ASTM E2017-99(2010)
(Guide)Standard Guide for Amendments to Health Information (Withdrawn 2017)
Standard Guide for Amendments to Health Information (Withdrawn 2017)
SIGNIFICANCE AND USE
The purpose of this guide is to assure comparability between paper-based and computer-based amendments. Paper-based and computer-based amendments must have comparable methods, practices and policies, in order to assure an unambiguous representation of the sequence and timing of documented events. Original and amended health information entries and documents must both be displayed and must be consistent across both domains. Comparability does not rule out, however, the use of capabilities specific to the electronic world, which do not have paper-based counterparts, for example, displaying the amended text with a pop-up window, which can show the text prior to its amendment.
Traditional paper-based health records and policies support the need of authorized authors of health information to amend entries and documents in the health record under appropriate circumstances. In a paper-based health record, amending entries is accomplished by drawing a line through the erroneous entry, writing in the correct information, and authenticating the amendment by signing and dating the change. Such corrections always display the original documentation along with the amendment. This procedure is used to assure an unambiguous representation of the sequence and timing of documented events and any appropriate amendments.
Current and emerging technologies for health records, including, but not limited to, computer-based health records, employ different input and display methodologies than the traditional paper-based record and, therefore, different amendment alternatives for health record or health information entries, or both. Health information may be entered directly into an automated, electronic, or computer-based health record system, for example, by voice, keyboard (either by the care practitioner, transcriptionist, or other intermediary), mouse, pen, tablet, a personal digital assistant, or through the use of structured data entry. Unlike a written record, which essentially i...
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.
WITHDRAWN RATIONALE
Formerly under the jurisdiction of Committee E31 on Healthcare Informatics, this guide was withdrawn in March 2017. This standard is being withdrawn without replacement due to its limited use by industry.
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: E2017 − 99 (Reapproved 2010) An American National Standard
Standard Guide for
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 to be protected against theft, disclosure, or improper use, or all
three, and must be disseminated only to authorized individuals
1.1 This guide addresses the criteria for amending
or organizations with an approved need to know; (2) private
individually-identifiable health information. Certain criteria for
information, which is entrusted to another with the confidence
amending health information is found in federal and state laws,
that unauthorized disclosure that will be prejudicial to the
rules and regulations, and in ethical statements of professional
individual will not occur. (E1869)
conduct.Although there are several sources for guidance, there
3.1.6 delete, v—(1) to eliminate by blotting out, cutting out
is no current national standard on this topic.
or erasing; (2) to remove or eliminate, as to erase data from a
2. Referenced Documents field or to eliminate a record from a file, a method of erasing
2 data. (Webster’s 1993, Webster’s New World Dictionary of
2.1 ASTM Standards:
Computer Terms, 1994)
E1762 Guide for Electronic Authentication of Health Care
3.1.7 error, n—act involving an unintentional deviation
Information
E1869 Guide for Confidentiality, Privacy, Access, and Data from truth or accuracy.
Security Principles for Health Information Including Elec-
3.1.8 health information, n—any information, whether oral
tronic Health Records
or recorded, in any form or medium (1) that is created or
received by a health care practitioner; a health plan; health
3. Terminology
researcher, public health authority, instructor, employer, school
3.1 Definitions: or university, health information service or other entity that
3.1.1 amendment, n—alteration of health information by creates, receives, obtains, maintains, uses or transmits health
modification, correction, addition, or deletion. information; a health oversight agency, a health information
service organization, or (2) that relates to the past, present, or
3.1.2 authentication, n—provision of assurance of the
future physical or mental health or condition of an individual,
claimed identity of an entity, receiver, or object.
3 theprovisionofhealthcaretoanindividual,orthepast,present
(E1869, E1762, CPRI )
or future payments for the provision of health care to a
3.1.3 author, n—person(s) who is (are) responsible and
protected individual; and, (3) that identifies the individual with
accountable for the health information creation, content,
respect to which there is a reasonable basis to believe that the
accuracy, and completeness for each documented event or
information can be used to identify the individual.
health record entry.
(HIPAA , E1869)
3.1.4 commission, n—act of doing, performing, or commit-
3.1.9 information, n—data to which meaning is assigned,
ting something. (Webster’s 1993)
according to context and assumed conventions (E1869)
3.1.5 confidential, adj—(1) status accorded to data or infor-
3.1.10 omission, n—something neglected or left undone, the
mation indicating that it is sensitive for some reason and needs
act of omitting. (Webster’s 1993)
3.1.11 permanence, n—quality of being in a constant, con-
1 tinuous state.
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
Informatics and is the direct responsibility of Subcommittee E31.25 on Healthcare
Data Management, Security, Confidentiality, and Privacy.
4. Significance and Use
Current edition approved March 1, 2010. Published August 2010. Originally
4.1 The purpose of this guide is to assure comparability
approvedin1999.Lastpreviouseditionapprovedin2005asE2017–99(2005).DOI:
10.1520/E2017-99R10.
between paper-based and computer-based amendments. Paper-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
based and computer-based amendments must have comparable
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 International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2017 − 99 (2010)
methods, practices and policies, in order to assure an unam- as established by organizational policies and procedures. Or-
biguous representation of the sequence and timing of docu- ganizational policies and procedures, regulations from regula-
mented events. Original and amended health information tory, accreditation, and standards organizations and agencies,
entries and documents must both be displayed and must be professional associations, as well as legislative and legal
consistent across both domains. Comparability does not rule requirements, define explicit rules as to what constitutes a
out, however, the use of capabilities specific to the electronic permanent entry into a health record and whether or not that
world, which do not have paper-based counterparts, for ex- entry or document must be authenticated by the author.
ample, displaying the amended text with a pop-up window,
6.2 Once an entry is complete, final and authenticated by its
which can show the text prior to its amendment.
author(s), permanent health information can be altered only
4.2 Traditional paper-based health records and policies sup- through the process of amendment.
port the need of authorized authors of health information to
6.3 Organizational policies and procedures that define per-
amend entries and documents in the health record under
manence must consider the following:
appropriate circumstances. In a paper-based health record,
6.3.1 Authenticated or unauthenticated health information
amending entries is accomplished by drawing a line through
in paper or electronic form is permanent when it becomes
the erroneous entry, writing in the correct information, and
available for viewing or reading by any health care practitioner
authenticating the amendment by signing and dating the
other than the author for concurrent or subsequent direct care
change. Such corrections always display the original documen-
of the patient about whom the health information is docu-
tation along with the amendment. This procedure is used to
mented.
assure an unambiguous representation of the sequence and
6.3.2 Unauthenticated health information used in the direct
timingofdocumentedeventsandanyappropriateamendments.
provision of health care or in the process of health care
4.3 Current and emerging technologies for health records,
decision making, must be marked clearly, legibly, and obvi-
including, but not limited to, computer-based health records,
ously as unauthenticated or defined and clearly understood as
employ different input and display methodologies than the
unauthenticated. Examples of unauthenticated health informa-
traditional paper-based record and, therefore, different amend-
tion are as follows:
ment alternatives for health record or health information
6.3.2.1 Dictated or Transcribed Reports—Notes, histories
entries, or both. Health information may be entered directly
and physicals, discharge summaries, consult reports, letters,
into an automated, electronic, or computer-based health record
procedure notes and reports, diagnostic study reports.
system, for example, by voice, keyboard (either by the care
6.3.2.2 Preliminary Reports—Diagnostic studies, laboratory
practitioner, transcriptionist, or other intermediary), mouse,
values, images and image reports.
pen, tablet, a personal digital assistant, or through the use of
6.3.2.3 Unsigned handwritten, typed, copied, facsimile,
structureddataentry.Unlikeawrittenrecord,whichessentially
printed or computer-based health information.
is always viewed in its original handwritten or typewritten
6.3.2.4 Handwritten notes or documents that also have been
form, the presentation and display of electronic and computer-
dictated and eventually will be transcribed.
based health information often is transformed. This transfor-
mation occurs when information is transferred from one
7. Amending Health Information
computerized system to another system or filtered by different
7.1 Amending health information is appropriate when an
display characteristics or views of the data. In addition, in
explicit error is recognized, information is disputed, or there is
contrast to the paper-based record, computers and computer
an error of omission or commission in documentation. Any
systemscanmodifydisplayofthedatadirectly,forexample,in
request to amend or modify health information must be
nonchronological order or filtering through queries. Amended
documented and retained as part of the health record, including
electronic records should display a distinct and obvious nota-
acceptance or denial of the request.
tion of their amended state. Access to the original health
information should be immediately available, that is, prior
7.2 An amendment may be appropriate when the following
amendments back to and including the original record. occurs:
7.2.1 An explicit error is detected while reviewing health
5. Authentication of Authorship
information, for example, when an image technician reviews
5.1 Under this guide, authentication is used to prove author- health information and determines the abnormal mammogram
ship of each documented event or health record entry.
actually belongs to the patient’s mother who has the same last
5.1.1 For handwritten records under this guide, authentica- name.
tion of the author is provided through the act of signing or
7.2.2 The author determines further health information
initialing an entry. needs to be added to an existing document, which constitutes
5.1.2 For computer-based health information systems under
an error of omission, for example, the dictating physician
this guide, authentication of the author is provided through the realizes that he or she left something out during the original
use of a digital signature (see Guide E1762).
dictation.
7.2.3 The author determines that the entry or document
6. Health Informa
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