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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
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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
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EHR Function Specification Triplet
WHATStatement of Function, Functionality
WHYRationale, with references
Conformance Criteria
HOWOut of Scope
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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
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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
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Statement of Function - WHATExample: Care delivery
Example hierarchy, decomposition
– L1: Prescribing– L2: Prescription validation– L3: Drug-Disease interaction warnings
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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”
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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
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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…
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Statement of Function - WHATExample: Infrastructure
Example hierarchy, decomposition
– L1: Security– L2: Entity authentication– L3: User authentication
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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.”
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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.”
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Rationale - WHYExample: Infrastructure (cont.)
User authentication references– HIPAA– JCAHO– IOM– ISO 18308, 18307, 21089, 17799– ASTM E1462, E1467– …
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Conformance Criteria
Method or basis for measuring conformance– Of EHR systems
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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
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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
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Contribution (cont.)
Join the email lists Join the Groove collaboration Lead the Groove collaboration Others…(Ken)
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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…
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EHR Ballot Schedule
21 JulyDraft 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
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EHR Ballot Schedule, con’t
1 Augv1.0 ballot opens
1 Septemberv1.0 ballot closes
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EHR Ballot Schedule, con’t
9-11 SeptemberMemphis, Tennessee
Ballot reconciliation
HL7 Fall Plenary and Working Group
Open meeting
Attendees must register w/HL7 and pay meeting fees
Sept/OctNext ballot draft and ballot round…
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EHR Roadmap
Now– v1.0– Draft Standard for Trial Use– 60% consensus needed
Future – v1.1,, v2…– Progressive iterations, each with greater specificity
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EHR Roadmap (cont.)
Functional Hierarchy and Decomposition
v1.0
General
v1.1, v2…
More Specific
Infrastructure Functions
1-5 levels 1-n levels
Care Delivery Functions
1-3 levels 1-n levels
Triplet WHAT, WHY + ConformanceCriteria
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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
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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
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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
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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
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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?
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Function Specification TripletBasis for Inclusion, 1st Screen, con’t
Position triplet within Functional Hierarchy and Decomposition
First pre-ballot draft - target 21 July 2003
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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)
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Function Specification TripletBasis for Inclusion, 2nd Screen, con’t
Post meeting revisions Final ballot draft
Target: End July 2003
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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?
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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
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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!!
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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)
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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
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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)
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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)
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Function Specification TripletBasis for Inclusion, 5th+ Screens
Sep/Oct Next ballot round Repeat Screens 3&4 until consensus is
achieved…
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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
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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
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Contacts Linda Fischetti, RNVeterans Health [email protected]
Gary DickinsonPer-Sé Technologies, [email protected]
Sam Heard, MDOpenEHR, [email protected]