EHR Systems Functional Model
and Standard
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Triplets (what + why + criteria)
Hierarchies/Decompositions
Timelines
Open Process Screens
Ballot
Reconciliation
14 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
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EHR Function Specification Triplet
 WHAT
Statement of Function, Functionality
 WHY
Rationale, with references
 Conformance Criteria
 HOW
Out 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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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
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Statement of Function - WHAT
Example: Care delivery
 Example hierarchy, decomposition
– L1: Prescribing
– L2: Prescription validation
– L3: Drug-Disease interaction warnings
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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”
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Rationale - WHY
 Rationale for inclusion of function(ality)
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–
–
–
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 - 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…
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Statement of Function - WHAT
Example: Infrastructure
 Example hierarchy, decomposition
– L1: Security
– L2: Entity authentication
– L3: User authentication
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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.”
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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.”
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Rationale - WHY
Example: 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 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
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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
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
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EHR Ballot Schedule, con’t
1 Aug
v1.0 ballot opens
1 September
v1.0 ballot closes
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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…
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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
+ Conformance
Criteria
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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 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?
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Function Specification Triplet
Basis for Inclusion, 1st Screen, con’t
 Position triplet within Functional Hierarchy and
Decomposition
 Register triplet
– Per triplet, per submitter
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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)
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Function Specification Triplet
Basis for Inclusion, 2nd Screen, con’t
 Post meeting revisions
 Final ballot draft
Target: End July 2003
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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?
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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
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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!!
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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)
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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
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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)
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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)
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Function Specification Triplet
Basis for Inclusion, 5th+ Screens
Sep/Oct
 Next ballot round
 Repeat Screens 3&4 until consensus is
achieved…
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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
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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
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Contacts
Linda Fischetti, RN
Veterans Health Administration
[email protected]
Gary Dickinson
Per-Sé Technologies, Inc.
[email protected]
Sam Heard, MD
OpenEHR, Australia
[email protected]