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, PhDrarocha@partners.org

http://scholar.harvard.edu/rarocha

This'work'by'Roberto'A.'Rocha'is'licensed'under'a'Crea9ve'Commons'AMribu9onO

NonCommercialOShareAlike'4.0'Interna9onal'License'