ASTM E2017-99(2005)
(Guide)Standard Guide for Amendments to Health Information
Standard Guide for Amendments to Health Information
SCOPE
1.1 This guide addresses the criteria for amending individually-identifiable health information. Certain criteria for amending health information is found in federal and state laws, rules and regulations, and in ethical statements of professional conduct. Although there are several sources for guidance, there is no current national standard on this topic.
General Information
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
An American National Standard
Designation:E2017–99 (Reapproved 2005)
Standard Guide for
1
Amendments to Health Information
This standard is issued under the fixed designation E2017; 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 information, which is entrusted to another with the confidence
that unauthorized disclosure that will be prejudicial to the
1.1 This guide addresses the criteria for amending
individual will not occur. (E1869)
individually-identifiablehealthinformation.Certaincriteriafor
3.1.6 delete, v—(1) to eliminate by blotting out, cutting out
amending health information is found in federal and state laws,
or erasing; (2) to remove or eliminate, as to erase data from a
rules and regulations, and in ethical statements of professional
field or to eliminate a record from a file, a method of erasing
conduct.Although there are several sources for guidance, there
data. (Webster’s 1993, Webster’s New World Dictionary
is no current national standard on this topic.
of Computer Terms, 1994)
2. Referenced Documents
3.1.7 error, n—act involving an unintentional deviation
2
from truth or accuracy.
2.1 ASTM Standards:
3.1.8 health information, n—any information, whether oral
E1762 Guide for Electronic Authentication of Health Care
or recorded, in any form or medium (1) that is created or
Information
received by a health care practitioner; a health plan; health
E1869 Guide for Confidentiality, Privacy,Access, and Data
researcher, public health authority, instructor, employer, school
Security Principles for Health Information Including Elec-
or university, health information service or other entity that
tronic Health Records
creates, receives, obtains, maintains, uses or transmits health
3. Terminology
information; a health oversight agency, a health information
service organization, or (2) that relates to the past, present, or
3.1 Definitions:
future physical or mental health or condition of an individual,
3.1.1 amendment, n—alteration of health information by
theprovisionofhealthcaretoanindividual,orthepast,present
modification, correction, addition, or deletion.
or future payments for the provision of health care to a
3.1.2 authentication, n—provision of assurance of the
protected individual; and, (3) that identifies the individual with
claimed identity of an entity, receiver, or object.
3
respect to which there is a reasonable basis to believe that the
(E1869, E1762, CPRI )
information can be used to identify the individual.
3.1.3 author, n—person(s) who is (are) responsible and
4
(HIPAA , E1869)
accountable for the health information creation, content, accu-
3.1.9 information, n—data to which meaning is assigned,
racy, and completeness for each documented event or health
according to context and assumed conventions
record entry.
(E1869)
3.1.4 commission, n—act of doing, performing, or commit-
3.1.10 omission, n—somethingneglectedorleftundone,the
ting something. (Webster’s 1993)
act of omitting. (Webster’s 1993)
3.1.5 confidential, adj—(1) status accorded to data or infor-
3.1.11 permanence, n—quality of being in a constant, con-
mation indicating that it is sensitive for some reason and needs
tinuous state.
to be protected against theft, disclosure, or improper use, or all
three, and must be disseminated only to authorized individuals
4. Significance and Use
or organizations with an approved need to know; (2) private
4.1 The purpose of this guide is to assure comparability
between paper-based and computer-based amendments. Paper-
1
based and computer-based amendments must have comparable
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
Informatics and is the direct responsibility of Subcommittee E31.25 on Healthcare
methods, practices and policies, in order to assure an unam-
Management, Security, Confidentiality, and Privacy.
biguous representation of the sequence and timing of docu-
Current edition approved May 10, 1999. Published September 1999. DOI:
mented events. Original and amended health information
10.1520/E2017-99R05.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or entries and documents must both be displayed and must be
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
CPRI (Computer-Based Record Institute), 4915 Saint Elmo Ave., Suite 401, HIPAA (Health Insurance Portability and Accountability Act), 1996 (http://
Bethesda, MD 20814 (http://www.cpri.org). www.hcfa.gov/hipaa/hipaahm.htm).
Copyright © ASTM Internati
...
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SCOPE
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1.3.2 The implementation details of any features of the standard on a device claiming conformance.
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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.
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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.
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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.
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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.
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1.3 This practice does not specify:
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1.3.2 The implementation details of any features of the standard on a device claiming conformance.
1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance.
1.4 Units—Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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.
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4.2.1 A predefined risk-based objective incorporating one or more relevant scientific hypotheses specific to the application;
4.2.2 Sufficient relevant data of requisite quality covering the variance space encountered during intended use, that is, pharmaceutical development, or pharmaceutical manufacturing, or both;
4.2.3 Appropriate data analysis and model utilization practices including considerations on testing, validation, and qualification of all new data prior to using a model to analyze it;
4.2.4 Appropriately trained staff;
4.2.5 Appropriate standard operating procedures; and
4.2.6 Life-cycle management.
4.3 This guide can be used to support data analysis activities associated with pharmaceutical development and manufacturing, process performance and product quality monitoring in manufacturing, as well as for troubleshooting and investigation events. Technical detai...
SCOPE
1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products after being validated appropriately using a science and risk-based approach.
1.2 The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:
1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status);
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers);
1.2.3 Considerations on the different types of data analysis, model testing, and validation;
1.2.4 Qualified and competent personnel; and
1.2.5 Life-cycle management of MVDA model.
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SIGNIFICANCE AND USE
5.1 This test method allows specification of the density calibration procedures to be used to calibrate and perform material density measurements using CT image data. Such measurements can be used to evaluate parts, characterize a particular system, or compare different systems, provided that observed variations are dominated by true changes in object density rather than by image artifacts. The specified procedure may also be used to determine the effective X-ray energy of a CT system.
5.2 The recommended test method is more accurate and less susceptible to errors than alternative CT-based approaches, because it takes into account the effective energy of the CT system and the energy-dependent effects of the X-ray attenuation process.
FIG. 1 Density Calibration Phantom
5.3 This (or any) test method for measuring density is valid only to the extent that observed CT-number variations are reflective of true changes in object density rather than image artifacts. Artifacts are always present at some level and can masquerade as density variations. Beam hardening artifacts are particularly detrimental. It is the responsibility of the user to determine or establish, or both, the validity of the density measurements; that is, they are performed in regions of the image which are not overly influenced by artifacts.
5.4 Linear attenuation and mass attenuation may be measured in various ways. For a discussion of attenuation and attenuation measurement, see Guide E1441 and Practice E1570.
SCOPE
1.1 This test method covers instruction for determining the density calibration of X- and γ-ray computed tomography (CT) systems and for using this information to measure material densities from CT images. The calibration is based on an examination of the CT image of a disk of material with embedded specimens of known composition and density. The measured mean CT values of the known standards are determined from an analysis of the image, and their linear attenuation coefficients are determined by multiplying their measured physical density by their published mass attenuation coefficient. The density calibration is performed by applying a linear regression to the data. Once calibrated, the linear attenuation coefficient of an unknown feature in an image can be measured from a determination of its mean CT value. Its density can then be extracted from a knowledge of its mass attenuation coefficient, or one representative of the feature.
1.2 CT provides an excellent method of nondestructively measuring density variations, which would be very difficult to quantify otherwise. Density is inherently a volumetric property of matter. As the measurement volume shrinks, local material inhomogeneities become more important; and measured values will begin to vary about the bulk density value of the material.
1.3 All values are stated in SI units.
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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