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Overview'of'Clinical'Data'Standards'
Roberto'A.'Rocha,'MD,'PhD,'FACMI'
Clinical'Informa9cs'Director,'
Partners'eCare,'Partners'Healthcare'System'
Assistant'Professor'of'Medicine'
Division'of'General'Internal'Medicine'and'Primary'Care,'Department'of'
Medicine,'Brigham'and'Women’s'Hospital,'Harvard'Medical'School'
Big%Data%in%Healthcare:%The%Impact%on%Healthcare%Quality,%Cost%and%Access%in%China%=%April%18=19,%2016%=%%
Overview'
• Background'– Data'representa9on,'knowledge'exchange'
• Clinical'data'representa9on'– Terminologies,'Documents,'Informa9on'models'
• Clinical'knowledge'exchange'– InfobuMons,'Order'Sets,'CDS'Services'
• Conclusions'– Opportuni9es,'forms'of'par9cipa9on'
Data'&'Knowledge'interoperability'
Home%
Ambulatory%Visit%
Hospital%
Procedure%
Rehabilita7on%
Phase%
Data%+%Knowledge%
Data%+%Knowledge%Data%+%Knowledge%
Data%+%Knowledge%
Interoperability%
Definitions'(1/2)'
• Standard%O'“A'document,'established'by'
consensus%and'approved'by'a'recognized%body,'which'provides'rules,'guidelines,'or'characteris9cs'for'ac9vi9es”'
J.H. van Bemmel & M.A. Musen - Handbook of Medical Informatics
Definitions'(2/2)'
• Interoperability%O'“The'ability'of'two'or'more'
systems'or'components'to'exchange%informa9on'and'to'use%the'informa9on'that'
has'been'exchanged.”'
IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries. Institute of Electrical and Electronics Engineers, 1990.
Development'of'standards'
• SDO:'Standards'Developing'Organiza9on'• Many'na9onal'and'interna9onal'organiza9ons'
– Interdependencies'and'overlapping'efforts'• Several'with'specific'focus'on'Healthcare'
– Examples:'HL7,'IHE,'DICOM,'CDISC,'…''
CLINICAL'DATA'REPRESENTATION'
Clinical'data'representation'(4/18)'
• Define'“data%points”'(elements%and'values)'using'available'standards'
• Define'logical'models%that'combine'data%points%and'provide'meaningful'clinical'
informa7on%
• Obtain'detailed'provenance%to'understand'how%and'when%data'was'acquired,'and'also'who%provided'the'data'
• Represent'seman7c%and'temporal%linkages%between'data'instances''
Clinical'data:'standards'
• Data'elements'and'data'values'
– Available:'reference'terminologies'and'ontologies'
• Informa9on'models'
– Work'in'progress:'isolated'efforts'and'collec9ons'
– Available:'clinical'documents'(mul9ple'types)'
• Provenance'models'
– Work'in'progress:'compe9ng'models'
• Seman9c'and'temporal'linkages'
– Preliminary'work'
AddiDonal%work%is%needed%!%opportuniDes%
LOINC'
• Logical%Observa7on%Iden7fiers%Names%and%Codes%
• Organiza9on:'LOINC'CommiMee'
• Purpose:'iden9fica9on'of'laboratory'and'clinical'observa9ons'(HL7'messages)'
• Content:'laboratory'tests,'clinical'measurements,'
documents,'etc.'
• Informa9on:'
– hMp://loinc.org''
hMps://search.loinc.org''
SNOMED'CT'
• Systema7zed%Nomenclature%of%Medicine%–%Clinical%Terms%
• OrganizaDon:'Interna9onal'Health'Terminology'Standards'
Development'Organisa9on'(IHTSDO)'– SNOMED'Terminology'Solu9ons'O'College'of'American'Pathologists'
• Purpose:'Encoding'of'mul9ple'clinical'domains'
• Content:'Comprehensive'(diseases,'signs,'symptoms,'living'
organisms,'chemicals,'body'parts,'morphology,'occupa9ons,'
modifiers,'etc.)'
• Informa9on:''
– hMp://www.ihtsdo.org''
hMp://browser.ihtsdotools.org'
Many'others'(incomplete'list)'
• RxNorm:'clinical'drugs'and'drug'delivery'devices'(NLM)'
hMps://www.nlm.nih.gov/research/umls/rxnorm/''
• NDFNRT:'Na9onal'Drug'File'O'Reference'Terminology'(VA)'
hMp://evs.nci.nih.gov/`p1/NDFORT/'''
• IIS:'Vaccina9on'code'sets'(CDC)'hMp://www.cdc.gov/vaccines/programs/iis/codeOsets.html'''
• HL7%Vocabulary%domains'(messaging,'documents,'services)'
hMp://www.hl7.org/documentcenter/public_temp_1A973D1BO1C23O
BA17O0CCBD68843B23790/standards/vocabulary/vocabulary_tables/infrastructure/
vocabulary/vocabulary.html''
Document'standards'
• Clinical%Document%Architecture%(CDA)%
• Organiza9on:'HL7'Interna9onal'• Purpose:'document'markup'standard'that'specifies'the'
structure%and'seman7cs%of'"clinical'documents"'for'the'
purpose'of'exchange'between'healthcare'providers'and'
pa9ents'
• Content:'– Con9nuity'of'care,'procedure'note,'pa9ent'assessments,'etc.'
– Clinical'oncology'treatment'plan,'PHR'plans,'gene9c'tes9ng'reports,'
public'cancer'registries,'etc.''
– Data'Provenance'• Informa9on:'
– hMp://www.hl7.org/implement/standards/product_brief.cfm?product_id=7'''
Information'models'
• Clinical%Informa7on%Modeling%Ini7a7ve%(CIMI)%
• Organiza9on:'HL7'Interna9onal'• Purpose:'Improve'the'interoperability'of'healthcare'systems'
through'shared'implementable'clinical'informa9on'models'O'a'
single%curated%collec7on%with'bindings'to'reference'terminologies%
• Content:'laboratory'test'results,'vital'signs,'diagnoses,'procedures,'pa9ent'measures,'etc.'
• Informa9on:'
– hMp://www.hl7.org/Special/CommiMees/cimi/index.cfm'
– hMp://www.opencimi.org''
CLINICAL'KNOWLEDGE'EXCHANGE'
Implementation'of'CDS'modalities%
CDS'modality% Types'of'Knowledge'Assets%
1.'Information'selection'and'
retrieval'Reference'
2.'Information'aggregation'and'
presentation' Actionable'
3.'Data'entry'assistance'
4.'Event'monitors'
Executable'
5.'Care'workflow'assistance'
6.'Descriptive'or'predictive'modeling'
Cost'
Ava
ilability'
Complex
ity'
Maint
aina
bility'
StandardsTbased'implementations?'CDS'modality% Relevant'Interoperability'Standards'
(data'&'knowledge'representation'and'exchange)'
1.'Information'selection'and'
retrieval'
Guideline%Elements%Model%(GEM):'ASTM'
ContextNaware%Info%Retrieval%(InfobuMon):'HL7'Structured%Product%Label'(medica9ons):%HL7'
2.'Information'aggregation'and'
presentation'Clinical%Document%Architecture%(CDA):'HL7'
Health'Quality'Measures'Format'(eMeasures):'HL7'
Order'sets:'HL7'3.'Data'entry'assistance'
4.'Event'monitors'
Arden%Syntax%for%Medical%Logic%Systems:'HL7'GELLO%N%A%Common%Expression%Language:'HL7'
Decision'Support'Services:'HL7'
Virtual'Medical'Record'(vMR):'HL7'
5.'Care'workflow'assistance'
6.'Descriptive'or'predictive'modeling'
Kawamoto K, Del Fiol G, Lobach DF, Jenders RA. Standards for scalable clinical decision support: need, current and emerging standards, gaps, and proposal for progress.
Open Med Inform J. 2010;4:235-44.
Problem'List'infobuttons'
Informa9on'about'
“Depression”'
HL7'Infobutton'standard'Del'Fiol'G,'Huser'V,'Strasberg'HR,'
Maviglia'SM,'Cur9s'C,'Cimino'JJ.'
Implementa9ons'of'the'HL7'ContextO
Aware'Knowledge'Retrieval'
("InfobuMon")'Standard:'Challenges,'
strengths,'limita9ons,'and'uptake.'J%Biomed%Inform.'2012'Jan'2.'
Integration'across'repositories'
• Common%Terminology%Services%–%Release%2%(CTS2)%
• Organiza9on:''HL7'+'Object'Management'Group'(OMG)'
• Purpose:'standardized'interface'for'the'use'and'management'
of'terminologies'(extensible'to'knowledge'assets)%
• Content:'concepts,'value'sets,'code'systems,'en99es,'
informa9on'models,'APIs,'etc.'
• Informa9on:'
– hMp://www.hl7.org/implement/standards/product_brief.cfm?product_id=384'
– hMp://www.omg.org/spec/CTS2/'
Content%Sources%(e.g.,%EHR%content,%Open%source%content,%Licensed%content,%etc.)%
IMPORT%(XML%format%compa7ble%with%available%standards%–%e.g.,%CTS2)%%
Content%Consumers%(e.g.,%Clinical%applica7ons%and%services,%EHR%systems,%etc.)%%
Publication
Authoring
Linking Validation
Review & Vetting
ETL%
CKMS%
EXPORT%(same%XML%format%used%for%Import)%%
ETL%
CONCLUSIONS'
Known'challenges'with'standards'
• Widespread%use%of'the'standard'– Measurement'of'acceptance%(success)'– Implementa9on'costs%versus'benefits%obtained'
• Standards'usually'define'a'nonNprescrip7ve%model'
– Formal'document,'precise'defini9ons,'wellOdefined'
problems'(scenarios)'
– Conformance,'variability,'evolu7on%
• High'degree'of'complexity%and'dynamism%– Wide'spectrum'of'scenarios'and'approaches'
– Con9nuous'evolu7on%(dynamic):'domain'+'technology'
– Extensive'(cumbersome)'documenta9on'
Participate!'
• Most'SDOs'welcome'open'and'broad%par9cipa9on'– Healthcare'providers,'government'stakeholders,'payers,'
pharmaceu9cal'companies,'system'vendors,'consultants'
• Understand'the'scope'and'applicability'of'exis9ng'standards'– Gain'access%to'available'standards'– Decide'how'each'standard'applies%to'your'organiza9on'
• Contribute'to'and'influence'the'development'of'standards'
– Bring'your'specific%needs%and'discuss'implementa9on'op9ons'
– Seek'informa9on'from'other'stakeholders'to'make'informed%decisions%
• Achieve'industry'leadership'by'demonstra9ng'interoperability'
– Learn'about'industry'best%prac7ces%– Understand'implementa9on'7meline%and'costs%
– Improve'the'quality%and'sustainability%of'your'local'systems'
Acknowledgements%
Perry'Mar'
Sarah'Collins'
David'Dubois'
Ben'Gross'
Saverio'Maviglia'
Beatriz'Rocha'
Other'members'of'the'Clinical%Informa7cs%Team%at'Partners'
Stanley'Huff'
Members'of'the'Modeling%and%Terminology%Teams%at'Intermountain'
Thank%you!%
Roberto A. Rocha, MD, [email protected]
http://scholar.harvard.edu/rarocha
This'work'by'Roberto'A.'Rocha'is'licensed'under'a'Crea9ve'Commons'AMribu9onO
NonCommercialOShareAlike'4.0'Interna9onal'License'