ASTM E1986-98
(Guide)Standard Guide for Information Access Privileges to Health Information
Standard Guide for Information Access Privileges to Health Information
SCOPE
1.1 This guide covers the process of granting and maintaining access privileges to health information. It directly addresses the maintenance of confidentiality of personal, provider, and organizational data in the healthcare domain. It addresses a wide range of data and data elements not all traditionally defined as healthcare data, but all elemental in the provision of data management, data services, and administrative and clinical healthcare services. In addition, this guide addresses specific requirements for granting access privileges to patient-specific health information during health emergencies.
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An American National Standard
Designation:E1986–98
Standard Guide for
Information Access Privileges to Health Information
This standard is issued under the fixed designation E 1986; 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 1.7 This guide does not directly define explicit disease-
specific and evaluation/treatment-specific data control or ac-
1.1 This guide covers the process of granting and maintain-
cess, or both. As defined under this guide, the confidential
ing access privileges to health information. It directly ad-
protection of elemental data elements in relation to which data
dresses the maintenance of confidentiality of personal, pro-
elements fall into restrictive or specifically controlled catego-
vider, and organizational data in the healthcare domain. It
ries, or both, is set by policies, professional practice, and laws,
addresses a wide range of data and data elements not all
legislation and regulations.
traditionally defined as healthcare data, but all elemental in the
provision of data management, data services, and administra-
2. Referenced Documents
tive and clinical healthcare services. In addition, this guide
2.1 ASTM Standards:
addresses specific requirements for granting access privileges
E 1384 Guide for Content and Structure of the Computer-
to patient-specific health information during health emergen-
Based Patient Record
cies.
E 1633 Specification for Coded Values Used in Computer-
1.2 This guide is based on long-term existing and estab-
Based Patient Record
lished professional practices in the management of healthcare
E 1869 Guide for Confidentiality, Privacy,Access, and Data
administrative and clinical data. Healthcare data, and specifi-
Security Principles for Health Information Including
cally healthcare records (also referred to as medical records or
Computer-Based Patient Records
patient records), are generally managed under similar profes-
E 1987 Guide for Individual Rights Regarding Health In-
sional practices throughout the United States, essentially re-
formation
gardless of specific variations in local, regional, state, and
PS 101 Provisional Guide on Security Framework for
federal laws regarding rules and requirements for data and
Healthcare Information
record management.
1.3 This guide applies to all individuals, groups, organiza-
3. Terminology
tions, data-users, data-managers, and public and private firms,
3.1 Definitions:
companies, agencies, departments, bureaus, service-providers,
3.1.1 access—the provision of an opportunity to approach,
and similar entities that collect individual, group, and organi-
inspect, review, retrieve, store, communicate with, or make use
zational data related to health care.
ofhealthinformationsystemresources(forexample,hardware,
1.4 This guide applies to all collection, use, management,
software, systems, or structure) or patient identifiable data and
maintenance, disclosure, and access of all individual, group,
information, or both. (E 1869)
and organizational data related to health care.
3.1.2 access control—the prevention of unauthorized use of
1.5 This guide does not attempt to address specific legisla-
a resource, including the prevention of use of a resource in an
tive and regulatory issues regarding individual, group, and
unauthorized manner.
organizational rights to protection of privacy.
3.1.2.1 Discussion—Access control counters the threat of
1.6 This guide covers all methods of collection and use of
unauthorized access to, disclosure of, or modification of data.
data whether paper-based, written, printed, typed, dictated,
(ISO 7498-2)
transcribed, forms-based, photocopied, scanned, facsimile,
3.1.3 accountability—the property that ensures that the
telefax, magnetic media, image, video, motion picture, still
actions of an entity can be traced. (ISO 7498-2)
picture, film, microfilm, animation, 3D, audio, digital media,
3.1.4 audit trail—data collected and potentially used to
optical media, synthetic media, or computer-based.
facilitate a security audit. (ISO 7498-2)
3.1.5 authentication—the corroboration that an entity is the
one claimed. (ISO 7498-2)
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
Informatics and is the direct responsibility of Subcommittee E31.20 on Data and
System Security for Health Information.
Current edition approved Oct. 10, 1998. Published November 1998. 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.
E1986–98
3.1.6 authorize—the granting to a user the right of access to 3.1.17 information—data to which meaning is assigned,
specified data and information, a program, a terminal, or a according to context and assumed conventions.
process. (E 1869) (National Security Council, 1991, E 1869)
3.2 Definitions of Terms Specific to This Standard:
3.1.7 authorization—(1) The granting of rights, which in-
3.2.1 disclosure—to release, transfer, or otherwise divulge
cludes the granting of access based on access rights. (2) The
protected health information to any entity other than the
mechanism for obtaining consent for the use and disclosure of
individual who is the subject of such information.
health information. (ISO 7498-2, CPRI, AHIMA)
3.2.1.1 external disclosure—disclosure outside an organiza-
3.1.8 confidential—status accorded to data or information
tion.
indicating that it is sensitive for some reason and needs to be
3.2.1.2 internal disclosure—disclosure within an organiza-
protected against theft, disclosure, or improper use, or both,
tion.
and must be disseminated only to authorized individuals or
organizations with an approved need to know. Private infor-
4. Significance and Use
mation which is entrusted to another with the confidence that
4.1 The maintenance of confidentiality in paper-based, elec-
unauthorized disclosure that will be prejudicial to the indi-
tronic, or computer-based health information requires that
vidual will not occur. (E 1869)
policies and procedures be in place to protect confidentiality.
3.1.9 confidentiality—the property that information is not
Confidentiality of information depends on structural and ex-
made available or disclosed to unauthorized individuals, enti-
plicit mechanisms to allow persons or systems to define who
ties, or processes. (ISO 7498-2)
has access to what, and in what situation that access is granted.
3.1.10 database—a collection of data organized for rapid
4.2 Confidential protection of data elements is a specific
search and retrieval. (Webster’s, 1993)
requirement.The classification of data elements into restrictive
3.1.11 data element—the combination of one or more data
and specifically controlled categories is set by policies, profes-
entities that forms a unit or piece of information, such as the
sional practice, and laws, legislation, and regulations.
social security number, a diagnosis, an address, or a medica-
4.3 There are three explicit concepts upon which the use of
tion.
and access to health information confidentiality are defined.
3.1.12 data entity—adiscreteformofdatasuchasanumber
Each of these concepts is an explicit and unique characteristic
or word.
relevant to confidentiality, but only through the combination
3.1.13 disclosure (health care)—the release of information
(convergence) of all three concepts can appropriate access to
to third parties within or outside the healthcare provider
an explicit data element at a specific point in time be provided,
organization from an individual’s record with or without the
and unauthorized access denied. The three concepts are:
consent of the individual to whom the record pertains.
4.3.1 The categorization and breakdown of data into logical
3.1.13.1 Discussion—Under this guide the definition is
and reasonable elements or entities.
slightly modified to read: the release of information to an
4.3.2 The identification of individual roles or job functions.
individual, group or organization from an individual’s health
4.3.3 The establishment of context and conditions of data
information with or without the authorization of the individual
use at a specific point in time, and within a specific setting.
to whom the health information pertains. (CPRI)
4.4 The overriding principle in preserving the confidential-
3.1.14 emergency—a sudden demand for action. Condition
ity of information is to provide access to that information only
that poses an immediate threat to the health of the patient.
under circumstances and to individuals when there is an
3.1.15 healthcare data—data which are input, stored, pro-
absolute, established, and recognized need to access that data,
cessed or output by the automated information system which
and the information accessed should itself be constrained only
support the business functions of the healthcare establishment.
to that information essential to accomplish a defined and
These data may relate to person identifiable records or may be
recognized task or process. Information nonessential to that
part of an administrative system where persons are not identi-
taskorprocessshouldideallynotbeaccessible,eventhoughan
fied. (CEN)
individual accessing that information may have some general
3.1.16 health information—any information, whether oral
right of access to that information.
or recorded in any form or medium (1) that is created or
5. Principles
received by a healthcare provider; a health plan; health
researcher, public health authority, instructor, employer, school 5.1 The following principles are based upon U.S. state and
or university, health information service or other entity that federal laws, current European Economic Community initia-
creates, receives, obtains, maintains, uses, or transmits health tives and laws and regulations resulting from those initiatives,
information; a health oversight agency, a health information and professional practice within the U.S. and European health-
service organization, or (2) that relates to the past, present, or care domains.
future physical or mental health or condition of an individual, 5.2 Individuals, groups, and organizations retain rights over
the provision of health care to an individual, or the past, the specific, intermediate, and ultimate use of any data col-
present, or future payments for the provision of health care to lected from them and about whom the data is retained and
a protected individual; and (3) that identifies the individual; managed.
with respect to which there is a reasonable basis to believe that 5.3 No individual, group, or organizational data shall be
the information can be used to identify the individual. collected, used, maintained, released, or disclosed without the
(HIPAA, E 1869) specific explicit informed consent of the individual, group, or
E1986–98
organization, unless specifically required for the protection of 6. Data Elements
public health, and mandated by local, state, regional, or federal
6.1 Data elements under this guide represent fragmentation
law.
(separation) of data into discrete entities. These entities (data
5.4 Individual, group, or organizational data may only be
elements) represent discrete elemental data types that can be
used for the purpose for which it was collected. Explicit
reconstructed into complete data sets according to varying
informedconsentoftheindividual,group,ororganizationfrom
needs and requirements of access and use, by appropriate
whichthedatawascollectedisrequiredifthedataistobeused
data-users, under appropriately defined and authorized roles.
for any additional purpose. Organizational policies shall state
Data elements exist as discrete data in their own right or can be
the purposes for which data will be collected, maintained, and
aggregated as data sets that represent data about a specific
used.
individual, provider, group, or organization, or they can be
5.5 All individuals, groups, organizations, data-users, data-
aggregated across individuals, providers, groups, or organiza-
managers, and public and private firms, companies, agencies,
tions.
departments, bureaus, service-providers, and similar entities
6.2 Data elements and data entities under this guide are
that collect individual, group and healthcare related data, are
explicitly delineated and apply to healthcare related data in
required to collect, manage, maintain, disclose, provide access
aggregate as well as discrete forms.
to, or release that data only in strict compliance with the data
6.3 If data exist in aggregate form and cannot be broken
access rules defined in this guide. If they are unable to adhere
down or protected from improper use or disclosure at the data
to this guide they will not retain data beyond its initial
element or entity level, then the aggregate data itself cannot be
collection and use, or will securely and confidentially entrust
released for use or disclosure to any data-user other than those
that data to an authorized organization that can abide by the
who meet the access privilege rules for the most confidential
rules under this guide.
data within that aggregate.
5.6 Data and data elements under this guide are defined at a
6.3.1 Example—HIVdata within a document, even if only a
discrete level. This is necessary in order to define data access
and use rights down to discrete elemental data. This guide is smallfractionofthecontentofthatdocument,makestheentire
established under the assumption that there is no such thing as document subject to the rules of disclosure defined for HIV
“dis-identified data” in that as long as data exist as discrete data, unless that HIV data (or any other data of that class) can
elemental data they are ultimately identifiable with an indi-
be stripped (removed) from the document.
vidual. For example a diagnosis or a patient weight is not
6.3.2 In addition, if aggregate data is stripped of any
dis-identified within a population just because it does not have
non-disclosable data for disclosure to a data-user, then the
a name or other outward identifying information attached or
disclosed data can have no evidence, sign, or indication of the
linked to it. The average weight within a population or the
fact that it was stripped of non-disclosable data. An exception
incidence of a given disease, both calculated or derived from a
under this requirement should be granted only in the instance
population aggregate, may be dis-identified from an individual
where it is impossible or impractical to screen or filter
withinapopulation,butmightstillpre
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