Standards are critical components in
the development and implementation of an electronic health record (EHR). The effectiveness
of healthcare delivery is dependent on the ability of the clinicians to access
critical health information when and where it is needed. The ability to
exchange health information across organizational and system boundaries,
whether between multiple departments within a single institution or among a
varied cast of providers, payers, regulators and others is essential. A common
set of rules and definitions both at the level of data meaning as well as the
technical level of data exchange is needed to make this possible. In addition,
there must be a sociopolitical structure in place that recognizes the benefits
of shared information and supports the adoption and implementation of such
standards.
Need for Healthcare Data Standards
Data standards as applied to
healthcare include the “methods, protocols, terminologies, and specifications
for the collection exchange, storage, and retrieval of information associated with
healthcare applications including medical records, medications, radiological
images, payment and reimbursement, medical devices and monitoring systems, and
administrative processes” (Washington Publishing Company 1998). In the domain
of information management, standards can be further categorized as those that
support the generic infrastructure and are not domain-specific, those that support
the exchange of information and are domain-specific, and those that support
activities and practices within a specific domain. Examples of the first type
of standard would include equipment specifications such as processor type or
network transmission protocols such as Ethernet or token ring.
The second type
of standard typically involves the specification data structures and content
and would include such standards as message formats and core data sets.
The third type of standard addresses the interpretation of that data as information, including how it should be acted on within a particular context. An example of this type of standard would be professional practice guidelines.
The third type of standard addresses the interpretation of that data as information, including how it should be acted on within a particular context. An example of this type of standard would be professional practice guidelines.
Healthcare is fundamentally a process
of communication. For much history, verbal communication between a patient and a
healthcare provider characterized this process. The temporal and physical proximity
of the communicators provided ample opportunity to clarify any ambiguity
regarding the intended meaning of what was being communicated. It is this
tremendous increase in the need for health information exchange that has driven
the push for use of electronic information and management systems in the
healthcare domain. Data standards are an attempt to reduce the level of
ambiguity in the communication of data so that actions taken based on the data
are consistent with the actual meaning of the data. Data are collections of
unstructured, discrete entities (facts) that exist outside of any particular context.
When data are interpreted within a given context and given meaningful structure
within that context, they become information. When information from various
contexts is aggregated following a defined set of rules, it becomes knowledge
and provides the basis for informed action (Saba and McCormick, 2000). Analysis
generates knowledge, which is the foundation of professional practice
standards.
Data interchange standards
address, primarily, the format of messages that are exchanged between computer
systems, document architecture, clinical templates, user interface, and patient
data linkage (Committee on Data Standards for Patient Safety, 2004). To achieve
data compatibility between systems, it is necessary to have prior agreement on
the syntax of the messages to be exchanged. The receiving system must be able
to parse the incoming message into discrete data elements that reflect what the
sending system wishes to communicate. In addition to a common message format,
it is necessary that the individual data elements be structured in a common way
as well. Although there is a great deal of interest in the development of
natural language processing capabilities, most health data exchange still
involves coded, or structured, information.
Message Format Standards
Four broad classes of message
format standards have emerged in the healthcare sector: medical device
communications, digital imaging communications, administrative data exchange,
and clinical data exchange (Saba and McCormick, 2000). The National Committee
on Vital and Health Statistics (NCVHS) is the advisory committee established to
make recommendations on health information policy to the Department of Health
and Human Services (HHS) and Congress. As part of its responsibilities under
the Health Insurance Portability and Accountability Act of 1996 (HIPAA), NCVHS
was called on to “study the issues related to the adoption of uniform data
standards for patient medical record information (PMRI) and the electronic
exchange of such information.” This public-private partnership has recommended
that several message format standards be adopted for federal healthcare
services programs including Health Level Seven (HL7) (v2.2 and later), Digital
Imaging Communication in Medicine Standards Committee (DICOM), National Council
for Prescription Drug Programs (NCPDP)
SCRIPT and Institute of Electrical and Electronic Engineers (IEEE) 1073.
Institute of Electrical and Electronic Engineers
The IEEE has developed a series
of standards known collectively as P1073 Medical Information Bus (MIB), which
support real-time, continuous, and comprehensive capture and communication of
the data from bedside medical devices such as those found in intensive care
units, operating rooms, and emergency departments. Current activities include
efforts to develop standards that support wireless technology. The IEEE 802.xx
suite of wireless networking standards, 802.11, 802.15, and 802.16, has stirred
up developments in an otherwise sluggish communications market. The most widely
known standard, 802,11, commonly referred to as Wi-Fi, allows anyone with a
computer and either a plug-in card or built-in circuitry to connect to the
internet wirelessly through a myriad access points installed in offices, hotels,
airports, coffeehouses, convention centers, and even parks, among other
locations.
National Electrical Manufacturers Association
National Electrical Manufacturers Association
The National Electrical
Manufacturers Association (NEMA), in collaboration with the American College of
Radiologists (ACR) and others, formed the DICOM to develop a generic digital
format and a transfer protocol for biochemical images and images-related information.
The DICOM standard is the dominant international data interchange message
format in biochemical imaging. The Joint NEMA/The European Coordination Committee
of Radiological and Electromedical Industry/ Japan Industries Association of
radiological Systems (COCIR/JIRA) Security and Privacy Committee (SPC) has
recently issued a white paper which provides a guide for vendors and users on
how to protect medical information systems against viruses, Trojan horses,
denial of service attacks, Internet worms and related forms of so-called “malicious
software.”
Accredited Standards Committee X12N/Insurance
Accredited Standards committee
(ASC) X12N has developed broad range electronic data interchange (EDI) standards
to facilitate electronic business transactions. In healthcare arena, X12N
standards have been adopted as national standards for such administrative
transactions as claims, enrollment, and eligibility in health plans and first
report of I injury under the requirements of the HIPAA. HIPAA directed the
secretary of the department of HHS to adopt standards for transactions to
enable health information to be exchange electronically, and the Administrative
Simplification Act (ASA), one of the HIPAA provisions, requires standard
formats to be used for electronically submitted healthcare transactions.
Terminologies
A fundamental requirement for effective communication is the ability to represent concepts in an unambiguous fashion between both the sender and receiver of the message. While there have been great advances in the ability of computers to process natural language, most communication between health information systems relies on the use of structured vocabularies, code sets, and classification systems to represent healthcare concepts. Standardized terminologies enable data collection at the point of care, and retrieval of data, information, and knowledge in support of clinical practice.
International Statistical Classification of Diseases and Related Health Care Problems: Ninth Revision and Clinical Modifications
It is also referred as ICD-9-CM, it is the latest version of a mortality and morbidity classification that originated in 1893. It is widely accepted and used in the healthcare industry and has been adopted for a number of purposes including data collection quality-of-care analysis, resource utilization, and statistical reporting. It is the basis for diagnostic related groups (DGRs), which are used extensively for hospital reimbursement. Effective October 1, 2004 medicare will no longer accept outpatient claims with ICD-9 procedure codes.
LOINC
Logical observation identifiers names and codes (Regenstrief
Institute, 1994) provides a set of universal names and numeric identifier codes
for laboratory and clinical observations and measurements in the database structure.
It is clear that such consistency in terminology is important for patient safety. LOINC is used to standardized the electronic exchange of laboratory test orders and drug label section headers.
RxNorm
RxNorm is a clinical drug nomenclature produced by NLM, in
consultation with the Food and Drug Administration (FDA), the department of Veterans
Affairs (VA), and HL7 SDO. RxNorm
provides standard names for clinical drugs (active ingredient + strength + dose
form) and for dose forms as administered. It provides links for from clinical
drugs to their active ingredients, drug components (active ingredient +
strength), and some related brand names. To the extent available from the FDA,
Nods (National Drug Codes) for specific drug products that deliver the clinical
drug are stored as attributes of the clinical drug in RxNorm.
There are specialized vocabularies, code sets, and classification systems for almost every practice domain in healthcare. Currently, the UMLS consist of metathesaurus of terms and concepts from dozens of vocabularies; a semantic network of relationships among the concepts recognized in the metathesaurus;
and an information sources map of the various biomedical databases references.
Data Content Standards
The concept of a minimum
data set is that of “a minimum set of items with uniform definitions and
categories specific aspect or dimension of the healthcare system which meets
the essential needs of the multiple users” (Health Information Policy Council,
1983). Core data elements are seen as serving as the building blocks for
well-formed minimum data sets and may appear in several minimum data sets. As
with code sets, professional specialty groups are the best source for current
information on minimum data set development efforts.
National Uniform Claim
Committee Recommended Data Set for a Non-institutional Claim
The NUCC was organized in
1995 to develop promote, and maintain a standard data set for use in non-institutional
claims and encounter information. The committee was chaired by the American
Medical Association, and its member organizations represent a number of the
major public and private sector payers.
Standard Guide for Content
and Structure of the Computer-Based Patient Record (ASTM E1384-96)
The American Society for
Testing and Materials (ASTM) is one of the largest SDOs in the world and
publishes over 9,000 standards covering all sectors in the economy. E1384-96
provides a framework vocabulary for the computer-based patient record (CPR)
content. A new work item being proposed by
the E31 subcommittee is the continuity of care record (CCR). The CCR is a core
data set of the most relevant and timely fact6s about patient’s healthcare.
The development and adoption of data standards is not only a
technical process; it takes place within a sociopolitical context. In
healthcare, there is an increasing recognition that there exist significant opportunities
to improve the quality of care provided and the outcomes associated with that
care. It has also been recognized that any potential improvement in quality of
care depends realty on the ability to communicate healthcare information
consistently, efficiently, and effectively.
At the core of such systems is the concept of secure, patient-centered HER
that (1) safeguards personal privacy, (2) uses standardized medical terminology
that can be correctly read by any care provider and incorporated into computerized
tools to support clinical decision masking, (3) eliminates the danger of
illegible handwriting and missing patient information and (4) can be
transferred as a patient’s care requires over a secure communications
infrastructure for electronic information exchange. There are primarily three
ways in which standards are commonly developed and adopted: proprietary
standards developed by vendors who hold a dominant position in the market,
legislated standards developed by government organizations, and census-based
standards developed by SDOs and adopted by virtue of their utility.
Although proprietary standards can respond
quickly to technologic changes, they can, paradoxically, also result in a delay
in the adoption of new technologies as the creator of the standard wishes too
ain a maximum return on the investment required to develop the standard in its
current form. Because government0-developed standards are in the public domain,
they are available at little or no cost and can be incorporated into any information
system; however, they are often developed to support particular in initiatives and
not be as suitable for general, private sector use. The most problematic aspect
of consensus-based standards is that there is no mechanism to ensure that they
are adopted by the industry, since there is usually little infrastructure in
place to actively and aggressively market them.
International Organization
of Standardization (ISO)
It is an organization that
develops and publishes standards internationally. ISO standards are developed,
in large part, from standards brought forth by member countries, and through liaison
activities with other SDOs. ISO
Technical committee (TC) 215 on Health Informatics recently published the first
international standard for nursing titled Integration of a Reference
Terminology Model for Nursing.
European Technical Committee
for Standardization
In 1990, TC 251 on medical
informatics was established by the European Committee for Standardization
(CEN). This works to develop a wide variety of standards in the area of
healthcare data management and interchange.
ANSI serves as the
coordinator for voluntary standards activity in the United States. Standrds are
submitted to ANSI by member SDOs and are approved as American National
Standardsnthrough a consensus methodology developed by ANSI.
Object Management Group
(OMG)
It is a representative of a
different approach to standards development. It is an international consortium
of over 800 organizations, primarily for-profit vendors of information system
technology, who are interested in the development of standards based on
object-oriented technologies.
Health Insurance Portability
and Accountability Act (HIPAA)
Administrative over-head
includes such tasks as enrolling an individual in a health plan, paying health
insurance premiums, checking insurance eligibility, getting authorization to
refer a patient to a specialist, filing a claim for insurance reimbursement for
delivered healthcare, requesting additional information to support a claim,
coordinating the processing of a claim across different insurance companies,
and notifying the provider about the payment of a claim.
National Committee on Vital
and Health Statistics Subcommittee on Standards and Security
The administrative
simplification provisions also begin the process of addressing the broader
standards issues of electronic healthcare records in general. NCVHS formed the CPR Workgroup. This work
group develops recommendations based on public hearings and input from informed
stakeholders and domain experts. The workgroup has identified six major areas
of interest (NCVHS, 1996):
1. Message
format standards that contain PMRI.
2. Medical
terminology related top PMRI including data element definitions data models,
and code sets.
3. Business
case issues related to the development and implementation of information data
standards for PMRI.
4. National
Healthcare Information Infrastructure (NHII).
5. Data
quality, accountability, and integrity related to PMRI.
6. Inconsistencies
and contraindications among state laws that discourage or prevent the creation,
storage, or communication of PMRI in a consistent manner nationwide.
Consolidated Health
Informatics
The goal of this ambitious
project is to develop and implement a standard means of exchanging and managing
health information across federal health providers. It is focusing on creating
interoperability between health information systems in terms of how data are
defined, structured, and exchanged.
The Business Value of Data Standards
Clearly the importance of data
standards to enhancing the quality and efficiency of healthcare delivery is
being recognized by our national leadership. Reviewing the business value of
the defining and using data standards is critical for driving the implementation
of these standards into applications and systems. Defining information exchange
and requirements will enhance the ability to automate interaction with external
partners which in turn will decrease costs. Considering the value proposition
for incorporating data standards into products, applications, and systems
should be a part of every organization’s information technology strategy.
