ASTM E2017-99

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

• Status: Historical
• Publication Date: 09-May-1999
• 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

Relations

• Replaced By: ASTM E2017-99(2005) - Standard Guide for Amendments to Health Information
• Effective Date: 10-May-1999

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
Standard Guide for
Amendments to Health Information
This standard is issued under the fixed designation E 2017; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope individual will not occur. (E 1869)
3.1.6 delete, v—(1) to eliminate by blotting out, cutting out
1.1 This guide addresses the criteria for amending
or erasing; (2) to remove or eliminate, as to erase data from a
individually-identifiable health information. Certaincriteriafor
field or to eliminate a record from a file, a method of erasing
amending health information is found in federal and state laws,
data. (Webster’s 1993, Webster’s New World Dictionary
rules and regulations, and in ethical statements of professional
of Computer Terms, 1994)
conduct.Although there are several sources for guidance, there
3.1.7 error, n—act involving an unintentional deviation
is no current national standard on this topic.
from truth or accuracy.
2. Referenced Documents
3.1.8 health information, n—any information, whether oral
or recorded, in any form or medium (1) that is created or
2.1 ASTM Standards:
received by a health care practitioner; a health plan; health
E 1762 Guide for Electronic Authentication of Health Care
researcher, public health authority, instructor, employer, school
Information
or university, health information service or other entity that
E 1869 Guide for Confidentiality, Privacy,Access, and Data
creates, receives, obtains, maintains, uses or transmits health
Security Principles for Health Information Including
information; a health oversight agency, a health information
Computer-Based Patient Records
service organization, or (2) that relates to the past, present, or
3. Terminology
future physical or mental health or condition of an individual,
theprovisionofhealthcaretoanindividual,orthepast,present
3.1 Definitions:
or future payments for the provision of health care to a
3.1.1 amendment, n—alteration of health information by
protected individual; and, (3) that identifies the individual with
modification, correction, addition, or deletion.
respect to which there is a reasonable basis to believe that the
3.1.2 authentication, n—provision of assurance of the
information can be used to identify the individual.
claimed identity of an entity, receiver, or object.
(HIPAA , E 1869)
(E 1869, E 1762, CPRI )
3.1.9 information, n—data to which meaning is assigned,
3.1.3 author, n—person(s) who is (are) responsible and
according to context and assumed conventions
accountable for the health information creation, content, accu-
(E 1869)
racy, and completeness for each documented event or health
3.1.10 omission, n—somethingneglectedorleftundone,the
record entry.
act of omitting. (Webster’s 1993)
3.1.4 commission, n—act of doing, performing, or commit-
3.1.11 permanence, n—quality of being in a constant, con-
ting something. (Webster’s 1993)
tinuous state.
3.1.5 confidential, adj—(1) status accorded to data or infor-
mation indicating that it is sensitive for some reason and needs
4. Significance and Use
to be protected against theft, disclosure, or improper use, or all
4.1 The purpose of this guide is to assure comparability
three, and must be disseminated only to authorized individuals
between paper-based and computer-based amendments. Paper-
or organizations with an approved need to know; (2) private
based and computer-based amendments must have comparable
information, which is entrusted to another with the confidence
methods, practices and policies, in order to assure an unam-
that unauthorized disclosure that will be prejudicial to the
biguous representation of the sequence and timing of docu-
mented events. Original and amended health information
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
entries and documents must both be displayed and must be
Informatics and is the direct responsibility of Subcommittee E31.20 on Data and
consistent across both domains. Comparability does not rule
System Security for Health Information.
Current edition approved May 10, 1999. Published September 1999.
Annual Book of ASTM Standards, Vol 14.01.
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
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, labora-
practitioner, transcriptionist, or other intermediary), mouse,
tory 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
7.2 An amendment may be appropriate when the following
information should be immediately available, that is, prior
occurs:
amendments back to and including the original record.
7.2.1 An explicit error is detected while reviewing health
information, for example, when an image technician reviews
5. Authentication of Authorship
health information and determines the abnormal mammogram
5.1 Under this guide, authentication is used to prove author-
actually belongs to the patient’s mother who has the same last
ship of each documented event or health record entry.
name.
5.1.1 For handwritten records under this guide, authentica-
7.2.2 The author determines further health information
tion of the author is provided through the act of signing or
needs to be added to an existing document, which constitutes
initialing an entry.
an error of omission, for example, the dictating physician
5.1.2 For computer-based health information systems under
realizes that he or she left something out during the original
this guide, authentication of the author is provided through the
dictation.
use of a digital signature (see Guide E 1762).
7.2.3 The author determines that the entry or document
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 that he or
thenticated by its author(s) as a complete and final document,
as established by organizational policies
...