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CEN ISO/TS 14441:2013

(Main)

Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment (ISO/TS 14441:2013)

Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment (ISO/TS 14441:2013)

ISO/TS 14441:2013 examines electronic patient record systems at the clinical point of care that are also interoperable with EHRs. ISO/TS 14441:2013 addresses their security and privacy protections by providing a set of security and privacy requirements, along with guidelines and best practice for conformity assessment.
ISO/TS 14441:2013 includes a cross-mapping of 82 security and privacy requirements against the Common Criteria categories in ISO/IEC 15408 (all parts).

Medizinische Informatik - Sicherheits- und Datenschutzanforderungen für die Konformitätsprüfung von EGA-Systemen (ISO/TS 14441:2013)

Diese Technische Spezifikation untersucht Systeme zur elektronischen Patientenerfassung an klinischen Versorgungsstellen, die auch mit EGAs (Elektronische Gesundheitsakte) interoperabel sind. Hardware- und Prozesskontrollen liegen außerhalb des Anwendungsbereichs. Diese Technische Spezifikation stellt deren Sicherheit und den Datenschutz durch die Festlegung von Sicherheits- und Datenschutzanforderungen sicher und gibt Richtlinien und bewährte Methoden für die Konformitätsbewertung an.
ISO/IEC 15408 (alle Teile) legt „Evaluationsgegenstände“ für die Bewertung der Sicherheit von IT-Produkten fest. Diese Technische Spezifikation enthält eine Gegenüberstellung der 82 Kernanforderungen in Bezug auf die Sicherheit und den Datenschutz und der Common-Critera-Kategorien aus ISO/IEC 15408 (alle Teile). Die klinische Software der Point-Of-Service-Systeme (POS) ist normalerweise Teil eines größeren Systems und wird z. B. auf einem Betriebssystem ausgeführt. Deshalb muss sie zusammen mit anderen Komponenten funktionieren, damit die Sicherheit und der Datenschutz sichergestellt werden können. Während ein Schutzprofil (PP) Anforderungen für Sicherheitsfunktionen von Komponenten für die Unterstützung von Systemsicherheitsdiensten umfasst, werden keine Protokolle oder Standards für die Konformitätsbewertung sowie keine Datenschutzanforderungen festgelegt.
Diese Technische Spezifikation konzentriert sich auf zwei Hauptthemen:
a) Sicherheits- und Datenschutzanforderungen (Abschnitt 5). Abschnitt 5 ist technisch orientiert und stellt eine umfangreiche Zusammenstellung von 19 Anforderungen bereit, die erforderlich sind, um Informationen (Patienten) vor den Hauptkategorien von Risiken zu schützen; dabei werden der breite Anwendungsbereich von Sicherheits- und Datenschutzaspekten für Versorgungsstellen und interoperable klinische Systeme (zur elektronischen Patientenerfassung) berücksichtigt. Diese Kernanforderungen werden anschließend in Form von Anforderungsgruppen/Profilen, die für Konformitätsbewertungszwecke geeignet sind, näher ausgeführt.
b) Bewährte Methoden und Anleitung zur Einrichtung und Wartung von Programmen zur Konformitäts-bewertung (Abschnitt 6). Abschnitt 6 gibt einen Überblick über Konzepte und Prozesse der Konformitätsbewertung, die von Regierungen, Lokalbehörden, Berufsverbänden, Softwareentwicklern, Gesellschaften für medizinische Informatik, Vertretern von Patienten und anderen Personen eingesetzt werden können, um eine höhere Konformität mit Sicherheits- und Datenschutzanforderungen für Software im Gesundheitswesen zu erreichen. Anhang A enthält ergänzende Informationen, die für Länder nützlich sind, die Programme zur Konformitätsbewertung entwickeln, z. B. weiterführendes Material zu Geschäftsmodellen zur Konformitätsbewertung, Prozessen der Konformitätsbewertung und anderen Betrachtungen sowie anschauliche Beispiele für Konformitätsbewertungsaktivitäten in vier Ländern.
Richtlinien, die lokale, regionale oder nationale Anwendung in der Umwelt finden sowie verfahrenstechnische, administrative und physikalische Aspekte (einschließlich Hardware) der Sicherheits- und Datenschutzverwaltung, liegen außerhalb des Anwendungsbereiches dieser Technischen Spezifikation. Sicherheitsmanagement ist in ISO 27799 beinhaltet.

Informatique de santé - Sécurité et exigences d'intimité des systèmes de EHR pour l'évaluation de la conformité (ISO/TS 14441:2013)

Zdravstvena informatika - Zahteve za varnost in zasebnost sistemov EHR (elektronski zdravstveni zapis) pri ocenjevanju skladnosti (ISO/TS 14441:2013)

General Information

Status
Published
Publication Date
17-Dec-2013
ICS
35.240.80 - IT applications in health care technology
Technical Committee
CEN/TC 251 - Medical informatics
Drafting Committee
CEN/TC 251/WG 1 - Information models
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
18-Dec-2013
Completion Date
18-Dec-2013
Ref Project
SIST-TS CEN ISO/TS 14441:2014 - Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment (ISO/TS 14441:2013)

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SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 14441:2014
01-marec-2014
Zdravstvena informatika - Zahteve za varnost in zasebnost sistemov EHR
(elektronski zdravstveni zapis) pri ocenjevanju skladnosti (ISO/TS 14441:2013)
Health informatics - Security and privacy requirements of EHR systems for use in
conformity assessment (ISO/TS 14441:2013)
Informatique de santé - Sécurité et exigences d'intimité des systèmes de EHR pour
l'évaluation de la conformité (ISO/TS 14441:2013)
Ta slovenski standard je istoveten z: CEN ISO/TS 14441:2013
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 14441:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN ISO/TS 14441:2014

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SIST-TS CEN ISO/TS 14441:2014

TECHNICAL SPECIFICATION
CEN ISO/TS 14441

SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION
December 2013
ICS 35.240.80
English Version
Health informatics - Security and privacy requirements of EHR
systems for use in conformity assessment (ISO/TS 14441:2013)
Informatique de santé - Sécurité et exigences d'intimité des Medizinische Informatik - Sicherheits- und
systèmes de EHR pour l'évaluation de la conformité Datenschutzanforderungen für die Konformitätsprüfung von
(ISO/TS 14441:2013) EGA-Systemen (ISO/TS 14441:2013)
This Technical Specification (CEN/TS) was approved by CEN on 7 April 2013 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 14441:2013 E
worldwide for CEN national Members.

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SIST-TS CEN ISO/TS 14441:2014
CEN ISO/TS 14441:2013 (E)
Contents Page
Foreword .3
2

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SIST-TS CEN ISO/TS 14441:2014
CEN ISO/TS 14441:2013 (E)
Foreword
This document (CEN ISO/TS 14441:2013) has been prepared by Technical Committee ISO/TC 215 “Health
informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of
which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 14441:2013 has been approved by CEN as CEN ISO/TS 14441:2013 without any
modification.


3

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SIST-TS CEN ISO/TS 14441:2014

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SIST-TS CEN ISO/TS 14441:2014
TECHNICAL ISO/TS
SPECIFICATION 14441
First edition
2013-12-15
Health informatics — Security and
privacy requirements of EHR systems
for use in conformity assessment
Informatique de santé — Sécurité et exigences d’intimité des systèmes
de EHR pour l’évaluation de la conformité
Reference number
ISO/TS 14441:2013(
...

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