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Regulatory Initiatives in HL7 Using XML and Structured Documents

Regulatory Initiatives in HL7 Using XML and Structured Documents. Liora Alschuler CDISC Interchange Bethesda September 30, 2003. Liora Alschuler Current alschuler.spinosa, consultants Co-chair HL7 Structured Documents TC & Marketing Committee Co-editor, Clinical Document Architecture

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Regulatory Initiatives in HL7 Using XML and Structured Documents

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  1. Regulatory Initiatives in HL7 Using XML and StructuredDocuments Liora Alschuler CDISC Interchange Bethesda September 30, 2003

  2. Liora Alschuler • Current • alschuler.spinosa, consultants • Co-chair HL7 Structured Documents TC & Marketing Committee • Co-editor, Clinical Document Architecture • liora@the-word-electric.com • Background • Broadcast engineering • Semi-conductor industry • Electronic text: 1986 -- 1998 • Helped bring XML to HL7 in 1997

  3. Outline • XML + • HL7 + • CDA + • CDISC ________ Starbrite Single-source trial

  4. Two observations: • applications need to change • data needs to persist

  5. Application-based interoperabilty • as systems evolve, data lost, recreated or converted

  6. Information-based interoperability • as systems evolve, data persists

  7. Two observations: corollary • applications need to change • data needs to persist depreciate appreciate

  8. Impact on Healthcare and Drug Information • Steve Ruberg, Applied Clinical Trials, February, 2002: “The essential kernal of the whole clinical development processs is the data… Thus, without a data-centric approach to developing any e-clinical solution, we are unlikely to be fully successful. The data is the foundation on which we build our entire effort.”

  9. XML • XML is about investing in information • writing code still important, but • information design should outlive system design • information outlives the system on which it is created • Research and patient care share this perspective

  10. How XML puts info at the center • XML: Extensible Markup Language (www.w3.org) • Platform and vendor independent • Data in XML persists over time • Data in XML can move between applications

  11. How XML puts info at the center • XML makes all types of information both human readable and machine processible: Allergies and adverse reactions: Penicillin - hives

  12. XML-encoded info <Section> <code code="10123-x" codeSystem="LOINC">Allergies and Adverse Reactions</code> <text> <list> <item><content>Penicillin - Hives</content></item> </list> </text> <component> <Observation> <code code="G-1001" codeSystem="SNOMED" displayName="Prior dx"/> <value xsi:type="CD" code="DF-10074" codeSystem="SNOMED" displayName="Allergy to penicillin"/> <pertinentInformation typeCode="MFST"> <Observation> <code code="G-1001" codeSystem="SNOMED" displayName="Prior dx"/> <value xsi:type="CD" code="D0-00165" codeSystem="SNOMED" displayName="Hives"/> </Observation> human readable machine processible CDA Release 2.0: Draft

  13. XML-encoded information • With a few simple tags, and controlled vocabulary, XML can describe anything • but… • the tags need to be defined: <orderNum> : HL7: order placed <orderNum> : CDISC: visit sequence

  14. Health Level Seven • ANSI-accredited Standards Development Organization • Established 1987 • Approx. 2000 members • 22 affiliates in Europe, Asia-Pacific, South America, Africa

  15. Board of Directors Business affairs Elected Technical Steering Committee Technical affairs Appointed officers plus chairs of the committees & SIGs The Working Group The Membership working "real" The The HL7 HL7 Any member can register Any member can register for any committee or SIG for any committee or SIG Technical Committees Special Interest Groups Create normative specifications Collaborate in area of interest to or chapters in the standard contribute to the work of the TCs HL7 • Working group meetings • 3 times each year • about 500 attendees

  16. a few of the HL7 TCs • Modeling & Methodology • Patient Care • Orders & Observations • Structured Documents: Clinical Document Architecture (CDA, SPL) • RCRIM: Regulated Clinical Research Information Management • CCOW: Context Management

  17. a few of the HL7 SIGs • XML • Genomics • Clinical Guidelines • Electronic Health Record • JAVA • Imaging Integration • Medication

  18. HL7 Standards • Informative or normative • Balloting (normative) • committee-level: 65% • membership level 90% • ANSI-certification • ISO fast track • New: Draft Standard for Trial Use (DSTU)

  19. HL7 Standards • Version 2.x • used worldwide, 90% of US hospitals • “pipe & hat”: HL7-proprietary, EDI-like PID||2247^^^Primary|098018500^^^MRN||FIX-INTF^PAT||19650618|Female| • Version 2.XML • a normative XML encoding for V2 <PatientGroup> - <PID PID07_DateOfBirth="19650618" PID08_Sex="Female"

  20. HL7 Standards • Version 3 • based on Reference Information Model (RIM) • technology independent: so far, developing XML schemas, JAVA API • RCRIM/CDISC lab reporting is a V3 draft standard, as is SPL • First normative V3 spec was CDA

  21. CDA • Clinical Document Architecture • ANSI/HL7 CDA R1.0-2000 • first certified XML spec for healthcare • first balloted portion of HL7’s “V3” • first RIM-based specification • created & maintained by HL7 Structured Documents Technical Committee (SDTC)

  22. CDA: scope • The scope of the CDA is the standardization of clinical documents for exchange. • CDA enables, but does not constrain: • authoring • document management • storage • distribution • display

  23. CDA: Release 1.0 • priority is patient care, other applications facilitated • minimize technical barriers to implementation • promote longevity of clinical records • scoped by exchange, independent of transfer or storage • enable policy-makers to control information requirements

  24. Applications of the CDA…or What can you dowith a few tags? • access/portability/exchange • query/locate by patient, provider, practioner, setting, encounter, date • integration • multiple transcription systems • with EHR records • re-use/derivative data • summaries • billing

  25. Applications of the CDA…or What can you dowith a few tags? • access • web portal, CCOW (Orion, Sybase, IBM) • integration • import into EMR (Epic) • re-use/derivative data • V3 Rx order (MS) • ADT (Orion, Epic) • OBX (Orion, TheraDoc)

  26. CDA: Major Implementations • PICNIC (European Union) • SCIPHOX (Germany) • HYGEIAnet/WebOnColl (Greece) • NHS South Staffordshire (United Kingdom) • Aluetietojärjestelmä (Finland) • MERIT-9 (Japan) • e-Claims Supporting Doc Arch (Canada); HIPAA Claims Attachments (US, proposed) • Mayo Clinic (US) • Buenos Aires project (Argentina) • Dalhousie U, QEII Health Sci Ctr (Canada)

  27. SCIPHOX, Germany Kai Heitmann

  28. Seamless Care and CDA, FinlandAluetietojärjestelmä • PICNIC project: integrated access

  29. The CDAdocument defined ANSI/HL7 CDA R1.0-2000, section 1.1: A clinical document ... has the following characteristics: • Persistence • Stewardship • Potential for authentication • Wholeness • Human readability A CDA document is a defined and complete information object that can include text, images, sounds, and other multimedia content. ANSI/HL7 CDA R1.0-2000, section 1.1: A clinical document ... has the following characteristics: • Persistence • Stewardship • Potential for authentication • Wholeness • Human readability A CDA document is a defined and complete information object that can include text, images, sounds, and other multimedia content. (material in blue is quoted from the Clinical Document Architecture Release 1.0)

  30. The CDAdocument defined CDA Release 2 (draft), section 2.1: A clinical document ... has the following characteristics: • Persistence • Stewardship • Potential for authentication • Context • Wholeness • Human readability “Context - Contents of a clinical document share a common context unless all or part of that context is overridden or nullified.” (material in blue is quoted from the Clinical Document Architecture Release 1.0)

  31. CDAdocuments::HL7messages Documents can be the same differ Messages can be the same differ Content Intent & use cases

  32. CDAdocuments::HL7messages Documents persistent human-to-human care-givers are trained to create documents ...have legal standing defined by precedent document as a whole Messages temporary system-to-system ... not messagessigned?legally accepted? designed per use case must be defined in each segment Lifetime Communication Relationto caregivers Legalaspects Source Context

  33. CDA::Readability • CDA documents are“human readable”= • This principle means that CDA documents are human readable using: a) widely-available and commonly deployed XML-aware browsers and print drivers and b) a generic CDA style sheet written in a standard style sheet language. • CDA documents are also “machine processable”to the degree that markup has been added • required markup provides initial functionality • optional markup can augment processing

  34. CDA & CDISC • eSource & electronic data capture • redundant with creation of clinic note • require information reside in EMR/EHR • proprietary data formats • CDA & CDISC in “single-source” • capture trial data, merge it into clinic note (re-use) • work with current technology, workflow • open, non-proprietary data formats

  35. CDA & CDISC in Starbrite Trial • Participants: • CDISC • Duke Clinic • Duke Clinical Research Institute (DCRI) • Technology partners: Microsoft, Arbortext, Topsail • Investigators • Liora Alschuler, Landen Bain, Rebecca Kush, MD, Meredith Nahm

  36. CDA & CDISC in Starbrite Trial Manual creation and re-entry of CRF HIS validation  lab, ADT, meds, source documents db LIS display manual entry to CRF re-key CRF  CLINIC CRO Current processes (dual source) HIS  lab, ADT, meds, source documents LIS display dictate chart note  Redundant creation of chart note

  37. CDA & CDISC in Starbrite Trial Merged workflow: electronic CRF re-used in chart note HIS validation  lab, ADT, meds, source documents CDA/ ODM LIS db display eCRF Proposed processes (single source)  dictate chart note CLINIC ARO

  38. Use of ODM & CDA in Single-source CDA Complete study-required data entry Complete data entry for patient chart Finalize, sign and archive Initiate document ODM Clinical document repository (EHR) Clinical trial management

  39. CDA & CDISC in Starbrite Trial • features: • eSource contributes to patient chart, not the reverse • no requirement to create/extract from EMR • fewer privacy and regulatory issues • can be driven from electronic protocol • uses HL7 CDA and CDISC ODM

  40. CDA & CDISC in Starbrite Trial • status: • initial study design and information analysis complete • information design, in progress • technology design launch October 14 • prototype implementation by 2/04

  41. The Universal “need a hub”diagram Diagnostic imaging Pathway, guidelines Public health Shared care Clinical trials Orders Reimbursement Quality improvement Decision support

  42. Clinical documents are the core of healthcare information Diagnostic imaging Pathway, guidelines Public health Shared care Clinical trials Documenting patient care Orders • Relationships: • Equal • Derive • Incorporate • Link • Transform Reimbursement Quality improvement Decision support

  43. selected references • Information on HL7: www.HL7.org • On SDTC: HL7.org -> TCs -> SDTC -> “Documents & Presentations” • CDA Release One: Dolin RH, Alschuler L, Beebe C, Biron PV, Boyer S, Essin D, Kimber E, Lincoln T, Mattison JE. The HL7 Clinical Document Architecture. J Am Med Inform Assoc. 2001;8:552-569. • CDA Draft Release 2.0: • Paper on CDA Implementations & the EHR: ttp://www.hl7.org/Library/Committees/structure/CDA_in_context_withpics.zip • Recent presentations on CDA: http://www.hl7.de/cdaiw200305/ • First International Conference on CDA: http://www.hl7.de/cda2002/index.html

  44. Thank you! any questions?

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