February 27, 2002
The Honorable Tommy G. Thompson
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
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.
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
- 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.
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
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.
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.
John Lumpkin, M.D., M.P.H.
Chair, National Committee on Vital and Health Statistics
Cc: HHS Data Council Co-Chairs