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EHR Systems Functional Model and Standard. • Triplets (what + why + criteria) • Hierarchies/Decompositions • Timelines • Open Process Screens • Ballot • Reconciliation 2 July 2003. Functional Decomposition. Functional decomposition Based on a functional hierarchy
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EHR Systems Functional Model and Standard • Triplets (what + why + criteria) • Hierarchies/Decompositions• Timelines • Open Process Screens • Ballot • Reconciliation 2 July 2003
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
EHR Function Specification Triplet • WHATStatement of Function, Functionality • WHYRationale, with references • Conformance Criteria • HOWOut of Scope
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
Core v. profile specific • 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
Statement of Function - WHATExample: Care delivery • Example hierarchy, decomposition • L1: Prescribing • L2: Prescription validation • L3: Drug-Disease interaction warnings
Statement of Function - WHATExample: 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”
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
Rationale - WHYExample: Care delivery • Prescription validation • Safety • Proven reduction in medication errors • Reference… • Utility • Proven reduced requirement for medication review by other staff (including pharmacist. • Reference…
Statement of Function - WHATExample: Infrastructure • Example hierarchy, decomposition • L1: Security • L2: Entity authentication • L3: User authentication
Statement of Function - WHATExample: 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.”
Rationale - WHYExample: 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.”
Rationale - WHYExample: Infrastructure (cont.) • User authentication references • HIPAA • JCAHO • IOM • ISO 18308, 18307, 21089, 17799 • ASTM E1462, E1467 • …
Conformance Criteria • Method or basis for measuring conformance • Of EHR systems
Conformance CriteriaExample: 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
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
Contribution (cont.) • Join the email lists • Join the Groove collaboration • Lead the Groove collaboration • Others…(Ken)
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…
EHR Ballot Schedule 21 July Draft published: Co-Chairs and Staff 23-24 July EHR SIG Open Meeting Rockville, MD - AHRQ Conference Center Attendees must register, no meeting fee Draft reviewed and vetted
EHR Ballot Schedule, con’t 1 Aug v1.0 ballot opens 1 September v1.0 ballot closes
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…
EHR Roadmap • Now • v1.0 • Draft Standard for Trial Use • 60% consensus needed • Future • v1.1,, v2… • Progressive iterations, each with greater specificity
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
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
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
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
Function Specification TripletBasis 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?
Function Specification TripletBasis for Inclusion, 1st Screen, con’t • Position triplet within Functional Hierarchy and Decomposition • First pre-ballot draft - target 21 July 2003
Function Specification TripletBasis 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)
Function Specification TripletBasis for Inclusion,2nd Screen, con’t • Post meeting revisions • Final ballot draftTarget: End July 2003
Function Specification TripletBasis for Inclusion, 3rd Screen • Ballot Opens/Closes: 1 Aug to 1 Sep • 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 • OK in future iteration?
Function Specification TripletBasis for Inclusion, 3rd Screen, con’t • Ballot options, con’t • Add/delete proposed EHR use setting • Revise Statement of Function(ality) - WHAT • Revise Rationale - WHY
Function Specification TripletBasis 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!!
Function Specification TripletBasis 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)
Function Specification TripletBasis 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 • Consensus of committee • No committee response to individual submitter
Function Specification TripletBasis 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)
Function Specification TripletBasis 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 toStatement of Function(ality) or Rationale • State reason or suggest compromise • Notify submitter, request withdrawal of negative (if any)
Function Specification TripletBasis for Inclusion, 5th+ Screens Sep/Oct • Next ballot round • Repeat Screens 3&4 until consensus is achieved…
Accepted SubmissionsEHR 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
Accepted SubmissionsEHR 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
Contacts Linda Fischetti, RNVeterans Health AdministrationLinda.Fischetti@med.va.gov Gary DickinsonPer-Sé Technologies, Inc.gary.dickinson@per-se.com Sam Heard, MDOpenEHR, Australiasam.heard@bigpond.com