SIST EN 17269:2020
(Main)Health informatics - The International Patient Summary
Health informatics - The International Patient Summary
This standard formalises the dataset required to share information about the medical background and history of a patient from the patient’s country of affiliation with a healthcare professional in another country where unscheduled treatment is required. It uses the European guidelines (version 2, November 2016) as an official source for the requirements.
The scope for the ‘Patient Summary for Unscheduled, Cross-border Care’ standard is of international significance. This standard, therefore, complements co-ordinated international efforts to maximise its utility and value, providing an interoperable dataset specification.
The dataset is minimal and non-exhaustive, providing a robust, well-defined set of items that are specialty-agnostic, condition-independent and usable by all clinicians for the unscheduled care of a person. The dataset will also be usable as a valuable subset of data items for scheduled care. The dataset enables cross-border application and it will support national communication of patient summary data, thereby providing wider applicability and greater benefit from the standard for the continuity of care of a person in need.
This international standard does not cover workflow processes of data entry, data collection, the summarisation act nor subsequent data presentation. Implementation guidance for specifically European concerns, e.g., Directives, terminologies, formats etc., is in the associated Technical Specification.
Medizinische Informatik - Die Patienten-Kurzakte für ungeplante, grenzüberschreitende medizinische Versorgung
Dieses Dokument legt den Kerndatensatz für eine Patienten Kurzakte fest, die die Kontinuität der Versorgung für eine Person und die Koordinierung der Gesundheitsversorgung unterstützt. Es hat die Unterstützung des Anwendungsfall Szenarios für die „ungeplante, grenzüberschreitende Versorgung“ zum Ziel und soll eine internationale Patienten Kurzakte (IPS) sein. Der Datensatz ist minimal und nicht allumfassend und stellt einen robusten, eindeutig definierten Satz an Datenelementen zur Verfügung. Diese enge Ausrichtung auf den Anwendungsfall ermöglicht, dass die IPS auch in der geplanten Versorgung verwendet werden können und dass sowohl die ungeplante als auch die geplante Versorgung durch diesen Datensatz in lokalen und nationalen Kontexten unterstützt wird, was dessen Nutzen und Wert erhöht.
Es verwendet die Europäischen Richtlinien der eHN als erste Quelle für die Anforderungen an Patienten Kurzakten, berücksichtigt aber auch andere internationale Bemühungen, um eine interoperable Spezifikation für Datensätze zur globalen Anwendung bereitzustellen.
In dieser IPS Norm wird eine abstrakte Definition einer Patienten Kurzakte aufgeführt. Von dieser abgeleitete Modelle sind implementierbar. Aufgrund ihrer Art sollten sich Leser daher bewusst sein, dass die Übereinstimmung mit dieser Norm nicht automatisch technische Interoperabilität impliziert. Dieses Ergebnis, das durch diese Norm ermöglicht wird, kann durch die Konformität mit Normen erreicht werden, die in der zugehörigen technischen Spezifikation und Implementierungsleitfäden angegeben sind.
Diese internationale Norm deckt keine Arbeitsabläufe der Dateneingabe, der Datenerhebung, der Tätigkeit der Zusammenfassung selbst oder der nachfolgenden Datendarstellung noch Datenassimilation oder Datenverdichtung ab.
Sie stellt keine Richtlinie zur Implementierung dar, die sich mit den verschiedenen technischen Abstufungen unter der Anwendungsstufe befasst. Anleitungen zur Implementierung für spezifisch gesetzliche Belange, z. B. Richtlinien, Terminologien, Formate usw., werden in der zugehörigen technischen Spezifikation (CEN/TS 17288) festgelegt.
Insbesondere die Darstellung durch verschiedene Kodierverfahren, zusätzliche Strukturen und Terminologien sind nicht Teil dieser Norm. Terminologie und ihre Verbindlichkeit werden in der zugehörigen technischen Spezifikation (CEN/TS 17288) behandelt. Die Normen zur Identifikation von Arzneimitteln (en: Identification of Medicinal Products, abgekürzt IDMP) sind das empfohlene Ziel für die Medikationsübersicht bezüglich dieser Norm. Jedoch kann diese IPS Norm vor der vollständigen praktischen Implementierung der IDMP derzeit nicht auf ihre Anwendung bestehen und erkennt an, dass vorläufige Verfahren notwendig sein können, bis die IDMP sich als Norm etabliert haben.
Informatique de santé - Résumé international du dossier médical du patient
Le présent document définit le jeu de données de base d'un document de synthèse appelé « résumé de dossier patient », servant à étayer la continuité et la coordination des soins de santé d'une personne. Il vise spécifiquement à faciliter le scénario d'utilisation de « soins transfrontaliers non planifiés » et doit aboutir à la création d'un « Résumé international de dossier patient » (IPS). Même si le jeu de données est minimal et non exhaustif, il fournit un ensemble d'éléments de données de base robuste et bien défini. Cette visée restreinte du cas d'utilisation permet d'utiliser également l'IPS dans les soins planifiés, et d'utiliser le jeu de données pour favoriser les soins planifiés et non planifiés dans des contextes locaux et nationaux, augmentant ainsi son utilité et sa valeur.
Le présent document utilise les lignes directrices européennes de l'eHN comme source initiale des exigences du résumé de dossier patient, mais prend en considération d'autres actions internationales, afin de fournir une spécification de jeu de données interopérable visant une application globale.
La présente norme IPS fournit une définition abstraite du résumé d'un dossier patient, à partir de laquelle des modèles dérivés peuvent être mis en œuvre. De par sa nature, il convient que les lecteurs soient conscients que la conformité à cette norme n'implique pas une interopérabilité technique automatique ; le résultat, rendu possible par cette norme, peut être atteint avec la conformité aux normes indiquées dans les spécifications techniques et les guides d'implémentation associés.
La présente Norme internationale ne couvre pas les processus des séquences de tâches, à savoir saisie, collecte et compilation proprement dite des données, pas plus que la présentation ultérieure, l'assimilation ou l'agrégation de ces données.
Il ne s'agit pas d'un guide d'implémentation traitant des différentes couches techniques se trouvant sous la couche application. Des recommandations de mise en œuvre concernant spécifiquement des questions propres à une juridiction, par exemple, des directives, des terminologies, des formats, etc., sont fournies dans la spécification technique associée (DTS 17288).
Notamment, la représentation par différents schémas de codage, les structures et les terminologies supplémentaires ne font pas partie de la présente norme. La terminologie et ses règles contraignantes sont traitées dans la spécification technique associée (DTS 17288). Les normes d'identification des médicaments (abrégées en IDMP de l'anglais « Identification of Medicinal Products ») sont la cible recommandée pour la liste récapitulative des traitements médicamenteux liée à la présente norme. Toutefois, avant la mise en œuvre complète des normes IDMP dans la pratique, la présente norme IPS ne peut pas insister, à l'heure actuelle, sur leur utilisation et reconnaît que des schémas provisoires peuvent être nécessaires jusqu'à ce que l'IDMP soit établie comme norme.
Zdravstvena informatika - Mednarodni povzetek podatkov o pacientu
Ta standard formalizira nabor podatkov, potreben za skupno rabo informacij o zdravstvenem ozadju in anamnezi bolnika iz bolnikove države pripadnosti z zdravstvenim strokovnjakom v drugi državi, v kateri je potrebno nenačrtovano zdravljenje. Kot uradni vir za zahteve uporablja evropske smernice (različica 2, november 2016). Področje uporabe standarda za »povzetek kartoteke bolnika za nenačrtovano, čezmejno oskrbo« je mednarodnega pomena. Ta standard zato dopolnjuje usklajena mednarodna prizadevanja za namene povečanja svoje uporabnosti in vrednosti ter ponuja specifikacijo interoperabilnega nabora podatkov. Nabor podatkov je minimalen in neizčrpen ter zagotavlja zanesljiv, natančno določen nabor elementov, ki je agnostičen, kar zadeva specialistično področje, neodvisen od stanja in uporaben za vse zdravnike, ki izvajajo nenačrtovano oskrbo bolnika. Nabor podatkov bo prav tako uporaben kot dragocen podnabor podatkovnih elementov za načrtovano nego. Nabor podatkov omogoča čezmejno uporabo ter bo podpiral nacionalno sporočanje podatkov s povzetkom kartoteke bolnika, s čimer bo zagotovil širšo uporabnost in večjo koristnost standarda za neprekinjenost nege osebe v stiski.
Ta mednarodni standard ne zajema procesov delovnega toka vnašanja podatkov, zbiranja podatkov, dejanja povzemanja ali nadaljnje predstavitve podatkov. Vodilo za uvedbo, ki upošteva predvsem evropske zahteve, npr. direktive, terminologijo, oblike zapisa itd., je zajeto v povezani tehnični specifikaciji.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 17269:2020
01-januar-2020
Zdravstvena informatika - Mednarodni povzetek podatkov o pacientu
Health informatics - The International Patient Summary
Medizinische Informatik - Die Patienten-Kurzakte für ungeplante, grenzüberschreitende
medizinische Versorgung
Informatique de santé - Résumé international du dossier médical du patient
Ta slovenski standard je istoveten z: EN 17269:2019
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN 17269:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 17269:2020
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SIST EN 17269:2020
EN 17269
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2019
EUROPÄISCHE NORM
ICS 35.240.80
English Version
Health informatics - The International Patient Summary
Informatique de santé - Résumé international du Medizinische Informatik - Die Patienten-Kurzakte für
dossier médical du patient ungeplante, grenzüberschreitende medizinische
Versorgung
This European Standard was approved by CEN on 7 October 2019.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17269:2019 E
worldwide for CEN national Members.
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EN 17269:2019 (E)
Contents Page
European foreword . 5
Introduction . 6
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Abbreviations . 11
5 Conformance . 12
5.1 Introduction . 12
5.2 IPS Conformance Detail . 12
6 Definition and Descriptors for the IPS Data Set . 15
6.1 International patient summary data set . 15
6.2 IPS Terms and Descriptors . 15
6.3 Patterns within the IPS Data Set . 17
6.3.1 General . 17
6.3.2 Label Concept . 18
6.3.3 List . 18
6.3.4 Reference . 19
6.3.5 Person Name . 19
6.3.6 Coded Element. 19
6.3.7 Date Time . 19
6.3.8 Identifier . 20
6.3.9 Address . 20
6.3.10 Telecom . 20
6.3.11 Organization Name . 20
6.3.12 Text . 21
6.3.13 Any . 21
6.3.14 Range . 21
6.3.15 Quantity . 21
6.3.16 Period . 22
6.3.17 General Time Specification . 22
6.3.18 Healthcare Provider . 22
6.3.19 String . 23
6.3.20 Ratio . 23
6.4 Model Extensibility . 23
7 Definition of the IPS Document or IPS . 24
7.1 Overview Description: THE IPS DOCUMENT . 24
7.2 Detailed Description: THE IPS DOCUMENT . 25
8 Definition for IPS Attribute Collection: PATIENT ATTRIBUTES . 28
8.1 Overview Description: PATIENT ATTRIBUTES. 28
8.2 Detailed Description: PATIENT ATTRIBUTES . 28
9 Definition for IPS Attribute Collection: PATIENT’S ADDRESS BOOK . 30
9.1 Overview Description for PATIENT’S ADDRESS BOOK . 30
9.2 Detailed Description for PATIENT’S ADDRESS BOOK . 31
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10 Definition for IPS Section: ADVANCE DIRECTIVES . 32
10.1 Overview Description for ADVANCE DIRECTIVES . 32
10.2 Detailed Description for ADVANCE DIRECTIVES . 32
11 Definition for IPS Section: ALLERGIES and INTOLERANCES . 34
11.1 Overview Description for ALLERGIES and INTOLERANCES . 34
11.2 Detailed Description for ALLERGIES and INTOLERANCES . 35
12 Definition for IPS Section: FUNCTIONAL STATUS. 38
12.1 Overview Description for FUNCTIONAL STATUS . 38
12.2 Detailed Description for FUNCTIONAL STATUS . 39
13 Definition for IPS Section: HISTORY OF PAST PROBLEMS . 40
13.1 Overview Description for HISTORY OF PAST PROBLEMS . 40
13.2 Detailed Description for HISTORY OF PAST PROBLEMS . 41
14 Definition for IPS Section: HISTORY OF PREGNANCY . 42
14.1 Overview Description for HISTORY OF PREGNANCY . 42
14.2 Detailed Description for HISTORY OF PREGNANCY . 43
15 Definition for IPS Section: HISTORY OF PROCEDURES . 45
15.1 Overview Description for HISTORY OF PROCEDURES . 45
15.2 Detailed Description for HISTORY OF PROCEDURES . 46
16 Definition for IPS Section: IMMUNIZATIONS. 47
16.1 Overview Description for IMMUNIZATIONS . 47
16.2 Detailed Description for IMMUNIZATIONS . 47
17 Definition for IPS Section: MEDICAL DEVICES . 49
17.1 Overview Description for MEDICAL DEVICES . 49
17.2 Detailed Description for MEDICAL DEVICES . 49
18 Definition for IPS Section: MEDICATION SUMMARY . 50
18.1 Overview Description for MEDICATION SUMMARY . 50
18.2 The IPS Medication Summary and IDMP . 51
18.3 Detailed Description for MEDICATION SUMMARY . 52
19 Definition for IPS Section: PLAN OF CARE . 55
19.1 Overview Description for PLAN OF CARE . 55
19.2 Detailed Description for PLAN OF CARE . 55
20 Definition for IPS Section: PROBLEMS . 57
20.1 Overview Description for PROBLEMS . 57
20.2 Detailed Description for PROBLEMS. 57
21 Definition for IPS Section: Results . 59
21.1 Overview Description for RESULTS . 59
21.2 Detailed Description for RESULTS . 59
22 Definition for IPS Section: SOCIAL HISTORY . 61
22.1 Overview Description for SOCIAL HISTORY . 61
22.2 Detailed Description for SOCIAL HISTORY . 61
23 Definition for IPS Section: Vital Signs . 63
23.1 Overview Description for VITAL SIGNS . 63
23.2 Detailed Description for VITAL SIGNS . 63
24 Definition for IPS Attribute Collection: Cross Border . 65
24.1 Overview Description for CROSS BORDER. 65
24.2 Detailed Description for CROSS BORDER . 65
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25 Definition for IPS Attribute Collection: Provenance Metadata . 66
25.1 Overview Description for PROVENANCE . 66
25.2 Detailed Description for PROVENANCE . 67
Annex A (informative) The first IPS Scenario focussed on ‘unscheduled, cross-border care’ . 69
Annex B (informative) Explicit Trace between eHN Guideline Version 2. 77
Annex C (informative) The eHN Guideline, the JIC PS Standards Set, and IPS . 81
Bibliography . 82
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EN 17269:2019 (E)
European foreword
This document (EN 17269:2019) has been prepared by Technical Committee CEN/TC 251 “Health
informatics”, the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2020, and conflicting national standards shall be
withdrawn at the latest by May 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
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EN 17269:2019 (E)
Introduction
The goal of this standard is to deliver a single, common International Patient Summary (IPS), comprising
core content.
The scope of this standard is to achieve that goal by defining a minimal yet non-exhaustive data set and
its associated business rules. This document is intended to be implementation independent yet still
supportive of any implementation by providing formal definition and clear description of a small data set.
The primary input to the data set is the second revision of the European eHealth Network’s data set [1],
which, in turn, builds upon significant clinical input from the European Patients-Smart Open Services
(epSOS) pilot project [2].
This document defines the International Patient Summary (IPS), with the initial focus upon unplanned
care across national borders. Starting from this focus, the specification is intended to be used and be
useful in local applications and also to be supportive of planned care. It emphasizes the data required
and the associated business rules to support use and the necessary conformance of the use case for an
international patient summary.
1
The data set described is intended for global use beginning with a shared vision from a collaboration
between CEN /TC 251 and HL7. CEN has produced a separate Technical Specification (CEN/TS 17288)
that provides a European-specific guideline for IPS implementation. HL7 have produced CDA and HL7
2
FHIR templates for realizing implementations of the IPS.
The ‘International’ element of the IPS emphasizes the need to provide generic solutions for global
application moving beyond a particular region or country; consequently, wherever possible, reference is
made to international standards, rather than local ones. However, different international contexts will
offer a variety of requirements that need to be considered to ensure that patient safety is not
compromised. The IPS is underpinned by the ISO standard “System of concepts to support continuity of
care” [3] and uses those concepts in the initial IPS scenario, which is fully described in Annex A.
This standard focuses upon the overall structure of the patient summary as well as the individual data
elements that comprise it. The layout of this document uses a hierarchy of levels (H0 to H7) to facilitate
more detailed description with the purpose of supporting consistent implementation of the data set. The
level ‘H0’ describes the IPS Document as a whole, whilst levels H1-H7 describe the IPS Data Blocks with
attributes. Descriptors are added to each data element to better define the characteristics. The ‘H0’ level
document structure and constraints will be described first, the components start with H1 (e.g. IPS
Sections, IPS Attribute Collections).
1
CEN/TC 251 and HL7 have a shared vision for the patient summary, “to further the care for citizens across the
globe by providing a single, common International patient summary (IPS) that is usable by all clinicians for the
cross-border, unscheduled care of a person”.
2
HL7, Health Level Seven, CDA and FHIR are registered trademarks of Health Level Seven International. Reg. U.S.
Pat & TM Off.
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Table 1 — Description of IPS Data Set concepts and their hierarchical relationships
Descriptive H0 H1 H2 – H7
hierarchy
IPS Data IPS All possible IPS and the Non-IPS Further detail is provided within
Transfer Object Document components are identified the IPS Data Blocks’ clauses
IPS Data Blocks - Individual IPS Sections, Hierarchical description of data
elements
IPS Attribute collections, and
IPS Metadata
The ordering of the IPS Data Blocks in this standard is alphabetic within three broad categories of Non-
Clinical Data, Clinical Data and Metadata. This follows the eHDSI patient summary deployment project
[4] and here is used purely to help presentation. However, in practice it is recognised that individual
attributes might appear in different categories depending on dynamic use rather than static classification.
As the amount of information for each data element is variable, and can be extensive, this standard
presents the information using a table with descriptors for each IPS Data Block; the table provides an
overview of the hierarchical structure and its requirement with explicit links to more details using a
consistent set of descriptors. Those attributes in the table that do not have a link to further detail are
either self-explanatory or explained by the hierarchical context. Note, the order of sibling attributes is
arbitrary and has no implication for any implementation. The name of the element is given in full, if the
hierarchical arrangement in the description with the term is still open to ambiguous interpretation. This
has been done to avoid any misunderstanding. For example, the term ‘Device Type’ will be used rather
than just “Type” albeit that it refers to a data element positioned within the Medical Device IPS Data Block.
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1 Scope
This document defines the core data set for a patient summary document that supports continuity of care
for a person and coordination of healthcare. It is specifically aimed at supporting the use case scenario
for ‘unplanned, cross border care’ and is intended to be an international patient summary (IPS). The data
set is minimal and non-exhaustive, providing a robust, well-defined core set of data items. This tight focus
on the use case enables the IPS to also be used in planned care, and for both unplanned and planned care
to be supported by this data set within local and national contexts, thereby increasing its utility and value.
It uses the European Guideline from the eHN as the initial source for the patient summary requirements
but takes into consideration other international efforts so as to provide an interoperable data set
specification for global application.
This IPS standard provides an abstract definition of a Patient Summary from which derived models are
implementable. Due to its nature therefore, readers should be aware that the compliance with this
standard doesn’t imply automatic technical interoperability; this result, enabled by this standard, can be
reached with the conformity to standards indicated in the associated technical specification and
implementation guides.
This international standard does not cover workflow processes of data entry, data collection, the
summarization act itself, nor subsequent data presentation, nor assimilation, nor aggregation.
It is not an implementation guide that is concerned with the various technical layers beneath the
application layer. Implementation guidance for specifically jurisdictional concerns, e.g. Directives,
terminologies, formats etc., is specified in the associated Technical Specification (CEN/TS 17288).
In particular, representation by various coding schemes, additional structures and terminologies are not
part of this standard. Terminology and its binding are addressed in the associated Technical Specification
(CEN/TS 17288). The Identification of Medicinal Products standards (abbreviated to IDMP) are the
recommended target for the Medication Summary related to this standard but, prior to IDMP’s full
implementation in practice, this IPS standard cannot insist in its use at this point in time and recognizes
that interim schemes may be necessary until IDMP becomes established as a norm.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 80000 (all parts), Quantities and units
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
compliance
adherence to requirements for the necessary consistency of one member of the family of specifications
or standards with another which are established during the standardization process
[SOURCE: ISO/IEC 10746-2 (ISO, 2010)]
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Note 1 to entry: In this context, compliance “refers to logical consistency and correspondence between a source
artefact and a target artefact, with the target having undergone a transformation (usually a restriction). That is,
given an existing source artefact such as a specification or standard, and a target artefact that resulted from applying
a known transformation to the source, the target is in compliance with the source if the transformation is considered
“legal” by the source artefact’s originator [5].
Note 2 to entry: The target artefact is therefore compliant with the source artefact if and only if
all conformant implementations of the target are also conformant with the source.
3.2
conformance
any proposition that is true of the specification must be true in its implementation
[SOURCE: ISO/IEC 10746-2 (ISO, 2010)]
Note 1 to entry: “A given implementation instance is said to be conformant to a given specification if the
implementation instance satisfies the various requirements defined in the specification.” [5].
3.3
continuity of care
efficient, effective, ethical care delivered through interaction, integration, co-ordination and sharing of
information between different healthcare actors over time
[SOURCE: EN ISO 13940:2016]
3.4
core care plan
reusable content and structure for a potential care plan for a specified set of circumstances
[SOURCE: EN ISO 13940:2016]
3.5
derived model
any conceptual, logical or implementable information model that is obtained from applying a known
transformation from a source information model
Note 1 to entry: example of derived models could be an EN 13606 archetype obtained from a conceptual model; or
an HL7 FHIR profile derived from a HL7 FHIR Logical model; or a CDA template that specializes, or is adapted from,
a parent CDA template. In this sense a CDA implementable specification can be considered a kind of derived model.
Note 2 to entry: An IPS derived model is any logical or implementable model or specification that complies with this
standard.
3.6
demand for care
demand for healthcare
demand for healthcare provider activities expressed by a healthcare actor
Note 1 to entry: A demand for care may be expressed either by the subject of care or on their behalf.
[SOURCE: EN ISO 13940:2016]
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3.7
demand for initial contact
first demand for care concerning one or more specific health issues to be assessed by a healthcare
provider
[SOURCE: EN ISO 13940:2016]
3.8
electronic patient summary
electronic health record extract containing essential healthcare information intended for specific uses
[SOURCE: EN ISO 13940:2016]
3.9
health condition
observed or potential observable aspects of the health state at a given time
[SOURCE: EN ISO 13940:2016]
3.10
health record component
part of a health record that is identifiable for the purposes of refere
...
SLOVENSKI STANDARD
oSIST prEN 17269:2018
01-oktober-2018
=GUDYVWYHQDLQIRUPDWLND3RY]HWHNSRGDWNRYRSDFLHQWX]DQHQDþUWRYDQR
þH]PHMQR]GUDYVWYHQRRVNUER
Health informatics - The Patient Summary for Unscheduled, Cross-border Care
Medizinische Informatik - Die Patienten-Kurzakte für ungeplante, grenzüberschreitende
Pflege
Ta slovenski standard je istoveten z: prEN 17269
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN 17269:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 17269:2018
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oSIST prEN 17269:2018
DRAFT
EUROPEAN STANDARD
prEN 17269
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2018
ICS 35.240.80
English Version
Health informatics - The Patient Summary for
Unscheduled, Cross-border Care
Informatique de santé - Résumé du dossier patient Medizinische Informatik - Die Patienten-Kurzakte für
pour les soins transfrontaliers imprévus ungeplante, grenzüberschreitende Pflege
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 251.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17269:2018 E
worldwide for CEN national Members.
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Contents Page
European foreword . 6
Introduction . 7
Table 1 — Description of IPS Data set concepts and their hierarchical relationships . 9
1 Scope . 10
2 Normative references . 10
3 Terms and definitions . 10
4 Abbreviations . 13
5 Conformance . 13
5.1 Introduction . 13
5.2 IPS Conformance Detail . 14
Table 2 — Requirement Descriptors for IPS Document, Section types and Metadata . 14
6 Definition and Descriptors for the IPS Data set . 17
6.1 international patient summary data set . 17
6.2 IPS Terms and Descriptors . 17
Table 3 — Listing and meaning of IPS Data Element Descriptors . 17
6.3 Patterns within the IPS data set . 19
6.4 Model Extensibility . 24
7 Definition of the IPS Document . 25
7.1 Overview Description: THE IPS DOCUMENT . 25
Table 4 — The IPS document . 25
7.2 Detailed Description: THE IPS DOCUMENT . 26
Table 5 — 1 IPS Document . 26
8 Definition for IPS Attribute Collection: PATIENT ATTRIBUTES . 29
8.1 Overview Description: PATIENT ATTRIBUTES. 29
Table 6 — Patient Attributes Overview. 29
8.2 Detailed Description: PATIENT ATTRIBUTES . 30
Table 7 — Patient Attributes — Details . 30
9 Definition for IPS Attribute Collection: PATIENT’S ADDRESS BOOK . 32
9.1 Overview Description for PATIENT’S ADDRESS BOOK . 32
Table 8 — Patient's Address Book Overview . 32
9.2 Detailed Description for PATIENT’S ADDRESS BOOK . 32
Table 9 — Patient's Address Book — Details . 32
10 Definition for IPS Section: ADVANCE DIRECTIVES . 34
10.1 Overview Description for ADVANCE DIRECTIVES . 34
Table 10 — Advance Directives Overview . 34
10.2 Detailed Description for ADVANCE DIRECTIVES . 35
Table 11 — Advance Directives — Details . 35
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11 Definition for IPS Section: ALLERGIES and INTOLERANCES . 37
11.1 Overview Description for ALLERGIES and INTOLERANCES . 37
Table 12 — Allergies and Intolerances Overview . 37
11.2 Detailed Description for ALLERGIES and INTOLERANCES . 38
Table 13 — Allergies and Intolerances — Details . 38
12 Definition for IPS Section: FUNCTIONAL STATUS. 41
12.1 Overview Description for FUNCTIONAL STATUS . 41
Table 14 — Functional Status Overview . 41
12.2 Detailed Description for FUNCTIONAL STATUS . 42
Table 15 — Functional Status — Details . 42
13 Definition for IPS Section: HISTORY OF PAST ILLNESS . 44
13.1 Overview Description for HISTORY OF PAST ILLNESS . 44
Table 16 — History of Past Illness Overview . 44
13.2 Detailed Description for HISTORY OF PAST ILLNESS . 44
Table 17 — History of Past Illness — Details . 44
14 Definition for IPS Section: HISTORY OF PREGNANCY . 47
14.1 Overview Description for HISTORY OF PREGNANCY . 47
Table 18 — History of Pregnancy Overview . 47
14.2 Detailed Description for HISTORY OF PREGNANCY . 48
Table 19 — History of Pregnancy — Details . 48
15 Definition for IPS Section: HISTORY OF PROCEDURES . 50
15.1 Overview Description for HISTORY OF PROCEDURES . 50
Table 20 — History of Procedures Overview . 50
15.2 Detailed Description for HISTORY OF PROCEDURES . 51
Table 21 — History of Procedures — Details . 51
16 Definition for IPS Section: IMMUNIZATIONS. 52
16.1 Overview Description for IMMUNIZATIONS . 52
Table 22 — Immunizations Overview . 52
16.2 Detailed Description for IMMUNIZATIONS . 53
Table 23 — Immunizations — Details . 53
17 Definition for IPS Section: MEDICAL DEVICES . 55
17.1 Overview Description for MEDICAL DEVICES . 55
Table 24 — Medical Devices Overview . 55
17.2 Detailed Description for MEDICAL DEVICES . 55
Table 25 — Medical Devices — Details . 55
18 Definition for IPS Section: MEDICATION SUMMARY . 57
18.1 Overview Description for MEDICATION SUMMARY . 57
Table 26 — Medication Summary Overview . 57
18.2 The IPS Medication Summary and IDMP . 57
Table 27 — Medication Summary and IDMP . 58
18.3 Detailed Description for MEDICATION SUMMARY . 59
Table 28 — Medication Summary — Details . 59
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19 Definition for IPS Section: PLAN OF CARE . 62
19.1 Overview Description for PLAN OF CARE . 62
Table 29 — Plan of Care Overview . 62
19.2 Detailed Description for PLAN OF CARE . 63
Table 30 — Plan of Care — Details . 63
20 Definition for IPS Section: PROBLEMS . 65
20.1 Overview Description for PROBLEMS . 65
Table 31 — Problems Overview . 65
20.2 Detailed Description for PROBLEMS . 65
Table 32 — Problems — Details . 65
21 Definition for IPS Section: Results . 67
21.1 Overview Description for RESULTS . 67
Table 33 — Results Overview . 67
21.2 Detailed Description for RESULTS . 68
Table 34 — Results — Details . 68
22 Definition for IPS Section: SOCIAL HISTORY . 70
22.1 Overview Description for SOCIAL HISTORY . 70
Table 35 — Social History Overview . 70
22.2 Detailed Description for SOCIAL HISTORY. 70
Table 36 — Social History — Details . 70
23 Definition for IPS Metadata: Cross Border . 72
23.1 Overview Description for CROSS BORDER . 72
Table 37 — Cross Border Overview . 72
23.2 Detailed Description for CROSS BORDER . 73
Table 38 — Cross Border — Details. 73
24 Definition for IPS Metadata: Provenance . 74
24.1 Overview Description for PROVENANCE . 74
Table 39 — Provenance Overview . 74
24.2 Detailed Description for PROVENANCE . 75
Table 40 — Provenance — Details . 75
Annex A (informative) The IPS Scenario of ‘unscheduled, cross-border care’ . 77
A.1 Introduction . 77
Figure A.1 — The IPS Scenario . 77
A.2 Commentary on the IPS Scenario . 78
Figure A.2 — Abstract version of the IPS Scenario . 79
A.3 Governance of the IPS Data set . 80
A.3.1 General . 80
A.3.2 Clinical and Information Governance . 80
Figure A.3 — The IPS relationship with Non-digital and Digital artefacts. 80
Figure A.4 — Source of data for the IPS . 81
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A.4 IPS Independence and Dependence . 81
Figure A.5 — The IPS concepts defined in the IPS Data Model . 82
Figure A.6 — The IPS standard within a System of Concepts . 83
Annex B (informative) Explicit Trace between eHN Guidelines Version 2 . 84
B.1 General . 84
B.2 The eHN Guidelines and this IPS standard . 84
Table B.1 —Naming of eHN Guideline and its Correspondence with the IPS Standard . 85
B.3 The Rationale for the IPS Naming . 86
B.4 Identifiers in eHN Guidelines . 87
Annex C (informative) The eHN Guidelines, the JIC PS Standards Set, and IPS . 88
Bibliography . 89
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European foreword
This document (prEN 17269:2018) has been prepared by Technical Committee CEN/TC 251 “Health
informatics”, the secretariat of which is held by NEN.
This document is currently submitted to the CEN Enquiry.
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Introduction
The goal of this standard is to deliver a single, common International Patient Summary (IPS), comprising
core content suitable for the scenario of cross-border, unplanned care of a person with a health need.
The scope of this standard is to achieve that goal by defining a minimal yet non-exhaustive data set and
its associated business rules. The resulting standard should be implementation independent yet
supportive of any implementation by providing formal definition and clear description of the data set and
its use. The primary input to the data set is the second revision of the European eHealth Network’s data
set (eHN: 2016), which, in turn, builds upon significant clinical input from the European Patients-Smart
Open Services pilot project (epSOS: 2011).
This particular standard defines the domain model for an International Patient Summary (IPS) focused
upon unplanned care across national borders. Notwithstanding this focus, the specification is intended
to be used and be useful in local applications and also to be supportive of planned care. It emphasizes the
data required and the associated business rules to support use and the necessary conformance.
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The data set is global in scope beginning with a shared vision of the IPS standard from a collaboration
between CEN /TC 251 and HL7. CEN will produce a separate Technical Specification that will accompany
this international standard to provide European-specific guidance profiling its implementation by the
Member States. HL7 will produce CDA and FHIR templates for realizing implementations of the IPS.
Patient summaries are not new. Indeed, they are part of the very fabric of healthcare delivery, probably
being the first examples of practical reuse of clinical data. They are in common and frequent use,
throughout the healthcare domain, used to support continuity of care and the coordination of that care;
consequently, patient summaries take many forms and have variable content. There is no doubt about
their importance and place in today’s healthcare provision, but their value to the individual and to the
healthcare providers suffers from the current lack of formality and precision. Paradoxically the
variability stemming from the pervasive, common-sense use of summaries makes them difficult to share
in digital form across boundaries and restricts interoperability between heterogeneous systems.
The absence of a patient summary, or the presence of a summary that is restrictive, irrelevant or open to
wrongful interpretation at the point of care, devalues its use, increases risk, and potentially compromises
patient safety. Whilst the focus of this standard is upon the person with the health need, it should also be
apparent that the potential problems have serious and adverse side effects (e.g. cost, liability) for the
healthcare providers that have to treat that person at the point of care.
The ‘International’ element of the IPS emphasizes the need to provide generic solutions for global
application beyond a particular region or country. This means that, where-ever possible, reference is
made to international standards, rather than local ones, to avoid wasteful re-invention. However,
different international contexts will offer a variety of requirements that need to be considered and
disambiguated if possible to ensure that patient safety is not compromised. The IPS is underpinned by
the ISO standard 13940:2016 “System of concepts to support continuity of care” and uses those concepts
throughout for the derivation of a logical model for interoperability.
The fact that patient summaries play an extensive and integral part in operational healthcare activities
argues against an intrusive standardization approach that attempts to formalize everything in one go.
Such a scattergun approach would be hit and miss, as well as highly disruptive; it would require a large
and inevitably error-prone specification with layers of optionality and flexibility to cope with the wide
diversity of practice that exists today. Not only would the design of the specification be over-complicated,
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CEN/TC 251 and HL7 have a shared vision for the patient summary, “to further the care for citizens across the
globe by providing a single, common International patient summary (IPS) that is usable by all clinicians for the
cross-border, unscheduled care of a person”.
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its translation to construction would mean that it would be very difficult to implement whilst
simultaneously increasing the likelihood of missing any designated target.
The argument for ‘focus’ goes beyond the difficulty of matching the complexity of the healthcare
ecosystem with an overly complicated specification, and is not just the problem for the standards
development organisations (SDOs) and the vendors. The greater issues lie with the area of ‘agreement’
and the respective positions of professional, organisational and legal perspectives. The more extensive
the scope of any patient summary, the more difficult it becomes to gain consensus between the various
parties over what it should and should not include.
Furthermore, the international aspiration of this standard magnifies the consensus issues and, in
addition, has to consider the different capabilities, capacities and competencies of different countries to
conform and manage an international norm. The adoption of an international standard in an important
and pervasive area of healthcare will inevitably impact those countries (e.g. in terms of cost and clinical
behaviours) that either do not currently collect the required data, or collect it in a way that differs from
the IPS standard. For all, the consequences of adoption of this data set will have sustainability,
management and governance issues going forward and this standard is tasked to ease that burden.
An IPS designed to be, and constructed as, the lowest common denominator would not satisfy the
majority of stakeholders and consequently it would be ignored. The IPS standard is a key to unlock other
health data and therefore has to balance the various known requirements and provide an incremental
approach, a viable opportunity to improve the availability of relevant person-based information at the
point of care. This balance has implications for the technical domain actors, i.e. the SDOs and vendors
who are tasked with specifying and implementing usable and useful solutions for the IPS.
Stating the intended use of any patient summary qualifies and adds meaning to its scope and application.
Importantly, the intended use provides a focus that differentiates this initiative from the multitude of
summary documents that purport to do the same job.
The naming of this standard as the International Patient Summary (IPS) uniquely distinguishes its
purpose; at the very least it should satisfy the given scenario of providing core content for ‘unscheduled,
cross-border care’. A secondary aim is to do so without compromising a wider, more general application.
A given scenario of unscheduled, cross-border care is taken to provide a basis for the standardization
activity that also extends its use to local and planned care. The IPS scenario is fully described in Annex A.
The layout uses a hierarchy of 6 levels (H0-H5) to facilitate more detailed description wi
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