1、PUBLISHED DOCUMENT Machine readable cards - Healthcare applications - Logical data structures and concepts for different card technologies for use by patients in health applications ICs 35.240.15; 35.240.80 PD CR 13643:2001 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW STDaB
2、SI PD CR 13b113-ENQL 2001 3rb24bbCl 09097b7 3b5 9 PD CR 13643:2001 Amd. No. National foreword Date Comments This Published Document reproduces verbatim CR 13643:2000. The UK participation in its preparation was entrusted to Technical Committee IST/17, Identification cards and related devices, which
3、has the responsibility to: - - aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK.
4、- A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “Inte
5、rnational Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a
6、 British Standard does not of itself confer immunity from legal obligations. This Published Doeument, having been prepared under the direction of the DISC bard, authority of the Standards Committee and comes into effect on 15 May 2001. Summary of pages This document comprises a front cover, an insid
7、e front cover, the CR title page, pages 2 to 50, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. published under the O BSI 05-2001 ISBN O 680 37322 3 CEN REPORT RAPPORT CEN CEN BERICHT PD CR 13643:2001 CR 13643 Dec
8、ember 2000 ICs English version Machine readable cards - Healthcare applications - Logical data structures and concepts for different card technologies for use by patients in health applications This CEN Report was approved by CEN on 25 November 2000. It has been drawn up by the Technical Committee C
9、ENTTC 224. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Noway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMTEE FOR STANDARDIZATION COMITE EUROP
10、gEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels O 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CR 13643:2000 E Page 2 PD CR 13643:2001 Contents Foreword 4 Introduction
11、 . 5 1 2 3 4 5 6 6.1 6.2 6.3 6.4 7 7.1 7.1.1 7.1.2 7.1.3 8 Scope 6 Normative references 6 Terms and definitions 7 Symbols and abbreviated terms . 8 Notations . 8 Logical model . 8 Existing data structures 8 Logical data structures 9 Encoding and storage of ASN.l objects 9 Storage of non-standardized
12、 data 9 Data definitions 9 “HealthCareData” data object . 10 The “DeviceData” data object . 11 The “DevDirectory” data object 11 Identification of card issuers and registered application providers . 11 Data encoding and manipulation rules 14 A.l A.2 A.2.1 A.2.2 A.2.3 A.2.4 A.3 A.4 A.4.1 A.4.2 A.4.3
13、A.4.4 AS A.5.1 A.5.2 A.5.3 A.6 A.6.1 A.6.2 A.6.3 Annexe A (normative) ICC technology . 16 Introduction 16 IC Cards memory layout . 16 Identification of directories and files . 16 Access conditions to data in a standard EF 17 The allocation of tags for data objects 17 Organisation bases 19 Device fil
14、es . 23 Holder file - EFHolder, path: 3FOO 506x . 28 Patient DF . 28 Miscellaneous files 35 Common data types . 39 RefPointer . 39 CodedData 39 AccessoryAttributes 39 Private templates and data elements . 40 Private EFs 40 Private DFs . 41 Structure of card memory . 16 Data objects distribution . 23
15、 Adding proprietary data to the HC card . 39 Annexe B (normative) Memory and optical cards . 42 B.l Data Model 42 8.2 The Patient Data Card data object 43 8.3 Data storage . 43 B.4 Data storage for without partitioning . 43 B.5 Storage of individual data element . B.6 Data tags . 44 8.7 Data storage
16、 for devices with partition 44 Annex C (normative) IS0 compatible magnetic stripe cards . 45 C.l Introduction 45 c.2 c.3 c.4 C.4.1 C.4.2 c.4.3 c.4.4 c.5 C.5.1 C.5.2 c.5.3 c.5.4 _- STD-BSI PD CR 13bq3-ENGL 2001 S lb2Libb9 0909970 95T W Page 3 PD CR 13643:2001 Data Model 45 The Patient Data Card data
17、object . 45 Track 1 46 Data encoding principles 46 ASN.l structure 46 Logical structure 46 Encoding . 46 Track 2 47 Data encoding principle 47 ASN.l structure 47 Logical structure 47 Encoding . 47 Annex D (normative) Temdates to be used with data stored on tracks 1 and 2 of patient data cards D.l D.
18、2 D.2.1 D.2.2 D.2.3 D.2.4 D.3 D.3.1 0.3.2 D.3.3 D.3.4 using IS0 compatible magnetic stripe cards 48 Introduction 48 Track data structure identifier =1 . 48 Data encoding principles 48 ASN.l Structure 48 Encoding . 49 Track data structure identifier =1 . 49 Data shall be encoded according to the prin
19、ciples outlined in EN iSO/IEC 781 1-2:1996 49 ASN.l Structure 49 Encoding . 50 Logical structure 48 Logical structure 49 Page 4 PD CB 13643:2001 Foreword This document has been prepared by CEN TTC 224, “Machine readable cards, related device interfaces and operations“. This CEN Report is published t
20、o provide availability of the work undertaken by CEN/TC 224 during the years 1992- 1997 which was aiming to produce a European standard entitled “Machine readable cards - Healthcare applications - Logical data structures and concepts for different card technologies for use by patients in health appl
21、ications“. CEN/TC 224 has decided to close its own work towards completing this standards work being convinced that the work effort should be concentrated and will be better continued in ISO/TC 251 “Health informatics“. The scope of the work presented herein was intended to provide solutions for dif
22、ferent types of storage technologies although the focus of interest in Europe has been the possibilities offered by Integrated Circuit Cards. This CEN Report describes an important approach towards providing a solution where, with certain constraints, the same structure of information objects could
23、be provided for different technologies facilitating the integration of card applications with various health related applications using databases and network communication in addition to the information stored on cards. The work of CENTTC 224 started in parallel with CENTTC 251, to a large extent wi
24、th the same experts. CEN/TC 251 received a mandate from EU and EFTA and developed the ENV 12018 entitled “Medical informatics - Identification, administrative, and common clinical data structure for Intermittently Connected Devices used in healthcare (including machine readable cards)“ which was ado
25、pted in 1997. This standard is currently undergoing a major revision in preparation for being transferred to a European Standard. This CEN Report is largely based on ENV 12018 and contains large parts of this standard. The reason for including those initially was that as it had not been finalized, i
26、t could not safely be referenced. During the completion of this CEWc 224 work a few amendments compared to ENV 1201 8:1997 were included and provide one of the inputs to the revision of ENV 12018. This CEN Report is also being presented to ISOTTC 215 and it is expected that the basic ideas and many
27、details will be able to provide the basis for one or very likely several International Standards on this topic. It is important to understand that the specification provided in this CEN Report although expressed as normative requirements, is not a European Standard. Page 5 PD CR 13643:2001 Introduct
28、ion This CEN report contains details regarding the standardization of logical data storage to be utilised in conjunction with machine readable cards intended for use by patients within health applications. Data objects have been defined within ENV 12018:1997 that, with respect to fitness of purpose,
29、 had similar attributes and thence fitted a common data storage potential such as is encompassed by a dedicated file (DF) as described within a smart card. This strategy has a number of advantages, the most important being that the “master file“ containing the data objects with all their sub compone
30、nts can be transmitted and thence stored as a single super object within media lacking processing capability. However for media with processing capabilities such objects can be subdivided into different logical files as described above and re-assembled on transmission. Because of the technological l
31、imitations of some types of media it is necessary that some data transformation take place when transferring data between some different types of technologies. However, as the interface devices to these technologies are dissimilar the software interface will always be aware of the technology with wh
32、ich it is interfacing and therefore able to perform these transformations. This approach to logical data storage can enable the storage of all types of information theoretically on any type of device and does away with the redundancy produced by the common core approach. In the case of some media (i
33、n particular IS0 compatible magnetic stripe media) it is expected that the interface will carry out transformation of the data when transferring it between different card technologies (to cope with differential encoding rules and the application of ASN.l context specific tags). Page 6 PD CR 13643:20
34、01 1 Scope This CEN Report specifies the logical data storage format for data in machine readable cards to be used by patients in health applications. The data structures and the methodology are described in plain text and ASN.l notation. This CEN Report is not applicable to bar coded data on machin
35、e readable cards. 2 Normative references This CEN Report incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments t
36、o or revisions of any of these publications apply to this CEN Report only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 1387:1996, Machine readable cards - Health care applications - Cards : General characterist
37、ics. EN 1867:1997, Machine readable cards - Health care applications - Numbering system and registration procedure for issuer identifers. EN IS0 31 66-1 :1997, Codes for the representation of names of countries and their subdivisions - Part 1 : Country codes (IS0 3 166- 1: 1997). EN ISO/IEC 7811-2:1
38、996, Identification cards - Recording technique - Part 2 : Magnetic stripe (ISO/lEC 78 1 1-2: 1995). EN ISOAEC 7812-1:1995, Identification cards - Identification of issuers - Part 1 : Numbering system (lSO/lEC 78 12- 1: 1993). EN ISOAEC 781 6-4:1996, Information technology - Identification cards - I
39、ntegrated circuit(s) cards with contacts - Part 4 : Interindustry commands for interchange (ISO/lEC 7816-4: 1995). EN ISOAEC 7816-5:1995, Identification cards - Integrated circut(s) cards with contacts - Part 5 : Numbering system and registration procedure for application identifiers (ISO/lEC 78 16-
40、5: 1994). EN ISO/IEC 781 6-6:l 997, Identification cards - Integrated circuit(s) cards with contacts - Part 6 : Interindustry data elements (ISO/lEC 78 16-6: 1996). ENV 1 201 8: 1 997, Identification, administrative, and common clinical data structure for Intermittently Connected Devices used in hea
41、lthcare (including machine readable cards). IS0 639:l 988, Code for the representation of names of languages. IS0 639-2:l 998, Code for the representation of names of languages - Part 2 : Alpha-3 code. IS0 7498-2:l 989, Information processing systems - Open Systems Interconnection - Basic Reference
42、Model - Part 2 : Security Architecture. ISO/IEC 781 6 (all parts), Identification cards - Integrated circuit(s) cards with contacts. ISOAEC 8824 (all parts), Information technology - Abstract Syntax Notation One (ASN. 1). ISOAEC 8825 (all parts), Information technology - ASN. 1 encoding rules. ISOAE
43、C 1 O1 18-2:1994, Information technology - Security techniques - Hash-functions - Part 2 : Hash-functions using an n-bit block cipher algorithm. - STD-BSI PD CR L3bIi3-ENGL 2UUL Lb2LibbS OSfl79 5T5 Page 7 PD CR 13643:2001 3 Terms and definitions For the purposes of this CEN Report, the terms and def
44、initions given in ISO/IEC 7816, IS0 7498-2:1989, ISO/IEC 8824:1990 and ISO/IEC 101 18-2:1994 and the following apply. 3.1 health professional card (HPC) an Health Professional Card (HPC) is designed to provide the function of allowing healthcare persons to have their identity and qualifications ackn
45、owledged by the information systems that they use, including informatics and telematics, and if necessary, to sign the transactions that they perform via these systems 3.2 application system an application system that can communicate with machine readable card 3.3 connecting unit a physical device w
46、hich may also contain software elements that enables communication to take place between a machine readable card and a host or application system 3.4 interface may be both physical or electrical or logical. An hypothetical junction between a machine readable card and the external environment NOTE po
47、int. This term can be used with a qualifier to describe an attribute to allow data flow to take place over this hypothetical 3.5 linkage may be physical, electrical or relational. The ability to join together two or more entities or parts 3.6 major industry identifier (MII) the code that identifies
48、the sector/industry within which the machine readable card is intended for use 3.7 dedicated file (DF) a file containing AC and allocable memory. It may be parent of elementary files and/or dedicated files 3.8 directory general name for MF or DF 3.9 elementary file (EF) a file containing AC, data or
49、 program. An EF cannot be parent of another file 3.1 O file a number of bytes with a certain structure 3.1 1 file identifier each file (MF,DF,EF) has a file identifier consisting of 2 bytes 3.12 master file the mandatory unique file representing the root of the file structure and containing AC and allocable memory. It may be parent of dedicated files and/or elementary files STDoBSI PD CR 13bV3-ENGL 2001 Lb2Vbb7 0709775 1131 Page 8 PD CR 13643:2001 4 Symbols and abbreviated terms ASN.1 DF HPC MF PDC S C M O AID RID PIX ICC IC IIN MI1 ID MRI Abstact Syntax Notation On
