ASTM E2553-07(2013)
(Guide)Standard Guide for Implementation of a Voluntary Universal Healthcare Identification System (Withdrawn 2022)
Standard Guide for Implementation of a Voluntary Universal Healthcare Identification System (Withdrawn 2022)
SIGNIFICANCE AND USE
5.1 This standard describes a proposal to provide unambiguous personal identification for any patient who requests it. In today’s world of specialized healthcare and mobile patients it is typical for clinical information on a single patient to reside in a variety of locations, some using manual data storage techniques, but an increasing number using electronic means. In order for a clinician to provide safe and appropriate clinical care in this environment it is necessary to be able to aggregate appropriate clinical information on a specific patient in order to gain an accurate and comprehensive picture of that patient’s clinical situation. This implies that all information relating to each patient should be identified in a unique manner to facilitate the process of accurately aggregating appropriate information.
5.2 The converse of the need for data aggregation is the patient’s need to protect the privacy of their information. Unless patients are confident that they can avoid inappropriate sharing of clinical information they will not readily share that information with caregivers. Thus, the same system that supports unambiguous linkage of all information concerning a patient must also play a role in protecting the privacy of that information.
5.3 The proposed patient identification system must be able to avoid or overcome the numerous objections that have prevented implementation of a universal patient identification system in the past including issues related to:
5.3.1 Technology—The proposed system must be technically feasible in a manner that promotes scalability, availability, and ease of implementation.
5.3.2 Integration with Existing Systems—To the maximum extent possible the proposed identification system should work seamlessly with existing information systems.
5.3.3 Cost-effectiveness—The proposed system should balance the costs and benefits required to implement a fully functional voluntary universal healthcare identification system.
5....
SCOPE
1.1 This document describes the implementation principles needed to create a Voluntary Universal Healthcare Identification (VUHID) system. The purpose of this system is to enable unambiguous identification of individuals in order to facilitate the delivery of healthcare.
1.2 The VUHID system should be dedicated exclusively to the needs and functions of healthcare.
1.3 The VUHID system is designed to represent no, or at least 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 to provide sustained benefit to healthcare.
1.6 The system should be designed and implemented in a manner that ensures that it can operate indefinitely.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This document describes the implementation principles needed to create a Voluntary Universal Healthcare Identification (VUHID) system.
Formerly under the jurisdiction of Committee E31 on Healthcare Informatics, this guide was withdrawn in January 2022 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
General Information
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E2553 −07 (Reapproved 2013)
Standard Guide for
Implementation of a Voluntary Universal Healthcare
Identification System
This standard is issued under the fixed designation E2553; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2.2 Other Standard:
AIIM Standard PDF417 Bar-coding
1.1 This document describes the implementation principles
needed to create a Voluntary Universal Healthcare Identifica-
3. Terminology
tion (VUHID) system. The purpose of this system is to enable
3.1 Acronyms:
unambiguous identification of individuals in order to facilitate
3.1.1 2D—two dimensional
the delivery of healthcare.
3.1.2 CDO—care delivery organization
1.2 The VUHID system should be dedicated exclusively to
3.1.3 EMPI—enterprise master patient index
the needs and functions of healthcare.
3.1.4 MO—managing organization
1.3 The VUHID system is designed to represent no, or at
leastminimal,increasedrisktohealthcareprivacyandsecurity. 3.1.5 OVID—open voluntary healthcare identifier
3.1.6 PVID—private voluntary healthcare identifier
1.4 The system should be as cost-effective as possible.
3.1.7 VUHID—voluntary universal healthcare identification
1.5 The system must be created and maintained in a way to
provide sustained benefit to healthcare.
4. Summary of Guide
1.6 The system should be designed and implemented in a
4.1 The VUHID facility described in this guide is respon-
manner that ensures that it can operate indefinitely.
sible for issuing unique personal healthcare identifiers to any
1.7 This standard does not purport to address all of the
cooperating EMPI facility (defined below) upon receipt of an
safety concerns, if any, associated with its use. It is the
authenticated request. The issued identifiers must be consistent
responsibility of the user of this standard to establish appro-
with Guide E1714 and, as appropriate, would consist of both
priate safety and health practices and determine the applica-
‘open’OVIDs (Open Voluntary Healthcare Identifiers) as well
bility of regulatory limitations prior to use.
as PVIDs (Private Voluntary Healthcare Identifiers). This
1.8 This international standard was developed in accor-
document will refer to any identifier issued by the VUHID,
dance with internationally recognized principles on standard-
whether OVID or PVID, as a VUHID identifier. OVIDs are
ization established in the Decision on Principles for the
used to provide linkage of healthcare information for circum-
Development of International Standards, Guides and Recom-
stances where the identity of the associated person is meant to
mendations issued by the World Trade Organization Technical
be freely accessible. PVIDs (which exist in various privacy
Barriers to Trade (TBT) Committee.
classes) permit linkage of various healthcare data items where
the identity of the associated individual is not meant to be
2. Referenced Documents
publicly available.
2.1 ASTM Standards:
4.2 The VUHID system should be created as a secure
E1714 Guide for Properties of a Universal Healthcare Iden-
high-availability server on the Internet which communicates
tifier (UHID)
exclusively with cooperating EMPI facilities using secure
communication techniques. The VUHID facility issues identi-
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
fiers and is responsible for maintaining policies and procedures
Informatics and is the direct responsibility of Subcommittee E31.35 on Healthcare
relating to various classes of PVIDs. It does not store patient
Data Analysis.
identification, demographic information, or clinical informa-
Current edition approved March 1, 2013. Published March 2013. Originally
tion and for this reason does not represent a security or privacy
approved in 2007. Last previous edition approved in 2007 as E2553–07. DOI:
10.1520/E2553-07R13.
vulnerability. (See Section 12 for a description of how this
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
approach is implemented when issuing a new identifier.) The
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
VUHID facility should receive requests for information relat-
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. ing to a given identifier and distribute those requests to all
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2553−07 (2013)
cooperating EMPI facilities in order to fulfill the information 5.3.6 Acceptable to the General Public—A voluntary uni-
sharing goals associated with unambiguous patient identifica- versal healthcare identification system must be accepted by the
tion. general public as a beneficial, effective and non-threatening
capability.
4.3 The identifiers issued by the VUHID facility can be
used, consistent with the policy established for each identifier 5.4 Experience has shown that a healthcare identification
class, by all of the participating healthcare facilities interacting system will only be feasible if it is dedicated exclusively to the
with a cooperating EMPI to facilitate storage, linkage, and needs of healthcare. It is only in this focused environment that
exchange within that system. it has been possible to create a consistent, feasible, functional,
and effective design for such a system.
4.4 TheVUHIDfacilityshouldbecontrolledbyamanaging
organization that is dedicated exclusively to the benefit of the
6. Anticipated VUHID Benefits
healthcare industry.
6.1 A universal healthcare identification system that is not
5. Significance and Use used will offer no benefit. Since the VUHID is designed as a
voluntary system, this is a significant risk if the system is not
5.1 Thisstandarddescribesaproposaltoprovideunambigu-
perceived by its potential users as offering sufficient value.
ous personal identification for any patient who requests it. In
Here is a partial list of the benefits that should accrue to people
today’sworldofspecializedhealthcareandmobilepatientsitis
who choose to participate in the VUHID system.
typical for clinical information on a single patient to reside in
a variety of locations, some using manual data storage 6.2 Increased Convenience—Giving your VUHID card to a
techniques, but an increasing number using electronic means. provider organization should eliminate the need to repeatedly
In order for a clinician to provide safe and appropriate clinical provide a list of identifying demographic information. Instead,
care in this environment it is necessary to be able to aggregate this information will be pulled automatically from the cooper-
appropriateclinicalinformationonaspecificpatientinorderto ating EMPI system.
gain an accurate and comprehensive picture of that patient’s
6.3 Improved Data Sharing—Use ofVUHID identifiers will
clinical situation. This implies that all information relating to
enable clinical information to be more readily shared both
each patient should be identified in a unique manner to
within organizations and between organizations. In addition,
facilitate the process of accurately aggregating appropriate
the existence of private identifiers will enable more granular
information.
data sharing based on a variety of policy- and patient-specified
5.2 The converse of the need for data aggregation is the principles.
patient’s need to protect the privacy of their information.
6.3.1 Locally—The use of a VUHID should permit conve-
Unless patients are confident that they can avoid inappropriate
nient and error-free linkage of information across all of the
sharing of clinical information they will not readily share that
providerfacilitiesoperatingwithinthedomainofacooperating
information with caregivers. Thus, the same system that
EMPI facility.
supports unambiguous linkage of all information concerning a
6.3.2 Nationally—The use of VUHID should permit rapid,
patient must also play a role in protecting the privacy of that
virtually error-free and comprehensive retrieval of any infor-
information.
mation stored within any cooperating EMPI that is participat-
ing in the VUHID network.
5.3 The proposed patient identification system must be able
to avoid or overcome the numerous objections that have
6.4 Decreased Incidence of Medical Errors—The use of
prevented implementation of a universal patient identification
VUHID identifiers permits comprehensive and virtually error-
system in the past including issues related to:
free linkage of medical records stored across a wide and
5.3.1 Technology—The proposed system must be techni-
heterogeneous mixture of healthcare provider facilities. Mak-
cally feasible in a manner that promotes scalability,
ing this information available to a physician can greatly
availability, and ease of implementation.
decrease the risk of inadvertent medical errors.
5.3.2 Integration with Existing Systems—To the maximum
6.5 Decreased Risk of Identity Theft—Use of a VUHID
extent possible the proposed identification system should work
identifier, particularly use of a PVID, means that an identifier,
seamlessly with existing information systems.
not the patient’s identity, is at risk should the information be
5.3.3 Cost-effectiveness—The proposed system should bal-
misused by a recipient or otherwise mishandled.
ance the costs and benefits required to implement a fully
6.6 Improved Control of Healthcare Information Privacy—
functional voluntary universal healthcare identification system.
The ability to use various classes of PVIDs to link clinical
5.3.4 Political Feasibility—Because many different con-
information means that a person participating in the VUHID
stituencies have a vested interest in a universal patient identi-
system has the ability to exercise precise control over various
fication system, it has been a significant challenge to gain
types of medical information.
consensus on how to implement such a system.
5.3.5 Gradually Implementable—In order to minimize the 6.7 Improved Support for Clinical Trials—Patients that
impact associated with its implementation, a desirable property participate in clinical trials can use a separate PVID to ensure
of a voluntary universal healthcare identification system is that that the clinical information needed for the trial is not linked to
it be gradually implementable over time. the remainder of their medical record.
E2553−07 (2013)
7. Functions Supported by the VUHID System 7.18 Private identifiers that are intended to label blinded
data may need to be unblinded. The VUHID will track the
7.1 Recruit cooperating EMPI facilities.
status of such identifiers to indicate if they are still blinded or
7.2 Validate each cooperating EMPI facility as a proper site
have been unblinded.
to support VUHID activities and establish a contract with each
8. Functions NOT Supported by the VUHID Facility
cooperating EMPI site.
8.1 Storageofdemographic,personalidentifying,orclinical
7.3 Establish secure encrypted trusted communication with
information associated with any identifier.
each cooperating EMPI facility.
8.2 Providing the identity of an individual associated with
7.4 Issue unique identifiers upon request from a validated
any identifier.
cooperating EMPI facility and for each issued identifier log the
8.2.1 AcooperatingEMPIfacilitymaysupportthisfunction
time/date and the identity of the cooperating EMPI facility to
as long as it is consistent with the usage policy for that class of
which it is issued.
PVID or the identifier is an OVID.
7.5 Respond to inquiries about an identifier’s status includ-
8.2.2 An example of the need for this function is unblinding
ing (1) whether it is valid based on examination of the check
of research results at the end of a particular study. This would
digits; (2)itsstatus–notissued,active,retired; (3)whenitwas
be supported by issuing a PVID class specifically designed to
issued (and possibly the identity of the cooperating EMPI if
support this activity.
usage policy permits this); and (4) if the identifier is
9. Identifier Principles
unblindable,itscurrentblindingstatus(notapplicable,blinded,
unblinded).
9.1 A VUHID identifier (both OVIDs and PVIDs) has the
following syntax:
7.6 Define each new PVID class including the usage poli-
9.1.1 Prefix – 16 digits
cies that apply to that class.
9.1.2 Delimiter – a period “.”
7.7 Establish the data items that need to be collected by the
9.1.3 Check digits – 8 digits
caregiver facility when requesting a VUHID identifier of any
9.1.4 Privacy digits – 7 digits
class (OVID or PVID), for example, the type of data, the type
9.1.5 Total identifier – 32 characters in length
of facility, and the location of the facility.
9.2 An identifier represents an OVID if, and only if, all of
7.8 Create a distributable electronic form to collect this
the privacy digits are zero. If any privacy digit is non-zero then
information.
the identifier is a PVID. Here are two examples:
9.2.1 OVID: 1234567890123456.123456780000000
7.9 Provideuponrequestadescriptionofthelimitationsand
9.2.2 PVID: 1234567890123456.926538261234567
restrictions that apply to any particular class of private identi-
fier.
9.3 Note that for purposes of brevity leading zeroes and
trailing zeros that are privacy digits can be omitted so that
7.10 Maintain the active/inactive status of each identifier.
58206305.416389065892 is a valid identifier. (Trailing zeros
7.11 Accept change of status indications from a cooperating
that are check digits cannot be omitted.)
EMPI for each identifier (active to retired/inactive, blinded to
9.4 An identifier can be represented as a character string
unblinded) and notify all cooperating EMPIs of these changes.
with a length of up to 32 digits and also as a 2D bar code using
7.12 Issue the current status of a specific identifier on the AIIM Standard PDF417 bar code format.
request.
9.5 Creation of other forms of representation of a VUHID,
such as a magnetic stripe, is also permitted.
7.13 Receive requests for clinical information from a coop-
erating EMPI relating to a specific identifier and distribute
9.6 It should be feasible to enter a VUHID identifier using
them to all cooperating EMPIs.
a telephone keypad. Either the ‘*’ or ‘#’ keys may be used to
represent the delimiter.
7.14 Log each clinical information request that is received
and each identifier issued.
9.7 Each VUHID identifier must be considered to be an
atomic item. It is not permitted to print, manipulate, represent,
7.15 Issue code objects to print identifier cards for OVIDs
process, or otherwise handle just a portio
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