1. EHR Systems Functional Model and Standard Triplets (what + why + criteria) Hierarchies/Decompositions Timelines Open Process Screens Ballot Reconciliation 14 July 2003

2. Copyright 2003, Health Level Seven 2 Functional Decomposition Functional decomposition –Based on a functional hierarchy –Abstract to specific EHR Function Specification Triplet –At arbitrary level of decomposition: 3+ (?) –Deemed useful for applicability across functional profiles or conformance measure

3. Copyright 2003, Health Level Seven 3 EHR Function Specification Triplet WHAT Statement of Function, Functionality WHY Rationale, with references Conformance Criteria HOW Out of Scope

4. Copyright 2003, Health Level Seven 4 Statement of Function - WHAT Statement of EHR System function(ality) Final Proposed Form [EHR Systems] “must/should/may” [verb-first function statement] Considered per care setting –must/shall :: essential –should :: desirable –may :: optional

5. Copyright 2003, Health Level Seven 5 Minimum (Core) v. Profile Specific Minimum (Core) –Deemed essential in all care settings –Deemed desirable in all care settings Functional Profile Specific –Deemed essential in one care setting and not in another –Deemed desirable in one care setting and not in another

6. Copyright 2003, Health Level Seven 6 Statement of Function - WHAT Example: Care delivery Example hierarchy, decomposition –L1: Prescribing –L2: Prescription validation –L3: Drug-Disease interaction warnings

7. Copyright 2003, Health Level Seven 7 Statement of Function - WHAT Example: Care delivery(cont.) Short statement, verb-first –“Warn of drug-disease interactions” Full statement –“EHRS provide a synchronous warning if a clinician is about to order a medication when the patient has an entry in their problem list which is a contraindication to this medication”

8. Copyright 2003, Health Level Seven 8 Rationale - WHY Rationale for inclusion of function(ality) –Utility based – efficiency, workflow –Safety based – prevent medical errors –Outcome based – improved patient outcomes –Empowerment based – patient in a better position to manage their own care References

9. Copyright 2003, Health Level Seven 9 Rationale - WHY Example: Care delivery Prescription validation Safety –Proven reduction in medication errors Reference… Utility –Proven reduced requirement for medication review by other staff (including pharmacist. Reference…

10. Copyright 2003, Health Level Seven 10 Statement of Function - WHAT Example: Infrastructure Example hierarchy, decomposition –L1: Security –L2: Entity authentication –L3: User authentication

11. Copyright 2003, Health Level Seven 11 Statement of Function - WHAT Example: Infrastructure (cont.) Short statement, verb-first –“Ensure user authentication” Full statement –“EHRS must/should/may ensure user authentication: at signon, at start of user session; and throughout user session.”

12. Copyright 2003, Health Level Seven 12 Rationale - WHY Example: Infrastructure (cont.) User Authentication example “To ensure… –“User identity is verified at signon; –“User identity is established for duration of user session; –“Accountable actions can be attributed (traced) to authenticated users, including acts of EHR authorship and amendment.”

13. Copyright 2003, Health Level Seven 13 Rationale - WHY Example: Infrastructure(cont.) User authentication references –HIPAA –JCAHO –IOM –ISO 18308, 18307, 21089, 17799 –ASTM E1462, E1467 –…

14. Copyright 2003, Health Level Seven 14 Conformance Criteria Method or basis for measuring conformance –Of EHR systems

15. Copyright 2003, Health Level Seven 15 Conformance Criteria Example: Infrastructure User Authentication example EHRS conforms if user identity –Is actively verified at each signon or session start –(and thus) is actively verified before EHR function(s) or content is accessed –Is maintained for duration of user session

16. Copyright 2003, Health Level Seven 16 Contribution Propose functional triplets Process documents and derive functional triplets Review functional triplets in an agreed manner and with agreed criteria Review functional triplets from limited set from the perspective of a care setting

17. Copyright 2003, Health Level Seven 17 Contribution (cont.) Join the email lists Join the Groove collaboration Lead the Groove collaboration Others…(Ken)

18. Copyright 2003, Health Level Seven 18 Proposal for Initial Ballot Functional Hierarchy and Decomposition (v1.0) –Infrastructure: 3-5 levels –Care delivery: 3 levels Triplet –What, Why: v1.0 –Conformance Criteria: v1.1, v2…

19. Copyright 2003, Health Level Seven 19 EHR Ballot Schedule Thru July 23 Accept submitted Hierarchies and Decompositions Triplets 23-24 July EHR SIG Open Meeting Rockville, MD - AHRQ Conference Center Attendees must register, no meeting fee Draft reviewed and vetted

20. Copyright 2003, Health Level Seven 20 EHR Ballot Schedule, con’t 1 Aug v1.0 ballot opens 1 September v1.0 ballot closes

21. Copyright 2003, Health Level Seven 21 EHR Ballot Schedule, con’t 9-11 September Memphis, Tennessee Ballot reconciliation HL7 Fall Plenary and Working Group Open meeting Attendees must register w/HL7 and pay meeting fees Sept/Oct Next ballot draft and ballot round…

22. Copyright 2003, Health Level Seven 22 EHR Roadmap Now –v1.0 –Draft Standard for Trial Use –60% consensus needed Future –v1.1, v2… –Progressive iterations, each with greater specificity

23. Copyright 2003, Health Level Seven 23 EHR Roadmap (cont.) Functional Hierarchy and Decomposition v1.0 General v1.1, v2… More Specific Infrastructure Functions 1-5 levels1-n levels Care Delivery Functions 1-3 levels1-n levels TripletWHAT, WHY+ Conformance Criteria

24. Copyright 2003, Health Level Seven 24 EHR Ballot, Part 1 (proposed) EHR Functional Model Framework Horizontal Axis - EHR Function –EHR Infrastructure Functions –EHR Care Delivery Functions Vertical Axis - EHR Use –EHR Care Setting Profiles –EHR Use Profiles Informative

25. Copyright 2003, Health Level Seven 25 EHR Ballot, Part 2 (proposed) Functional Hierarchy/Decomposition Framework Hierarchical framework –Establishes functional groupings and relationships –Identifies functional inter-dependencies and redundancies –Supports Functional Decomposition Informative Does not dictate implementation

26. Copyright 2003, Health Level Seven 26 EHR Ballot, Part 3 (proposed) EHR Function Specification Triplets One per EHR function(ality) proposed for inclusion Placed at parent or leaf nodes in Functional Hierarchy Where applicability/conformance metric is deemed useful

27. Copyright 2003, Health Level Seven 27 EHR Ballot, Part 3 (proposed, con’t) EHR Function Specification Triplets Now –v1.0 –Informative (as DTSU) –What + Why Next –v1.1, v2… –Normative –What + Why + Conformance Criteria

28. Copyright 2003, Health Level Seven 28 Function Specification Triplet Basis for Inclusion, 1st Screen SIG Co-Chairs and Staff Applicability: Within EHR scope? –Does function(ality) apply to at least one EHR system in one EHR use setting? –Identify applicable use settings Now or Next Iteration: Within EHR v1.0 scope? –Is function(ality) within decomposition scope for v1.0?

29. Copyright 2003, Health Level Seven 29 Function Specification Triplet Basis for Inclusion, 1st Screen, con’t Position triplet within Functional Hierarchy and Decomposition Register triplet –Per triplet, per submitter

30. Copyright 2003, Health Level Seven 30 Function Specification Triplet Basis for Inclusion, 2nd Screen Review in open session –EHR SIG Open Meeting, 23-24 July –HL7 membership not required Consensus of attendees Per triplet: –Applicability? –Now or next iteration? –Typical Use Setting(s)

31. Copyright 2003, Health Level Seven 31 Function Specification Triplet Basis for Inclusion, 2nd Screen, con’t Post meeting revisions Final ballot draft Target: End July 2003

32. Copyright 2003, Health Level Seven 32 Function Specification Triplet Basis for Inclusion, 3rd Screen Ballot Opens/Closes: 1 Aug to 1 Sep 2003 Ballot options –Add new function(ality), including proposed: Function Specification Triplet Placement within Functional Hierarchy and Decomposition Urgency: now or future iteration –Exclude proposed function(ality) Reason for exclusion Exclude now but include in future iteration?

33. Copyright 2003, Health Level Seven 33 Function Specification Triplet Basis for Inclusion, 3rd Screen, con’t Ballot options, con’t –Per triplet, add/delete applicable EHR use setting –Per use setting, set mandatory, desirable or other –Revise Statement of Function(ality) - WHAT –Revise Rationale - WHY

34. Copyright 2003, Health Level Seven 34 Function Specification Triplet Basis for Inclusion, 4th Screen Review in open session –EHR SIG Meeting, 9-11 September –In conjunction with HL7 Annual Plenary, Memphis –HL7 membership not required but meeting fee is Consensus of attendees Ballot submitters are encouraged to attend while their comments are discussed and resolution sought!!

35. Copyright 2003, Health Level Seven 35 Function Specification Triplet Basis for Inclusion, 4th Screen, con’t Ballot Resolution Options Accept vote to add function(ality) –Establish Statement of Function(ality) - WHAT –Establish Rationale - WHY –Within v1.0 scope? Place in Functional Hierarchy and Decomposition –Beyond v1.0 scope? Log for future consideration, inclusion –Establish related EHR Use Setting(s) –Revise ballot draft –Request submitter to withdraw negative (if any)

36. Copyright 2003, Health Level Seven 36 Function Specification Triplet Basis for Inclusion, 4th Screen, con’t Ballot Resolution Options, con’t Decline vote to add function(ality) –State reason: e.g., out of scope –Offer compromise to submitter: e.g., future consideration –Notify submitter, request withdrawal of negative (if any) Votes to include or exclude care settings Votes for mandatory, desirable… –Consensus of committee –No committee response to individual submitter

37. Copyright 2003, Health Level Seven 37 Function Specification Triplet Basis for Inclusion, 4th Screen, con’t Ballot Resolution Options, con’t Accept vote to exclude function(ality) –State reason: e.g., out of scope –Offer compromise to submitter: e.g., future consideration –Revise ballot draft –Notify submitter, request withdrawal of negative (if any) Decline vote to exclude function(ality) –State reason –Notify submitter, request withdrawal of negative (if any)

38. Copyright 2003, Health Level Seven 38 Function Specification Triplet Basis for Inclusion, 4th Screen, con’t Ballot Resolution Options, con’t Accept revision to Statement of Function(ality) or Rationale –Revise draft –Notify submitter, request withdrawal of negative (if any) Decline revision to Statement of Function(ality) or Rationale –State reason or suggest compromise –Notify submitter, request withdrawal of negative (if any)

39. Copyright 2003, Health Level Seven 39 Function Specification Triplet Basis for Inclusion, 5th+ Screens Sep/Oct Next ballot round Repeat Screens 3&4 until consensus is achieved…

40. Copyright 2003, Health Level Seven 40 Accepted Submissions EHR Functional Hierarchies Proposed EHR functional hierarchies and decompositions, as scoped for v1.0: –EHR Infrastructure Functions Decomposition - target 5 levels –EHR Care Delivery Functions Decomposition - target 3 levels

41. Copyright 2003, Health Level Seven 41 Accepted Submissions EHR Specification Triplets Proposed EHR Specification Triplets –1) What 2) Why 3) Conformance Criteria Proposed in context of: –Applicable use setting(s) –Placement within Functional Hierarchy and Decomposition

42. Contacts Linda Fischetti, RN Veterans Health Administration Linda.Fischetti@med.va.gov Linda.Fischetti@med.va.gov Gary Dickinson Per-Sé Technologies, Inc. gary.dickinson@per-se.com gary.dickinson@per-se.com Sam Heard, MD OpenEHR, Australia sam.heard@bigpond.com sam.heard@bigpond.com