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HL7 The Data Standard for Biomedical Informatics GCRC Biomedical Informatics Workshop October 29-30, 2003, Bethesda, MD Gunther Schadow, MD, PhD Regenstrief.

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Presentation on theme: "HL7 The Data Standard for Biomedical Informatics GCRC Biomedical Informatics Workshop October 29-30, 2003, Bethesda, MD Gunther Schadow, MD, PhD Regenstrief."— Presentation transcript:

1 HL7 The Data Standard for Biomedical Informatics GCRC Biomedical Informatics Workshop October 29-30, 2003, Bethesda, MD Gunther Schadow, MD, PhD Regenstrief Institute, Indiana University School of Medicine, Indianapolis, IN

2 11/10/2002Copyright (c) Regenstrief Institute for Health Care2 What is HL7? ANSI accredited Standard Development Organization (SDO) to provide standards forANSI accredited Standard Development Organization (SDO) to provide standards for the exchange, management and integration ofthe exchange, management and integration of data that supportdata that support clinical patient care and theclinical patient care and the management, delivery and evaluation of healthcare services. Specifically, tomanagement, delivery and evaluation of healthcare services. Specifically, to create flexible, cost effectivecreate flexible, cost effective approaches, standards, guidelines, methodologies, and related services forapproaches, standards, guidelines, methodologies, and related services for interoperability between healthcare information systems.interoperability between healthcare information systems.

3 11/10/2002Copyright (c) Regenstrief Institute for Health Care3 What HL7 Products Exist? HL7 version 2 messaging standards forHL7 version 2 messaging standards for Patient administration, Order Entry, ResultsPatient administration, Order Entry, Results Medical data “attachments” to HIPAA transactionsMedical data “attachments” to HIPAA transactions HL7 version 3 specifications forHL7 version 3 specifications for all of the above, plusall of the above, plus Clinical Document ArchitectureClinical Document Architecture Reference Information Model (RIM) for HealthcareReference Information Model (RIM) for Healthcare includes Data Type Specification for health careincludes Data Type Specification for health care XML Data Formats for Medical InformationXML Data Formats for Medical Information Controlled VocabularyControlled Vocabulary Others (by acquisition)Others (by acquisition) Arden SyntaxArden Syntax C-COW (clinical desktop integration)C-COW (clinical desktop integration)

4 11/10/2002Copyright (c) Regenstrief Institute for Health Care4 Good friends of HL7 Logical Observation Identifiers, Names and Codes (LOINC)Logical Observation Identifiers, Names and Codes (LOINC) vocabulary of medical observations (laboratory and clinical)vocabulary of medical observations (laboratory and clinical) practical developed for and with the industrypractical developed for and with the industry Unified Code for Units of Measure (UCUM)Unified Code for Units of Measure (UCUM) comprehensive vocabulary of units of measures, semantically enabledcomprehensive vocabulary of units of measures, semantically enabled supporting seamless auto-conversion between unitssupporting seamless auto-conversion between units realistic, practical, includes customary unitsrealistic, practical, includes customary units

5 11/10/2002Copyright (c) Regenstrief Institute for Health Care5 What Others Say: CDC “ “HL7 is the undisputed leader in the establishment of standards for interoperability among computerized information systems in healthcare. A key aspect of the HL7 methodology is the HL7 Reference Information Model (HL7 RIM).” US. Dept. For Health and Human Services, Public Health Service, Centers For Disease Control and Prevention. Public Health Conceptual Data Model. July 2000.

6 11/10/2002Copyright (c) Regenstrief Institute for Health Care6 What Others Say: NCVHS “NCVHS recommends that HL7 be recognized as the core PMRI standard.” “NCVHS recommends that HHS provide incentives to accelerate the development and early adoption of HL7 version 3 standards.” “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).” Recommendation Letter from the National Council of Vital and Health Statistics to the Secretary U.S. Department of Health and Human Services.

7 11/10/2002Copyright (c) Regenstrief Institute for Health Care7 What Others Say: AAMC “An optimal clinical information system for patient care and clinical research [depends upon] common standards […]. Existing standards such as Health Level Seven (HL7) for message data interchange and Logical Observation Identifier Names and Codes (LOINC) […] have the potential to make data more consistent and comparable. […] Clinical research should not create new standards; rather, it should build its requirements into the standards now being developed, using the capabilities they provide.” Information Technology Enabling Research: Information Technology Enabling Research: Findings and Recommendations from a Conference Sponsored by the Association of American Medical Colleges with Funding from the National Science Foundation; October 30-31, 2002

8 11/10/2002Copyright (c) Regenstrief Institute for Health Care8 HL7 Reference Information Model (UML)

9 11/10/2002Copyright (c) Regenstrief Institute for Health Care9 HL7 RIM Backbone (UML)

10 11/10/2002Copyright (c) Regenstrief Institute for Health Care10 HL7 RIM Backbone as Block-Diagram

11 11/10/2002Copyright (c) Regenstrief Institute for Health Care11 HL7 Data in XML ... ...

12 11/10/2002Copyright (c) Regenstrief Institute for Health Care12 Refined Model – Observation on Patient

13 11/10/2002Copyright (c) Regenstrief Institute for Health Care13 Observation on Patient in XML JohnDoe St., Josephs Hospital St., Josephs Hospital

14 11/10/2002Copyright (c) Regenstrief Institute for Health Care14 Refined Model – Observation on Trial Subject

15 11/10/2002Copyright (c) Regenstrief Institute for Health Care15 Observation on Trial Subject in XML JohnDoe Eli Lilly Eli Lilly

16 11/10/2002Copyright (c) Regenstrief Institute for Health Care16 Data Types for Biomedical Information Medical information needs more than just string, int and float.Medical information needs more than just string, int and float. Coded data: code, codeSystem, displayName, originalText.Coded data: code, codeSystem, displayName, originalText. Measurement values (physical quantities) value and unit.Measurement values (physical quantities) value and unit. Incomplete information (null flavors): not applicable, unknown, vs. not asked.Incomplete information (null flavors): not applicable, unknown, vs. not asked. Uncertain values with probabilities and distributions, aggregate distribution data.Uncertain values with probabilities and distributions, aggregate distribution data. Correlated data series, time series, multidimensional data.Correlated data series, time series, multidimensional data.

17 11/10/2002Copyright (c) Regenstrief Institute for Health Care17 Current Applications of HL7 v3 Traditional individual health careTraditional individual health care New Frontiers:New Frontiers: Laboratory AutomationLaboratory Automation Veterinary medicine (AVMA)Veterinary medicine (AVMA) Public health (CDC’s PHDM)Public health (CDC’s PHDM) Food and Drug Safety (FDA)Food and Drug Safety (FDA) Clinical Trials Reporting (FDA, CDISC)Clinical Trials Reporting (FDA, CDISC) Chemical Stability Testing (FDA)Chemical Stability Testing (FDA) Adverse Event Reporting (FDA, E2BM)Adverse Event Reporting (FDA, E2BM) Clinical GenomicsClinical Genomics Implantable Devices – CardiologyImplantable Devices – Cardiology Patient SafetyPatient Safety

18 11/10/2002Copyright (c) Regenstrief Institute for Health Care18 Advantages of HL7 and the RIM make data more consistent and comparablemake data more consistent and comparable reduce differences at overlaps between specialty standardsreduce differences at overlaps between specialty standards common data-patterns for common problemscommon data-patterns for common problems highly flexible and deep model of medical informationhighly flexible and deep model of medical information minimize cost of data collection by tapping into existing data streamsminimize cost of data collection by tapping into existing data streams

19 11/10/2002Copyright (c) Regenstrief Institute for Health Care19 HL7 for Biomedical Research Regulated Clinical Research Information Management Technical Committee (RCRIM)Regulated Clinical Research Information Management Technical Committee (RCRIM) Clinical Genomics Special Interest Group (CG SIG)Clinical Genomics Special Interest Group (CG SIG) Orders and Observations Technical CommitteeOrders and Observations Technical Committee

20 11/10/2002Copyright (c) Regenstrief Institute for Health Care20 R Clinical Research IM TC Clinical trials related medical informationClinical trials related medical information Clinical trials protocols specification frameworkClinical trials protocols specification framework Surveillance, product labeling, regulatory documentsSurveillance, product labeling, regulatory documents Collaborative with industry and government (e.g., Lilly, FDA, CDISC)Collaborative with industry and government (e.g., Lilly, FDA, CDISC)

21 11/10/2002Copyright (c) Regenstrief Institute for Health Care21 Clinical Genomics SIG support application of genomics in clinical medicinesupport application of genomics in clinical medicine specify use-cases and data requirementsspecify use-cases and data requirements review existing genomics specificationsreview existing genomics specifications recommend enhancements to HL7 standards to support genomicsrecommend enhancements to HL7 standards to support genomics

22 11/10/2002Copyright (c) Regenstrief Institute for Health Care22

23 11/10/2002Copyright (c) Regenstrief Institute for Health Care23 HL7 CT SIG and other Specifications in Bioinformatics CT SIG understands that there exist other specifications in the field:CT SIG understands that there exist other specifications in the field: Bioinformatic Sequence Markup Language (BSML)Bioinformatic Sequence Markup Language (BSML) Microarray Gene Expression Markup Language (MAGE-ML)Microarray Gene Expression Markup Language (MAGE-ML) Interoperable Informatics Infrastructure Consortium (I3C)Interoperable Informatics Infrastructure Consortium (I3C) Systems Biology Markup Language (SBML)Systems Biology Markup Language (SBML) CellML, BioML, MoDL …CellML, BioML, MoDL … There is significant overlap between those, which one should one pick?There is significant overlap between those, which one should one pick? It’s easy to make an XML schema for a special purpose, but how does it integrate?It’s easy to make an XML schema for a special purpose, but how does it integrate?

24 11/10/2002Copyright (c) Regenstrief Institute for Health Care24 Myths and Facts about HL7 HL7 is only about EDI messaging in hospitalsHL7 is only about EDI messaging in hospitals Must pay royalties to use the HL7 specificationsMust pay royalties to use the HL7 specifications Must be a member to use the HL7 specificationsMust be a member to use the HL7 specifications Must be a member to participate in developmentMust be a member to participate in development HL7 develops information modelsHL7 develops information models Final specification must be purchased, no fee for useFinal specification must be purchased, no fee for use No fee for useNo fee for use HL7 invites all stakeholders to participateHL7 invites all stakeholders to participate Members can vote, membership open to anyoneMembers can vote, membership open to anyone

25 11/10/2002Copyright (c) Regenstrief Institute for Health Care25 Take-Home Points Data integration problem is not technological but conceptualData integration problem is not technological but conceptual Making a special XML schema is easyMaking a special XML schema is easy With HL7 you think integrated across specialty applicationsWith HL7 you think integrated across specialty applications Unlikely that clinical research needs require special technologyUnlikely that clinical research needs require special technology The general model facilitates harmonization and interoperabilityThe general model facilitates harmonization and interoperability HL7 has what it takes, work with itHL7 has what it takes, work with it

26 11/10/2002Copyright (c) Regenstrief Institute for Health Care26 thank you Gunther Schadow, Regenstrief Institute, Inc Wishard Blvd. Indianapolis, IN


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