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 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

EHR Ballot Schedule, con’t

1 Augv1.0 ballot opens

1 Septemberv1.0 ballot closes

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…

EHR Roadmap

Now– v1.0– Draft Standard for Trial Use– 60% consensus needed

Future – v1.1,, v2…– Progressive iterations, each with greater specificity

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

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 draft

Target: 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