ASTM E2553-2007 Standard Guide for Implementation of a Voluntary Universal Healthcare Identification System《自动通用卫生保健识别系统实施的标准指南》.pdf

1、Designation: E 2553 07Standard Guide forImplementation of a Voluntary Universal HealthcareIdentification System1This standard is issued under the fixed designation E 2553; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of

2、 last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This document describes the implementation principlesneeded to create a Voluntary Universal Healthcare Identifica-ti

3、on (VUHID) system. The purpose of this system is to enableunambiguous identification of individuals in order to facilitatethe delivery of healthcare.1.2 The VUHID system should be dedicated exclusively tothe needs and functions of healthcare.1.3 The VUHID system is designed to represent no, or atlea

4、st minimal, increased risk to healthcare privacy and security.1.4 The system should be as cost-effective as possible.1.5 The system must be created and maintained in a way toprovide sustained benefit to healthcare.1.6 The system should be designed and implemented in amanner that ensures that it can

5、operate indefinitely.1.7 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior t

6、o use.2. Referenced Documents2.1 ASTM Standards:2E 1714 Guide for Properties of a Universal HealthcareIdentifier (UHID)2.2 Other Standard:AIIM Standard PDF417 Bar-coding3. Terminology3.1 Acronyms:3.1.1 2Dtwo dimensional3.1.2 CDOcare delivery organization3.1.3 EMPIenterprise master patient index3.1.4

7、 MOmanaging organization3.1.5 OVIDopen voluntary healthcare identifier3.1.6 PVIDprivate voluntary healthcare identifier3.1.7 VUHIDvoluntary universal healthcare identification4. Summary of Guide4.1 The VUHID facility described in this guide is respon-sible for issuing unique personal healthcare iden

8、tifiers to anycooperating EMPI facility (defined below) upon receipt of anauthenticated request. The issued identifiers must be consistentwith Guide E 1714 and, as appropriate, would consist of bothopen OVIDs (Open Voluntary Healthcare Identifiers) as wellas PVIDs (Private Voluntary Healthcare Ident

9、ifiers). Thisdocument will refer to any identifier issued by the VUHID,whether OVID or PVID, as a VUHID identifier. OVIDs areused to provide linkage of healthcare information for circum-stances where the identity of the associated person is meant tobe freely accessible. PVIDs (which exist in various

10、 privacyclasses) permit linkage of various healthcare data items wherethe identity of the associated individual is not meant to bepublicly available.4.2 The VUHID system should be created as a securehigh-availability server on the Internet which communicatesexclusively with cooperating EMPI faciliti

11、es using securecommunication techniques. The VUHID facility issues identi-fiers and is responsible for maintaining policies and proceduresrelating to various classes of PVIDs. It does not store patientidentification, demographic information, or clinical informa-tion and for this reason does not repr

12、esent a security or privacyvulnerability. (See Section 12 for a description of how thisapproach is implemented when issuing a new identifier.) TheVUHID facility should receive requests for information relat-ing to a given identifier and distribute those requests to allcooperating EMPI facilities in

13、order to fulfill the informationsharing goals associated with unambiguous patient identifica-tion.4.3 The identifiers issued by the VUHID facility can beused, consistent with the policy established for each identifierclass, by all of the participating healthcare facilities interactingwith a cooperat

14、ing EMPI to facilitate storage, linkage, andexchange within that system.1This guide is under the jurisdiction of ASTM Committee E31 on HealthcareInformatics and is the direct responsibility of Subcommittee E31.35 on HealthcareData Analysis.Current edition approved Aug. 15, 2007. Published September

15、2007.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO

16、 Box C700, West Conshohocken, PA 19428-2959, United States.4.4 The VUHID facility should be controlled by a managingorganization that is dedicated exclusively to the benefit of thehealthcare industry.5. Significance and Use5.1 This standard describes a proposal to provide unambigu-ous personal ident

17、ification for any patient who requests it. Intodays world of specialized healthcare and mobile patients it istypical for clinical information on a single patient to reside ina variety of locations, some using manual data storage tech-niques, but an increasing number using electronic means. Inorder f

18、or a clinician to provide safe and appropriate clinicalcare in this environment it is necessary to be able to aggregateappropriate clinical information on a specific patient in order togain an accurate and comprehensive picture of that patientsclinical situation. This implies that all information re

19、lating toeach patient should be identified in a unique manner tofacilitate the process of accurately aggregating appropriateinformation.5.2 The converse of the need for data aggregation is thepatients need to protect the privacy of their information.Unless patients are confident that they can avoid

20、inappropriatesharing of clinical information they will not readily share thatinformation with caregivers. Thus, the same system thatsupports unambiguous linkage of all information concerning apatient must also play a role in protecting the privacy of thatinformation.5.3 The proposed patient identifi

21、cation system must be ableto avoid or overcome the numerous objections that haveprevented implementation of a universal patient identificationsystem in the past including issues related to:5.3.1 TechnologyThe proposed system must be techni-cally feasible in a manner that promotes scalability, availa

22、bil-ity, and ease of implementation.5.3.2 Integration with Existing SystemsTo the maximumextent possible the proposed identification system should workseamlessly with existing information systems.5.3.3 Cost-effectivenessThe proposed system should bal-ance the costs and benefits required to implement

23、 a fullyfunctional voluntary universal healthcare identification system.5.3.4 Political FeasibilityBecause many different con-stituencies have a vested interest in a universal patient identi-fication system, it has been a significant challenge to gainconsensus on how to implement such a system.5.3.5

24、 Gradually ImplementableIn order to minimize theimpact associated with its implementation, a desirable propertyof a voluntary universal healthcare identification system is thatit be gradually implementable over time.5.3.6 Acceptable to the General PublicA voluntary uni-versal healthcare identificati

25、on system must be accepted by thegeneral public as a beneficial, effective and non-threateningcapability.5.4 Experience has shown that a healthcare identificationsystem will only be feasible if it is dedicated exclusively to theneeds of healthcare. It is only in this focused environment thatit has b

26、een possible to create a consistent, feasible, functional,and effective design for such a system.6. Anticipated VUHID Benefits6.1 A universal healthcare identification system that is notused will offer no benefit. Since the VUHID is designed as avoluntary system, this is a significant risk if the sy

27、stem is notperceived by its potential users as offering sufficient value.Here is a partial list of the benefits that should accrue to peoplewho choose to participate in the VUHID system.6.2 Increased ConvenienceGiving your VUHID card to aprovider organization should eliminate the need to repeatedlyp

28、rovide a list of identifying demographic information. Instead,this information will be pulled automatically from the cooper-ating EMPI system.6.3 Improved Data SharingUse of VUHID identifiers willenable clinical information to be more readily shared bothwithin organizations and between organizations

29、. In addition,the existence of private identifiers will enable more granulardata sharing based on a variety of policy- and patient-specifiedprinciples.6.3.1 LocallyThe use of a VUHID should permit conve-nient and error-free linkage of information across all of theprovider facilities operating within

30、 the domain of a cooperatingEMPI facility.6.3.2 NationallyThe use of VUHID should permit rapid,virtually error-free and comprehensive retrieval of any infor-mation stored within any cooperating EMPI that is participat-ing in the VUHID network.6.4 Decreased Incidence of Medical ErrorsThe use ofVUHID

31、identifiers permits comprehensive and virtually error-free linkage of medical records stored across a wide andheterogeneous mixture of healthcare provider facilities. Mak-ing this information available to a physician can greatlydecrease the risk of inadvertent medical errors.6.5 Decreased Risk of Id

32、entity TheftUse of a VUHIDidentifier, particularly use of a PVID, means that an identifier,not the patients identity, is at risk should the information bemisused by a recipient or otherwise mishandled.6.6 Improved Control of Healthcare Information PrivacyThe ability to use various classes of PVIDs t

33、o link clinicalinformation means that a person participating in the VUHIDsystem has the ability to exercise precise control over varioustypes of medical information.6.7 Improved Support for Clinical TrialsPatients thatparticipate in clinical trials can use a separate PVID to ensurethat the clinical

34、information needed for the trial is not linked tothe remainder of their medical record.7. Functions Supported by the VUHID System7.1 Recruit cooperating EMPI facilities.7.2 Validate each cooperating EMPI facility as a proper siteto support VUHID activities and establish a contract with eachcooperati

35、ng EMPI site.37.3 Establish secure encrypted trusted communication witheach cooperating EMPI facility.3For model contract language that might form a basis for the development of aVUHID contract, see http:/www.connectingforhealth.org/commonframework/model_contract.html.E25530727.4 Issue unique identi

36、fiers upon request from a validatedcooperating EMPI facility and for each issued identifier log thetime/date and the identity of the cooperating EMPI facility towhich it is issued.7.5 Respond to inquiries about an identifiers status includ-ing (1) whether it is valid based on examination of the chec

37、kdigits; (2) its status not issued, active, retired; (3) when it wasissued (and possibly the identity of the cooperating EMPI ifusage policy permits this); and (4) if the identifier is unblind-able, its current blinding status (not applicable, blinded, un-blinded).7.6 Define each new PVID class incl

38、uding the usage poli-cies that apply to that class.7.7 Establish the data items that need to be collected by thecaregiver facility when requesting a VUHID identifier of anyclass (OVID or PVID), for example, the type of data, the typeof facility, and the location of the facility.7.8 Create a distribu

39、table electronic form to collect thisinformation.7.9 Provide upon request a description of the limitations andrestrictions that apply to any particular class of private identi-fier.7.10 Maintain the active/inactive status of each identifier.7.11 Accept change of status indications from a cooperating

40、EMPI for each identifier (active to retired/inactive, blinded tounblinded) and notify all cooperating EMPIs of these changes.7.12 Issue the current status of a specific identifier onrequest.7.13 Receive requests for clinical information from a coop-erating EMPI relating to a specific identifier and

41、distributethem to all cooperating EMPIs.7.14 Log each clinical information request that is receivedand each identifier issued.7.15 Issue code objects to print identifier cards for OVIDsand PVIDs.7.16 Issue code objects to write OVIDs and PVIDs as 2Dbar-codes.7.17 Issue code objects to read OVIDs and

42、 PVIDs as 2Dbar-codes.7.18 Private identifiers that are intended to label blindeddata may need to be unblinded. The VUHID will track thestatus of such identifiers to indicate if they are still blinded orhave been unblinded.8. Functions NOT Supported by the VUHID Facility8.1 Storage of demographic, p

43、ersonal identifying, or clinicalinformation associated with any identifier.8.2 Providing the identity of an individual associated withany identifier.8.2.1 Acooperating EMPI facility may support this functionas long as it is consistent with the usage policy for that class ofPVID or the identifier is

44、an OVID.8.2.2 An example of the need for this function is unblindingof research results at the end of a particular study. This wouldbe supported by issuing a PVID class specifically designed tosupport this activity.9. Identifier Principles9.1 A VUHID identifier (both OVIDs and PVIDs) has thefollowin

45、g syntax:9.1.1 Prefix 16 digits9.1.2 Delimiter a period “.”9.1.3 Check digits 8 digits9.1.4 Privacy digits 7 digits9.1.5 Total identifier 32 characters in length9.2 An identifier represents an OVID if, and only if, all ofthe privacy digits are zero. If any privacy digit is non-zero thenthe identifie

46、r is a PVID. Here are two examples:9.2.1 OVID: 1234567890123456.1234567800000009.2.2 PVID: 1234567890123456.9265382612345679.3 Note that for purposes of brevity leading zeroes andtrailing zeros that are privacy digits can be omitted so that58206305.416389065892 is a valid identifier. (Trailing zeros

47、that are check digits cannot be omitted.)9.4 An identifier can be represented as a character stringwith a length of up to 32 digits and also as a 2D bar code usingthe AIIM Standard PDF417 bar code format.9.5 Creation of other forms of representation of a VUHID,such as a magnetic stripe, is also perm

48、itted.9.6 It should be feasible to enter a VUHID identifier usinga telephone keypad. Either the * or # keys may be used torepresent the delimiter.9.7 Each VUHID identifier must be considered to be anatomic item. It is not permitted to print, manipulate, represent,process, or otherwise handle just a

49、portion of an identifier.Specifically, it is not valid to isolate the prefix portion andattach it by itself to a document or electronic file.9.8 A VUHID identifier (both OVIDs and PVIDs) can onlyhave one of two statuses: activeor inactive.4An identifier ismarked as active when it is issued and it is marked as inactivewhen a valid request to do so is received by the VUHID facilityfrom a cooperating EMPI facility. Any cooperating EMPI canrequest the current status of a specific identifier at any time asneeded.9.9 Each time an automated syst