National Committee on Vital and Health Statistics'
Recommendations on Medical Information Data Standards
February 27, 2002
The Honorable Tommy G. Thompson
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C., 20201
Dear Secretary Thompson:
As part of its responsibilities under the Health Insurance Portability
and Accountability Act of 1996 (HIPAA), the National Committee on
Vital and Health Statistics (NCVHS) was called upon 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." NCVHS presented the results of studying
these issues in a report to the HHS Data Council on August 9th,
2000 (enclosed). This report provided a framework to accelerate
the development of PMRI standards and a set of guiding principles
for the selection of specific PMRI standards. This letter sets forth
recommendations for the first set of PMRI standards, which are limited
to PMRI message format standards.
Standards for PMRI are important because they will facilitate significant
improvements in the quality of patient care, promote patient safety,
control rising healthcare costs, enhance the productivity of clinical
research and strengthen the nation's ability to identify and respond
to healthcare emergencies. They are critical to the creation of
a National Health Information Infrastructure.
Process to Select PMRI Message Format Standards
NCVHS used the following process for the selection of PMRI message
format standards to obtain industry input from standards development
organizations (SDOs), healthcare information system vendors, health
care organizations and professional societies, and other users of
these standards. First, the Committee adapted the PMRI guiding principles
to make them more appropriate for the selection of message format
standards. Next, the Committee incorporated the revised guiding
principles into a questionnaire that was designed to help NCVHS
evaluate the PMRI standards candidates in an objective manner. Finally,
the Committee compiled, analyzed, and reviewed the SDOs' responses
to the PMRI questionnaire. Additional information and perspective
about the candidate PMRI standards were obtained via direct testimony
from healthcare information system vendors and other users of these
standards. This process continued from December 2000 through February
2002.
Guiding Principles Used as Criteria for Selection
NCVHS recommendations for PMRI message format standards are selected
from the responses to the PMRI questionnaire of six SDOs:
- ASTM (American Society for Testing and Materials)
- DICOM (Digital Image Communications)
- HL7 (Health Level Seven)
- IEEE (Institute of Electrical and Electronic Engineers)
- NCPDP (National Council for Prescription Drug Programs) and
- Object Management Group, Healthcare Domain Task Force
The Committee emphasized the following four criteria derived from
the PMRI guiding principles: the degree of market acceptance of
the standard; the extent to which the standard enables interoperability
between information systems; the ability of the standard to facilitate
the comparability of data; and the aspects of the standard that
support data quality, accountability and integrity. The criterion
of market acceptance is helpful because it identifies those PMRI
message format standards that are implementable, cost-justified
and flexible enough to meet the needs of most of the relevant marketplace.
Recognition of Current Standards and Incentives for Emerging
Standards
NCVHS has recognized the important role played by PMRI standards
currently used by the healthcare industry. Because it has taken
years for several of today's standards to achieve broad market acceptance,
they are based on older conceptual models. Those models do not uniformly
provide the high degree of interoperability and data comparability
that are necessary to support significant improvements in healthcare
cost, quality and productivity. To promote more rapid realization
of these benefits in accordance with the prior recommendations in
the PMRI report, NCVHS is recommending that HHS provide specific
incentives to accelerate the development and early adoption of emerging
PMRI standards as well as recognize current standards.
Recommendations Encourage HHS Guidance and Incentives Rather
Than Mandates
NCVHS recommends that HHS set forth guidance for industry use of
PMRI message format standards and migration to new versions, rather
than create new federal regulations. NCVHS also recommends that
the Secretary direct government agencies to follow this guidance
by becoming early adopters of emerging PMRI standards, thereby serving
as an example and as an incentive to the industry. NCVHS further
recommends that HHS use its healthcare market position to promote
and encourage the use of PMRI standards.
NCVHS Recommendations for Specific PMRI Message Format Standards
NCVHS recommends that HL7 be recognized as the core PMRI standard
and that DICOM, NCPDP SCRIPT and IEEE 1073 be recognized as standards
for specific PMRI market segments. The recommendations for all of
these PMRI standards are set forth in a framework identifying which
version of the standard should be considered as retired, current,
or emerging.
Core PMRI Message Format Standards
Retired Standards
NCVHS recommends that HHS recognize the following PMRI message
format standard as retired.
- Health Level Seven (HL7 v2.1)
HHS Guidance to Government and Industry--Users should specify that
no new products using this version of the HL7 standard be purchased
or developed. Vendors and users should plan to upgrade any system
using HL7 v2.1 to a current version of HL7.
Current Standards
NCVHS recommends that HHS recognize the following HL7 versions
and transaction sets as the current PMRI message format standard.
- * Health Level Seven (HL7 v2.2, v2.3, v2.4, and later v2.x)
This includes standards for the following transaction sets:
- Order Entry
- Scheduling
- Medical Record/Image Management
- Patient Administration
- Observation Reporting
- Financial Management
- Patient Care
HHS Guidance to Government and Industry--HHS recognition of HL7
versions 2.2, 2.3, 2.4 and later v2.x, as current standards means
that vendors and users of these versions will not be asked to migrate
to newer versions until the more advanced version is fully implementable
with the supporting implementation guides and conformance tests.
Emerging Standards
NCVHS recommends that HHS recognize the following PMRI message
format standard as an emerging standard based on its potential to
provide superior levels of interoperability and data comparability.
- * Health Level Seven (HL7 version 3)
This includes standards for the following transaction sets:
- v3 Administrative Management
- v3 Health and Clinical Management
- v3 Infrastructure Management
Recommendation to HHS--NCVHS recommends that HHS provide incentives
to accelerate the development and early adoption of HL7 version
3 standards. These incentives should include but not necessarily
be limited to the funding of publication of version 3 implementation
guides and the development of conformance tests, and the early adoption
of version 3 standards by government agencies.
HHS Guidance to Government and Industry--After the implementation
guides and conformance tests are available and early adoption of
HL7 version 3 proves to be successful, additional HHS guidance to
the industry will be forthcoming.
Market Segment PMRI Message Format Standards
Current Standards
NCVHS recommends that HHS recognize the following as current PMRI
market segment message format standards based on their market acceptance,
ability to address specific market segment needs, and their cost
effectiveness.
- Digital Imaging and Communications in Medicine (DICOM)--This
standard supports retrieval of information from imaging devices/equipment
to diagnostic and review workstations, and to short-term and long-term
storage systems.
- NCPDP SCRIPT Standard--This standard communicates prescription
information between prescribers and pharmacies. These transactions
include new prescriptions, prescription refill requests, prescription
fill status notifications, and cancellation notifications.
HHS Guidance to Government and Industry--New users should adopt
the latest versions of the DICOM and NCPDP SCRIPT PMRI market segment
standards whenever possible.
Emerging Standards
NCVHS recommends that HHS recognize the following as an emerging
PMRI market segment message format standard based on its potential
for vendor acceptance and its anticipated ability to address specific
market segment needs.
- IEEE 1073 (1.1.1, 1.2.1, 1.3, 2.1.1, 3.2)--This is a set of
medical device communications standards also known as ISO 11073
standards. These standards communicate patient data from medical
devices typically found in acute- and chronic-care environments
(e.g., patient monitors, ventilators, infusion pumps, etc.).
HHS Guidance to Government and Industry--Users should consider
becoming early adopters of the IEEE 1073 medical device communication
standard. HHS should encourage government agencies to pilot the
use of this standard where appropriate.
Harmonization among PMRI Message Format Standards
NCVHS recommends that HHS encourage PMRI SDOs to share their data
elements and data definitions with the U.S. Health Information Knowledgebase
(a metadata registry). Additionally, HHS should encourage PMRI SDOs
to continue their collaboration to reduce or eliminate duplicate
or inconsistent data elements especially those for patient information.
Furthermore, HHS should encourage PMRI SDOs to harmonize their data
elements and data definitions for future versions so that they are
consistent with the HL7 Reference Information Model (RIM).
NCVHS also recommends that HHS provide funding to support PMRI
SDO collaborative efforts toward harmonization.
PMRI Standards for Future Consideration
In this letter, NCVHS has limited its PMRI-specific recommendations
to message format standards. The Committee plans to further investigate
medical terminologies and code sets and will be forwarding additional
recommendations to you. The Committee will also consider PMRI standards
for clinical documents and the content and structure of patient
records.
NCVHS wishes to thank you for the opportunity to submit these recommendations
within the framework of the Administrative Simplification Provisions
of HIPAA.
Sincerely,
/s/
John Lumpkin, M.D., M.P.H.
Chair, National Committee on Vital and Health Statistics
Cc: HHS Data Council Co-Chairs
Enclosure
Read NCVHS' recommendations
from November 2001 on research provisions.
Read NCVHS' recommendations
from October 2001 on consent and minimum necessary.
|
