Standards for Structure and Content of Electronic Health Records

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Standards for Structure and Content of
Electronic Health Records

• Mike Lincoln

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Electronic Health Records (EHR)

• Wide scope of intended application
• Acute care hospitals, ambulatory care, long term
  care, home health care, emergency rooms
• Content and logical structure important
• Must organize all health related information over
  time (e.g., physicians problem list,
  radiologists impression, nurses assessment)
• Content and structure must work with standards
  for vocabulary and messaging

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Discussion Goals

• Review standards for EHR content and logical
  structure
• Understand relationship of regulatory
  requirements
• Request discussion and help on additional sources
  for this document

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Standards for EHR Content

• ASTM E-1384-99
• Open health care initiatives
• GEHR (Good Electronic Health Record)
• RIM efforts
• Standards Development Organizations (SDO)
• Government RIM
• Imposition of some structure by regulatory
  agencies
• e.g., JCAHO

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ASTM E-1394-99

• ASTM standard for EHR content, structure
• Available at http//www.astm.org for 60.00
• Does NOT deal with messaging (4.1.3.3)
• Does NOT dictate data required or particular
  applications (4.1.3)
• e.g., Recognizes rapid change in regulatory and
  quality improvement data standards

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Electronic Health Records

• Roles of EHR (ASTM 1384)
• Represents patients health history
• Communication among health care practitioners
• Legal document for health care
• Source for clinical, outcomes and health services
  research
• Resource for practitioner education
• Alerts, reminders, quality improvement

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Contents of ASTM E-1384-99

• Four main parts
• Segments of traditional paper record (pt.5)
• Privacy and security principles (pt. 6)
• Common data model for EHR (pt. 7)
• Content views and minimum data for EHR (pts. 8-9,
  including section 10, a list of data dictionary
  elements)

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ASTM E-1384 part 5

• Catalogue of primary record components by source
• For tests without CPT codes uses listings from
  Appendix X1 of E-1238
• Breaks down EHR into more and more finely grained
  components (see following slides)
• Largely fudges on when/where to use free text vs.
  structured data
• Recognizes lack of widely accepted standard terms
  for elements like HP

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ASTM E-1384 EHR Components
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ASTM E-1384 EHR Components Procedure
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ASTM E-1384 EHR Components Procedure Physical
Exam
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ASTM E-1384 EHR Components Low level
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ASTM E-1384 Operational Considerations, part 6

• General principles
• Identify EHR as primary repository
• Establish minimal EHR components, includingdata
  views, structure, data element definitions,
  coding systems, security
• Define EHR data types
• For example, date-time, number see E-1384 table
  3
• Coded values point to referential master tables
  (then magic occurs.)
• They recommend a National Health Identifier (!)

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ASTM E-1384 Operational Considerations, part 6

• Recommends Essential Data Elements
• Refer to section 6.7.1 of E-1384

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ASTM E-1384 EHR Structure, part 7

• ASTM has a small RIM for EHR based on an object
  model described in E-1715
• Allows links between this RIM and the list of
  data elements in A (annex) 1
• Overall list of content data segments (pg 11
  part 7, table 4)
• List of sites of care (pg 12 part 7, table 5)

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ASTM E-1384 Part 8Alternate Logical Structure

• Standard data views include the standard data
  sets (somewhat antique) in part 6
• Alternate data views are object-oriented views
  using the methods in part 7 (note section 8,
  table 7, pp. 17-19)

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ASTM E-1384 Part 9Object Perspective

• Major objects of the ASTM

1. Patient 9.2 2. Problem list 9.3 3. Orders
(General)/Interventions/Treatment Plan
9.4 Treatment orders 9.4.2 Observation orders
9.4.3 order specialization 9.4.4 4. Service
instances 9.5 Specimen collection instances
9.5.2 Observation service instances
9.5.3 Observation battery instances
9.5.4 Treatment instances 9.5.5 5. Observations
9.6 6. Encounters 9.7 7. Appointments 9.8 8.
Procedures 9.9 9. Legal agreements 9.10 10.
Service order concept master 9.11 11. Provider
master 9.12
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ASTM E-1384 Part 9Example of Patient (9.2)

• ASTM defines each aspect of Patient
• Patient name (see also E-1239)
• Multiple birth indicator
• Universal patient Health ID (!)
• SSN
• Date of birth
• Sex
• ()
• ASTM sometimes (not always) proposes codes
• M, F, U for sex
• W (White), B (Black), NA (Native American), H
  (Hispanic) O (Oriental), OTH (other)

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ASTM E-1384 Part 9Tests and orders

• Includes numerous proposed code sets for orders
  and observations
• Example, table 18, pg. 31 Specimen Source
• LOINC seems to incorporate many elements for lab

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ASTM E-1384 Part 10

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

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Open Health Care Initiatives

• GEHR, Good European Health Record
• Developed 1991-1995 by European partners
• Now placed in public domain
• http//www.chime.ucl.ac.uk/HealthI/GEHR/
• GEHR, Good Electronic Health Record
• Outgrowth of European effort
• http//www.gehr.org

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GEHR (European)Architectural components

• EHCR (Electronic Health Care Record)
• provides the container for all data about a
  particular patient
• Transaction
• provides the majority of the features needed for
  the medico-legal aspects of healthcare data
• provides the mechanism for the control of
  amendments
• represents the smallest amount of data which can
  safely be transferred between EHCR systems
• Health Record Item (HRI)
• provides the structure for recording the content
  values of EHCR entries
• HRI Collection
• provides for aggregation of HRIs and other HRI
  Collections
• provides the means of changing the scope (data
  subject) of the data
• Heading
• provides annotation for groups of HRIs/Collections

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GEHR Structures

• Transactions
• These are clinical observations (typically groups
  of observations)
• Clinical observations/transactions do not impose
  structure on the EHR
• Structure in GEHR
• Structure is provided by annotation, and
  annotation comes via architectural elements
  called headings

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GEHR Headings
Heading Investigations Peak flow 420 l/min
OR
Heading Physical Examination Abdomen Tenderne
ss Location right upper zone Guarding
present Mass Location right lower
zone Size large Tenderness absent
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Collections constrain data subjects
Heading Family history Collection
Father Heading Post mortem finding Collectio
n Liver HRI Weight 17 Kg

• Collections are hierarchical constructs that
  define the subject of a data collection
• For example, 17 kg refers to the liver and not
  father right upper zone tenderness refers to
  abdomen and not to the mass

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GEHR Health Record Items

• GEHR Health Record Items
• a construct for the representation of a health
  record entry
• a meaningful quantity of information when
  considered alone CEN TC 251 PT 011
• composed of a name and a content
• Examples
• symptom pain in epigastrium
• Pulse rate 84/min
• family history maternal diabetes
• What it is not
• not a content alone, e.g., diabetes, 85mmHg

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GEHR HRI Collections
Heading Reason for encounter Collection
pain Item name location Content value
epigastrium Item name duration Content value
4 units days Item name comment Content value
Worried Collection vomiting Item name
timing Content value 24.7.94 Item name
frequency Content value x2 Reason for encounter
worried pain in epigastrium for 4 days, vomiting
twice 4 days ago (free text)
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GEHR Headings

• Headings provide a means of grouping or labelling
  combinations of Collections/HRIs.
• Headings allow instances of clinical concepts,
  expressed through Collections and HRIs, to be
  related to the context of healthcare (and its
  recording) for the patient.
• This property of labelling or grouping is called
  Annotation in the GEHR Object Model

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

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

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Reference Information Models

• Several sources of RIM models
• HL7 RIM
• Government GCPR RIM
• Vendors RIMs

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Influence of Regulations

• JCAHO Information Management standards
• HIPPA

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Links to other sources

• For open source initiatives, tryhttp//www.openh
  ealth.com/en/healthlinks.html
• Dept. of Veterans Affairs VistA
• http//www.hardhats.org (open source)
• http//www.va.gov/about_va/orgs/vha/vista.htm
• Littlefish project (primary care)
• http//www.paninfo.com.au/
• Telemed/Openmed (Los Alamos labs)
• http//www.acl.lanl.gov/TeleMed/

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Other sources suggested 5/25/00

• Other web sites
• Http//www.centc251.org (go to finalized work, 4
  part EHR standards, username/password
  expert/health251 (compliments of
  david_at_clinical-info.co.uk)
• Try Davids web site (probably www.clinical-info.c
  o.uk
• ISO TC Working Group 1
• DICOM
• Veterans Admin