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  1. Project Name and ID

Enter the name of the project here: Outcome Criteria Framework Implementation Guide

Project ID: 1633

Complete this section for all “Direct to Normative” ballot projects and when a project proceeds from “Informative to Normative” or “STU to Normative”.

Forward PSS to the TSC (via; this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.


TSC Notification:  Informative/STU to Normative 

Date:  Submission date


- or -                     Direct to Normative (no STU) (includes reaffirmations)       


Identify ISO, IEC or ISO/IEC standard to be adopted in text box below

Enter info here if an ISO, IEC, or ISO/IEC Standard is to be adopted as an American National Standard; Enter the designation of the standard(s) to be adopted:

Includes text from ISO, IEC or ISO/IEC standard: Check here if this standard includes excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption.




Select the unit of measure used in the standard; if no measurements are in the standard, select N/A









Investigative Project (aka PSS-Lite)

Date : 

Check this box when the project is investigative or exploratory in nature, which allows limited project scope definition. Sections 1-Project Name, 2-Sponsoring Group(s)/Project Team, 3a-Project Scope, 3b-Project Need, 3e-Project Objectives/Deliverables/Target Dates, 3i-Project Document Repository, 6b-[Realm, if known], and 6d-[applicable Approval Dates] are required for Investigative Project. Investigative Project specific instructions are highlighted in yellow. An investigative project must advance in two WGM cycles, requiring a full scope statement. Otherwise the project will be closed.

2. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

Primary Sponsor/Work Group
(1 (And Only 1) Allowed)

Clinical Quality Information

2.b. Co-sponsor Work Group(s)

Co-sponsor Work Group(s):

(Enter co-sponsor approval dates in Section 6.d Project Approval Dates)

Clinical Decision Support

Indicate the level of involvement that the co-sponsor will have for this project:
 Request formal content review prior to ballot
x Request periodic project updates. Specify periodduring ballot prep; during ballot reconciliation
 Other Involvement. Specify details here: 

2.c. Project Team

All names should have confirmed their role in the project prior to submission to the TSC.

Project facilitator (1Mandatory)

Michelle Leavy

Other interested parties and their roles

Multi-disciplinary project team (recommended)

     Modeling facilitator

Bob Dolin

    Publishing facilitator

Bob Dolin

    Vocabulary facilitator

Gay Dolin

     Domain expert rep

Michelle Leavy

     Business requirement analyst

Bob Dolin, Yan Heras

     Conformance facilitator (for IG projects)

Bob Dolin

     Other facilitators (SOA, etc)

Peter Emmanuel

Implementers (2Mandatory for STU projects)

FHIR Project Note: The implementer requirement will be handled by the “balloting” project.  Therefore work groups do not fill out the above section.  However, feel free to list implementers specific to your work group’s resources if you know of any.

1) Elimu Informatics

2) OM1

3. Project Definition

3.a. Project Scope

The AHRQ Outcome Measures Framework (OMF) defines six categories of outcomes: Survival, Clinical Response, Events of Interest, Patient-Reported, Resource Utilization, Impact on Non-Participant, and Experience of Care. Using this Framework, expert panels have converged on a core set of outcome definitions and criteria for a number of conditions, including Depression, Asthma, Lung Cancer, Lumbar Spondylolisthesis, and others. Depression outcomes include such items as 'improvement in depressive symptoms', 'suicidal ideation', and 'work productivity'. Lung Cancer outcomes include such items as 'progression', 'disease-free survival', 'healthcare utilization'. Asthma outcomes include such items as 'exacerbation', 'asthma control', 'quality of life'.

As one might expect, different groups with different use cases (e.g. research, quality measurement, clinical decision support) might define these outcomes differently, hampering data reuse.

We seek in this project to define a method and a formalism for representing outcome definitions and criteria, such that the criteria can be reused across different use cases. We propose aligning with the direction the United States is going with quality measurements and decision support, so that a common set of definitions can be used across quality measurement, decision support, research, and patient care; and so that we are better able to extract and use data captured in the process of patient care.

We will start with an example based on content available for depression outcomes including such items as those mentioned above. Other potential examples might include criteria in other expert panel reviewed domains. 

In scope for this project:

[1] Define a reproducible method and a formalism for representing condition outcome definitions and criteria, such that the representations can be reused across different use cases.

[2] Align the formalism with the direction the United States is going with quality measurements and decision support, using FHIR, QI-Core, and CQL.

[3] Demonstrate this process end to end through the development of a set of examples, beginning with Depression.  [The example will be used to demonstrate the use of the Framework and not to ballot the content.]

[4] Publish this process and set of examples in a FHIR Implementation Guide.


This FHIR implementation guide will use the US Core profiles. If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.

3.b. Project Need

Learning Health Systems are hampered by differences in condition definitions and criteria across quality measurements, decision support, research, and direct patient care. These differences further add to provider data capture burden, and hamper our ability to reuse data generated in the process of patient care.

3.c. Security Risks

Will this project produce executable(s), for example, schemas, transforms, style sheets, executable program, etc.  If so the project must review and document security risks. Refer to the Cookbook for Security Considerations for additional guidance, including sample spreadsheets that may be used to conduct the security risk assessment. 





3.d. External Drivers

This work is supported by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund under Interagency Agreement 18-596R-18 through Agency for Healthcare Research and Quality contract no. 75Q80119C00005.

3.e. Project Objectives / Deliverables / Target Dates

Within each row, enter the explicit work product(s) / objective(s).  Indicate their target date at the right in WGM/Ballot Cycle format.  Include the project end date as the last objective (for standards projects, the end date will be the projected ANSI approval date). 

Target Date(in WGM or ballot cycle format, e.g.

‘2017 Sept WGM’ or

‘2017 Jan Ballot’)

Comment-Only ballot

  • Connectathon
  • Submit
  • Reconcile
  • Publish
  • May, 2021 connectathon
  • May, 2021 ballot cycle
  • 3 mo to reconcile and publish

STU ballot

  • Connectathon
  • Submit
  • Reconcile
  • Publish
  • Sept, 2021 connectathon
  • Sept, 2021 ballot cycle
  • 6 mo to reconcile and publish
Real world testing and possible additional STU ballot(s)Through Sept, 2022

Normative ballot

  • Connectathon
  • Submit
  • Reconcile
  • Publish
  • Sept, 2022 connectathon
  • Sept, 2022 ballot cycle
  • 6 mo to reconcile and publish

Project End Date (all objectives have been met)

Note:  For PSS-Lite/Investigative Project, End date must be no more than two WGM cycles, e.g. project initiated at January WGM must complete investigation by September WGM.

2023 May

3.f.   Common Names / Keywords / Aliases

Outcome Measures Framework, OMF

3.g. Lineage


3.h. Project Dependencies

QI-Core; CQL; FHIR Library resource

3.i.   HL7-Managed Project Document Repository Location

Projects must adhere to the TSC's guidelines (which were approved on 2016-04-04 and summarized in Appendix A).

A template to create a Project Page on the HL7 Wiki is available at:

Enter the SPECIFIC URL of the HL7-MANAGED SITE where supporting project documents, deliverables, ballot reconciliation work and other project information will be kept

3.j.   Backwards Compatibility

Are the items being produced by this project backward compatible?






If you check 'Yes' please indicate the earliest prior release and/or version to which the compatibility applies:

For V3, are you using the current data types? 

(Refer to TSC position statement on new projects using R2B for more information on the current V3 data types)






If you check no, please explain the reason:

If desired, enter additional information regarding Backwards Compatibility.

3.k. External Vocabularies

Will this project include/reference external vocabularies?






If Yes, please enter the vocabularies: We currently anticipate at least SNOMED, ICD10CM, LOINC, RxNorm

4. Products (check all that apply)

Arden Syntax

V2 Messages – Administrative

Clinical Information Modeling Initiative (CIMI)

V2 Messages - Clinical

Clinical Context Object Workgroup (CCOW)

V2 Messages - Departmental

Domain Analysis Model (DAM)

V2 Messages – Infrastructure

Electronic Health Record (EHR) Functional Profile

V3 Domain Information Model (DIM / DMIM)

FHIR Extensions

V3 Documents – Administrative (e.g. SPL)


FHIR Implementation Guide (enter FHIR product version below)

V3 Documents – Clinical (e.g. CDA)

FHIR Profiles (enter FHIR product version below)

V3 Documents - Knowledge

FHIR Resources

V3 Foundation – RIM

Guidance (e.g. Companion Guide, Cookbook, etc)

V3 Foundation – Vocab Domains & Value Sets

Logical Model

V3 Messages - Administrative

New/Modified/HL7 Policy/Procedure/Process

V3 Messages - Clinical

New Product Definition (please define below)

V3 Messages - Departmental

New Product Family (please define below)

V3 Messages - Infrastructure

Non Product Project - (Educ. Marketing, Elec. Services, etc.)

V3 Rules - GELLO

White Paper

V3 Services – Java Services (ITS Work Group)

Creating/Using a tool not listed in the HL7 Tool Inventory

V3 Services – Web Services (SOA)


If you checked New Product Definition or New Product Family, please define below:

For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?


5. Project Intent (check all that apply)

Create new standard

Supplement to a current standard

Revise current standard (see text box below)


Implementation Guide (IG) will be created/modified

Reaffirmation of a standard

Project is adopting/endorsing an externally developed IG:

New/Modified HL7 Policy/Procedure/Process

Specify external organization in Sec. 6 below;

Externally developed IG is to be (select one):

White Paper (select one):

Adopted  - OR -



Balloted Informative OR

Non-balloted WG White Paper

N/A  (Project not directly related to an HL7 Standard)


If revising a current standard, indicate the following:

-    Name of the standard being revised:
-    Date it was published (or request for publication, or ANSI designation date)
-    Rationale for revision
-    The relationship between the new standard and the current standard (is it designed to replace the current standard, a supplement to the current standard, etc.)

5.a. Ballot Type (check all that apply)

Comment (aka Comment-Only)

Joint Ballot (with other SDOs)


N/A  (project won’t go through ballot)


STU to Normative     - OR -

Normative (no STU)


If necessary, add any additional ballot information here.  If artifacts will be jointly balloted with other SDOs, list the other groups.

5.b. Joint Copyright

Check this box if you will be pursuing a joint copyright.  Note that when this box is checked, a Joint Copyright Letter of Agreement must be submitted to the TSC in order for the PSS to receive TSC approval.

Joint Copyrighted Material will be produced?




6. Project Logistics

6.a. External Project Collaboration

Include SDOs or other external entities you are collaborating with, including government agencies as well as any industry outreach.  Indicate the nature and status of the Memorandum of Understanding (MOU) if applicable.

For projects that have some of their content already developed:

How much content for this project is already developed?

Portions of the examples, but none of the normative content

Was the content externally developed ? :



Is this a hosted (externally funded) project?  (not asking for amount just if funded)




6.b. Realm


- OR -


Realm Specific


Check here if this standard balloted or was previously approved as realm specific standard


6.c. Stakeholders / Vendors / Providers

This section must be completed for projects containing items expected to be ANSI approved, as it is an ANSI requirement for all ballots








Clinical and Public Health Laboratories




Clinical and Public Health Laboratories


Immunization Registries




Emergency Services


Quality Reporting Agencies




Local and State Departments of Health


Regulatory Agency


Health Care IT


Medical Imaging Service


Standards Development Organizations (SDOs)


Clinical Decision Support Systems


Healthcare Institutions (hospitals, long term care, home care, mental health)






Other (specify in text box below)


Other (specify in text box below)








Other (specify below)







Other:  Indicate other stakeholders, vendors or providers not listed above.

6.d. Project Approval Dates

Click here to go to HL7 Project Scope Statement Instructions#Appendix A for more information regarding this section.
Approvals are by simple majority vote of the approving body