Standards for Structure and Content of Electronic Health Records Mike Lincoln.

Standards for Structure and Standards for Structure and Content of Content of

Electronic Health RecordsElectronic Health Records

Mike LincolnMike Lincoln

Electronic Health Records (EHR)Electronic Health Records (EHR)

Wide scope of intended applicationWide scope of intended application– Acute care hospitals, ambulatory care, long Acute care hospitals, ambulatory care, long

term care, home health care, emergency roomsterm care, home health care, emergency rooms Content and logical structure importantContent and logical structure important

– Must organize all health related information Must organize all health related information over time (e.g., physician’s problem list, over time (e.g., physician’s problem list, radiologist’s impression, nurse’s assessment)radiologist’s impression, nurse’s assessment)

– Content and structure must work with standards Content and structure must work with standards for vocabulary and messagingfor vocabulary and messaging

Discussion GoalsDiscussion Goals

Review standards for EHR content and Review standards for EHR content and logical structurelogical structure

Understand relationship of regulatory Understand relationship of regulatory requirementsrequirements

Request discussion and help on additional Request discussion and help on additional sources for this documentsources for this document

Standards for EHR ContentStandards for EHR Content ASTM E-1384-99ASTM E-1384-99 Open health care initiativesOpen health care initiatives

– GEHR (Good Electronic Health Record) GEHR (Good Electronic Health Record) RIM effortsRIM efforts

– Standards Development Organizations (SDO)Standards Development Organizations (SDO)– Government RIM Government RIM

Imposition of some structure by regulatory Imposition of some structure by regulatory agenciesagencies– e.g., JCAHOe.g., JCAHO

ASTM E-1394-99ASTM E-1394-99

ASTM standard for EHR content, structureASTM standard for EHR content, structure– Available at http://www.astm.org for $60.00Available at http://www.astm.org for $60.00– Does NOT deal with messaging (4.1.3.3)Does NOT deal with messaging (4.1.3.3)– Does NOT dictate data required or particular Does NOT dictate data required or particular

applications (4.1.3)applications (4.1.3)» e.g., Recognizes rapid change in regulatory and e.g., Recognizes rapid change in regulatory and

quality improvement data standardsquality improvement data standards

Electronic Health RecordsElectronic Health Records

Roles of EHR (ASTM 1384)Roles of EHR (ASTM 1384)– Represents patient’s health historyRepresents patient’s health history– Communication among health care practitionersCommunication among health care practitioners– Legal document for health careLegal document for health care– Source for clinical, outcomes and health Source for clinical, outcomes and health

services researchservices research– Resource for practitioner educationResource for practitioner education– Alerts, reminders, quality improvementAlerts, reminders, quality improvement

Contents of ASTM E-1384-99Contents of ASTM E-1384-99

Four main partsFour main parts– Segments of traditional paper record (pt.5)Segments of traditional paper record (pt.5)– Privacy and security principles (pt. 6)Privacy and security principles (pt. 6)– Common data model for EHR (pt. 7)Common data model for EHR (pt. 7)– Content views and minimum data for EHR (pts. Content views and minimum data for EHR (pts.

8-9, including section 10, a list of data 8-9, including section 10, a list of data dictionary elements)dictionary elements)

ASTM E-1384: part 5ASTM E-1384: part 5

Catalogue of primary record components by Catalogue of primary record components by sourcesource– For tests without CPT codes uses listings from For tests without CPT codes uses listings from

Appendix X1 of E-1238 Appendix X1 of E-1238 – Breaks down EHR into more and more finely Breaks down EHR into more and more finely

grained components (see following slides)grained components (see following slides)» Largely fudges on when/where to use free text vs. Largely fudges on when/where to use free text vs.

structured datastructured data

» Recognizes lack of widely accepted standard terms Recognizes lack of widely accepted standard terms for elements like H&Pfor elements like H&P

ASTM E-1384 ASTM E-1384 EHR ComponentsEHR Components

PatientRegistration

Problem List Encounters("extended")

Encounters(clinic)

Care Plans Orders

Serviceinstances

Procedures Legaldocuments

Schedules Supplies &equipment

ASTM E-1384 ASTM E-1384 EHR Components: ProcedureEHR Components: Procedure

Surgicalprocedure

Outpatientprocedure

Invasive Dxstudy

Bedsideprocedures

Imaging Physiologictracings

Special studies Practitionernotes

Providerdiscreteobservations

Identifyinginformation

Health history Physical exam

ASTM E-1384 ASTM E-1384 EHR Components: Procedure: EHR Components: Procedure:

Physical ExamPhysical Exam

General status Vital signs Skin

Head Ears Eyes

Nose Mouth/tooth/throat

Thorax/lungs

Breast Heart Etc….

ASTM E-1384 ASTM E-1384 EHR Components: Low levelEHR Components: Low level

Sample Patient: 999999MeasurementsLV Diameter (LAX) NormalsDiastolic 4.65 cm (3.6–5.2)Systolic 3.21 cm (2.3–3.9)%Shortening 0.31 (0.18–0.42)IVS Thickness NormalsDiastolic 1.34 cm (0.6–1.1)LVPW Thickness NormalsDiastolic 1.25 cm (0.6–1.1)SAX Endocardial Area NormalsDiastolic 20.34 cm (9.5–22.3)Systolic 11.40 cm (4.0–11.6)% Change 0.44 (0.36–0.64)LA Diameter NormalsSystolic 4.17 cm (2.1–3.7)Diagnostic ImpressionsLeft Atrial DilatationLeft Ve ntricular HypertrophyOverall Normal LV Systolic FunctionSeverely hypokinetic inferior, posterior, and proximal lateral wallsOverall Normal LV Systolic FunctionNo intracardiac masses or vegetations notedMinimal Mitral RegurgitationFIG. 3 Echocardiograph Consultation

ASTM E-1384: Operational ASTM E-1384: Operational Considerations, part 6Considerations, part 6

General principlesGeneral principles» Identify EHR as primary repositoryIdentify EHR as primary repository» Establish minimal EHR components, including:Establish minimal EHR components, including:

data views, structure, data element definitions, coding data views, structure, data element definitions, coding systems, security systems, security

Define EHR data typesDefine EHR data types» For example, date-time, number; see E-1384 table 3For example, date-time, number; see E-1384 table 3» Coded values point to referential master tables (then Coded values point to referential master tables (then

magic occurs….)magic occurs….)» They recommend a National Health Identifier (!)They recommend a National Health Identifier (!)

ASTM E-1384: Operational ASTM E-1384: Operational Considerations, part 6Considerations, part 6

Recommends “Essential Data Elements”Recommends “Essential Data Elements”» Refer to section 6.7.1 of E-1384Refer to section 6.7.1 of E-1384

6.7.1.1 Department of defense/composite healthcare system6.7.1.2 Uniform hospital discharge data set (DHEW 1984)6.7.1.3 Basic ambulatory medical care data set (DHEW 1974)6.7.1.4 Minimum uniform data set for home care (AMRA 1986)6.7.1.5 Minimum hospice data set (AMRA 1984)6.7.1.6 Minimum data set for long-term care (DHHS 1980)6.7.1.7 Health record core data set (AMRA 1986)6.7.1.8 Occupational health data set (AMRA 1986)6.7.1.9 Emergency medical information data set6.7.1.10 Summarized health profile6.7.1.11 The nursing minimum data set6.9.1.8 Master table of laboratory tests, etc.6.9.2 Tests, supplies and equipment (primarily vendor lists?)

ASTM E-1384: ASTM E-1384: EHR Structure, part 7EHR Structure, part 7

ASTM has a small RIM for EHR based on ASTM has a small RIM for EHR based on an object model described in E-1715an object model described in E-1715– Allows links between this RIM and the list of Allows links between this RIM and the list of

data elements in A (annex) 1data elements in A (annex) 1 Overall list of content data segments (pg 11; Overall list of content data segments (pg 11;

part 7, table 4)part 7, table 4) List of sites of care (pg 12; part 7, table 5)List of sites of care (pg 12; part 7, table 5)

ASTM E-1384: Part 8ASTM E-1384: Part 8Alternate Logical StructureAlternate Logical Structure

““Standard data views” include the standard Standard data views” include the standard data sets (somewhat antique) in part 6data sets (somewhat antique) in part 6

““Alternate data views” are object-oriented Alternate data views” are object-oriented views using the methods in part 7 (note views using the methods in part 7 (note section 8, table 7, pp. 17-19)section 8, table 7, pp. 17-19)

ASTM E-1384: Part 9ASTM E-1384: Part 9Object PerspectiveObject Perspective

Major objects of the ASTMMajor objects of the ASTM1. Patient 9.22. Problem list 9.33. Orders (General)/Interventions/Treatment Plan 9.4

Treatment orders 9.4.2Observation orders 9.4.3 order specialization 9.4.4

4. Service instances 9.5Specimen collection instances 9.5.2Observation service instances 9.5.3Observation battery instances 9.5.4Treatment instances 9.5.5

5. Observations 9.66. Encounters 9.77. Appointments 9.88. Procedures 9.99. Legal agreements 9.1010. Service order concept master 9.1111. Provider master 9.12

ASTM E-1384: Part 9ASTM E-1384: Part 9Example of “Patient” (9.2)Example of “Patient” (9.2)

ASTM defines each aspect of PatientASTM defines each aspect of Patient Patient name (see also E-1239)Patient name (see also E-1239) Multiple birth indicatorMultiple birth indicator Universal patient Health ID (!)Universal patient Health ID (!) SSNSSN Date of birthDate of birth SexSex (…)(…)

– ASTM sometimes (not always) proposes codesASTM sometimes (not always) proposes codes M, F, U for sexM, F, U for sex W (White), B (Black), NA (Native American), H (Hispanic) O W (White), B (Black), NA (Native American), H (Hispanic) O

(Oriental), OTH (other)(Oriental), OTH (other)

ASTM E-1384: Part 9ASTM E-1384: Part 9Tests and ordersTests and orders

Includes numerous proposed code sets for Includes numerous proposed code sets for orders and observationsorders and observations

» Example, table 18, pg. 31 “Specimen Source”Example, table 18, pg. 31 “Specimen Source”

» LOINC seems to incorporate many elements for labLOINC seems to incorporate many elements for lab

ASTM E-1384: Part 10ASTM E-1384: Part 10

Appendix X1 and Annex A1 list the data Appendix X1 and Annex A1 list the data attributes and definitions for the proposed attributes and definitions for the proposed ASTM EHR standardASTM EHR standard

Open Health Care InitiativesOpen Health Care Initiatives

GEHR, Good European Health RecordGEHR, Good European Health Record– Developed 1991-1995 by European partnersDeveloped 1991-1995 by European partners– Now placed in public domainNow placed in public domain– http://www.chime.ucl.ac.uk/HealthI/GEHR/http://www.chime.ucl.ac.uk/HealthI/GEHR/

GEHR, Good Electronic Health RecordGEHR, Good Electronic Health Record– Outgrowth of European effortOutgrowth of European effort– http://www.gehr.orghttp://www.gehr.org

GEHR (European)GEHR (European)Architectural componentsArchitectural components

EHCR (Electronic Health Care Record)EHCR (Electronic Health Care Record)– provides the container for all data about a particular patientprovides the container for all data about a particular patient

TransactionTransaction– provides the majority of the features needed for the medico-legal aspects of healthcare dataprovides the majority of the features needed for the medico-legal aspects of healthcare data

– provides the mechanism for the control of amendmentsprovides the mechanism for the control of amendments

– represents the smallest amount of data which can safely be transferred between EHCR represents the smallest amount of data which can safely be transferred between EHCR systemssystems

Health Record Item (HRI)Health Record Item (HRI)– provides the structure for recording the content values of EHCR entriesprovides the structure for recording the content values of EHCR entries

HRI CollectionHRI Collection– provides for aggregation of HRIs and other HRI Collectionsprovides for aggregation of HRIs and other HRI Collections

– provides the means of changing the scope (data subject) of the dataprovides the means of changing the scope (data subject) of the data

HeadingHeading– provides annotation for groups of HRIs/Collectionsprovides annotation for groups of HRIs/Collections

GEHR StructuresGEHR Structures

TransactionsTransactions» These are clinical observations (typically groups of These are clinical observations (typically groups of

observations)observations)

» Clinical observations/transactions do not impose Clinical observations/transactions do not impose structure on the EHRstructure on the EHR

Structure in GEHRStructure in GEHR» Structure is provided by “annotation”, and Structure is provided by “annotation”, and

annotation comes via architectural elements called annotation comes via architectural elements called “headings”“headings”

GEHR “Headings”GEHR “Headings”

Heading: Physical ExaminationAbdomen:

Tenderness:Location = right upper zoneGuarding = present

Mass:Location = right lower zoneSize = largeTenderness = absent

Heading: InvestigationsPeak flow = 420 l/min

OR

““Collections” constrain Collections” constrain data subjectsdata subjects

Collections are hierarchical constructs that Collections are hierarchical constructs that define the subject of a data collectiondefine the subject of a data collection

» For example, 17 kg refers to the liver and not father; For example, 17 kg refers to the liver and not father; right upper zone tenderness refers to abdomen and right upper zone tenderness refers to abdomen and not to the massnot to the mass

Heading: Family historyCollection: Father

Heading: Post mortem findingCollection: Liver

HRI: Weight= 17 Kg

GEHR Health Record ItemsGEHR Health Record Items

GEHR Health Record ItemsGEHR Health Record Items– a construct for the representation of a health record entrya construct for the representation of a health record entry

– ““a meaningful quantity of information when considered alone” a meaningful quantity of information when considered alone” [CEN: TC 251 PT 011][CEN: TC 251 PT 011]

– composed of a name and a contentcomposed of a name and a content

Examples:Examples:– symptom : pain in epigastriumsymptom : pain in epigastrium

– Pulse rate : 84/minPulse rate : 84/min

– family history: maternal diabetesfamily history: maternal diabetes

What it is notWhat it is not– not a content alone, e.g., diabetes, 85mmHgnot a content alone, e.g., diabetes, 85mmHg

GEHR HRI CollectionsGEHR HRI Collections

Heading: Reason for encounterCollection: pain

Item name: location Content value: epigastriumItem name: duration Content value: 4 units: daysItem name: comment Content value: “Worried”

Collection: vomitingItem name: timing Content value: 24.7.94Item name: frequency Content value: x2

Reason for encounter: worried: pain in epigastrium for 4 days,vomiting twice 4 days ago (free text)

GEHR “Headings”GEHR “Headings”

Headings provide a means of grouping or Headings provide a means of grouping or labelling combinations of Collections/HRIs. labelling combinations of Collections/HRIs. – Headings allow instances of clinical concepts, Headings allow instances of clinical concepts,

expressed through Collections and HRIs, to be expressed through Collections and HRIs, to be related to the context of healthcare (and its related to the context of healthcare (and its recording) for the patient. recording) for the patient.

– This property of labelling or grouping is called This property of labelling or grouping is called “Annotation” in the GEHR Object Model“Annotation” in the GEHR Object Model

See pages 68, 70 of GEHR Deliverable 19 for illustrations of HRIs, Collections in GEHR Object model

GEHR Object ModelGEHR Object Model

Appendix B of GEHR Technical Overview Appendix B of GEHR Technical Overview shows worked-out examples for GEHR shows worked-out examples for GEHR object modelobject model

Reference Information ModelsReference Information Models

Several sources of RIM modelsSeveral sources of RIM models– HL7 RIMHL7 RIM– Government GCPR RIMGovernment GCPR RIM– Vendors’ RIMsVendors’ RIMs

Influence of RegulationsInfluence of Regulations

JCAHO Information Management standardsJCAHO Information Management standards HIPPAHIPPA

Links to other sourcesLinks to other sources For open source initiatives, try:For open source initiatives, try:

http://www.openhealth.com/en/healthlinks.htmlhttp://www.openhealth.com/en/healthlinks.html Dept. of Veterans Affairs VistADept. of Veterans Affairs VistA

– http://www.hardhats.org (open source)http://www.hardhats.org (open source)– http://www.va.gov/about_va/orgs/vha/vista.htmhttp://www.va.gov/about_va/orgs/vha/vista.htm

Littlefish project (primary care)Littlefish project (primary care)– http://www.paninfo.com.au/http://www.paninfo.com.au/

Telemed/Openmed (Los Alamos labs)Telemed/Openmed (Los Alamos labs)– http://www.acl.lanl.gov/TeleMed/http://www.acl.lanl.gov/TeleMed/

Other sources suggested 5/25/00Other sources suggested 5/25/00

Other web sitesOther web sites» Http://www.centc251.org (go to finalized work, 4 part Http://www.centc251.org (go to finalized work, 4 part

EHR standards, username/password = expert/health251 EHR standards, username/password = expert/health251 (compliments of [email protected])(compliments of [email protected])

» Try David’s web site (probably www.clinical-info.co.ukTry David’s web site (probably www.clinical-info.co.uk

ISO TC Working Group 1]ISO TC Working Group 1] DICOMDICOM Veterans AdminVeterans Admin