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.
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An American National Standard
Designation:E2017–99 (Reapproved 2005)
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 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
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.
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
(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-
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.
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 International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2017–99 (2005)
consistent across both domains. Comparability does not rule permanent entry into a health record and whether or not that
out, however, the use of capabilities specific to the electronic entry or document must be authenticated by the author.
world, which do not have paper-based counterparts, for ex-
6.2 Once an entry is complete, final and authenticated by its
ample, displaying the amended text with a pop-up window, author(s), permanent health information can be altered only
which can show the text prior to its amendment.
through the process of amendment.
4.2 Traditional paper-based health records and policies sup-
6.3 Organizational policies and procedures that define per-
port the need of authorized authors of health information to
manence must consider the following:
amend entries and documents in the health record under
6.3.1 Authenticated or unauthenticated health information
appropriate circumstances. In a paper-based health record,
in paper or electronic form is permanent when it becomes
amending entries is accomplished by drawing a line through
available for viewing or reading by any health care practitioner
the erroneous entry, writing in the correct information, and
other than the author for concurrent or subsequent direct care
authenticating the amendment by signing and dating the
of the patient about whom the health information is docu-
change. Such corrections always display the original documen-
mented.
tation along with the amendment. This procedure is used to
6.3.2 Unauthenticated health information used in the direct
assure an unambiguous representation of the sequence and
provision of health care or in the process of health care
timingofdocumentedeventsandanyappropriateamendments.
decision making, must be marked clearly, legibly, and obvi-
4.3 Current and emerging technologies for health records,
ously as unauthenticated or defined and clearly understood as
including, but not limited to, computer-based health records,
unauthenticated. Examples of unauthenticated health informa-
employ different input and display methodologies than the
tion are as follows:
traditional paper-based record and, therefore, different amend-
6.3.2.1 Dictated or Transcribed Reports—Notes, histories
ment alternatives for health record or health information
and physicals, discharge summaries, consult reports, letters,
entries, or both. Health information may be entered directly
procedure notes and reports, diagnostic study reports.
into an automated, electronic, or computer-based health record
6.3.2.2 Preliminary Reports—Diagnostic studies, labora-
system, for example, by voice, keyboard (either by the care
tory values, images and image reports.
practitioner, transcriptionist, or other intermediary), mouse,
6.3.2.3 Unsigned handwritten, typed, copied, facsimile,
pen, tablet, a personal digital assistant, or through the use of
printed or computer-based health information.
structureddataentry.Unlikeawrittenrecord,whichessentially
6.3.2.4 Handwritten notes or documents that also have been
is always viewed in its original handwritten or typewritten
dictated and eventually will be transcribed.
form, the presentation and display of electronic and computer-
based health information often is transformed. This transfor-
7. Amending Health Information
mation occurs when information is transferred from one
7.1 Amending health information is appropriate when an
computerized system to another system or filtered by different
explicit error is recognized, information is disputed, or there is
display characteristics or views of the data. In addition, in
an error of omission or commission in documentation. Any
contrast to the paper-based record, computers and computer
request to amend or modify health information must be
systemscanmodifydisplayofthedatadirectly,forexample,in
documented and retained as part of the health record, including
nonchronological order or filtering through queries. Amended
acceptance or denial of the request.
electronic records should display a distinct and obvious nota-
7.2 An amendment may be appropriate when the following
tion of their amended state. Access to the original health
occurs:
information should be immediately available, that is, prior
7.2.1 An explicit error is detected while reviewing health
amendments back to and including the original record.
information, for example, when an image technician reviews
5. Authentication of Authorship
health information and determines the abnormal mammogram
actually belongs to the patient’s mother who has the same last
5.1 Under this guide, authentication is used to prove author-
name.
ship of each documented event or health record entry.
7.2.2 The author determines further health information
5.1.1 For handwritten records under this guide, authentica-
needs to be added to an existing document, which constitutes
tion of the author is provided through the act of signing or
an error of omission, for example, the dictating physician
initialing an entry.
realizes that he or she left something out during the original
5.1.2 For computer-based health information systems under
dictation.
this guide, authentication of the author is provided through the
7.2.3 The author determines that the entry or document
use of a digital signature (see Guide E1762).
contains information that does not actually apply to what has
6. Health Information Permanence
transpired with a patient and about whom the information has
6.1 Health information attains permanence when it is au- been entered or documented, which constitutes an error of
commission, for example, when a physician realizes th
...
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