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Standards for Structure and Content of Electronic Health Records

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

2 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., physician’s problem list, radiologist’s impression, nurse’s assessment) Content and structure must work with standards for vocabulary and messaging

3 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

4 Standards for EHR Content
ASTM E 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

5 ASTM E-1394-99 ASTM standard for EHR content, structure
Available at for $60.00 Does NOT deal with messaging ( ) Does NOT dictate data required or particular applications (4.1.3) e.g., Recognizes rapid change in regulatory and quality improvement data standards

6 Electronic Health Records
Roles of EHR (ASTM 1384) Represents patient’s 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

7 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)

8 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 H&P

9 ASTM E EHR Components

10 ASTM E-1384 EHR Components: Procedure

11 ASTM E-1384 EHR Components: Procedure: Physical Exam

12 ASTM E-1384 EHR Components: Low level

13 ASTM E-1384: Operational Considerations, part 6
General principles Identify EHR as primary repository Establish minimal EHR components, including: data 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 (!)

14 ASTM E-1384: Operational Considerations, part 6
Recommends “Essential Data Elements” Refer to section of E-1384

15 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)

16 ASTM E-1384: Part 8 Alternate 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 ASTM E-1384: Part 9 Object 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

18 ASTM E-1384: Part 9 Example 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)

19 ASTM E-1384: Part 9 Tests 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

20 ASTM E-1384: Part 10 Appendix X1 and Annex A1 list the data attributes and definitions for the proposed ASTM EHR standard

21 Open Health Care Initiatives
GEHR, Good European Health Record Developed by European partners Now placed in public domain GEHR, Good Electronic Health Record Outgrowth of European effort

22 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

23 GEHR Structures Transactions Structure in GEHR
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”

24 GEHR “Headings” Heading: Investigations Peak flow = 420 l/min OR
Heading: Physical Examination Abdomen: Tenderness: Location = right upper zone Guarding = present Mass: Location = right lower zone Size = large Tenderness = absent

25 “Collections” constrain data subjects
Heading: Family history Collection: Father Heading: Post mortem finding Collection: 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

26 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

27 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: Item name: frequency Content value: x2 Reason for encounter: worried: pain in epigastrium for 4 days, vomiting twice 4 days ago (free text)

28 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

29 GEHR Object Model Appendix B of GEHR Technical Overview shows worked-out examples for GEHR object model

30 Reference Information Models
Several sources of RIM models HL7 RIM Government GCPR RIM Vendors’ RIMs

31 Influence of Regulations
JCAHO Information Management standards HIPPA

32 Links to other sources For open source initiatives, try: Dept. of Veterans Affairs VistA (open source) Littlefish project (primary care) Telemed/Openmed (Los Alamos labs)

33 Other sources suggested 5/25/00
Other web sites (go to finalized work, 4 part EHR standards, username/password = expert/health251 (compliments of Try David’s web site (probably ISO TC Working Group 1] DICOM Veterans Admin

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