[Federal Register Volume 70, Number 246 (Friday, December 23, 2005)]
[Notices]
[Pages 76287-76288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[CMS-0015-N]
RIN 0938-ZA62


Consolidated Health Informatics (CHI) Initiative; Health Care and 
Vocabulary Standards for Use in Federal Health Information Technology 
Systems

AGENCY: Office of the Secretary (OS), HHS.

ACTION: Notice.

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SUMMARY: This notice identifies the 20 messaging and vocabulary 
standards adopted for use in Federal government health information 
technology systems. The first set of 5 standards was adopted on March 
21, 2003. The second set of 15 standards was adopted on May 6, 2004, 
thus completing the initial portfolio of

[[Page 76288]]

the Consolidated Health Informatics (CHI) initiative.

FOR FURTHER INFORMATION CONTACT: Cheryl Ford, (410) 786-7415.

SUPPLEMENTARY INFORMATION:

I. Background

    The Consolidated Health Informatics (CHI) initiative began in 
October 2001 as one of 24 E-Government initiatives included in the 
President's Management Agenda (PMA). The CHI initiative is a 
collaborative effort to adopt Federal government-wide health 
information interoperability standards to be implemented by Federal 
agencies in order to enable the Federal government to exchange 
electronic health information.
    On May 6, 2004, the Secretary of the Department of Health and Human 
Services (HHS) announced the adoption by HHS, the Department of 
Defense, the Department of Veterans Affairs, the Office of Management 
and Budget, and other participating Federal partners of 15 healthcare 
messaging and vocabulary standards recommended by the CHI initiative 
(http://www.hhs.gov/news/press/2004pres/20040506.html). The adoption of 
these standards supplemented the first 5 standards adopted on March 21, 
2003 (http://www.hhs.gov/news/press/2003pres/20030321a.html), thereby 
completing the initial CHI portfolio.
    The portfolio of 20 adopted standards will be used by all Federal 
agencies in implementing new, and to the extent possible, in modifying 
existing health information technology systems, as well as related 
business processes.

II. CHI Adopted Standards

    As a result of work completed in furtherance of CHI, the 20 
clinical standards that have been adopted for use by all Federal 
agencies as they develop and implement new information technology 
systems are as follows:
    1. Laboratory Results Names. Standard: Logical Observation 
Identifiers Names and Codes (LOINC[supreg]).
    2. Messaging Standards. Includes: Scheduling, medical record/image 
management, patient administration, observation reporting, financial 
management, public health notification, and patient care. Standard: 
Health Level Seven[supreg] (HL7[supreg]) Version 2.3 and greater.
    3. Messaging Standards. Includes: Retail pharmacy transactions. 
Standard: National Council for Prescription Drug Programs (NCPDP) 
SCRIPT[supreg].
    4. Messaging Standards. Includes: Device-device connectivity. 
Standard: Institute of Electrical and Electronics Engineers, Inc. 
TM 1073.
    5. Messaging Standards. Includes: Image information to 
workstations. Standard: Digital Imaging and Communications in 
Medicine[supreg] (DICOM[supreg]).
    6. Demographics. Standard: HL7[supreg] Version 2.4 and greater.
    7. Lab Result Contents. Standard: Systematized Nomenclature of 
Medicine Clinical Terms[supreg] (SNOMED CT[supreg]).
    8. Units of Measure. Standard: HL7[supreg] Version 2.X+.
    9. Immunizations. Standard: HL7[supreg] Version 2.3.1, specifically 
the Vaccines Administered (CVX) and Manufacturers of Vaccines (MVX) 
external code sets maintained by the Centers for Disease Control and 
Prevention's (CDC) National Immunization Program (NIP).
    10. Medications. Standards: Federal Drug Terminologies: (Sub-
domain: Standard Adopted):
     Active Ingredient: FDA Established Names & Unique 
Ingredient Identifier (UNII) codes.
     Manufactured Dosage Form: FDA/CDER Data Standards Manual.
     Drug Product: FDA's National Drug Codes (NDC).
     Medication Package: FDA Standards Manual.
     Label Section Headers: LOINC[supreg] Clinical Structured 
Product Labeling (SPL).
     Special Populations: HL7 Version 2.4 and greater.
     Drug Classifications: The Department of Veterans Affairs' 
National Drug File Reference Terminology (NDF-RT) for mechanism of 
action and physiologic effect.
     Clinical Drug: the National Library of Medicine's RxNorm.
    11. Interventions/Procedures (Part A): Lab Test Order Names. 
Standard: LOINC[supreg].
    12. Interventions/Procedures (Part B): Non-laboratory. Standard: 
SNOMED CT[supreg].
    13. Anatomy. Standards: SNOMED CT[supreg] and the National Cancer 
Institute's (NCI) Thesaurus.
    14. Diagnosis/Problem Lists. Standard: SNOMED CT[supreg].
    15. Nursing. Standard: SNOMED CT[supreg].
    16. Financial/Payment. Standard: HIPAA Transactions and Code Sets.
    17. Genes. Standard: Human Genome Nomenclature.
    18. Clinical Encounters. Standard: HL7[supreg] Version 2.4 and 
greater.
    19. Text-Based Reports. Standards: HL7[supreg] and Clinical 
Document Architecture (CDA) Version 1.0-2000 Chemicals.
    20. Chemicals. Standard: Environmental Protection Agency's 
Substance Registry System.
    Specific details of these CHI standards can be obtained from the 
domain-specific full reports available for download at: http://www.hhs.gov/healthit/chi.html.

III. Collection of Information Requirements

    This notice does not impose information collection and 
recordkeeping requirements regulated by the Paperwork Reduction Act of 
1995; that is, it does not require obtaining facts or opinions or 
answers to questions by or for a Federal agency. Consequently, it need 
not be reviewed by the Office of Management and Budget under 44 U.S.C. 
35.

IV. Impact Statement

    We have chosen to explain the impact we foresee this notice having 
on the public as follows: There are indirect impacts for Federal 
contractors or potential contractors who may be involved in health 
information technology design, development, or evaluation. The Federal 
government will require all future health information technology system 
acquisitions to be based on CHI standards when applicable, whether 
system development occurs within the Agency or through the use of 
contractor services.

    Authority: The E-Government Act of 2002 (Pub. L. 107-347) (H.R. 
2458)

    Dated: September 13, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: August 25, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-24289 Filed 12-22-05; 8:45 am]
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