CEN 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)

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
Foreword .3
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.
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(E)
©
ISO 2013
ISO/TS 14441:2013(E)
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
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Published in Switzerland
ii © ISO 2013 – All rights reserved

ISO/TS 14441:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 9
5 Security and privacy requirements . 9
5.1 General . 9
5.2 Theoretical foundation . 9
5.3 Privacy and security requirements .12
5.4 Common Criteria .28
6 Best practice and guidance for establishing and maintaining conformity
assessment programs .30
6.1 Concepts .31
6.2 Conformity assessment processes .33
Annex A (informative) Conformity assessment programs — Design considerations and illustrative
examples from member countries as of 2010 .36
Annex B (informative) Comparison of jurisdictional requirements .54
Bibliography .112
ISO/TS 14441:2013(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of document:
— an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical
experts in an ISO working group and is accepted for publication if it is approved by more than 50 %
of the members of the parent committee casting a vote;
— an ISO Technical Specification (ISO/TS) represents an agreement between the members of a
technical committee and is accepted for publication if it is approved by 2/3 of the members of the
committee casting a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for
a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or
ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be
transformed into an International Standard or be withdrawn.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TS 14441 was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2013 – All rights reserved

ISO/TS 14441:2013(E)
Introduction
As local, regional and national EHR infostructures develop, electronic patient record systems are
being implemented at the many points of care where patients are seen [point-of-service (POS) clinical
systems]. In addition to institutional settings like hospitals, where the systems in various departments
(e.g. nursing units) are typically integrated into a single patient record, smaller single purpose systems
such as electronic medical records (EMRs) are also being implemented in physician offices and other
non-institutional settings such as public health where the sophistication of the systems and the local
IT support infrastructure is much less. As countries begin to connect these POS clinical systems to
EHR infostructures (or directly exchange clinical information with other POS clinical systems through
system-to-system communications), the security and privacy of these systems becomes much more
critical and complex than when the systems operated in a disconnected or ‘stand-alone’ state. To
ensure the required standards are implemented correctly into these systems, so that they will securely
interact with EHR infostructures and maintain the privacy of patient information, many countries
are implementing certification and conformance testing programs to provide objective evidence of
conformity with these requirements.
This Technical Specification identifies the security and privacy requirements, harvested from the above
mentioned standards and international experiences, which should be in place for conformance testing
for interoperable POS clinical (electronic patient record) systems interfacing with EHRs.
The POS clinical systems profiled receive, store, process, display and communicate clinical data and
administrative actions, as well as information related to system users (demographics, personal).
The systems are always accessed by authorized and authenticated users. These users are:
— health professionals that input, access and use patient data, clinical procedures, and statistics;
— administrative users that input and read patient’s personal and demographics data, administrative
and statistical information;
— administrators that control users power, perform backups, provide system configuration, including
security ones;
— auditors that read audit trails;
— other EHR systems that input and receive data;
— subjects of care and their substitute decision makers, who may have restricted access to input and
retrieve authorized data.
Key assumptions that apply for compliant POS clinical systems are as follows:
— the Target of Evaluation (TOE) comprises commercial off the shelf (COTS), governmental, proprietary
and free and open source software;
— authenticated users recognize the need for a secure IT environment;
— authenticated users can be truste
...