2016 version); in alignment with CEF workplan

38Cross-border healthcaren/aHealthcarePolicy

Healthcare provided or prescribed in a Member State other than the Member State of affiliation.

Source: Art. 3 (e) of Directive 2011/24/EU

39Cross-border interoperabilityn/aDigital Service InfrastructurePolicyInteroperability between neighbouring and non-neighbouring countries and their entire territories.
Source: Identity Management Specification
40Cross-border servicen/aDigital Service InfrastructurePolicyServices provided in a country different from Country A (e.g. Healthcare services).
Source: eHDSI Requirements Catalogue
41

Common Terminology Services - Release 2

CTS2TerminologySemantic

HL7 Common Terminology Services - Service Functional Model (SFM) Specification Release 2 - the goal of CTS2 Specification is to expand the original functionality outlined in HL7's Common Terminology Service (CTS) Specification. CTS2 defines the functional requirements of a set of service interfaces to allow the representation, access, and maintenance of terminology content either locally, or across a federation of terminology service nodes. 

Source: National Cancer Institute Wiki, HL7 Common Terminology Services - Release 2 (Normative)

42

Current prescription

n/aHealthcare, ePrescriptionClinical

Any prescribed medicine whose period of time indicated for the treatment has not yet expired, whether it has been dispensed or not. This mean that it might not be an ‘available’ prescription since the time to withdraw the medicine may have expired but the treatment is still on.

Source: eHDSI Requirements Catalogue

43Current problems/ Diagnosisn/aHealthcare, Patient SummaryClinical

Problems/diagnosis that fit under these conditions: conditions that may have a chronic or relapsing course, conditions for which the patient receives repeat medications and conditions that are persistent and serious contraindications for classes of  medication.
Source: eHDSI Requirements Catalogue

44

Data concerning health

n/aData ProtectionPolicy

Personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status.
Source: REGULATION 2016/679 (data protection)

45Data Processorn/aData ProtectionPolicy

Natural or legal person, public authority, agency or any other body which processes personal data on behalf of the controller.

Source: REGULATION 2016/679 (data protection)

eHDSI use: Identity Management Specification

46

Demographics

n/aIdentity and Access ManagementTechnical

Sufficient data to characterize a person, like for example: name, date of birth, gender.

Source: eHDSI Requirements Catalogue

47Deploying countryn/aDigital Service InfrastructurePolicy

EU Member State or nation participating in the set up and operation of services for cross-border health data exchange under the CEF eHealth Digital Service Infrastructure (eHDSI).

Rationale: Under the Connecting Europe Facility (CEF) funding, those countries participating in the eHDSI, will provide generic services through the preparation, setting-up, deployment, and operation of the NCPeH, eHN - Governance model (2016 version) adopted by the eHealth Network, Brussels, 21 November 2016.

48

Digital Service Infrastructures

DSIDigital Service InfrastructurePolicy

Describe solutions that support the implementation of EU-wide projects. They provide trans-European interoperable services of common interest for citizens, businesses and/or public authorities, and which are composed of core service platforms and generic services.

Source: CEF Telecom guidelines Regulation (EU) N° 283/2014

49Dispensed Medicinen/aHealthcare, ePrescriptionClinical

The medicine given to a patient as indicated in the prescription ordered by a prescriber.

Source: eHDSI Requirements Catalogue

50Dispensern/aHealthcare, ePrescription, eDispensationClinical

Healthcare professional who provides the order of a prescription. The professional person must be authorized to do so.

Source: Identity Management Specification, eHDSI Requirements Catalogue

51Domain of applicabilityn/aIdentity and Access ManagementTechnical

Domain (area, space) where an entity can use a set of attributes for identification and other purposes (e.g. cross-border environment, eHealth systems of a country).

Source: Identity Management Specification

52(Pharmaceutical) Dose Formn/aHealthcare, Patient Summary, ePrescriptionClinical

The physical manifestation (“entity”) that contains the active and/or inactive ingredients that deliver a dose of the medicinal product. The key defining characteristics of the Dose Form can be the state  of  matter,  delivery  method,  release characteristics and  the administration site or route for which the product is formulated.

A term for the physical characteristics of a drug product - e.g., tablet, capsule or solution - which contains the drug substance and almost invariably other ingredients, such as excipient, fillers, flavours, preservatives or emulsifiers.


The form in which a pharmaceutical product is presented in the medicinal product package as supplied by the marketing authorization holder/manufacturer/distributor (e.g. tablets, syrup).


Source: DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending DIRECTIVE 2001_83_EC on the Community code relating to medicinal products for human use, The Free Dictionary-Medical Dictionary

eHDSI use: eHDSI Requirements Catalogue
53

e-Dispensing/ eDispensation

eDHealthcare, ePrescriptionClinical

The act of electronically retrieving a prescription and giving the medicine to the patient. Once the medicine has been dispensed, a report on the items dispensed is sent to the prescribing Member State in a structured format.

eHDSI use: eHDSI Requirements Catalogue

54

eHealth Digital Service Infrastructure

eHDSIDigital Service InfrastructurePolicy

Term used for the generic and core services for the cross border services of eP and PS during CEF financing.

Source:  Guideline on an Organisational Framework for eHealth National Contact Point

55

eHDSI Central Configuration Services

eHDSI-CCSDigital Service InfrastructurePolicy

eHDSI Central Configuration Services

56

eHDSI Central Terminology Services

eHDSI-CTSDigital Service InfrastructureSemantic

A set of components used for the representation, access, and maintenance of the terminology content of the electronic documents exchanged within eHDSI. It allows to centrally manage controlled vocabularies and the creation of common subsets and mappings from them that will subsequently be accessed and synchronized at deploying country level (national repositories).

57eHealthn/aHealthcare, Patient Summary, ePrescriptionPolicy

The use of information and communication technologies (ICT) for health. 

Source: http://www.who.int/ehealth/en/

58

eHealth Member State Expert Group

eHMSEGDigital Service InfrastructurePolicy

eHealth Member State Expert Group

Source: eHN - Governance model (2016 version) for the eHDSI, adopted by the eHealth Network, Brussels, 21 November 2016

59

eHealth National Contact Point

eHNCPDigital Service InfrastructurePolicy

Similar to NCPeH. This term has been introduced in the second release of the PS and eP guidelines issued by eHealth Network.

Source: PS/eP guidelines

60eHealth NetworkeHNHealthcarePolicy

eHealth Network according to Article 14 of Directive 2011/24/EU.

61

eHealth Operational Management Board

eHOMBDigital Service InfrastructurePolicy

eHealth Operational Management Board.

Source: eHN - Governance model (2016 version) for the eHDSI, adopted by the eHealth Network, Brussels, 21 November 2016

62eIDAS-Noden/aIdentity and Access ManagementTechnical

eIDAS-Node, as defined for the CEF eID building block, is an application component that:

  • provides standardised common interfaces therefore hides national complexities from other countries;
  • elevates the national circle of trust to European level; and,
  • guarantees scalability (as any change in a Member State will only affect its own node).

Source: Introduction to the Connecting Europe Facility eID building block, referring to "Interoperable Delivery of European eGovernment Services to public Administrations, Businesses and Citizens (IDABC)"

63

Electronic Health Record

EHRHealthcarePolicy

A comprehensive, structured set of clinical, demographic, environmental and social data information in electronic form, documenting the Health Care given to a single individual.
Source: http://www.astm.org

Comprehensive medical record or similar documentation of the past and present physical and mental state of health of an individual in electronic form, and providing for ready availability of these data for medical treatment and other closely related purposes.

eHDSI use: Identity Management Specification

A comprehensive, structured set of clinical, demographic, environmental and social data information in electronic form, documenting the Health Care given to a single individual.

Source: http://www.astm.org/

eHDSI use: eHDSI Requirements Catalogue

64Electronic Health Record Systemn/aHealthcareTechnical

System for recording, retrieving and manipulating information in electronic health records.

Source: Identity Management Specification

65

Electronic identification

eIDIdentity and Access ManagementTechnical

The process of using person identification data in electronic form uniquely representing either a natural or legal person, or a natural person representing a legal person.

Source: Regulation (EU) No 910/2014 (eIDAS)

66

Electronic identification scheme

n/aIdentity and Access ManagementTechnical

A system for electronic identification under which electronic identification means are issued to natural or legal persons, or natural persons representing legal persons.

Source: Regulation (EU) No 910/2014 (eIDAS)

67

Electronic seal

n/aIdentity and Access ManagementTechnical

Data in electronic form, which is attached to or logically associated with other data in electronic form to ensure the latter’s origin and integrity.

Source: Regulation (EU) No 910/2014 (eIDAS)

68

Electronic signature

eSignatureIdentity and Access ManagementTechnical

Data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign.

Source: Regulation (EU) No 910/2014 (eIDAS)

69

Electronic time stamp

n/aIdentity and Access ManagementTechnical

Data in electronic form which binds other data in electronic form to a particular time establishing evidence that the latter data existed at that time.
Source: Regulation (EU) No 910/2014 (eIDAS)

70European Medicines Agency EMAHealthcarePolicy

A decentralised agency of the European Union (EU). It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

Source: http://www.ema.europa.eu/

71

Enrolment

n/aIdentity and Access ManagementTechnical

Process consisting of identity proofing and identity registration to allow an entity to be known within a particular domain of applicability.

Note: In general enrollment collates and creates identity information for storage in an identity register to be used in subsequent authentication of the entity in the domain of applicability. It is the start of the life cycle of an identity in the domain of applicability for an entity.

Source: Identity Management Specification

72Entityn/aGenericTechnicalNatural person, organisation, active or passive object, device or group of such items that has an identity. (Patient, HP, HPCO, patient summary, patient consent documents are entities of the cross-border environment).
Source: Identity Management Specification
73

ePrescription

ePHealthcare, ePrescriptionClinical

A medicinal prescription issued and transmitted electronically.

Source: Commission Recommendation 2008/594/EC on cross-border interoperability of electronic health records - Point 3(f), PS/eP guidelines

The concept of the ePrescription service is understood as the ordering of a prescription in software, the electronic transmission of that prescription from the Prescription provider to a Dispense provider, the electronic dispensing of the medicine and the electronic transmission of the dispensed medicine information from the dispenser provider to the prescription provider.

The ePrescription service is made up of electronic prescribing and electronic dispensing:

  • ePrescribing is defined as prescribing of medicines in software by a health care professional legally authorized to do so, for dispensing once it has been electronically transmitted, at the pharmacy.
  • eDispensing is defined as the act of electronically retrieving a prescription and giving out the medicine to the patient as indicated in the corresponding ePrescription. Once the medicine is dispensed, the dispenser shall report via software the information about the dispensed medicine(s).

Source: eHDSI Requirements Catalogue

Medical prescription, provided in electronic format: "A prescription is understood as a set of data like drug ID, drug name, strength, form, dosage, indication or as a list of drugs together covering the patients current medication. The data set might differ slightly between the countries.“ In the context of eHealth DSI, this definition of ePrescription data will apply. However, it is not excluded that the use of the infrastructure and the service developed in eHealth DSI might be afterwards extended to handle ePrescription data different from medicinal prescriptions.

Source: Identity Management Specification

74Episode of caren/aHealthcareClinical

An  interval  of  care  by  a  HCP  for  a  specific  medical  problem  or condition. It  may  be  continuous  or  it  may  consist of  a series  of intervals marked by one or more brief separations from care, and can also  identify  the  sequence  of  care (e.g., emergency,  inpatient, outpatient), thus serving as one measure of healthcare provided.

Source: eHDSI Requirements Catalogue, http://www.mondofacto.com/dictionary/medical.html

75

Smart Open Services for European Patients

epSOS LSPHealthcarePolicy, Technical

Open eHealth initiative for a European large scale pilot of patient summary and electronic prescription.

Source: http://www.epsos.eu/home/about-epsos.html

76eHDSI Servicen/aDigital Service InfrastructurePolicy, Technical

The Patient Summary and ePrescription services built on top of the NCPs (internal and external communications and processes).

Source: eHDSI Requirements Catalogue

77External Validation ServerEVSTestingTechnical

Document or message conformance testing.

For example, ePrescription document in CDA standard format is analysed and validated with this conformance tool.

Source: Test Framework

78EVS Clientn/aTestingTechnical

A front-end which allows the user to use the external validation services from a user-friendly interface instead of the raw web service offered by the Gazelle tools.

Source: Test Framework

79

Friendly Document

n/aHealthcareTechnical

eHDSI Friendly documents reflect the semantics and information scope as defined by the selected eHDSI semantic signifier and conform to the pivot schema and value sets of that semantic signifier.

Source: eHDSI Requirements Catalogue

Rationale: Runtime semantic processes perform the dynamic transformation of the clinical documents; producing from the original Country A format the eHDSI Friendly CDA that will feed the NCPeH-A, and then, in Country B, the eHDSI pivot document to the eHDSI Friendly Country B, generated by the NCPeH-B, which is finally transferred to the Portal B or the national infrastructure B (Semantic Assets rationale for Maintenance and Evolution under the eHDSI time frame, V1.0).

80

Functional Requirement

FRBusiness Analysis and Requirements ManagementTechnical

Describes the capabilities that a solution must have in terms of the behavior and information that the solution will manage.

Source: BABOK®

eHDSI use: eHDSI Business Analysis and Requirements Management Approach

81

General Practitioner

GPHealthcareClinical

A physician who provides primary care.

A general practitioner treats acute and chronic illnesses and provides preventive care and health education for all ages and both sexes.

Source: http://www.medical-solutions.co.za/General_Practitioners.php, eHDSI Requirements Catalogue
82Generic medicinal productn/aHealthcareClinical

Shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product had been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives or an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy or the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriated detailed guidelines.

Source: DIRECTIVE 2001_83_EC on the Community code relating to medicinal products for human use

eHDSI use: eHDSI Requirements Catalogue

83

Generic services

n/aDigital Service InfrastructurePolicy, Technical

The generic services are the necessary implementation of data exchange at country level.
Source: eHN - Governance model (2016 version); in alignment with CEF workplan.

Generic services are gateway services linking national infrastructures to core service platforms or other national infrastructures
Source: CEF Telecom guidelines Regulation (EU) N° 283/2014

84

Guideline

n/aGenericPolicy, Technical

A suggested way of compliance when doing something. It is visible to those using or supporting the use of a particular service, but there are no sanctions if it is not followed.

Source: Guideline on an Organisational Framework for eHealth National Contact Point

85

Healthcare

n/aHealthcareClinical

Health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices.

Source: Art. 3(a) of Directive 2011/24/UE

86Health ProfessionalHP/HCPHealthcareGeneric

A doctor of medicine, a nurse responsible for general care, a dental practitioner, a midwife or a pharmacist within the meaning of Directive 2005/36/EC, or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC, or a person considered to be a health professional according to the legislation of the Member State of treatment;

In some documents, the acronym HCP is used.
Source: Art. 3 (f) of Directive 2011/24/UE

Doctor of medicine or a nurse responsible for general care or a dental practitioner or a midwife or a pharmacist within the meaning of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC . This means that a Health Care Professional is a person who delivers health care or care products professionally to any individual in need of health care services, in order to prevent, relieve or treat a medical problem. A Health Care Professional must be related to at least one HCPO.

Source: Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications or another professional exercising activities in the healthcare sector

87Healthcare Providern/aHealthcareGeneric

Any natural or legal person or any other entity legally providing healthcare on the territory of a Member State.

Source: Art. 3(g) of Directive 2011/24/UE

88

Healthcare Provider Organisation

HCPOHealthcareGeneric

An institution, authorized to provide health care services, univocally identified in the set of the Health Care Institutions.
Examples: Health Center, Hospital, Medical Emergency Vehicle, Medical Practice, Pharmacy.

An institution, authorized to provide health care services, univocally identified in the set of the Health Care Institutions.

Examples: Health Center, Hospital, Medical Emergency Vehicle, Medical Practice, Pharmacy.

Source: Identity Management Specification and eHDSI Requirements Catalogue

89

Health services provider organisations

HPOHealthcareGeneric

Associations or federations of health care providers, who search a benefit from coordinating or associating among them. Health services provider organisations can include GP practices, general hospitals, specialized hospitals, teaching and university hospitals, social care organisations, and so on.

Source: Identity Management Specification

90Healthcare Service ProviderHSPHealthcareGeneric

Organisation that delivers proper health care in a systematic way professionally to any individual in need of health care services. It is an entity that provides, coordinates, and/or insures health and medical services for people (International Classification for Patient Safety, World Health Organization). They can vary considerably in size (they range from small organisations run by a single person, through medium sized commercial enterprises, to large Trusts). They can be commercial, public or non-profit (Picker Institute). Examples: hospitals, home health agencies, clinics, nursing homes, ambulance companies, and the health care provider corporations formed by individuals.

Source: Identity Management Specification

91Hospital Information Systemn/aHealthcareTechnical

Implemented Solutions in Hospitals for documentation, accounting, etc. HIS delivers PS, eP for eHealth DSI.

Source: Identity Management Specification

92

Information and Communication Technologies

ICTGenericTechnicalInformation and Communication Technologies.
93

Identification

n/aSoftware ArchitectureTechnical

Process to determine that presented identity information associated with a particular entity is sufficient for the entity to be recognized in a particular domain of applicability.
Source: Identity Management Specification

Assignment of a unique number or string to an entity within a registration procedure which unambiguously identifies the entity. This number or string serves thereafter as an identifier uniquely attached to this entity.

Source: eHDSI Requirements Catalogue

Note: Identification should not be confused with Authentication.

94IdentifierIDSoftware ArchitectureTechnical

Non-empty set of attribute values that uniquely characterize an entity in a specific domain of applicability.

Source: Identity Management Specification

95Identityn/aSoftware ArchitectureTechnical

Set of attributes related to an entity.

Note: Each entity is represented by one holistic identity, which comprises all possible information elements characterizing such entity (the attribute). Since such identity can be very large, even infinite for practical purposes only a subset of relevant attributes represents the entity. (e.g. name, address, date of birth, passport number, etc.).

Source: Identity Management Specification

96Identity authorityn/aIdentity and Access ManagementTechnical

Entity related to a particular domain of applicability that can make authoritative assertions on the validity of one or more attribute values in an identity.

Source: Identity Management Specification

97Identity evidencen/aIdentity and Access ManagementTechnical

Identity information pertaining to an entity required for successful enrolment of the entity.

Source: Identity Management Specification

98Identity federationn/aIdentity and Access ManagementTechnical

Agreement between two or more identity authorities to mutually recognize credentials for authorisation

Note: Establishing an identity federation typically includes an agreement on the use of common protocols and procedures for privacy control, data protection and auditing and the use of standardized data formats and cryptographic techniques.

Source: Identity Management Specification

99Identity informationn/aIdentity and Access ManagementTechnical

Set of values of attributes in an identity.

Source: Identity Management Specification

100

Identity provider

IdPIdentity and Access ManagementTechnical

An Identity Provider can be defined as: the stakeholder that provides the means of electronic identity to a person who’s identity has been established. The provider of the electronic identity can be a public administration or a private sector provider (on behalf of or officially recognised by the government). The identity provider can also play the role of Service Operator or Implementer or may leave this to other actors.

Source: STORK: Architecture, Implementation and Pilots

Entity that makes available identity information and entity that operates the functions necessary to complete authentication.

Note: A verifier may be the same as or act on behalf of the entity that controls identification of entities for a particular domain of applicability.
Source: Identity Management Specification

101Identity referencen/aSoftware ArchitectureTechnical

Attribute that is an identifier and that persists in a domain of applicability for the existence of the entity.

Source: Identity Management Specification

102Identity registerIDMS registerSoftware ArchitectureTechnical

Repository of identities for different entities indexed by their identity reference during enrolment.

Examples: Driver license number, the number printed on a membership card, a phone number.

Note: The identity reference may exist longer than the entity.

Source: Identity Management Specification

103Information Technology Infrastructure Library ITIL® Information SecurityTechnical

Defines the organisational structure and skill requirements of an information technology organisation and a set of standard operational management procedures and practices to allow the organisation to manage an IT operation and associated infrastructure. The operational procedures and practices are supplier independent and apply to all aspects within the IT Infrastructure.

ITIL works as a set of detailed practices for IT service management (ITSM) and focuses on aligning IT services with the needs of the business.

ITIL Service Management supports the use of the Service Lifecycle, which is split into 5 distinct lifecycle stages:

  • Service Strategy
  • Service Design
  • Service Transition
  • Service Operation
  • Continual Service Improvement

Source: https://wiki.en.it-processmaps.com/index.php/History_of_ITIL

104Information Security Management System ISMSInformation SecurityTechnical

An ISMS is a systematic approach to managing sensitive company information, so that it remains secure. It includes people, processes and IT systems by applying a risk management process.

ISO/IEC 27001 is the best-known standard in the family providing requirements for an information security management system (ISMS).

Source: International Organization for Standardization (ISO) web page: https://www.iso.org/isoiec-27001-information-security.html

105

Integrating the Healthcare Enterprise

IHEHealthcareTechnical

An initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 to address specific clinical needs in support of optimal patient care. Systems developed in accordance with IHE communicate with one another better, are easier to implement, and enable care providers to use information more effectively.

Source: https://www.ihe.net

106Integrityn/aIdentity and Access ManagementTechnical

The property that sensitive data has not been modified or deleted in an unauthorized and undetected manner.

Source: Identity Management Specification

107

Interoperability

n/aGenericPolicy, Technical

Interoperability, within the context of European public service delivery, is the ability of disparate and diverse organisations to interact towards mutually beneficial and agreed common goals, involving the sharing of information and knowledge between the organisations, through the business processes they support, by means of the exchange of data between their respective ICT systems.

Source: European Interoperability Framework

108

Interoperability framework

n/aGenericPolicy, Technical

An interoperability framework is an agreed approach to interoperability for organisations that wish to work together towards the joint delivery of public services. Within its scope of applicability, it specifies a set of common elements such as vocabulary, concepts, principles, policies, guidelines, recommendations, standards, specifications and practices.

Source: European Interoperability Framework

109International Organization for StandardizationISOGenericPolicy, Technical

ISO is an independent, non-governmental international organization with a membership of 161 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.

Source: https://www.iso.org

110

Jurisdictional Domain

n/aGenericSemantic

Identifies a country, region, organization or other domain that may define and manage its own code systems or concepts, including localization of a broader code system. Its presence in this model is specifically to allow for localization of certain concept elements.

Source: HL7 Common Terminology Services Service Functional Model Specification - Release 2

eHDSI use: Terminology Services

111

Level of Assurance (Level of Trust)

n/aIdentity and Access ManagementTechnical

A risk category for objects to be protected. It defines the set of required security controls to reduce the risk to an acceptable level. The purpose is to hide the particular implementation details of a security policy on the level of a single electronic transaction.

Source: Identity Management Specification

112Long term treatmentn/aHealthcareClinical

Refers to those treatments in which one prescription includes several dispenses of the same medicine distributed along a period of time.

Source: eHDSI Requirements Catalogue

113Large Scale PilotLSPHealthcarePolicy

Is the EU wide pilot project to implement a Patient Summary and ePrescription service to support continuity of care.

Source: eHDSI Requirements Catalogue

114

Mandatory PS dataset

n/aHealthcare, Patient SummaryTechnical

It is a subgroup of the ‘Minimum PS dataset’ in which the fields must have a valid value. If the values are not valid, the PS will be rejected.

Source: eHDSI Requirements Catalogue

115Maximum PS datasetn/aHealthcare, Patient SummaryTechnical

Desirable health information from the clinical point of view to be exchanged between the eHDSI Deploying countries. The fields contained within the maximum dataset are not compulsory to be sent. It is also called ‘Extended dataset’.

Source: eHDSI Requirements Catalogue

116Medical devicen/aHealthcareClinical, Technical

Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. Devices are to be used for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease. alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process and for control of conception.

Source: Directive 2007/47/EC

117

Medical (Health) Record

n/aHealthcareClinical

A systematic documentation of a patient's medical history and care. The term 'Medical record' is used both for the physical folder for each individual patient and for the body of information which comprises the total of each patient's health history. Medical records are highly personal documents and there are many ethical and legal issues surrounding them such as the degree of third-party access and appropriate storage and disposal. Although medical records are traditionally compiled and stored by healthcare providers (HP) personal health records maintained by individual patients have become more popular in recent years.

Source: Identity Management Specification and eHDSI Requirements Catalogue

118Medication Summaryn/aHealthcareClinical

All prescribed medicine which period of time indicated for the treatment has not yet expired, whether they have been dispensed or not. It is a synonymous of current medication. It contains the following information of each one: active ingredient, strength, posology (number of units per intake, frequency of intakes (per day/month or week) and duration of treatment) and onset date of treatment.

At least, a list of current prescriptions with the following information of each one: brand name, active ingredient, pharmaceutical dose form, strength, package size, posology, onset date of treatment and end date of treatment.

Source: eHDSI Requirements Catalogue

119Medicinal Prescriptionn/aHealthcareClinical

Any medicinal dispensation issued by a professional person qualified to do so.

Source: Identity Management Specification

120Medicinal Productn/aHealthcareClinical

(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying   physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’

Source: DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending DIRECTIVE 2001_83_EC on the Community code relating to medicinal products for human use

eHDSI use: eHDSI Requirements Catalogue

121Medicinal Product Package/ Package Typen/aHealthcareClinical

Delivery unit of a medicinal product in an outer container.

Source: DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending DIRECTIVE 2001_83_EC on the Community code relating to medicinal products for human use

122

Member State of affiliation

Country AHealthcarePolicy
  • The Member State that is competent to grant to the insured person a prior authorization to receive appropriate treatment outside the Member State of residence according to Regulations (EC) No 883/2004 and (EC) No 987/2009;
  • The Member State that is competent to grant to the insured person a prior authorization to receive appropriate treatment in another Member State according to Regulation (EC) No 859/2003 or Regulation (EU) No 1231/2010. If no Member State is competent according to those Regulations, the Member State of affiliation shall be the Member State where the person is insured or has the rights to sickness benefits according to the legislation of that Member State.

Source: Art. 3(c) of Directive 2011/24/EU

eHDSI use: Guideline on an Organisational Framework for eHealth National Contact Point

The home country of the patient which holds information about the patient, where the patient can be univocally identified and his/her data may be accessed. To each patient one country is attributed as “Country A''.

Source: Identity Management Specification, eHDSI Requirements Catalogue

123

Member State of treatment

Country BHealthcarePolicy

The country where cross-border healthcare is provided when the patient seeks care abroad. In the case of telemedicine, healthcare is considered to be provided in the Member State where the healthcare provider is established.

Source: Art. 3(d) of Directive 2011/24/EU

eHDSI use: Guideline on an Organisational Framework for eHealth National Contact Point

The country (different from Country A) in which information about a patient is needed in case the patient needs healthcare.

Source: Identity Management Specification

124Minimum PS datasetn/aHealthcare, Patient Summary, ePrescriptionTechnical

It is defined as the agreed set of essential health information that is required from the clinical point of view to be sent to deliver safe care to the patient in country B. It may be sent with a value ‘null flavor’ if the source system of the country does not track that information. It is also called ''Basic PS dataset''.

Source: eHDSI Requirements Catalogue

125

(Multilateral) Legal Agreement

MLAHealthcarePolicy

Agreement between National Authorities or National Organisations responsible for National Contact Points for eHealth on the Criteria required for the participation in Cross-Border eHealth Information Services.

Source: eHealth Network

126Master Translation/ Transcoding CatalogueMTCHealthcareSemantic

The eHDSI Master Translation/Transcoding Catalogue contains, in addition to the original terms in English, their translation into different languages corresponding to the respective deploying countries and the possible cross-referencing (transcoding) with other code systems that are used at national level. Translation and transcoding are national responsibilities.

Source: eHDSI Requirements Catalogue

127Master Value Sets CatalogueMVCHealthcareSemantic

A collection of terms used within certain parts of the eHDSI pivot documents (either parts describing the patient demographics or the clinical problems for example) based on standardised code system such as ICD-10, SNOMED CT, ATC classification, EDQM Standard Tems, and UCUM.

Source: eHDSI Requirements Catalogue

128

National infrastructure

NIHealthcareTechnical

The healthcare IT infrastructure, which manages patient and HP/HCP8 identification and healthcare records in MS.

Source: Guideline on an Organisational Framework for eHealth National Contact Point

129National Authority responsible for NCPeHn/aHealthcarePolicy

Ministry responsible for eHealth, or an organization at a lower level to which the competence of either operating the NCPeH and/or signing this Agreement was demonstrably delegated by the Ministry responsible for eHealth, or an Authority at an even higher level than the Ministry responsible for eHealth (e.g. Government as collegial organ) as required by the national laws and procedures of a Contracting Party.

Source: Glossary of abbreviations and definitions from: "Agreement between National Authorities or National Organisations responsible for National Contact Points for eHealth on the Criteria required for the participation in Cross-Border eHealth Information Services''

130National ConnectorNCGenericTechnical

The National Connector is the entry and exit point from and to the eHDSI NCP. Deploying countries are free to develop and build the implementation of the National Connector with the interfaces defined in the eHDSI Specifications. Deploying countries can export the interface as service, to communicate with the National Connector needed. This component is designed to implement the objectives related to national infrastructures connection and national data handling. Its implementation is a very specific task for each deploying country and depends on the national infrastructure.

Source: eHDSI Requirements Catalogue

131

National Contact Point

NCPGenericPolicy, Technical

National Contact Point as referred to in Article 6 of Directive 2011/24/EU
Source: Guideline on an Organisational Framework for eHealth National Contact Point

Organisations delegated by each participating Country, acting as a bidirectional way of interfacing between the existing different national functions provided by the national IT infrastructures and those provided by the common European infrastructure, created in eHDSI. The NCP takes care of external and internal national communication and functions in eHDSI and the semantic mapping (if necessary) between information on either side. The NCP also acts as a kind of mediator as far as the legal and regulatory aspects are concerned. The NCP creates the conditions (by supporting trust, data protection and privacy) for a trusted relationship with other countries’ NCPs.

Source: Identity Management Specification

Single node where a set of  functionalities and services is provided at national level for the proper working of the eHDSI platform.

Source: eHDSI Requirements Catalogue

132

National Contact Point for eHealth

NCPeHHealthcarePolicy, Technical

National Contact Point for eHealth, which may act as an organisational and technical gateway for the provision of eHealth Cross-Border Information Services. 
Source: Guideline on an Organisational Framework for eHealth National Contact Point

133

NCPeH deployment

n/aHealthcarePolicy, Technical

Set of activities aiming to ensure NCPeH compliance with the full range of requirements (LOST) established towards CBeHIS provision.

Source: Guideline on an Organisational Framework for eHealth National Contact Point

134

NCPeH implementation

n/aHealthcarePolicy, Technical

Process of preparing, deploying and operating an NCPeH.
Source: Guideline on an Organisational Framework for eHealth National Contact Point

135

NCPeH operation

n/aHealthcarePolicy, Technical

Set of activities performed by the MS while providing services to citizens and Health Professionals.
Source: Guideline on an Organisational Framework for eHealth National Contact Point

136

NCPeH preparation

n/aHealthcarePolicy, Technical

Set of activities aiming to set up an NCPeH.
Source: Guideline on an Organisational Framework for eHealth National Contact Point

137Need-to-known/aDigital Service InfrastructureTechnical

The term "need to know", when used by government and other organizations, describes the restriction of data which is considered very sensitive. Under need-to-know restrictions, even if one has all the necessary official approvals (such as a security clearance) to access certain information, one would not be given access to such information, or read into

a clandestine operation, unless one has a specific need to know; that is, access to the information must be necessary for the conduct of one's official duties.

As with most security mechanisms, the aim is to make it difficult for unauthorized access to occur, without inconveniencing legitimate access. Need-to-know also aims to discourage "browsing" of sensitive material by limiting access to the smallest possible number of people.

Source: Identity Management Specification

138National Health ServiceNHSHealthcarePolicy, Technical

National Health Service.

Source: eHDSI Requirements Catalogue
139Non-functional Requirement/ Quality of service RequirementsNFRBusiness Analysis and Requirements ManagementTechnical

Describe conditions under which a solution must remain effective or qualities that a solution must have.

Source: BABOK®

eHDSI use: eHDSI Business Analysis and Requirements Management Approach

140Non-repudiationn/aInformation SecurityPolicy, Technical

The security service by which the entities involved in a communication cannot deny having participated. Specifically the sending entity cannot deny having sent a message (non-repudiation with proof of origin) and the receiving entity cannot deny having received a message (non-repudiation with proof of delivery).

Source: Identity Management Specification

141

Object identifier

OIDGenericTechnical

An extensively used identification mechanism jointly developed by ITU-T and ISO/IEC for naming any type of object, concept, or "thing" with a globally unambiguous name which requires a persistent name (long life-time), once allocated, should not be re used for a different object/thing.

It is based on a hierarchical name structure based on the "OID tree". This naming structure uses a sequence of names, of which the first name identifies a top-level "node" in the OID tree, and the next provides further identification of arcs leading to sub-nodes beneath the top-level, and so on to any depth.

Source: OID Repository

142

OpenNCP

n/aHealthcareTechnical

eHDSI NCP software publicly available under Open Source licensing.

Source: Guideline on an Organisational Framework for eHealth National Contact Point

143

Organisational Framework

OFW-NCPeHHealthcarePolicy

Guidelines on an Organisational Framework for NCPeH.

Source: Guideline on an Organisational Framework for eHealth National Contact Point

144Original prescriptionn/aHealthcareClinical

The minimum data set defined but as prescribed in the origin country (e.g. the brand name of country A that it will probably be different than the one dispensed in country B).

Source: eHDSI Requirements Catalogue

145

Project-a-thon

PATTestingTechnical

Project-a-thon (organised by eHDSI)

Source: Test Framework

146

Patient

n/aHealthcareClinical

Any natural person who receives or wishes to receive healthcare in a country.
Person or defined groups of persons receiving or registered as eligible to receive health care services or having received health care services.

Source: eHDSI Requirements Catalogue

147

Patient consent provided to the data controller

n/aData ProtectionPolicy

Any freely given specific and informed indication of his/her wishes by which the data subject signifies his agreement to personal data relating to him/her being processed.

Source: Identity Management Specification

148

Patient Summary

PSHealthcareClinical

An identifiable “data set of essential and understandable health information” that is made available “at the point of care to deliver safe patient care during unscheduled care [and planned care] with its maximal impact in the unscheduled care”; it can also be defined at a high level as: “the minimum set of information need to assure Health Care Coordination and the continuity of care”.

Source: PS Guidelines

149

Personal data

n/aData ProtectionPolicy

Any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.

Source: REGULATION 2016/679 (data protection)

Set of data directly linked to a physical person and used to identify and authenticate this person.

Source: Identity Management Specification

150Pivot documentn/aHealthcareTechnical

A document whose structure allows for semantic interoperability between eHDSI Countries. Its structure is based on the data contained in the eHN Guidelines for ePrescription and Patient Summary and a commonly used syntax standard. If a country document is mapped onto this schema it ensures that the meaning of the concept transferred is commonly understood by the other countries. The schema tags are in English. The document structures sections necessary for the data presented such as "Allergies", "Medical Problems", etc.

Source: eHDSI Requirements Catalogue

151

Point of Care

PoCHealthcareClinical

A location where an EU citizen may seek healthcare services. This may be a hospital, pharmacy or any other facility in the healthcare system of Country B.
Source: Directive 2011/24/UE

Any location where health care is provided.
Source: Identity Management Specification

Any natural or legal person or any other subject having legal capacity that relies on the usage of personal health related data in order to fulfill tasks or business purposes notwithstanding whether those tasks have been delegated by law or not.

Source: eHDSI Requirements Catalogue

152Posologyn/aHealthcareClinical

Instruction on number of units per intake, frequency of intakes (per day/month or week) and duration of treatment.

Source: eHDSI Requirements Catalogue

153Pre-Production Testing environmentPPTInfrastructureTechnicalPre-production testing environment (1 of the 3 environments that a country should establish for the NCP, that are DEV, PPT, OP).
154Prescribern/aHealthcareClinical

Health Care Professional who issues a prescription.

Source: eHDSI Requirements Catalogue

155

Prescription

n/aHealthcareClinical

A prescription for a medicinal product or a medical device issued by a member of a regulated health profession within the meaning of Article 3 (1) (a) of Directive 2005/36/EC, who is legally entitled to do so in the Member State in which the prescription is issued.

Source: Directive 2011/24/UE

156Privacyn/aData ProtectionPolicy

The right of individuals to control or influence what information related to them may be collected and stored and by whom and to whom that information may be disclosed.

Source: Identity Management Specification

157

Processing of personal data

n/aData ProtectionPolicy

Any operation or set of operations which is performed upon personal data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, blocking, erasure or destruction.

Source: REGULATION 2016/679 (data protection)

158

Processor

n/aData ProtectionPolicy

A natural or legal person, public authority, agency or any other body which processes personal data on behalf of the controller.

Source: REGULATION 2016/679 (data protection)

159Profilen/aIdentity and Access ManagementTechnical

Identity that contains attributes that are relevant in the interactions with one or more distinct domains of applicability by the entity associated with the identity.

Source: Identity Management Specification

160

Qualified electronic signature

n/aElectronic SignaturePolicy, Technical

An advanced electronic signature that is created by a qualified electronic signature creation device, and which is based on a qualified certificate for electronic signatures;

Source: Regulation (EU) No 910/2014 (eIDAS)

161Quality Management SystemQMSInformation SecurityTechnical

A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization, which aim at continuous improvement of quality, in order to ensure customer expectations and regulatory requirements are met or exceeded.

A process based QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance. ''ISO 9001'' is an example of a Quality Management System.

Source and more information: International Organization for Standardization (ISO) web page: ISO 9001 Quality Management SystemThe beginners guide to quality management systems

162

Reliability

n/aInformation SecurityTechnical

Ability to provide security on the veracity of the information provided. http://thesaurus.reference.com

Source: eHDSI Requirements Catalogue

163

Relying Party

n/aIdentity and Access ManagementTechnical

An individual or organization providing a service that depends on identity provider about a subject to control access to the service.

Source: Identity Management Specification

164Rolen/aIdentity and Access ManagementTechnical

A role typically implies a collection of privileges to access or use resources available in a domain of applicability (the most important roles in eHealth DSI are patient and various kinds of HP).

Source: Identity Management Specification

165Route of administrationn/aHealthcareClinical

Indicates the part of the body through or into which, or the way in which, the medicinal product is intended to be introduced. In some cases a medicinal product can be intended for more than one route and/or method of administration.

Source: DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending DIRECTIVE 2001_83_EC on the Community code relating to medicinal products for human use

166Routine Operationn/aDigital Service InfrastructurePolicy, Technical

Defines a NCPeH that has started the exchange of real patient data (after approval for going life).

It runs on the Production/Operation (OP) environment (1 of the 3 environments that a country should establish for the NCP, that are DEV, PPT, OP).

167

Semantic services

n/aDigital Service InfrastructurePolicy, Technical

A collection of services surrounding the exchange of the Patient Summary, ePrescription and eDispensation between deploying countries. The services address the syntax (structure), the terminology (or Value Sets), and the translation and transcoding services that might be needed, so that healthcare professionals can make informed decisions concerning patient care.

Source: Semantic Services Specification

168

Semantic transformation

n/aSemanticTechnical

During the semantic document workflow, upon request from Country B, the NCPeH-A obtains the medical information for the requested patient and transforms the data, respecting the defined pivot documents syntax and vocabulary. The NCPeH-A generates the pivot document by data transformation, which is sent to the NCPeH-B. In the NCPeH-B, the pivot document is transformed into the local data format and into the official language used for expressing medical information in Country B. The meaning should be preserved during the whole process.

Source: Semantic Services Specification

The eHMSEG Semantic Task Force has proposed an alternative to this term to better express the intended meaning and avoid any confusion. An alternative, depending on the exact context, could be "semantic processing for document transformation". The definition suggested for it is "applying the semantic assets to the original clinical document and providing it to the healthcare professional in country B, with the same legal and clinical value as the original clinical document". This new term clarifies that there is no change in the meaning of the document and that it is only the document what is transformed.

169Service Metadata Locator/ Dynamic Service LocationSMLDigital Service InfrastructureTechnical

The key component that enables dynamic discovery of participants in message exchange networks. As a result, these networks can scale up without being affected by the management of an increasing number of participants. Instead of having participants managed by a central node, address resolution becomes fully distributed and consequently much more scalable.

Source: CEF eDelivery Services

170Service Metadata Publisher/ Capability LookupSMPDigital Service InfrastructureTechnical

Enables the participants of an eDelivery Messaging Infrastructure to dynamically discover each other's capabilities (Legal, Organisational, and Technical). For this to happen, each participant must publish its capabilities and settings in an SMP.

In the context of eHDSI, in order to enable other eHDSI Deploying countries to access another country's services, the service endpoints and digital certificates must be registered in a way that allows each Deploying country to discover all other country’s service endpoints and verify the services’ authenticity. For providing such a register, eHDSI makes use of “Service Metadata Publisher files” where each Deploying country provides information about its managed services in a Central Service Registry.

Source: CEF eDelivery: Service Metadata Publisher (SMP)Service Location and Capability Lookup Profile_v2.1.0.pdf

171

Service Offerings

n/aDigital Service InfrastructurePolicy, Technical

Is a formal description of the CEF DSIs services from the point of view of the users who primarily perceive the services provided
Source: Adaptation https://ec.europa.eu/cefdigital/wiki/display/CEFDIGITAL/Service+Offering

172Systematized Nomenclature of MedicineSNOMED CTSemanticTechnical

The Systematized Nomenclature of Medicine (SNOMED) is a multiaxial hierarchical and computer processable classification of medical terminology covering most areas of clinical information such as diseases, procedures, pharmaceuticals etc.

Source: eHDSI Requirements Catalogue

173Strengthn/aHealthcareClinical

The  content  of  the  active  ingredient  expressed  quantitatively  per dosage unit, per unit of volume or per unit of weight, according to the pharmaceutical dose form.

Source: DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending DIRECTIVE 2001_83_EC on the Community code relating to medicinal products for human use

174Storkn/aHealthcarePolicy, Technical

STORK 2.0: in follow-up of the first STORK LSP (Large Scale Pilot) the STORK 2.0 LSP builds on the results of STORK to establish interoperability of different approaches at national and EU level, eID for persons, eID for legal entities. The STORK 2.0 LSP includes four pilots, among which the pilot on eHealth that aims to adapt or extend existing eHealth Services using eID for patients and healthcare professionals. This pilot includes the use case that allow patient and representative (e.g. third parties, like family members or Health Care Professionals (HCPs)) access to electronic health records (EHRs) and Health care professional identification via STORK attributes.

Source: https://www.eid-stork2.eu/pilots/ehealth/index.php/en/

175Substancen/aHealthcareClinical

Any matter irrespective of origin which may be: human, e.g. human blood  and  human  blood  products;  animal,  e.g.  micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts; chemical, e.g. elements, naturally   occurring   chemical   materials   and   chemical   products obtained by chemical change or synthesis.

Source: DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending DIRECTIVE 2001_83_EC on the Community code relating to medicinal products for human use
176Surgical proceduren/aHealthcareClinical

A medical procedure involving an incision with instruments performed to repair damage or a disease in a living body.

Source: www.wordreference.com/definition

177SVS simulatorn/aSoftware ArchitectureTechnical

Sharing Value Set simulator

The SVS Simulator is an application that emulates the Value Set Consumer and Value Set Repository actors defined in the IT-Infrastructure technical framework.

Source: Test Framework , IHE Gazelle eHealth test framework for interoperability

178

Time valid prescription

n/aHealthcareClinical

It is the time during which the prescription can be dispensed (see Terminology in section 11).
E.g. In Andalusia the time validity means that the patient can withdraw the medicine from the pharmacy until the date of the end of treatment while in other countries, like the UK, the patient can withdraw the medicine up to a maximum number of days from the date of issue, e.g. 6 months.

Source: eHDSI Requirements Catalogue

179

Trust service

n/aInformation SecurityPolicy, Technical

An electronic service normally provided for remuneration which consists of:

(a) the creation, verification, and validation of electronic signatures, electronic seals or electronic time stamps, electronic registered delivery services and certificates related to those services, or

(b) the creation, verification and validation of certificates for website authentication; or

(c) the preservation of electronic signatures, seals or certificates related to those services;

Source: Regulation (EU) No 910/2014 (eIDAS)

180

Use Case

UCBusiness Analysis and Requirements ManagementTechnical

Is a methodology used in systems analysis to identify, organize and describe system requirements involved in Health Care scenarios. Contains all system activities that has significance to the user. www.businessanalysisbooks.com

Source: eHDSI Requirements Catalogue

181

Valid prescription

n/aHealthcareClinical

An ''official'' prescription, i.e., a prescription  made  fulfilling  the  legislation  and  the procedures defined in that country.

Source: eHDSI Requirements Catalogue

182Validationn/aSoftware ArchitectureTechnical

Process to determine that presented identity information associated with a particular entity is applicable for the entity to be recognized in a particular domain of applicability at a point in time.

Note: Validation usually involves verifying the syntax, and correctness of attribute values, controlling their validity status and matching them with the requirements to recognize an entity.

Source: Identity Management Specification

183

Web Services Enhancements

WSETestingTechnical

Web Services Enhancements

Source: Test Framework

Source: Commission Recommendation 2008/594/EC on cross-border interoperability of electronic health records Healthcare




6 Comments

  1. The eHMSEG Semantic Task Force requests a new addition to the Glossary, the expression "semantic transformation", along with a clarification to it.

    The term semantic transformation should be interpreted as "applying the semantic assets to the original clinical document and providing it to the healthcare professional in country B, with the same legal and clinical value as the original clinical document".

    This term needs to be replaced by a better alternative as it could be wrongly interpreted as "changing the meaning of the clinical document". An alternative could be "document transformation" as this conveys the idea that a transformation actually occurs to the document from country A in the NCPeH of country B, although the meaning is maintained in the process.

     

     

     

     

    1. Thank you Marta TERRON CUADRADO for your request.

      Please give us 1 or 2 days to perform a consistency check.

      We will come to you shortly about this request.

    2. Dear Marta TERRON CUADRADO

      Could you please confirm the final exact text to be added after the clarification process performed?

  2. A few suggestions for terms to be added:

    • Friendly
    • Pivot
    • National connector
    • OpenNCP
    • eDispensation
    • MVC
    • MTC
    1. Dear Konstantin HYPPONEN thank you for the suggestions.

      I was surprised by some of the suggested terms not being present due to the abundant usage in specification (wink)

      We will take care of adding them.

  3. I suggest to include two new terms in the eHDSI Glossary:

    • Object Identifier (OID)
    • eHDSI Semantic services