# Presentation: 100758

## More and Better Data for Research:U.S. Health Data Content Standards

- Betsy L. Humphreys
- Assistant Director for Health Services Research Information
- National Library of Medicine
- AcademyHealth
- Annual Research Meeting
- June 6, 2004

## Presidential Executive OrderApril 27,2004

-  With goal of ubiquitous electronic health records and a national health information infrastructure in 10 years:
- New National Health Information Technology Coordinator in HHS with responsibility for strategic plan to:
- “(i) Advance the development, adoption, and implementation of *health care information technology standards* nationally through collaboration among public and private interests, and *consistent with current efforts to set* health information technology *standards for use by the Federal Government**;*
- (ii) ....”

- http://www.whitehouse.gov/news/releases/2004

## Electronic Health Data Standards (including Standard Vocabularies)

- Key element of the health information technology infrastructure for:
- Effective decision support
- Safe, evidence-based, and coordinated health care
- Cost-effective care, assisted by robust market-place and increased/informed choice
- More efficient clinical, public health, and health services research
- Timely public health and bioterrorism surveillance

## Types of Health Data

- Administrative health data
- 	e.g., health insurance claims
- Clinical data
- 	e.g., lab test results, problems, diagnoses, history and physical
- Public health data
- 	e.g., disease prevalence, immunization rates, environmental monitoring
*All *potentially relevant to health services research

## Data Content Standards include:

- Data elements, e.g., gender, presenting complaint
- Descriptions of entities, e.g., birth certificate
- Messages, e.g., medication order
- Allowable values for data elements, which can be entire ***vocabularies***
- Mappings between different value sets, e.g., between SNOMED and ICD-9-CM
- Information models that define the context in which standards are used
- Survey questions and any coded responses
- Guideline, protocol, and algorithm formats

## Standard Clinical Data

- Enhanced ability to provide access to knowledge where clinical decisions are being made
- Generation of research data as a by-product of health care
- Efficient exchange of data between health care and public health

## Key Acronyms

**HIPAA** - *Administrative Simplification section of Health Insurance Portability and Accountability Act of 1996*
**NCVHS** - *National Committee on Vital and Health Statistics, a long-standing (50+ years) advisory committee to HHS, strengthened and expanded by HIPAA*
**CHI** - *Consolidated Health Informatics project, a cross-agency eGov initiative led by HHS, DOD, and VA*
**LOINC** - *Logical Observations: Identifiers,Names,Codes*
**RxNorm** - *Clinical drug nomenclature (ingredient + strength + dose form)*
**SNOMED CT** - *Systematized Nomenclature of Medicine Clinical Terms - formed by merger of SNOMED and Read*
**HL7 ***– Health Level 7 standard for electronic exchange of clinical data, e.g., lab test results*

## Recommended Steps to Achieving  U.S. Health Data Standards (1990-2003)

- Establish a mechanism for designating U.S. Standards - HIPAA, NCVHS, CHI
- Pick best available as starting point - NCVHS, CHI
- *Support development, maintenance, and low/no cost distribution
- *Coordinate development of selected standards to achieve non-overlapping, interlocking set
- Broaden participation in standards development
- Promote use and improvement

## Standards Have Been Selected

- U.S. *National* Administrative Standards
- HIPAA transactions and code sets _[ncvhs.hhs.gov](http://ncvhs.hhs.gov/)_
- U.S. *Government-wide *Target Clinical Standards
- CHI message and vocabulary standards _[www.whitehouse.gov/omb/egov](http://www.whitehouse.gov/omb/egov)_
- 		Choose “Government to Business”

## NLM-led Support for Development and Maintenance

**1999** – LOINC (lab tests/instrument observations) - contract support
**2002** – RxNorm (clinical drugs) - direct development
**2003** – SNOMED CT contract & license for U.S-wide use *(as distributed by NLM in UMLS)*

## NLM No-Cost Distribution

- http://umlsinfo.nlm.nih.gov

## UMLS® Metathesaurus® a Vocabulary Database

- Preserves the meanings, hierarchical connections, and other relationships between terms present in its source vocabularies
- Adds certain basic definitional information about each of its concepts
- Establishes new relationships between concepts and terms from different source vocabularies
- Distributes many vocabularies in a common, explicit format

## Other UMLS Resources

- Semantic Network
- SPECIALIST lexicon
- Natural language processing programs
- In combination with the Metathesaurus, powerful tools for interpretation/indexing of electronic full text

## UMLS Metathesaurus Growth, 1992 -

## 2004AA UMLS Metathesaurus  (May 2004)

- ~1,022,000 concepts
- ~2,383,000 unique “strings”
- 	  (Eye, Eyes, eye = 3)
- ~3,030,000 source vocabulary terms
- 111 source vocabularies
- 15 different languages

## SNOMED CT® in 2004AA UMLS Metathesaurus

- Active, English content - Jan 31, 2004 edition, including basic mapping to ICD-9-CM
- Spanish 2004AB;  Inactive 2004AC
- ~300,000 concepts;  ~700,000 strings
- ~37,000 *new *concepts; ~350,000 *new *strings
- UMLS concept view differs: 13% of SNOMED
- Majority intentional differences
- Some undiscovered or incorrect synonymy

## Coordinate development and alignment  to achieve interlocking set (1)

- UMLS Metathesaurus  – common distribution format/mechanism for CHI standards and HIPAA code sets
- 2004AA - UMLS distribution format changes to support
- Complete “Source Transparency”
- Easier extraction of subsets for particular purposes
- Complete “change sets” from previous versions
- Sophisticated, purpose-specific inter-vocabulary mapping

## Coordinate development and alignment  to achieve interlocking set (2)

- Definition of boundaries and relationships
- SNOMED CT / LOINC / RxNorm
- Alignment of HL7 messages and CHI vocabularies
- 2004 NLM/HHS contract with HL7 standards organization
- Mappings between vocabularies and classifications

## Mapping Projects planned/underway

- CHI standards – HIPAA code sets
- SNOMED CT - ICD-9-CM, ICD-10-CM
- SNOMED CT – CPT
- LOINC - CPT
- SNOMED CT - “other” vocabularies
- Medical Dictionary for Regulatory Affairs (MedDRA)
- International Classification of Primary Care (ICPC)
- Medcin
- Will require:
- Robust testing/validation
- Alignment of update schedules

## Broaden participation: Public Health 

- http://www.phstandards.info

## Slide 21

## Broaden participation: Clinical Research

- http://nihroadmap.nih.gov

## Accelerate Adoption and Use

- Promote testing use of standards by Federal partners, grantees, and contractors
*CDC’s Public Health Information Network (PHIN) *(_[www.cdc.gov/phin](http://www.cdc.gov/phin)_)
*NIH emphasis on use in clinical research networks*
- Encourage manufacturers to include standard identifiers (e.g., LOINC) in device output/test kit packaging
- Collaborate with other HHS agencies to support demonstration/testing

## http://privacyruleandresearch.nih.gov

## Take Home Messages

- Health data standards have “arrived”; electronic health records are coming
- Both will affect health care, public health functions, and the data available for HSR
- It’s not too early (*or too late*)
- to contribute to standards development, testing, and refinement
- to begin to study the impact of standards on health care, public health, and clinical research
- If you work with electronic data, the UMLS resources might be helpful