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.

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 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®).

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® (HL7®) Version 2.3 and greater.

3. Messaging Standards. Includes: Retail pharmacy transactions. Standard: National Council for Prescription Drug Programs (NCPDP) SCRIPT®.

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® (DICOM®).

6. Demographics. Standard: HL7® Version 2.4 and greater.

7. Lab Result Contents. Standard: Systematized Nomenclature of Medicine Clinical Terms® (SNOMED CT®).

8. Units of Measure. Standard: HL7® Version 2.X+.

9. Immunizations. Standard: HL7® 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® 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®.

12. Interventions/Procedures (Part B): Non-laboratory. Standard: SNOMED CT®.

13. Anatomy. Standards: SNOMED CT® and the National Cancer Institute's (NCI) Thesaurus.

14. Diagnosis/Problem Lists. Standard: SNOMED CT®.

15. Nursing. Standard: SNOMED CT®.

16. Financial/Payment. Standard: HIPAA Transactions and Code Sets.

17. Genes. Standard: Human Genome Nomenclature.

18. Clinical Encounters. Standard: HL7® Version 2.4 and greater.

19. Text-Based Reports. Standards: HL7® 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)