1、BSI Standards PublicationDD ISO/TS 14265:2011Health informatics Classification of purposes for processing personal health informationPD CEN ISO/TS 14265:2013Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking
2、permitted without license from IHSPD CEN ISO/TS 14265:2013 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of CEN ISO/TS 14265:2013. It is identical to ISO/TS 14265:2011. It supersedes DD ISO/TS 14265:2011, which is withdrawn.The UK participation in its preparatio
3、n was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applicati
4、on. The British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 77577 2ICS 35.240.80Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was published under the authority of the Standards Policy and Strategy Commit
5、tee on 30 November 2011.Amendments/corrigenda issued since publicationDate Text affected31 March 2014 This corrigendum renumbers DD ISO/TS 14265:2011 as PD CEN ISO/TS 14265:2013Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for Resale-,-,-TECHN
6、ICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 14265 October 2013 ICS 35.240.80 English Version Health Informatics - Classification of purposes for processing personal health information (ISO/TS 14265:2011) Informatique de sant - Classification des besoins pour le trai
7、tement des informations de sant personnelles (ISO/TS 14265:2011) Medizinische Informatik - Klassifikation des Zwecks zur Verarbeitung von persnlichen Gesundheitsinformationen (ISO/TS 14265:2011) This Technical Specification (CEN/TS) was approved by CEN on 25 June 2012 for provisional application. Th
8、e 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 thi
9、s 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 r
10、eached. 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
11、, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploit
12、ation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 14265:2013 ECopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for Resale-,-,-CEN ISO/TS 14265:2013 (E) 3 Foreword The text of ISO/TS 14265:2011 has
13、 been prepared by Technical Committee ISO/TC 215 “Health informatics” of the International Organization for Standardization (ISO) and has been taken over as CEN ISO/TS 14265:2013 by Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. Attention is drawn to the
14、 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 countr
15、ies 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,
16、 Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/TS 14265:2011 has been approved by CEN as CEN ISO/TS 14265:2013 without any modification. PD CEN ISO/TS 14265:2013CEN ISO/TS 14265:2013 (E)Copyright British S
17、tandards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for Resale-,-,-DD ISO/TS 14265:2011ISO/TS 14265:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword iv 0 Introduction v 0.1 Rationale v 0.2 Background v 0.3 Context for defining data purposes vi 1 Scope 1
18、2 Terms and definitions . 2 3 Abbreviated terms . 4 4 Conformance . 4 5 Context . 4 6 Terminology for classifying purposes for processing personal health information 5 Annex A (informative) Examples . 7 Bibliography 13 PD CEN ISO/TS 14265:2013ISO/TS 14265:2011(E)Copyright British Standards Instituti
19、on Provided by IHS under license with BSI - Uncontrolled Copy Not for Resale-,-,-DD ISO/TS 14265:2011ISO/TS 14265:2011(E) iv ISO 2011 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The w
20、ork 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-govern
21、mental, 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
22、 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.
23、 In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working gr
24、oup 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
25、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 furthe
26、r 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 ri
27、ghts. ISO/TS 14265 was prepared by Technical Committee ISO/TC 215, Health informatics. PD CEN ISO/TS 14265:2013ISO/TS 14265:2011(E)Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license
28、from IHSDD ISO/TS 14265:2011ISO/TS 14265:2011(E) ISO 2011 All rights reserved v0 Introduction 0.1 Rationale A fundamental principle underlying the use of personal health data is that it is essential to know the purposes for which data was originally collected and that all subsequent processing activ
29、ities be the same as, or consistent with, the original purpose. This principle, when applied in conjunction with a standardized list of purposes, forms the foundation for a correspondence of permitted purpose between different users, systems, organizations or policy domains who might need to share p
30、ersonal health information. Interoperability standards, and their progressive adoption by e-health programmes, are expanding the capacity for organizations to exchange health data. For this to occur on a wide scale, the majority of decisions regarding requests for health data will need to take place
31、 automatically. In order that data processing activities (collection, storage, access, analysis, linkage, communication, disclosure and retention) are appropriate, it is important that policies are defined in fully computable ways that are themselves interoperable. Interoperable policies will enable
32、 requests between heterogeneous systems and services to be evaluated consistently. In order for automatic processing policies to be defined and operationalized, it is important that governance structures, processes and rules are applied to the design of information and information technology at an e
33、nterprise or inter-enterprise level through a number of administrative mechanisms. These mechanisms include enterprise architecture/frameworks, standards, strategy, procedures, laws, regulations, principles and policy, and include operational controls such as committees, budgets, plans, and responsi
34、bility agreements (e.g. information sharing agreements, service level agreements and contracts). It is recognized that not all disclosures will take place automatically, and that individual (human) decisions will at times be made, taking policies and governance arrangements into account. For ethical
35、 and legal reasons, it is normally the case that information is used only for the purpose for which it was collected or created. This purpose can be specified explicitly and consented to. Consent to use data for a particular purpose can also be implied, although it is almost always a requirement tha
36、t the purposes be declared. Where data are intended for further and different purposes, a new purpose can require a new consent. For example, in some jurisdictions, data collected for health care cannot automatically be used for research, nor information collected for research used for care, without
37、 obtaining new consent. Knowing the purpose for which access to information is intended is essential in order to determine if access to data for processing activities are appropriate. Increasingly, this problem has become not only one of determining that a user has permission to access particular it
38、ems of information but also that the user has permission to use them for a specified purpose. It is therefore essential to ensure that the context within which access and use is asserted is the correct one. Purpose (or use, purpose of use, or context of use) when clearly defined, helps to ensure tha
39、t access to protected information items is granted to properly authorized users under a specific, appropriate and unambiguous policy. The explicit declaration of intended purpose prior to being granted access also helps to ensure that users understand that such access does not imply that use is also
40、 permitted for other undeclared, inconsistent purposes. Purpose of use helps bring clarity to situations where there are multiple and potentially conflicting contextually sensitive policies for identical users access to identical information items. 0.2 Background ISO/TS 22600-1 defines a generic arc
41、hitectural approach for policy services, and a generic framework for defining policies in a formal way. However, like any generic architecture, a structural framework to support policy interoperability has to be instantiated for use. A policy domain needs also to specify which information properties
42、 they wish to take into account when making processing decisions. They need to specify a high level policy model containing those properties, to which all instances of that kind of policy must conform. PD CEN ISO/TS 14265:2013ISO/TS 14265:2011(E)Copyright British Standards Institution Provided by IH
43、S under license with BSI - Uncontrolled Copy Not for Resale-,-,-DD ISO/TS 14265:2011ISO/TS 14265:2011(E) vi ISO 2011 All rights reservedISO/TS 13606-4 defines such a policy model for requesting and providing electronic health record (EHR) extracts i.e. for one particular use case. Even if two or mor
44、e parties share a common policy model, this is not sufficient to support policy bridging (automated inter-policy negotiation): the terms used for each property within the shared policy model need to be mutually understood between requesters and providers of health information. In other words, the pr
45、operties and terms used in the request (collection) policy need to have a computable correspondence with the terms and policies of the recipients disclosure policy in order for an automated access decision to be made. Historically, data uses have been categorized as Primary and Secondary. Because th
46、ese are relative terms, they only have meaning when one knows the perspective of the user. This then has the further problem of giving the impression that some purposes are more important than others when it could be argued that the secondary use of health information for the benefit of society is a
47、n important purpose. It is therefore proposed that those terms be replaced with explicit and neutral but informative labels. Data collected for inclusion in an EHR is initially collected for the purpose of care, although it may be subsequently used for other purposes. Explicitly stating those uses r
48、ather than using a generic label such as “secondary use” will improve communications, transparency and support appropriate use of data. This Technical Specification is intended to be a semantic complement to ISO/TS 22600-1 and ISO/TS 13606-4, which both provide formal architectural and modelled repr
49、esentations of policies, but do not themselves include a vocabulary for purpose. However, it is not a requirement for a jurisdiction to adopt either of these two specifications in order to use this classification of purposes. There are other standards that define interoperability vocabularies which might also be used to instantiate parts of a policy. ISO/TS 13606-4 defines a standard vocabulary for the sensitivi
