Overview'of'EHR$Systems$and'Clinical$Data$

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'– Clinical'Systems,'EHR'Systems,'Data'Capture'

• Types'of'clinical'data'– Unstructured,'Structured,'Coded''

• Structured'and'coded'clinical'data'– Consistency,'level'of'detail,'seman9cs,'standards'

• Conclusions'– Current'efforts,'methodology,'par9cipa9on'

Clinical$System$

• �…'an'automated'system'with'a'long'term'

database'containing'clinical'informa9on'used'

for'pa9ent'care.�'

– Bruce'Blum,'1986'

• Support'(automa9on)'for'one'or'mul9ple'

clinical%(pa9ent'care)'func9ons'• Electronic*Health/Medical*Record*system'is'

an'integrated'suite%of'clinical'systems'

Separate$“clinical”$systems$

Clinical*Research*Systems*

Medical*Record*Systems*

EHRs/EMRs:*Electronic'Health/

Medical'Record'Systems'

PHRs:'Pa9ent'Health'

Records'

EDCs:*Electronic'Data'Capture'

Systems'

eCRFs:*Electronic'Case'

Report'Forms'

EHR$systems$

•  Electronic'Health'Record'(EHR)'–  “electronic'version'of'a'pa<ents*medical*history,'…'maintained'by'the'

provider'over'9me,'…'clinical'data*relevant*to'that'persons*care*…'including'demographics,'progress'notes,'problems,'medica<ons,'vital*signs,'past*medical*history,'immuniza<ons,'laboratory*…'radiology”'

–  (hZps://www.cms.gov/medicare/e[health/ehealthrecords/index.html)'

• US'market'

–  Commercial'EHRs'dominate;'small'number'of'vendors'

– Designed'for'data'storage'&'communica9on:'human*users*

– High'tolerance*for'incomplete,'incorrect,'ambiguous'data'

–  Limited*capability'for'computerCassisted*decision*making*

–  Emphasis'on'data'sharing*(government'incen9ves)*

Outpatient$EHR$@$Partners$

Documenta<on,*ordering,*results*review,*messaging,*etc.*

Historical$perspective:$1991$(1/2)$

•  Percent'of'pa9ent's'paper'chart'contained'in'the'EHR?'–  “Using'the'number'of'pages'in'the'record'as'the'criteria,'the'answer'is'

about'26%*overall,'but'between'35%'and'40%'for'pa9ents'in'nursing'divisions'where'computerized'nurse'char9ng'is'used.”'

Kuperman'GL,'Maack'BB,'Bauer'K,'Gardner'RM.'The'impact'of'the'HELP'computer'system'on'

the'LDS'Hospital'paper'medical'record.'Top%Health%Rec%Manage.'1991'Aug;12(1):1[9.'

Historical$perspective:$1991$(2/2)$(C)'Computerized:'EHR'na9ve'data'

(F)'Form:'pre[printed'material'

(H)'HandwriKen:'handwriZen'notes'(T)'Typed:'typed'notes'

(O)'Other'

•  130'different'categories*of*data*iden9fied'

•  Notes*alone'represent'over'26%'of'the'record'

Kuperman'GL,'Maack'BB,'Bauer'K,'Gardner'RM.'The'impact'of'the'HELP'computer'system'on'

the'LDS'Hospital'paper'medical'record.'Top%Health%Rec%Manage.'1991'Aug;12(1):1[9.'

Data$capture$methods$

•  typing*(keyboard)'•  forms*and'flowsheets*(with'or'without'voice'recogni9on)'

•  text'macros*and'pre[defined'note'templates'

•  dicta<on*(with'or'without'voice'recogni9on)'•  digital'handwri9ng'•  document'scanning*(with'or'without'OCR)'

•  data'extrac9on'(natural'language'processing)'•  automated'data'acquisi9on'(biomedical'devices)'

TYPES$OF$CLINICAL$DATA$

Clinical$data$

• Highly'complex'

– Diverse'types'of'data'! structured'and'unstructured,'images,'sounds,'etc.'

– Dynamic'(changing)'nature'

! flexible'and'extensible'underlying'models'

• Large'quan99es'– High'performance'database'environment'

! response'9me'is'the'cri9cal'factor'

• Confiden9ality'and'privacy'(security)'

Types$of$clinical$data$

• Unstructured'–  “Mr.'Jones'has'Appendici<s”'– No'structure'or'codes'

•  Structured'– Diagnosis:'“Appendici<s”'– Ques9on'is'defined'(coded)'but'answer'(value)'is'free[text'

•  Structured'&'Coded'– Diagnosis:'K35*(Appendici<s)'– Ques9on'&'answer'are'defined'(coded)'

Unstructured$(narrative)$data$

• Significant'por9on'of'the'medical'record'is'

available'as'narra9ve'data'(70[95%)'! medical'history,'physical'exam,'progress'notes,'discharge'summary,'radiology'reports,'opera9ve'notes'

– advantages:'widespread,'comprehensive,'

convenient,'expressive,'natural*

– disadvantages:'ambiguous,'complex,'different'

styles,'redundant,'embedded'errors,'loose'

structure'

Structured$&$Coded$data$

• Clinical'and'epidemiological'research'

• Clinical'event'monitoring'(decision'support)'

• Audi9ng'(clinical'and/or'administra9ve)'

• Quality'control'(computerized)'

• Indexing'and'retrieval'(images,'sounds,'etc.)'

• Portability'(language'independence)'• Text'genera9on'• Advanced'analy9cs'

STRUCTURED$AND$CODED$CLINICAL$DATA$

Standard$data$definitions$

LOINC'

8339[4:' Body'weight^at'birth'

' Mass;'Pt;'^Pa9ent;'Qn;'Measured'

SNOMED'CT'(or'UCUM)'

258681007:'Units'of'mass'(SI)'

SNOMED'CT'

258682000:'gram,'g'

Data*Element'(aZribute):'numeric'measurement'

with'unit'

Topic*

Value*set*

Value'(concept)'

Standard*data*defini<ons:*data'elements'+'data'values'

Birth*Weight:*<number><units>*

Coded$data:$variation$

AZribute' Value'

Pain* Severe*

AZribute' Value'

Severe*Pain* Yes'

AZribute' Value'

Severe*Pain* 02[01[2001'

AZribute' Value'

Sys'BP' 180*mmHg*

AZribute' Value'

Sys'BP' Elevated*

AZribute' Value'

Sys'BP' Abnormal*

AZribute' Value'

Problem' Severe*Pain* AZribute' Value'

Finding' Elevated*Sys*BP*

Clinical$data$representation$(1/3)$

• Not'sufficient'to'catalog*all'possible'combina9ons'of'

data*elements*and'data'values**–  Cataloging'is'the'state'of'the'prac9ce'for'US'EHR'systems'

•  Essen9al'to'combine'data'points'and'obtain'

meaningful'clinical'informa9on:'informa<on*models'–  Focus'on'high*priority*clinical*domains*given'the'significant'effort'to'develop'and'implement'models'

–  Leverage'and'contribute'to'ongoing*efforts*to'validate'and'share'clinical'informa9cs'models'

! HL7'Clinical'Informa9on'Modeling'Ini9a9ve'(CIMI)''

Coded$data:$information$model$

•  Acute*Pain*model:'1.  Pain'Quality'(Character)'2.  Pain'Primary'Loca9on'

3.  Pain'Onset'4.  Speed'of'Pain'Onset'5.  Pain'Periodicity'6.  Pain'Temporal'PaZern'

7.  Pain'Allevia9ng'Factors'8.  Pain'Aggrava9ng'Factors'9.  Pain'Dura9on'(Hours,'Minutes)'

10. Associated'Signs'and'Symptoms'

11. Pa9ent'Severity'Score'12. Pain'Course'13. Rela9ve'Temporal'Context'

14. Pa9ent'Stated'Goal''

Gesner'E,'Collins'SA,'Rocha'R.'Pain'Documenta9on:'Valida9on'of'a'

Reference'Model.'Stud%Health%Technol%Inform.'2015;216:805[9.'

Clinical$data$representation$(2/3)$

• Not'sufficient'to'develop'informa<on*models*for'high'priority'data'domains'

– Models'have'to'be'shared*to'enable'data*exchange*

• Need'to'also'capture'detailed'provenance*to'understand'how'and'when'data'was'acquired,'

and'also'who'provided'the'data'

Coded$data:$provenance$

Oniki'TA,'Zhuo'N,'Beebe'CE,'Liu'H,'Coyle'JF,'Parker'CG,'Solbrig'HR,'

Marchant'K,'Kaggal'VC,'Chute'CG,'Huff'SM.'Clinical'element'models'in'the'

SHARPn'consor9um.'J%Am%Med%Inform%Assoc.'2016'Mar;23(2):248[56.'

Clinical$data$representation$(3/3)$

• Not'sufficient'to'develop'informa9on'models'

with'detailed'provenance*– Missing'important'rela<onships*between'data'instances'

– Cri9cal'for'understanding'the'pa9ent'medical'

history'and'the'evolu9on'of'clinical'condi9ons'

• Need'to'represent'seman<c*and'temporal*linkages*between'models'(data'instances)'

Coded$data:$linkages$

Ontology*is*the*source*

Puleston'C,'Parsia'B,'Cunningham'J,'Rector'A.'Integra9ng'Object[Oriented'and'Ontological'Representa9ons:'A'Case'Study'in'Java'and'OWL'Export.'The%SemanJc%Web%=%ISWC%2008%(2008),'pp.'130[145.'

CONCLUSIONS$

Known$consequences$

Medical*Record*Systems*

Clinical*Research*Systems*

Manual'data'entry'

Data're[entry'

Missing'data'

Misinterpreta9ons'

Limited'contextual'details'

Disparate'data'defini9ons'

Laborious'data'extrac9on'

Overlapping'standards'

…'

Data$capture:$guiding$principles$

1.  Be'clinically*per<nent,'pa<entCcentric,'and'represent'an'individual’s'life9me'

health'and'healthcare.'

2.  Support'capture'of'high'quality'informa9on'that'is'accurate,'relevant,'confiden<al,'reliable,'valid,'complete,'and'secure.'

3.  Be'efficient*and'usable'while'enhancing'the'healthcare'organiza9on’s'and'the'care'team’s'overall'efficiency,'effec9veness'and'produc9vity.'

4.  Support'mul9ple'downstream*uses*as'a'byproduct'of'the'recording'of'care'delivery'including'quality'measurement,'performance'improvement,'popula9on'

health'care'delivery,'policymaking,'research,'educa9on,'and'reimbursement.'

5.  Enable'joint*pa<entCprovider*decision*making,'team'collabora9on,'care'process'

management,'and'advanced'clinical'decision'support.'

6.  Enable'collec9on'of'data'and'interpreta9on'of'informa9on'from'mul<ple*sources*as'appropriate'and'necessary,'including'nuanced'medical'discourse,'structured'items,'and'data'captured'in'other'systems'and'devices.'

7.  Automa9on'of'data'capture'and'documenta9on'should'be'op9mized'whenever'

appropriate,'allowing'human'beings'to'focus'on'gathering'and'entering'data'that'

cannot*be*effec<vely*collected*by*automated*tools.'

Cusack'CM'et'al.'The'future'state'of'clinical'data'capture'and'documenta9on:'a'report'from'AMIA's'2011'Policy'Mee9ng.'J%Am%Med%Inform%Assoc.'2013'Jan'1;20(1):134[40.'

Methodology$@$Partners$

Collins'SA,'Gesner'E,'Morgan'S,'Mar'P,'Maviglia'S,'Colburn'D,'Tierney'D,'Rocha'R.'

A'Prac9cal'Approach'to'Governance'and'Op9miza9on'of'Structured'Data'Elements.'

Stud%Health%Technol%Inform.'2015;216:7[11.'

Example:$SHARPn$

•  Strategic'Health'IT'Advanced'Research'Project'area'four'(SHARPn)'

–  Open[source'tools'to'normalize*EHR'data'for'secondary'use'–'e.g.'high'throughput'phenotyping'

!  Sources:'HL7'messages,'NLP'output,'and'C[CDA'documents'

–  Standards[conformant'structured*and'coded*data*suitable'for'secondary'uses'

–  28'generic'models:'diagnosis,'procedure,'allergy,'findings,'

medica9ons,'laboratory'results,'vital'signs,'plus'linkages,'collec9on,'

and'detailed'provenance'

!  Values'defined'using'standard'terminologies:'RxNorm,'HL7,'SNOMED'CT,'LOINC'

–  Reliance'on'specialized'resources'that'are'not'commonly'available'

–  Recommenda9ons:'training,'beZer'tools,'model'library'

Oniki'TA,'Zhuo'N,'Beebe'CE,'Liu'H,'Coyle'JF,'Parker'CG,'Solbrig'HR,'Marchant'K,'Kaggal'VC,'Chute'CG,'Huff'SM.'Clinical'element'models'in'the'SHARPn'consor9um.'J%Am%Med%Inform%Assoc.'2016'Mar;23(2):248[56.'

Opportunity$to$participate$

•  The'Clinical*Informa<on*Modeling*Ini<a<ve*(CIMI)'is'

an'HL7'Work'Group'that'is'producing'detailed'clinical'informa9on'models'to'enable'interoperability'of'

health'care'informa9on'systems'

•  CIMI'models'are'free'for'use'for'all'purposes'

•  See'hZp://www.opencimi.org/'for'more'details'

Acknowledgements*

Perry'Mar'

Sarah'Collins'

Emily'Gesner'

Saverio'Maviglia'

Charles'Lagor'

Li'Zhou'

Beatriz'Rocha'

Other'members'of'the'Clinical*Informa<cs*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'AZribu9on[

NonCommercial[ShareAlike'4.0'Interna9onal'License'