ASTM E2553-2007(2013) Standard Guide for Implementation of a Voluntary Universal Healthcare Identification System《自愿全民医疗鉴定系统实施的标准指南》.pdf

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1、Designation: E2553 07 (Reapproved 2013) An American National StandardStandard Guide forImplementation of a Voluntary Universal HealthcareIdentification System1This standard is issued under the fixed designation E2553; the number immediately following the designation indicates the year oforiginal ado

2、ption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This document describes the implementation principlesneeded to create a

3、 Voluntary Universal Healthcare Identifica-tion (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

4、 system is designed to represent no, or atleast 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 imp

5、lemented in amanner that ensures that it can 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 app

6、lica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E1714 Guide for Properties of a Universal Healthcare Iden-tifier (UHID)2.2 Other Standard:AIIM Standard PDF417 Bar-coding3. Terminology3.1 Acronyms:3.1.1 2Dtwo dimensional3.1.2 CDOcare delivery organization

7、3.1.3 EMPIenterprise master patient index3.1.4 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-sib

8、le for issuing unique personal healthcare identifiers to anycooperating EMPI facility (defined below) upon receipt of anauthenticated request. The issued identifiers must be consistentwith Guide E1714 and, as appropriate, would consist of bothopen OVIDs (Open Voluntary Healthcare Identifiers) as wel

9、las PVIDs (Private Voluntary Healthcare Identifiers). 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 fre

10、ely accessible. PVIDs (which exist in various 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 communica

11、tesexclusively with cooperating EMPI facilities 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 i

12、nforma-tion and for this reason does not represent 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 r

13、equests to allcooperating EMPI facilities in 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 hea

14、lthcare facilities interacting1This 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 March 1, 2013. Published March 2013. DOI: 10.1520/E2553-07R13.2For referenced

15、 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.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Consh

16、ohocken, PA 19428-2959. United States1with a cooperating EMPI to facilitate storage, linkage, andexchange within that system.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 st

17、andard describes a proposal to provide unambigu-ous personal identification 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 storagetechni

18、ques, but an increasing number using electronic means.In order for 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

19、patientsclinical situation. This implies that all information relating 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 thei

20、r information.Unless patients are confident that they can avoid 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

21、the privacy of thatinformation.5.3 The proposed patient identification 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 tec

22、hni-cally feasible in a manner that promotes scalability,availability, 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 syste

23、m should bal-ance the costs and benefits required to implement 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 chal

24、lenge to gainconsensus on how to implement such a system.5.3.5 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 th

25、e General PublicA voluntary uni-versal healthcare identification 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 h

26、ealthcare. It is only in this focused environment thatit has been 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 desig

27、ned as avoluntary system, this is a significant risk if the system 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 a

28、provider organization should eliminate the need to repeatedlyprovide 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 rea

29、dily shared bothwithin organizations and between organizations. 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 inf

30、ormation across all of theprovider facilities operating within 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 net

31、work.6.4 Decreased Incidence of Medical ErrorsThe use ofVUHID 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 t

32、he risk of inadvertent medical errors.6.5 Decreased Risk of Identity 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 In

33、formation PrivacyThe ability to use various classes of PVIDs to 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 clini

34、cal trials can use a separate PVID to ensurethat the clinical 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.E2553 07 (2013)27.2 Validate each cooperating EMPI facility as a prop

35、er siteto support VUHID activities and establish a contract with eachcooperating EMPI site.37.3 Establish secure encrypted trusted communication witheach cooperating EMPI facility.7.4 Issue unique identifiers upon request from a validatedcooperating EMPI facility and for each issued identifier log t

36、hetime/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 checkdigits; (2) its status not issued, active, retired; (3) when it wasissued (and possibly the iden

37、tity of the cooperating EMPI ifusage policy permits this); and (4) if the identifier isunblindable, its current blinding status (not applicable, blinded,unblinded).7.6 Define each new PVID class including the usage poli-cies that apply to that class.7.7 Establish the data items that need to be colle

38、cted 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 distributable electronic form to collect thisinformation.7.9 Provide upon request a description of the limita

39、tions 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 cooperatingEMPI for each identifier (active to retired/inactive, blinded tounblinded) and notify all cooperating

40、 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 distributethem to all cooperating EMPIs.7.14 Log each clinical information request that is receivedan

41、d 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 PVIDs as 2Dbar-codes.7.18 Private identifiers that are intended to label blindeddata may need to be

42、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, personal identifying, or clinicalinformation associated with any identifier.8.2 Providing the identity

43、 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 an OVID.8.2.2 An example of the need for this function is unblindingof research results at the end of

44、 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 thefollowing syntax:9.1.1 Prefix 16 digits9.1.2 Delimiter a period “.”9.1.3 Check digits 8 digits9.1.4 Privacy d

45、igits 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 identifier is a PVID. Here are two examples:9.2.1 OVID: 1234567890123456.1234567800000009.2.2 PVID: 1234567890

46、123456.9265382612345679.3 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 zerosthat are check digits cannot be omitted.)9.4 An identifier can be represented as a character stringwi

47、th 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 permitted.9.6 It should be feasible to enter a VUHID identifier usinga telephone keypad. Either the * or

48、# 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 portion of an identifier.Specifically, it is not valid to isolate the prefix portion andattach it by

49、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.3For model contract language that might form a basis for the development of aVUHID contract, see http:/www.connectingforhealth.org