ASTM E1869-97
(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
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. Although there are many sources for guidance, there is no current national standard guide on this topic.
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An American National Standard
Designation: E 1869 – 97
Standard Guide for
Confidentiality, Privacy, Access, and Data Security
Principles for Health Information Including Computer-Based
Patient Records
This standard is issued under the fixed designation E 1869; 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 3. Terminology
1.1 This guide covers the principles for confidentiality, 3.1 Definitions:
privacy, access, and security of person identifiable health 3.1.1 access—the provision of an opportunity to approach,
information. The focus of this standard is computer-based inspect, review, retrieve, store, communicate with, or make use
systems; however, many of the principles outlined in this guide ofhealthinformationsystemresources(forexample,hardware,
alsoapplytohealthinformationandpatientrecordsthatarenot software, systems or structure) or patient identifiable data and
in an electronic format. Basic principles and ethical practices information, or both.
for handling confidentiality, access, and security of health 3.1.2 authentication:
information are contained in a myriad of federal and state laws, 3.1.3 authentication (data entry)—to authorize or validate
rules and regulations, and in ethical statements of professional an entry in a record by: a signature including first initial, last
conduct. Although there are many sources for guidance, there name, and discipline or a unique identifier allowing identifica-
is no current national standard guide on this topic. tion of the responsible individual.
1.2 This guide includes principles related to: 3.1.4 authentication (data origin/sender)—corroboration
that the source/sender of data received is as claimed.
Section
Privacy 7
3.1.5 authentication (user/receiver)—the provision of as-
Confidentiality 8
surance of the claimed identity of an entity/receiver.
Collection, Use, and Maintenance 9
Ownership 10 3.1.6 authorize—the granting to a user the right of access to
Access 11
specified data and information, a program, a terminal, or a
Disclosure/Transfer of Data 12
process.
Data Security 13
3.1.7 clinical data centers—all computer-based (and
Penalties/Sanctions 14
Education 15
manual) systems which handle and store patient records and
health information, that is, solo practitioners, clinics, hospitals,
1.3 This guide does not address specific technical require-
state departments of health, data centers, and health mainte-
ments.Itisintendedasabasefordevelopmentofmorespecific
nance organizations.
standards.
3.1.8 clinical information—data and information collected
2. Referenced Documents
from the patient or patient’s family by a healthcare practitioner
or healthcare organization. A healthcare practitioner’s objec-
2.1 ASTM Standards:
tive measurement or subjective evaluation of a patient’s
E 1384 Guide for the Content and Structure of the
physical or mental state of health, descriptions of an individu-
Computer-Based Patient Record
al’s health history and family health history, diagnostic studies,
E 1714 Guide for the Properties of Electronic Health
decision rationale, descriptions of procedures performed, find-
Records and Record Systems
ings, therapeutic interventions, medications prescribed, de-
E 1762 Guide for Electronic Authentication of Health In-
scription of responses to treatment, prognostic statements and
formation
descriptions of socioeconomic factors, and environmental fac-
E 1769 Guide for the Properties of Electronic Health
tors related to the patient’s health.
Records and Record Systems
3.1.9 computer-based patient record—see patient record.
3.1.10 confidential—status accorded to data or information
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
indicating that it is sensitive for some reason, and therefore it
Informatics and are the direct responsibility of Subcommittee E31.20 on Data and
needs to be protected against theft, disclosure, or improper use,
System Security for Health Information.
Current edition approved April 10, 1997. Published April 1997.
Annual Book of ASTM Standards, Vol 14.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1869–97
or both, and must be disseminated only to authorized individu- 3.1.19 informational privacy—( 1) a state or condition of
als or organizations with a need to know. controlled access to personal information. (2) The ability of an
individual to control the use and dissemination of information
3.1.11 data—collection of elements on a given subject;
that relates to himself or herself. ( 3)The individual’s ability to
things known, given, or assumed, as the basis for decision
control what information is available to various users and to
making; the raw material of information systems expressed in
limit redisclosures of information.
text, numbers, symbols and images; facts.
3.1.20 patient record:
3.1.12 data protection measure—a planned operation, for
3.1.21 longitudinal patient record—a permanent, coordi-
example, procedure, policy, program, or technology, employed
nated patient record of significant information. It is a birth-to-
intheprivacysystemtoprevent,detect,orsanctionbreachesof
death synopsis of significant demographic, genetic, clinical,
security.
and environmental facts and events.
3.1.13 disclosure—to release, transfer, or otherwise divulge
3.1.22 patient health record—( 1) a set of information for a
confidential health information to any entity other than the
single individual’s encounter with the healthcare system. It
individual who is the subject of such information.
contains data and information generated across care settings
3.1.14 health care—(1) preventive, diagnostic, therapeutic,
and from different health care interactions. The set of data may
rehabilitative, maintenance, or palliative care, public health,
be viewed in various ways, like brief summary or emergency
counseling, service, or procedure with respect to the physical
data. ( 2) It is the primary legal record documenting the
or mental condition of an individual; or affecting the structure
healthcare services provided to an individual.
or function of the human body; or (2) any sale or dispensing of
3.1.23 Discussion—patient health record is used to refer to:
a drug, device, equipment, or other item to an individual, or for
medical record, patient care record, hospital record, clinical
the use of an individual, pursuant to a prescription.
record, client record, resident record, electronic medical
3.1.15 health information—any information, whether oral
record, and computer-based patient record. The term includes
or recorded in any form or medium (1) that is created or
routine clinical or office records, hospital records, records of
received by a health care provider; a health plan; health
care in any health-related setting, research protocols, preven-
researcher, public health authority, instructor, employer, school
tive care, life style evaluation, special study records, and
or university; health information service or other entity that
various clinical databases.
creates, receives, obtains, maintains, uses, or transmits health
3.1.24 patient record system—the set of components that
information; a health oversight agency, a health information
form the mechanism by which patient records are created,
service organization, or ( 2) that relates to the past, present, or
used, stored, and retrieved. A patient record system is usually
future physical or mental health or condition of an individual,
located within a healthcare provider setting. It includes people,
the provision of health care to an individual, or the past,
data, rules and procedures, processing and storage devices (for
present, or future payment for the provision of health care to a
example, paper and pen, hardware and software), and commu-
protected individual; and (3) that identifies the individual, with
nications and support function. The system supports users by
respect to which there is a reasonable basis to believe that the
providing access to complete and accurate data, alerts, remind-
information can be used to identify the individual.
ers, clinical decision support systems, links to medical knowl-
3.1.16 inference—refers to the ability to deduce the identity
edge, and other aids.
of a person associated with a set of data through “clues”
3.1.25 secondary patient record—a record that is derived
contained in that information. This analysis permits determi-
from the primary health record and contains selected data
nation of the individual’s identity based on a combination of
elementstoaidinproviding,supporting,evaluating,oradvanc-
facts associated with that person even though specific identi-
ing patient care. Patient care provision refers to practitioner
fiershavebeenremoved,likenameandsocialsecuritynumber.
access to a coordinated database containing limited informa-
3.1.17 information—data that have been processed for use;
tion (for example, immunization data, problem list, medication
human interpretation of data; data that have been processed record, lab results). Patient care support refers to administra-
into a meaningful form.
tion,regulation,andpaymentfunctions.Patientcareevaluation
refers to quality management activities including: quality
3.1.18 informed consent—informed consent requires that
improvement,qualityassurance,patientsatisfaction,utilization
individuals be informed, in advance, of the information being
management, and audits examining specific aspects of patient
collected from them, or generated, and the purposes for which
care. Patient care advancement refers to research. Secondary
it will be used; and be given an opportunity to accept, reject, or
record data are often combined to form a secondary database,
modify the terms presented. Central to the principle of in-
for example, an immunization tracking database, a disease
formed consent is providing individuals with the ability to
index, a trauma registry, and an emergency department log.
control the use of information once collected. The general rule
3.1.26 personally identifiable health information— health
is that information collected for one purpose must not be used
information which contains an individual’s identifiers (name,
for another purpose without the individual’s consent. In prac-
social security number) or contains a sufficient number of
tice, this requires that no use or disclosure occur, except to a
variables to allow identification of an individual.
documented request by, or with the prior consent of, the
individual to whom the record pertains. Under some circum- 3.1.27 practitioner (licensed/certified)—an individual at
stances a guardian or designee may consent on behalf of the any level of professional specialization who requires a public
individual. license to deliver health care to individuals. An individual at
E1869–97
any level of professional specialization who is certified by a denceofthecourseofthepatient’shealthevaluation,treatment
public agency or professional organization to provide health and change in condition; to document an individual’s health
services to individuals. A practitioner may also be a provider. status; to provide data for preventive care; to document
3.1.28 privacy—the right of individuals to be left alone and communication between the practitioner responsible for the
to be protected against physical or psychological invasion or
patient’s care and any other healthcare practitioner who con-
the misuse of their property. It includes freedom from intrusion tributes to the patient’s care; to assist in protecting the legal
or observation into one’s private affairs, the right to maintain
interest of the patient, the health care facility and the respon-
control over certain personal information, and the freedom to sible practitioner; to provide continuity of care; to provide data
act without outside interference. See also informational pri-
to substantiate insurance claims; to provide a basis for evalu-
vacy. ating the adequacy and appropriateness of care; and to provide
3.1.29 privilege—the individual’s right to hold private and
data for use in continuing education and research.
confidential the information given to a healthcare provider in
4.3 Health information is a broad concept. It includes all
the context of a professional relationship. The individual may,
information related to an individual’s physical and mental
by overt act of consent or by other means, waive the right to
health, the provision of health care generally, and payment for
privilege. For example, if a patient brings a lawsuit against a
health care. The patient record is a major component of the
facilityandtherecordsareneededtopresentthefacility’scase,
health information system.The creation of electronic databases
the privilege is waived.
and communication protocols to transfer data between systems
3.1.30 provider—a business entity which furnishes health
presents new opportunities to implement more effective sys-
care to a consumer; it includes a professionally licensed
tems for health information, to enhance patient care, reduce the
practitioner who is authorized to operate a healthcare delivery
cost of health care, and improve patient outcomes. National
system.
standards will guide all who have responsibilities for records
3.1.31 security:
and information systems containing person identifiable health
3.1.32 data security—the result of effective data protection
data and information.
measures; the sum of measures that safeguard data and
4.4 This guide also acknowledges the large and growing list
computer programs from undesired occurrences and exposure
of health information databases already in existence. These
to: (1) accidental or intentional access or disclosure to unau-
databases have been assembled to pay for services rendered
thorized persons, or a combination thereof, (2) accidental or
(insurance), to validate the appropriate use of patient services
malicious alteration, (3) unauthorized copying, (4) loss by theft
(utilizationmanagement),tosupportpolicy(nationallevels),to
or destruction by hardware failures, software deficiencies,
gather data for research/tracking of specific problems
operating mistakes; physical damage by fire, water, smoke,
(registries—such as tumor, trauma, birth defects, mental health
excessive temperature, electrical failure or sabotage; or a
case management), to prevent the spread of disease (required
combination thereof. Data security exists when data are pro-
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