alschuler.spinosa c o p y r i g h t 2 0 0 3 , L i o r a A l s c h u l e r Regulatory Initiatives in HL7 Using XML and Structured Documents Liora Alschuler CDISC Interchange Bethesda September 30, 2003
Jan 08, 2016
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Regulatory Initiatives in HL7 Using XML and
Structured Documents
Regulatory Initiatives in HL7 Using XML and
Structured Documents
Liora AlschulerCDISC Interchange
BethesdaSeptember 30, 2003
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• Liora Alschuler• Current
– alschuler.spinosa, consultants– Co-chair HL7 Structured Documents TC & Marketing
Committee– Co-editor, Clinical Document Architecture– [email protected]
• Background– Broadcast engineering– Semi-conductor industry– Electronic text: 1986 -- 1998– Helped bring XML to HL7 in 1997
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Outline• XML +• HL7
+• CDA
+• CDISC________Starbrite Single-source trial
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Two observations:
• applications need to change
• data needs to persist
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Application-based interoperabilty
• as systems evolve, data lost, recreated or converted
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Information-based interoperability
• as systems evolve, data persists
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Two observations: corollary
• applications need to change
• data needs to persist
depreciate
appreciate
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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.”
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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
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• XML: Extensible Markup Language (www.w3.org)
• Platform and vendor independent• Data in XML persists over time• Data in XML can move between
applications
How XML puts info at the center
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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
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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>
CDA Release 2.0: Draft
human readable
machine processible
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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
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Health Level Seven
• ANSI-accredited Standards Development Organization
• Established 1987• Approx. 2000 members• 22 affiliates in Europe,
Asia-Pacific, South America, Africa
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HL7• Working group meetings
– 3 times each year– about 500 attendees
Technical Steering CommitteeTechnical affairs
Appointed officers plus chairsof the committees & SIGs
Technical CommitteesCreate normative specifications
or chapters in the standard
Special Interest GroupsCollaborate in area of interest tocontribute to the work of the TCs
The Working GroupThe working HL7
Any member can registerfor any committee or SIG
Board of DirectorsBusiness affairs
Elected
The MembershipThe "real" HL7
Any member can registerfor any committee or SIG
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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
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a few of the HL7 SIGs
• XML• Genomics• Clinical Guidelines• Electronic Health Record• JAVA• Imaging Integration• Medication
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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)
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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"
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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
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• 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)
CDA
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• 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
CDA: scope
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• 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
CDA: Release 1.0
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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
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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)
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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)
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SCIPHOX, GermanyK
ai Heitm
ann
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Seamless Care and CDA, FinlandAluetietojärjestelmä
• PICNIC project: integrated access
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The CDA document definedANSI/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 theClinical Document Architecture Release 1.0)
(material in blue is quoted from theClinical Document Architecture Release 1.0)
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.
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The CDA document defined
(material in blue is quoted from theClinical Document Architecture Release 1.0)
(material in blue is quoted from theClinical Document Architecture Release 1.0)
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.”
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CDA documents::HL7 messages
Messages
can be the same
differ
Messages
can be the same
differ
Documents
can be the same
differ
Documents
can be the same
differ
Content
Intent & use cases
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CDA documents::HL7 messages
Messages
temporary
system-to-system
... not messages
signed?legally accepted?
designed per use case
must be defined in each segment
Messages
temporary
system-to-system
... not messages
signed?legally accepted?
designed per use case
must be defined in each segment
Documents
persistent
human-to-human
care-givers are trained to create documents ...
have legal standing
defined by precedent
document as a whole
Documents
persistent
human-to-human
care-givers are trained to create documents ...
have legal standing
defined by precedent
document as a whole
Lifetime
Communication
Relationto caregivers
Legalaspects
Source
Context
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• 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
CDA::Readability
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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
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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
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dblab, ADT, meds, source documents
display manual entry to CRF
re-key CRF
lab, ADT, meds, source documents
display dictate chart note
LIS
LIS
HIS
HIS
Manual creation and re-entry of CRF
Redundant creation of chart note
CLINIC CRO
validation
Current processes (dual source)
CDA & CDISC in Starbrite Trial
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db
LIS
HIS
lab, ADT, meds, source documents
display eCRF
dictate chart note
Merged workflow: electronic CRF re-used in chart note
validation
Proposed processes (single source)
CLINIC ARO
CDA/ ODM
CDA & CDISC in Starbrite Trial
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Use of ODM & CDA in Single-source
ODM
Initiate document
Complete study-required data entry
Complete data entry for patient chart
Finalize, sign and archive
Clinical trial management
Clinical document repository (EHR)
CDA
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• 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
CDA & CDISC in Starbrite Trial
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• status:– initial study design and information
analysis complete– information design, in progress– technology design launch October 14– prototype implementation by 2/04
CDA & CDISC in Starbrite Trial
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The Universal “need a hub”diagram
Shared care
Clinical trials
Public health
Orders
Quality improvement
Reimbursement
Diagnostic imaging
Pathway, guidelines
Decision support
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Clinical documents are the core of healthcare information
Documenting patient care
Shared care
Clinical trials
Public health
Orders
Quality improvement
Reimbursement
Diagnostic imaging
Pathway, guidelines
Decision support
Relationships:
• Equal
• Derive
• Incorporate
• Link
• Transform
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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
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any questions?Thank you!
any questions?