More and Better Data for Research: U.S. Health Data Content Standards Betsy L. Humphreys Assistant Director for Health Services Research Information National.

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Presentation transcript:

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: 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) ….”

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

Types of Health Data Administrative health data Administrative health data e.g., health insurance claims Clinical data Clinical data e.g., lab test results, problems, diagnoses, history and physical Public health data 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 Data elements, e.g., gender, presenting complaint Descriptions of entities, e.g., birth certificate Descriptions of entities, e.g., birth certificate Messages, e.g., medication order Messages, e.g., medication order Allowable values for data elements, which can be entire vocabularies Allowable values for data elements, which can be entire vocabularies Mappings between different value sets, e.g., between SNOMED and ICD-9-CM Mappings between different value sets, e.g., between SNOMED and ICD-9-CM Information models that define the context in which standards are used Information models that define the context in which standards are used Survey questions and any coded responses Survey questions and any coded responses Guideline, protocol, and algorithm formats Guideline, protocol, and algorithm formats

Standard Clinical Data Enhanced ability to provide access to knowledge where clinical decisions are being made Enhanced ability to provide access to knowledge where clinical decisions are being made Generation of research data as a by-product of health care Generation of research data as a by-product of health care Efficient exchange of data between health care and public health 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 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 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 CHI - Consolidated Health Informatics project, a cross- agency eGov initiative led by HHS, DOD, and VA LOINC - Logical Observations: Identifiers,Names,Codes LOINC - Logical Observations: Identifiers,Names,Codes RxNorm - Clinical drug nomenclature (ingredient + strength + dose form) RxNorm - Clinical drug nomenclature (ingredient + strength + dose form) SNOMED CT - Systematized Nomenclature of Medicine Clinical Terms - formed by merger of SNOMED and Read 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 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 ( )  Establish a mechanism for designating U.S. Standards - HIPAA, NCVHS, CHI  Establish a mechanism for designating U.S. Standards - HIPAA, NCVHS, CHI  Pick best available as starting point - NCVHS, CHI  Pick best available as starting point - NCVHS, CHI *Support development, maintenance, and low/no cost distribution *Support development, maintenance, and low/no cost distribution *Coordinate development of selected standards to achieve non-overlapping, interlocking set *Coordinate development of selected standards to achieve non-overlapping, interlocking set Broaden participation in standards development Broaden participation in standards development Promote use and improvement Promote use and improvement

Standards Have Been Selected U.S. National Administrative Standards U.S. National Administrative Standards HIPAA transactions and code sets ncvhs.hhs.gov HIPAA transactions and code sets ncvhs.hhs.gov ncvhs.hhs.gov U.S. Government-wide Target Clinical Standards U.S. Government-wide Target Clinical Standards CHI message and vocabulary standards CHI message and vocabulary standards Choose “Government to Business”

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

NLM No-Cost Distribution

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

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

UMLS Metathesaurus Growth,

2004AA UMLS Metathesaurus (May 2004) ~1,022,000 concepts ~1,022,000 concepts ~2,383,000 unique “strings” ~2,383,000 unique “strings” (Eye, Eyes, eye = 3) (Eye, Eyes, eye = 3) ~3,030,000 source vocabulary terms ~3,030,000 source vocabulary terms 111 source vocabularies 111 source vocabularies 15 different languages 15 different languages

SNOMED CT ® in 2004AA UMLS Metathesaurus Active, English content - Jan 31, 2004 edition, including basic mapping to ICD-9-CM Active, English content - Jan 31, 2004 edition, including basic mapping to ICD-9-CM Spanish 2004AB; Inactive 2004AC Spanish 2004AB; Inactive 2004AC ~300,000 concepts; ~700,000 strings ~300,000 concepts; ~700,000 strings ~37,000 new concepts; ~350,000 new strings ~37,000 new concepts; ~350,000 new strings UMLS concept view differs: 13% of SNOMED UMLS concept view differs: 13% of SNOMED Majority intentional differences Majority intentional differences Some undiscovered or incorrect synonymy 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 UMLS Metathesaurus – common distribution format/mechanism for CHI standards and HIPAA code sets 2004AA - UMLS distribution format changes to support 2004AA - UMLS distribution format changes to support Complete “Source Transparency” Complete “Source Transparency” Easier extraction of subsets for particular purposes Easier extraction of subsets for particular purposes Complete “change sets” from previous versions Complete “change sets” from previous versions Sophisticated, purpose-specific inter-vocabulary mapping Sophisticated, purpose-specific inter-vocabulary mapping

Coordinate development and alignment to achieve interlocking set (2) Definition of boundaries and relationships Definition of boundaries and relationships SNOMED CT / LOINC / RxNorm SNOMED CT / LOINC / RxNorm Alignment of HL7 messages and CHI vocabularies Alignment of HL7 messages and CHI vocabularies 2004 NLM/HHS contract with HL7 standards organization 2004 NLM/HHS contract with HL7 standards organization Mappings between vocabularies and classifications Mappings between vocabularies and classifications

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

Broaden participation: Public Health

Broaden participation: Clinical Research

Accelerate Adoption and Use Promote testing use of standards by Federal partners, grantees, and contractors Promote testing use of standards by Federal partners, grantees, and contractors CDC’s Public Health Information Network (PHIN) ( CDC’s Public Health Information Network (PHIN) ( NIH emphasis on use in clinical research networks NIH emphasis on use in clinical research networks Encourage manufacturers to include standard identifiers (e.g., LOINC) in device output/test kit packaging Encourage manufacturers to include standard identifiers (e.g., LOINC) in device output/test kit packaging Collaborate with other HHS agencies to support demonstration/testing Collaborate with other HHS agencies to support demonstration/testing

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