INTERNATIONAL STANDARD ISO 21549-7 Second edition 2016-12-01 Health informatics — Patient healthcard data — Part 7: Medication data Informatique de santé — Données relatives aux cartes de santé des patients — Partie 7: Données de médication Reference number ISO 21549-7:2016(E) I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n © ISO 2016 ISO 21549-7:2016(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2016, Published in Switzerland All rights reserved Unless otherwise specified, no part o f 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 o f the requester ISO copyright o ffice Ch de Blandonnet • CP 401 CH-1214 Vernier, Geneva, Switzerland Tel +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org ii I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 21549-7:2016(E) Page Contents Foreword iv Introduction vi Scope Normative references Terms and definitions Abbreviated terms Basic data object model for a healthcare data card 5.1 5.2 5.3 5.4 Functional requirements on card information for prescriptions 6.1 6.2 6.3 6.4 Patient healthcard data object structure Basic data objects for referencing 5.2.1 Overview 5.2.2 Coded data Device and data security attributes Accessory attributes Overview of supported uses Carry a prescription from prescriber to the dispenser 6.2.1 General 6.2.2 Prescription set 6.2.3 Who 6.2.4 What 6.2.5 Times 6.2.6 How Card information on dispensed prescriptions Medication notes Medication data 10 7.1 7.2 General 10 “MedicationNotes” class 11 7.2.1 General 11 7.2.2 “MedicationHistory” class 12 7.2.3 “MedicationRelevantCharacteristics” class 13 7.2.4 “KnownMedicationRisks” class 14 7.3 “MedicationPrescriptions” class 15 7.4 “MedicationsDispensed” data object 23 7.5 MedicationReferences 30 Annex A (normative) ASN.1 data definitions 32 Annex B (informative) Example of medication notes 48 Bibliography 50 © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n iii ISO 21549-7:2016(E) Foreword I SO (the I nternational O rganiz ation for Standardiz ation) is a worldwide federation of national s tandards bodies (ISO member bodies) The work o f preparing International Standards is normally carried out through ISO technical committees Each member body interested in a subject for which a technical committee has b een es tablished has the right to b e represented on that committee I nternational organi zation s , governmental and non- governmental, in liaison with I SO, al so take p ar t in the work ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters o f elec trotechnical s tandardi z ation T he procedures used to develop this cument and those intended for its fur ther maintenance are describ ed in the I SO/I E C D irec tives , Par t I n p ar ticu lar the different approval criteria needed for the di fferent types o f ISO documents should be noted This document was dra fted in accordance with the editorial ru les of the I SO/I E C D irec tives , Par t (see www iso org/direc tives) Attention is drawn to the possibility that some o f the elements o f this document may be the subject o f patent rights ISO shall not be held responsible for identi fying any or all such patent rights Details o f any patent rights identified during the development o f the document will be in the Introduction and/or on the I SO l is t of p atent declarations received (see www iso org/p atents) Any trade name used in this document is in formation given for the convenience o f users and does not cons titute an endors ement For an explanation on the meaning o f ISO specific terms and expressions related to formity assessment, as well as information about I SO ’s adherence to the World Trade O rganization ( WTO) principles in the Technical B arriers to Trade (TB T ) see the following URL: www.iso.org/iso/foreword html T he committee res p ons ible for this cument is I SO/ TC , Health informatics This second edition cancels and replaces the first edition (ISO 21549-7:2007), which has been technically revised with the following changes: — medication notes definition in C lause is modified; — the list o f definitions in C lause is shortened and several definitions are corrected and clarified; — the lis t of abbreviation in C lause — an — “healthcare p erson” in explanation is added PatientHealthcardData; in is shortened; why MedicationData is modelled as a direct child o f the is replaced by “healthcare pro fessional”; — “ factor o f the quantity” in is replaced by “quantity units”; — “medication history” in is major use is modified; — changed to “medication notes ” in the title and an explanation of a in C lause 7, al l the names of attributes in the tables are harmonized with the clas s diagrams T he term “data object” is replaced by “class” Additional comments are included in the tables For implementer’s convenience, the fragments o f ASN.1 definitions are gathered together in the new Annex A ; is modified; — explanation of MedicationNotes in — comments in Table are modified; — comments in Table are modified; — comments in Table are modified; — E xample in is moved to informative Annex B iv I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ; ISO 49-7: 01 6(E) — Figures and are merged Class “Prescriber” is defined as an attribute The attribute “qualification” is replaced by the attribute “qualifier” having datatype “CodedData” The attribute “medicinalProduct” is renamed as “prescribedMedicinalProduct” The class “MedicinalProduct” is renamed as “PrescribedMedicinalProduct” The class “ManufacturedMedicinalProduct” is renamed as “PrescribedManufacturedMedicinalProduct” The class “MagistralMedicinalProduct” is renamed as “PrescribedMagistralMedicinalProduct” Datatype o f the attribute “strength” is replaced by “Strength”, the definition o f this new datatype is added Datatype o f the attribute “quantityO fMedicinalProduct” is replaced by “Quantity” Datatype o f the attribute “amountO fIngredient” is replaced by “Amount” The class “AmountO fIngredient” is replaced by the class “Amount”; — Figures 17 and 18 are merged Class “Dispenser” is defined as an attribute The attribute “dispensedMedicinalCode” is replaced by the attribute “dispensedMedicinalProduct” having new datatype “DispensedMedicinalProduct” This new datatype is a generalization o f the classes “DispensedManufacturedMedicinalProduct” and “DispensedMagistralMedicinalProduct” The attributes “strength”, “form”, manufacturerOfMedicinalProduct” are moved from the class “ActualDispensedItem” to the class “DispensedManufacturedMedicinalProduct” The attributes “batchIdentifier”, “genericSubstitution” are moved from the class “DispensingIn formation” to the class “DispensedManu facturedMedicinalProduct” Datatype o f the attribute “quantityDispensed” is replaced by “QuantityToDispense”, so the class “QuantityDispensed” becomes unused and is deleted The attributes “magistralMedicinalProductName” and “dispensedQuantity” are added to the class “DispensedMagistralMedicinalProduct” The attribute “nameOfIngredient” is deleted from the class “DispensedIngredient” Datatype o f the attribute “quantityO fIngredient” is replaced by “Amount” The attribute “nameO fContainerOrApplicationAid” is deleted from the class “DispensedContainerOrApplicationAid”; — Figures 26 and 27 are merged; — new ASN.1 definition is added in Annex A A list of all parts in the ISO 21549 series can be found on the ISO website © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n v ISO 1549-7:2 016(E) Introduction With a more mobile population, greater healthcare delivery in the community and at patients’ homes, together with a growing demand for improved quality o f ambulatory care, portable in formation systems and stores have increasingly been developed and used Such devices are used for tasks ranging from identification, through portable medical record files, and on to patient-transportable monitoring systems The functions o f such devices are to carry and to transmit person-identifiable in formation between themselves and other systems; there fore, during their operational li fetime, they may share in formation with many technologically di fferent systems which di ffer greatly in their functions and capabilities Healthcare administration increasingly relies upon similar automated identification systems For instance, prescriptions may be automated and data exchange carried out at a number o f sites using patient transportable computer readable devices Healthcare insurers and providers are increasingly involved in cross-region care, where reimbursement may require automated data exchange between dissimilar healthcare systems The advent o f remotely accessible databases and support systems has led to the development and use o f “Healthcare Pro fessional” identification devices that are also able to per form security functions and transmit digital signatures to remote systems via networks With the growing use o f data cards for practical everyday healthcare delivery, the need has arisen for a s tandardized data format for interchange The person-related data carried by a data card can be categorized in three broad types: identification (of the device itsel f and the individual to whom the data it carries relates) , adminis trative and cl inical It is imp or tant to reali ze that a given healthcare data card “de fac to” has to contain device data and identification data and may, in addition, contain administrative, clinical, medication and linkage data Device data is defined to include — identification o f the device itsel f, and — identification o f the functions and functioning capabilities o f the device Identification data may include unique identification o f the device holder or o f all other persons to whom the data carried by the device are related Administrative data may include the following: — complementary person(s) related data; — identification o f the funding o f health care, whether public or private, and their relationships, i.e insurer(s), contract(s) and policy(ies) or types o f benefits; — other data (distinguishable from clinical data) that are necessary for the purpose o f healthcare delivery Clinical data may include — item s that provide information ab out health and health events , — their appraisal and labelling by a healthcare provider (HCP), and — related ac tions planned reques ted or p erformed Medication data may include — a record o f medications purchased by the patient for sel f administration, — copies o f prescriptions including the authority to dispense records o f dispensed medications, vi I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 49-7: 01 6(E) — re cord s o f me d ic ation s d i s p en s e d by a ph armac i s t to the p atient, a nd — p oi nters to o ther s ys tem s that contai n i n formation that hold me d ic ation data, either me d ic ation h i s tor y or pre s c rib e d me d ic i ne s , (or b o th) and i n the c a s e o f pre s c rib e d me d ic i ne s , the authority to dispense B e cau s e a data c a rd e s s enti a l ly provide s s p e ci fic an s wers to defi nite querie s wh i le h avi ng at the s ame ti me a ne e d to op ti m i ze the u s e o f memor y by avoid i ng re du ndancie s , “h igh level” O bj e c t M o del l i ng Te ch n ique (OM T ) has b e en appl ie d with re s p e c t to the defi n ition o f he a lthc are data c ard data s truc tu re s Patient D ata C a rd s may o ffer fac i l itie s to — communicate prescription information from one healthcare professional to another healthcare professional such as to a healthcare agent or healthcare organization, and — provide i ndexe s a nd/or authority to acce s s pre s crip tion i n formation held o ther th an on the p atient data card © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n vii I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n INTERNATIONAL STANDARD ISO 21549-7:2016(E) Health informatics — Patient healthcard data — Part 7: Medication data Scope This document applies to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions o f ID-1 cards defined by ISO/IEC 7810 This document specifies the basic structure o f the data contained within the medication data object, but does not speci fy or mandate particular data sets for storage on devices The purpose of this document is for cards to provide information to other health professionals and to the patient or its non-professional caregiver It can also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets Medication data include the following four components: — medication notes: additional in formation related to medication and the sa fe use o f medicines by the patient such as medication history, sensitivities and allergies; — medication prescriptions: dispenser/pharmacy; to carry a new prescription rom the prescriber to the f — medication dispensed: the records of medications dispensed for the patient; — medication references: pointers to other systems that contain in formation medication prescription and the authority to dispense that makes up The following topics are beyond the scope o f this document: — physical or logical solutions for the practical functioning o f particular types o f data cards; — how the message is processed further “downstream” o f the inter face between two systems; — the form which the data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere NOTE Not only does the definition o f “medicinal products” di ffer from country to country, but also the same name can relate to entirely di fferent products in some countries There fore, it is important to consider the sa fety of the patient when the card is used across borders This document describes and defines the Medication data objects used within or re ferenced by patientheld health data cards using UML, plain text and Abstract Syntax Notation (ASN.1) This document does not describe nor define the common objects defined within ISO 21549-2, even though they are re ferenced and utilized within this document Normative references The following documents are re ferred to in the text in such a way that some or all o f their content constitutes requirements o f this document For dated re ferences, only the edition cited applies For undated re ferences, the latest edition o f the re ferenced document (including any amendments) applies © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 21549-7:2016(E) I SO 49 -2 , Health informatics — Patient healthcard data — Part 2: Common objects Terms and definitions For the pu rp o s e s o f th i s c ument, the fol lowi ng term s and defi nition s apply I SO and I E C maintain terminological datab ases for us e in s tandardiz ation at the fol lowing addres ses: — I E C E lec trop edia: avai lable at http://www elec trop edia org/ — I SO O n l ine brows ing platform: avai lable at https://www iso org/obp/ NO TE T here a re pu r p o s e s ava i l ab le m a ny d i fferent ter m s fro m used to de s c r ib e the b a s ic concep ts I S O , C E N , H L7 a nd va r io u s n ation a l orga n i z ation s T he me a nt to b e u n i vers a l i n I S O work i n he a l th i n fo r m atic s , on l y to fac i l itate in he a lthc a re fo l lowi ng for d i fferent de fi n itio n s a re no t the u nders ta nd i ng o f th i s c u ment 3.1 attribute charac teri s tic o f an obj e c t or entity 3.2 batch amou nt of materi a l wh ich is u ni form in ch arac ter and quantity as shown by compl ia nce with pro duc tion and qua l ity a s s u rance te s t re qui rements and pro duce d duri ng a defi ne d va l idate d pro ce s s of manufac ture [SOURC E: E N 75 :19 92 E , E N 76:19 92 E ] 3.3 coding scheme col lec tion of ru les that map s the elements of one set onto the elements of a s econd set [SOURC E: I SO 10 : 0 4, ] 3.4 data object in formation obj ec t ins tance of some information object class (3 11) , b ei ng comp o s e d o f a s e t o f field s wh ich form to the field s p e c i fic ation s o f the cla s s [SOURC E: I SO/I EC 82 -2 : 01 , 4.9] 3.5 dispenser healthcare professional (3 ) wh ich i s a repre s entation fi l l i ng/d i s p en s i ng the prescription (3 2 ) o f a n i nd i vidua l , pro fe s s iona l ly re s p on s ible for N o te to entr y: T h i s i s u s u a l l y the p h a r m ac i s t, b ut m ay b e o ther i nd i vidu a l s acco rd i n g to lo c a l j u r i s d ic tion 3.6 healthcare ac tivities , ser vices or s uppl ies related to the health of an individual N o te to entr y: T h i s i nclude s more th a n p er for m i n g p ro ce du re s fo r s ub j e c ts o f c a re I t i nclude s , for e xa mp le , the ma nagement of i nformation ab out p atients , he a lth s tatus and relations with i n he althcare framework N o te to entr y: I n th i s c u ment, the ter m “c a re” i s to b e u nders to o d a s a s yno nym [S O U RC E : I S O : 01 , 1 , mo d i fie d] I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n for “he a l thc a re” ISO 49-7: 01 6(E) 38 I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 49-7: 01 6(E) T he fol lowi ng defi nition s s l l b e u s e d on ly for c u ment T he s e defi n ition s may b e ob s ole te d i n © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n b ackwa rd comp atibi l ity with the fi rs t e d ition o f th i s futu re e d ition s 39 ISO 49-7: 01 6(E) 40 I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 49-7: 01 6(E) © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n 41 ISO 49-7: 01 6(E) 42 I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 49-7: 01 6(E) © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n 43 ISO 49-7: 01 6(E) 44 I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 49-7: 01 6(E) © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n 45 ISO 49-7: 01 6(E) 46 I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 49-7: 01 6(E) © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n 47 ISO 21549-7:2016(E) Annex B (informative) Example of medication notes An example of medication notes is shown in Table B T he card holder b eing al lergic to mi l k received Nifedipine on 03 - - He or she had received Nifedipine b efore 03 - -18 T here is known drugto - drug interac tion b etween Ni fedipine and B isoprolol Table B.1 — Example of medication notes Class/Attribute name Data type Example data M ed icationNo tes C la s s - M e d ic ation H i s to r y C la s s - - Me dic ationReceived C la s s - - - genericM ed ici neC o de C o dedD ata - - - - co d i ngS chemeRef I nteger - - - - co deD ataValue String C C A0 - - - - co deD ataFre eText String Ni fed ipi ne - - - med icationReceivingD ate1 D ate 03 090 - - - med icationReceivingD ate2 D ate 0 61 - - - me d ic ation D el iver yTyp e C o dedD ata - - - - co d i ngS chemeRef I nteger - - - - co deD ataValue String A - - - - co deD ataFre eText String P res crip tion - M ed icationRelevantC harac teri s tics C la s s - - PatientC harac teri s tic C la s s - - - cha rac teri s ticC o de C o dedD ata - - - - co d i ngS chemeRef I nteger - - - - co deD ataValue String C - - - - co deD ataFre eText String a l lergic to m i l k - - - entr yD ate D ate 02 1011 - - - re co rde d B yI D C o ded D ata - - - - co d i ngS chemeRef I nteger - - - - co deD ataValue String < id o f p hys ic i a n> - KnownM ed icationRi sks C la s s - - KnownI nterac tionO rC ontra indic ation C la s s - - - l i n kTyp e C o dedD ata - - - - co d i ngS chemeRef I nteger - - - - co deD ataValue String C - - - - co deD ataFre eText String I nterac tion - - - fi rs tP a r tnerTyp e C o dedD ata - - - - co d i ngS chemeRef I nteger - - - - co deD ataValue String A - - - - co deD ataFre eText String D r ug 48 I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 21549-7:2016(E) Table B.1 (continued) Class/Attribute name - - - secondPartnerType - - - - codingSchemeRef - - - - codeDataValue - - - - codeDataFreeText - - - firstPartnerCode - - - - codingSchemeRef - - - - codeDataValue - - - - codeDataFreeText - - - secondPartnerCode - - - - codingSchemeRef - - - - codeDataValue - - - - codeDataFreeText - - - entryDate © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n Data type CodedData Integer String String CodedData Integer String String CodedData Integer String String Date Example data A Drug C08CA05 Nifedipine C07AB07 Bisoprolol 20030317 49 ISO 21549-7:2016(E) Bibliography [1] I S O 749 -2 , Information processing system s — Open System s Interconnection — Basic Reference Model — Part 2: Security Architecture Health informatics — System of concepts to support continuity of care [2 ] I S O 40 , [3 ] I S O/I EC 7810 , [4] I S O 01 , Identification cards — Physical characteristics Data elements and interchange formats — Information interchange — Representation of dates and times [5 ] [6] I S O/I EC 82 (al l p ar ts) , I S O/I EC 82 -1 , Information technology — Abstract Syntax Notation One (ASN.1) In formation technology — ASN.1 encoding rules: Specification o f Basic Encoding Rules (BER), Canonical Encoding Rules (CER) and Distinguished Encoding Rules (DER) [7 ] I S O/I EC 959 - , Information technology — Open System s Interconnection — The Directory — Part 8: Public-key and attribute certificate frameworks [8 ] I S O/I E C 79 -1 , In formation technology — Security techniques — Entity authentication — Part : General [9] I S O/I EC 10181-2 , for open [10] I S O 10 : 0 4, [11] EN V 07, Prescription s 50 In formation technology — Open System s Interconnection — Security frameworks system s: Authentication framework — Part I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n Health in formatics — Trusted end-to-end in formation flows Health in formatics — Messages for the Exchange o f In formation on Medicine I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 49-7: 01 6(E) ICS 35.240.80 Price based on 50 pages © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n