ASTM E1869-04(2010)
(Guide)Standard Guide for Confidentiality, Privacy, Access, and Data Security Principles for Health Information Including Electronic Health Records
Standard Guide for Confidentiality, Privacy, Access, and Data Security Principles for Health Information Including Electronic Health Records
SIGNIFICANCE AND USE
Many U.S. healthcare and health information systems leaders believe that electronic health information systems that include computer-based patient records will improve health care. To achieve this goal these systems will need to protect individual privacy of patient data, provide appropriate access, and use adequate data security measures. Sound information policies and practices must be in place prior to the wide-scale deployment of health information systems. Strong enforceable privacy policies must shape the development and implementation of these systems.
The purposes of patient records are to document the course of the patient's illness or health status during each encounter and episode of care; to furnish documentary evidence of the course of the patient's health evaluation, treatment and change in condition; to document an individual's health status; to provide data for preventive care; to document communication between the practitioner responsible for the patient's care and any other healthcare practitioner who contributes to the patient's care; to assist in protecting the legal interest of the patient, the health care facility and the responsible practitioner; to provide continuity of care; to provide data to substantiate insurance claims; to provide a basis for evaluating the adequacy and appropriateness of care; and to provide data for use in continuing education and research.
Health information is a broad concept. It includes all information related to an individual's physical and mental health, the provision of health care generally, and payment for health care. The patient record is a major component of the health information system. The creation of electronic databases and communication protocols to transfer data between systems presents new opportunities to implement more effective systems for health information, to enhance patient care, reduce the cost of health care, and improve patient outcomes. National standards guide all that have responsib...
SCOPE
1.1 This guide covers the principles for confidentiality, privacy, access, and security of person identifiable health information. The focus of this standard is computer-based systems; however, many of the principles outlined in this guide also apply to health information and patient records that are not in an electronic format. Basic principles and ethical practices for handling confidentiality, access, and security of health information are contained in a myriad of federal and state laws, rules and regulations, and in ethical statements of professional conduct. The purpose of this guide is to synthesize and aggregate into a cohesive guide the principles that underpin the development of more specific standards for health information and to support the development of policies and procedures for electronic health record systems and health information systems.
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
Designation:E1869 −04(Reapproved 2010) An American National Standard
Standard Guide for
Confidentiality, Privacy, Access, and Data Security
Principles for Health Information Including Electronic Health
Records
This standard is issued under the fixed designation E1869; 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
Health Record (EHR)
1.1 This guide covers the principles for confidentiality,
E1714 Guide for Properties of a Universal Healthcare Iden-
privacy, access, and security of person identifiable health
tifier (UHID)
information. The focus of this standard is computer-based
E1762 Guide for Electronic Authentication of Health Care
systems; however, many of the principles outlined in this guide
Information
alsoapplytohealthinformationandpatientrecordsthatarenot
E1769 Guide for Properties of Electronic Health Records
in an electronic format. Basic principles and ethical practices
and Record Systems
for handling confidentiality, access, and security of health
E1986 Guide for Information Access Privileges to Health
informationarecontainedinamyriadoffederalandstatelaws,
Information
rules and regulations, and in ethical statements of professional
E1987 Guide for Individual Rights Regarding Health Infor-
conduct. The purpose of this guide is to synthesize and
mation
aggregate into a cohesive guide the principles that underpin the
E1988 Guide for Training of Persons who have Access to
development of more specific standards for health information
Health Information
and to support the development of policies and procedures for
E2017 Guide for Amendments to Health Information
electronic health record systems and health information sys-
E2147 Specification for Audit and Disclosure Logs for Use
tems.
in Health Information Systems
1.2 This guide includes principles related to:
Section
3. Terminology
Privacy 7
Confidentiality 8 3.1 Definitions:
Collection, Use, and Maintenance 9
3.1.1 access—the provision of an opportunity to approach,
Ownership 10
inspect, review, retrieve, store, communicate with, or make use
Access 11
Disclosure/Transfer of Data 12 ofhealthinformationsystemresources(forexample,hardware,
Data Security 13
software, systems or structure) or patient identifiable data and
Penalties/Sanctions 14
information, or both.
Education 15
3.1.2 authentication:—
1.3 This guide does not address specific technical require-
3.1.2.1 authentication (data entry)—to authorize or validate
ments.Itisintendedasabasefordevelopmentofmorespecific
an entry in a record by a signature including first initial, last
standards.
name, and discipline or a unique identifier allowing identifica-
2. Referenced Documents tion of the responsible individual.
3.1.2.2 authentication (data origin/sender)—corroboration
2.1 ASTM Standards:
that the source/sender of data received is as claimed.
3.1.2.3 authentication (user/receiver)—the provision of as-
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
surance of the claimed identity of an entity/receiver.
Informatics and are the direct responsibility of Subcommittee E31.25 on Healthcare
Data Management, Security, Confidentiality, and Privacy.
3.1.3 authorize—the granting to a user the right of access to
Current edition approved March 1, 2010. Published August 2010. Originally
specified data and information, a program, a terminal, or a
approved in 1997. Last previous edition approved in 2004 as E1869–04. DOI:
process.
10.1520/E1869-04R10.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
3.1.4 clinical data centers—all computer-based (and
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
manual) systems which handle and store patient records and
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. health information, for example, solo practitioners, clinics,
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1869−04 (2010)
hospitals, state departments of health, data centers, and health facts associated with that person even though specific identi-
maintenance organizations. fiershavebeenremoved,likenameandsocialsecuritynumber.
3.1.14 information—data that have been processed for use;
3.1.5 clinical information—data and information collected
from the patient or patient’s family by a healthcare practitioner human interpretation of data; data that have been processed
into a meaningful form.
or healthcare organization. A healthcare practitioner’s objec-
tive measurement or subjective evaluation of a patient’s
3.1.15 informed consent—informed consent requires that
physical or mental state of health, descriptions of an individu-
individuals be informed, in advance, of the information being
al’s health history and family health history, diagnostic studies,
collected from them, or generated, and the purposes for which
decision rationale, descriptions of procedures performed, find-
it will be used; and be given an opportunity to accept, reject, or
ings, therapeutic interventions, medications prescribed, de-
modify the terms presented. Central to the principle of in-
scription of responses to treatment, prognostic statements and
formed consent is providing individuals with the ability to
descriptions of socioeconomic factors, and environmental fac-
control the use of information once collected. The general rule
tors related to the patient’s health.
is that information collected for one purpose must not be used
for another purpose without the individual’s consent. In prac-
3.1.6 computer-based patient record—see patient record.
tice, this requires that no use or disclosure occur, except to a
3.1.7 confidential—status accorded to data or information
documented request by, or with the prior consent of, the
indicating that it is sensitive for some reason, and therefore it
individual to whom the record pertains unless the disclosure is
needs to be protected against theft, disclosure, or improper use,
permitted by law. Under some circumstances a guardian or
or both, and must be disseminated only to authorized individu-
designee may consent on behalf of the individual.
als or organizations with a need to know.
3.1.16 informational privacy—(1) a state or condition of
3.1.8 data—collection of elements on a given subject;
controlled access to personal information. (2) The ability of an
things known, given, or assumed, as the basis for decision
individual to control the use and dissemination of information
making; the raw material of information systems expressed in
that relates to himself or herself. (3) The individual’s ability to
text, numbers, symbols and images; facts.
control what information is available to various users and to
3.1.9 data protection measure—a planned operation, for
limit redisclosures of information.
example, procedure, policy, program, or technology, employed
3.1.17 patient record:—
intheprivacysystemtoprevent,detect,orsanctionbreachesof
3.1.17.1 longitudinal patient record—a permanent, coordi-
security.
nated patient record of significant information, in chronologi-
3.1.10 disclosure—to release, transfer, or otherwise divulge
cal sequence. It may include all historical data collected or be
confidential health information to any entity other than the
retrieved as a user designated synopsis of significant demo-
individual who is the subject of such information.
graphic, genetic, clinical and environmental facts and events
maintained within an automated system.
3.1.11 health care—(1) preventive, diagnostic, therapeutic,
rehabilitative, maintenance, or palliative care, public health,
3.1.17.2 patient health record—the primary legal record
counseling, service, or procedure with respect to the physical
documenting the healthcare services provided to a person, in
or mental condition of an individual; or affecting the structure
any aspect of healthcare delivery.
or function of the human body; or (2) any sale or dispensing of
Discussion—The term patient health record is synonymous
a drug, device, equipment, or other item to an individual, or for
with: medical record, patient care record, hospital record,
the use of an individual, pursuant to a prescription.
clinical record, client record, resident record, electronic medi-
cal record, and computer-based patient record. The term
3.1.12 health information—anyinformation,whetheroralor
includes routine clinical or office records, hospital records,
recorded in any form or medium (1) that is created or received
recordsofcareinanyhealth-relatedsetting,researchprotocols,
by a health care provider; a health plan; health researcher,
preventivecare,lifestyleevaluation,specialstudyrecords,and
public health authority, instructor, employer, life insurer,
various clinical databases.
school or university; health care clearinghouse, health infor-
mation service or other entity that creates, receives, obtains,
3.1.17.3 patient record system—the set of components that
maintains, uses, or transmits health information; a health form the mechanism by which patient records are created,
oversight agency, a health information service organization, or
used, stored, and retrieved. A patient record system is usually
(2) that relates to the past, present, or future physical or mental located within a healthcare provider/practitioner setting. It
health or condition of an individual, the provision of health
includes people, data, rules and procedures, processing and
care to an individual, or the past, present, or future payment for storage devices (for example, paper and pen, hardware and
the provision of health care to an individual; and (3) that
software), and communications and support function.
identifies the individual, with respect to which there is a
3.1.17.4 secondary patient record—a record that is derived
reasonable basis to believe that the information can be used to
from the primary health record and contains selected data
identify the individual.
elements to aid nonclinical persons (that is, persons not
3.1.13 inference—refers to the ability to deduce the identity involved in direct patient care) in supporting, evaluating, or
of a person associated with a set of data through “clues" advancing patient care. Patient care support refers to adminis-
contained in that information. This analysis permits determi- tration, regulation, and payment functions. Patient care evalu-
nation of the individual’s identity based on a combination of ation refers to quality assurance, utilization management, and
E1869−04 (2010)
medical or legal audits. Patient care advancement refers to 4. Significance and Use
research. These records are often combined to form a second-
4.1 Many U.S. healthcare and health information systems
ary database, for example, an insurance claims database.
leaders believe that electronic health information systems that
include computer-based patient records will improve health
3.1.18 personally identifiable health information—health
care. To achieve this goal these systems will need to protect
information which contains an individual’s identifiers (name,
individual privacy of patient data, provide appropriate access,
social security number) or contains a sufficient number of
and use adequate data security measures. Sound information
variables to allow identification of an individual.
policies and practices must be in place prior to the wide-scale
3.1.19 practitioner (licensed/certified)—anindividualatany
deployment of health information systems. Strong enforceable
level of professional specialization who requires a public
privacy policies must shape the development and implementa-
license to deliver health care to individuals. An individual at
tion of these systems.
any level of professional specialization who is certified by a
4.2 The purposes of patient records are to document the
public agency or professional organization to provide health
course of the patient’s illness or health status during each
services to individuals. A practitioner may also be a provider.
encounter and episode of care; to furnish documentary evi-
denceofthecourseofthepatient’shealthevaluation,treatment
3.1.20 privacy—the right of individuals to be left alone and
and change in condition; to document an individual’s health
to be protected against physical or psychological invasion or
status; to provide data for preventive care; to document
the misuse of their property. It includes freedom from intrusion
communication between the practitioner responsible for the
or observation into one’s private affairs, the right to maintain
patient’s care and any other healthcare practitioner who con-
control over certain personal information, and the freedom to
tributes to the patient’s care; to assist in protecting the legal
act without outside interference. See also informational pri-
interest of the patient, the health care facility and the respon-
vacy.
sible practitioner; to provide continuity of care; to provide data
3.1.21 privilege—the individual’s right to hold private and
to substantiate insurance claims; to provide a basis for evalu-
confidential the information given to a healthcare provider in
ating the adequacy and appropriateness of care; and to provide
the context of a professional relationship. The individual may,
data for use in continuing education and research.
by overt act of consent or by other means, waive the right to
4.3 Health information is a broad concept. It includes all
privilege. For example, if a patient brings a lawsuit against a
information related to an individual’s physical and mental
facilityandtherecordsareneededtopresentthefacility’scase,
health, the provision of health care generally, and payment for
the privilege is waived.
health care. The patient record is a major component of the
healthinformationsystem.Thecreationofelectronicdatabases
3.1.22 provider—a business entity which furnishes health
and communication protocols to transfer data between systems
care to a consumer; it includes a professionally licensed
presents new opportunities to implement more effective sys-
practitioner who is authorized to operate a healthcare delivery
tems for health information, to enhance patient care, reduce the
facility.
cost of health care, and improve patient outcomes. National
3.1.23 security:—
standards guide all that have responsibilities for records and
3.1.23.1 data security—the result of effective data protec-
information system
...
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