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Standards for Structure and Content of Electronic Health Records

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

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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-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

  5. 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

  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-1384 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 6.7.1 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 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)

  17. 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

  18. 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)

  19. 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

  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 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

  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 • 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 • 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: 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)

  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:http://www.openhealth.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/

  33. 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@clinical-info.co.uk) • Try David’s web site (probably www.clinical-info.co.uk • ISO TC Working Group 1] • DICOM • Veterans Admin

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