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ASTM E1714-07(2013)

(Guide)

Standard Guide for Properties of a Universal Healthcare Identifier (UHID) (Withdrawn 2022)

Standard Guide for Properties of a Universal Healthcare Identifier (UHID) (Withdrawn 2022)

SIGNIFICANCE AND USE
4.1 Recent experience with computer-based patient records (CPRs) has revealed many valuable potential benefits, but it has also become apparent that the effective application of this technology creates some new problems. CPRs offer the option for lifelong linkage of all records on a patient, from birth to death. Such longitudinal record linkage would make the patient’s entire past health history retrievable. This could make possible a quantum leap in the clinical practice of health care, but a reliable patient identifier is essential to make large-scale regional and nationwide record linkage feasible. The design of a patient identifier system is not a simple task. Incorrect record linkage would create confusion, at least, or possibly cause serious consequences. To gain the benefits from such an identifier, it must be used by all relevant organizations. A universal patient identifier system must resist unauthorized access to confidential clinical data.
Furthermore, the creation of personal identifiers for the entire population must be a cost-effective process in light of ongoing fiscal constraints. The creation and administration of personal identifiers for the entire population must be accomplished at a cost that is widely accepted as affordable and justified. Last, but not least, a time pressure exists. The solution to the patient identifier challenge should use technology to facilitate rapid deployment of the system to permit the expeditious implementation of CPRs. A companion document, Guide E2553, provides the implementation strategy concerning how to actually implement the UHID system.
SCOPE
1.1 This guide covers a set of requirements outlining the properties required to create a universal healthcare identifier (UHID) system. Use of the UHID is expected to initially be focused on the population of the United States but there is no inherent limitation on how widely these identifiers may be applied.  
1.2 This guide sets forth the fundamental considerations for a UHID that can support at least four basic functions effectively:  
1.2.1 Positive identification of patients when clinical care is rendered;  
1.2.2 Automated linkage of various computer-based records on the same patient for the creation of lifelong electronic health care files;  
1.2.3 Provision of a mechanism to support data security for the protection of privileged clinical information; and  
1.2.4 The use of technology for patient records handling to keep health care operating costs at a minimum.  
1.3 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 guide covers a set of requirements outlining the properties required to create a universal healthcare identifier (UHID) system. Use of the UHID is expected to initially be focused on the population of the United States but there is no inherent limitation on how widely these identifiers may be applied.
Formerly under the jurisdiction of Committee E31 on Healthcare Informatics, this guide was withdrawn in July 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

Status
Withdrawn
Publication Date
28-Feb-2013
Withdrawal Date
18-Jul-2022
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E31 - Healthcare Informatics
Drafting Committee
E31.25 - Healthcare Data Management, Security, Confidentiality, and Privacy
Current Stage
Ref Project

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ASTM E1714-07(2013) - Standard Guide for Properties of a Universal Healthcare Identifier (UHID) (Withdrawn 2022)ASTM E1714-07(2013) - Standard Guide for Properties of a Universal Healthcare Identifier (UHID) (Withdrawn 2022)
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ASTM E1714-07(2013) - Standard Guide for Properties of a Universal Healthcare Identifier (UHID) (Withdrawn 2022)
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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:E1714 −07 (Reapproved 2013)
Standard Guide for
1
Properties of a Universal Healthcare Identifier (UHID)
This standard is issued under the fixed designation E1714; 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 E1384 Practice for Content and Structure of the Electronic
3
Health Record (Withdrawn 2017)
1.1 This guide covers a set of requirements outlining the
E2553 Guide for Implementation of a Voluntary Universal
properties required to create a universal healthcare identifier
Healthcare Identification System
(UHID) system. Use of the UHID is expected to initially be
focused on the population of the United States but there is no
3. Terminology
inherent limitation on how widely these identifiers may be
applied. 3.1 Definitions:
3.1.1 clinical record linkage—individual unit records linked
1.2 This guide sets forth the fundamental considerations for
for the purpose of documenting the sequence of events or care,
a UHID that can support at least four basic functions effec-
or both, for a specific patient.
tively:
3.1.2 discriminating power of an identifier— the capability
1.2.1 Positive identification of patients when clinical care is
rendered; of an identifier to reduce the possible global population to a
smaller number. For example, sex identification reduces the
1.2.2 Automated linkage of various computer-based records
populationsizetoapproximatelyhalf.Dateofbirthreducesthe
onthesamepatientforthecreationoflifelongelectronichealth
population size to approximately one of 25 000 in the United
care files;
States. The smaller the population size covered by an identifier
1.2.3 Provision of a mechanism to support data security for
(that is, the greater the discriminating power), the better that
the protection of privileged clinical information; and
identifier is.
1.2.4 The use of technology for patient records handling to
keep health care operating costs at a minimum.
3.1.3 encounter—an instance of direct interaction, regard-
less of the setting, between a patient and a practitioner vested
1.3 This standard does not purport to address all of the
with primary and autonomous responsibility for diagnosing,
safety concerns, if any, associated with its use. It is the
evaluating, treating, or some combination thereof, the patient’s
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica- condition or providing social worker services (See Guide
E1384).(Encountersdonotincludeancillaryservices,visits,or
bility of regulatory limitations prior to use.
1.4 This international standard was developed in accor- telephone contacts.)
dance with internationally recognized principles on standard-
3.1.4 episode of care—a chain of events over a period of
ization established in the Decision on Principles for the
time during which clinical care is provided for an illness or a
Development of International Standards, Guides and Recom-
clinical problem (See Guide E1384).
mendations issued by the World Trade Organization Technical
3.1.5 healthcare identifier—a tag for the identification of an
Barriers to Trade (TBT) Committee.
individual created for exclusive use of the health care system.
3.1.6 identifier—a datum, or a group of data, that allows
2. Referenced Documents
positive recognition of a particular individual.
2
2.1 ASTM Standards:
3.1.7 management organization—an organization respon-
sible for the management and oversight of the UHID system
and its operations.
1
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
Informatics and is the direct responsibility of Subcommittee E31.25 on Healthcare
3.1.8 occasion of service—a specified identifiable instance
Data Management, Security, Confidentiality, and Privacy.
of an act of service involved in the care of patients or
Current edition approved March 1, 2013. Published March 2013. Originally
consumers (See Guide E1384).
approved in 1995. Last previous edition approved in 2007 as E1714 – 07. DOI:
10.1520/E1714-07R13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1714−07 (2013)
3.1.9 permanent identifier—a characteristic feature of an 3.1.1
...

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ABSTRACT
This specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems, and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight; and to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it.
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4.1 Data that document health services in health care organizations are business records and must be archived to a secondary but retrievable medium. Audit logs should be retained, at a minimum, according to the statute governing medical records in the geographic area.  
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5.1 Personnel that are responsible for the creation, transfer, and storage of digital X-ray test results will use this standard. This practice defines a set of information modules that, along with Practice E2339 and the DICOM standard, provides a standard means to organize digital X-ray test parameters and results. The digital X-ray test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any digital X-ray inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.
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3.2 Although the recommended field listing includes more than 100 field numbers, only about half of those are regarded as essential and are marked Footnote C in Table 1. Fields so marked must be included in the data base. The other fields recommended provide additional information that a user will find helpful in understanding the radiological image and examination result. These header field items will, in most cases, make up only a very small part of a radiological examination file. The actual stream of radiological data that make up the image will take up the largest part of the data base. Since a radiological image file will normally be large, the concept of data compression will be considered in many cases. Compressed data should be noted, along with a description of the compression method, as indicated in Field No. 92 (see Table 1). (A) Field numbers are for reference only. They do not imply a necessity to include all these fields in any specific data base nor imply a requirement that fields used be in this particular order.(B) Units listed first are SI; those in parentheses are inch-pound (English).(C) Denotes essential field for computerization of examination results, regardless of examination method.(D) Denotes essential field for radiogra...
SCOPE
1.1 This guide provides a listing and description of the fields that are recommended for inclusion in a digital radiological examination data base to facilitate the transfer of such data. This guide sets guidelines for the format of data fields for computerized transfer of digital image files obtained from radiographic, radioscopic, computed radiographic, or other radiological examination systems. The field listing includes those fields regarded as necessary for inclusion in the data base: (1) regardless of the radiological examination method (as indicated by Footnote C in Table 1), (2) for radioscopic examination (as indicated by Footnote F in Table 1), and (3) for radiographic examination (as indicated by Footnote D in Table 1). In addition, other optional fields are listed as a reminder of the types of information that may be useful for additional understanding of the data or applicable to a limited number of applications.  
1.2 It is recognized that organizations may have in place an internal format for the storage and retrieval of radiological examination data. This guide should not impede the use of such formats since it is probable that the necessary fields are already included in such internal data bases, or that the few additions can easily be made. The numerical listing and its order indicated in this guide is only for convenience; the specific numbers and their order carry no inherent significance and are not part of the data file.  
1.3 Current users of Guide E1475 do not have to change their software. First time users should use the XML structure of Table A1.1 for their data.  
1.4 The types of radiological examination systems that appear useful in relation to this guide include radioscopic systems as described in Guide E1000, Practices E1255, E1411, E2597, E2698 and E2737, and radiographic systems as described in Guide E94 and Practices E748, E1742, E2033, E2445, and E2446. Many of the terms used are def...

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ASTM
ASTM F3107-14(2023)(Test Method)
Standard Test Method for Measuring Accuracy After Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for comparison and evaluation of the accuracy of different CAS systems.  
5.2 The use of CAS systems and robotic tracking systems is becoming increasingly common and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting point accuracy is needed. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.
SCOPE
1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: cutting saw (sagittal or reciprocating), burrs, drills, and impact loading. The change in accuracy from detaching and re-attaching or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.  
1.2 It should be noted that one system may need to undergo multiple iterations (one for each clinical application) of this standard to document its accuracy during different clinical applications since each procedure may have different exposure to outside forces given the surgical procedure variability from one procedure to the next.  
1.3 All units of measure will be reported as millimeters for this standard.  
1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM F2554-22(Practice)
Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.  
5.2 The use of surgical navigation and robotic positioning systems is becoming increasingly common. In order to make informed decisions about the suitability of such systems for a given procedure, their accuracy capability needs to be evaluated under clinical application and compared to the requirements. As the performance of a whole system is constrained by those of its subparts, a preliminary step must be to objectively characterize the accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy is needed. Parameters such as coordinate system, units of measurement, terminology, and operational conditions must be standardized.
SCOPE
1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):
(1) Accuracy of a single point relative to a coordinate system.
(2) Sensitivity of tracking accuracy due to changes in pointer orientation.
(3) Relative point-to-point accuracy.  
1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume.  
1.2 This practice defines a standardized reporting format, which includes definition of the coordinate systems to be used for reporting the measurements, and statistical measures (for example, mean, RMS, and maximum error).  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, except for angular measurements, which may be reported in terms of radians or degrees.  
1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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  • Standard
    9 pages
    English language
    sale 15% off