NOTE: To use Track Changes, turn off “protection” by clicking on (pre-MS Word 2007) Tools > Unprotect Document or (MS Word 2007 and higher) Review > Protect Document. PSS-Lite/Investigative Projects: Sections surrounded by a BOLD OUTLINE must be completed for approval of "Investigative Projects" (a.k.a PSS-Lite).

1. Project Name and ID

Harmonization of Health Quality Information Models - FHIR Project ID: 1125TSC Notification Informative/STU to Normative Date :

Investigative Project Date :

2. Sponsoring Group(s) / Project Team2.a.Primary Sponsor/Work Group

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

Clinical Quality Information (CQI)

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 (CDS) – 2017-01-18 Clinical Information Modeling Initiative (CIMI) –2017-01-18

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 period: Monthly, at WGMs, etc. Other Involvement. Specify details here:

2.c.Project TeamAll names should have confirmed their role in the project prior to submission to the TSC.

Project facilitator (1 Mandatory) Bryn RhodesOther interested parties and their roles Clinical Statement, ArB, FHIR Management Group,

Other Work Groups with overlapping Content (Patient Care, Orders and Observations, Pharmacy, etc.)

Multi-disciplinary project team (recommended)Modeling facilitator Claude Nanjo, Graham Grieve, Richard EsmondPublishing facilitator Bryn RhodesVocabulary facilitator Rob McClureDomain expert rep Ken Kawamoto, Floyd Eisenberg, Bryn Rhodes,

Claude Nanjo, Marc Hadley Business requirement analyst Bryn Rhodes, Floyd Eisenberg, Michelle Dardis,

Cynthia Barton, Anne Marie SmithConformance facilitator (for IG projects)Other facilitators (SOA, etc)

Implementers (2 Mandatory 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) Clinical Quality Framework2) CMS

document.docx 2017 Release Page 1 of 5© 2023 Health Level Seven® International.  All rights reserved

3. Project Definition3.a.Project Scope

The scope of this project is to develop FHIR artifacts needed for clinical quality measurement and clinical decision support. The information is based on the Quality Information Domain Analysis Model balloted in 2013 and has expanded to develop a set of FHIR resources with some constraints based on needs for clinical decision support and quality evaluation. The result, QI Core and the logical view, QUICK (Quality Improvement Clinical Knowledge) was developed and published for piloting in 2015. The plan is to evolve the existing requirements and model to CIMI detailed clinical models to enable a standard methodology to manage data models across HL7 standards. Specifically, the project will focus on several high-value models and demonstrate a process for mapping from the CIMI model representation to FHIR resources and profiles that allow for developers and measure authors to be able to interact with instances of the model using the same view of the information. This will require a methodology for mapping from CIMI models to FHIR resources and/or profiles, as well as tooling to ensure that:

Primitive values can be treated as primitives directly Extensions can be accessed as first-class properties References can be followed simply

When requirements drive changes to core resources, these changes will be applied through the standard process of making changes to FHIR core resources, or submitting new resources as appropriate. For profiles, these changes will be applied to the QI-Core profiles and published as part of the QI-Core Implementation Guide.

In addition, the project will work to ensure the suitability of the resulting QI-Core profiles for use by payers. In particular, profiles for the Claim and Coverage resources will be added to QI-Core.

3.b.Project NeedThis project is part of a broader effort to align the HL7 Product Line related to Health Quality using principals and language of the HL7 Services Aware Interoperability Framework. The expression of clinically relevant information needs to initiate with data capture to enable re-use in clinical decision support and quality evaluation. The project is part of a harmonization effort combining approaches from pre-existing artifacts to enable a standardized approach to managing information. This project seeks perform that harmonization and build the FHIR QI Core from basic FHIR resources developed by representative domain Workgroups.

3.c.Security RisksWill 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.

YesX No

Unknown

3.d.External DriversStandardization of information to manage clinical decision support and quality evaluation addressing clinical workflow is a clear requirement to support value based care such in US and other government programs.

3.e.Project Objectives / Deliverables / Target DatesTarget Date

Sponsoring Group Approval DatesInitial CQI WG Approval 2014-05-08, CDS WG 2014-05-08document.docx 2017 Release Page 2 of 5

© 2023 Health Level Seven® International.  All rights reserved

New DSTU Ballot: CQI WG 2016-05-11Submit for STU Ballot 2016 Sep WGMComplete STU Reconciliation 2016 NovemberSubmit for 2nd STU Ballot with additional content TBDComplete STU Reconciliation TBDSTU Period Publication 2017 March – 2019

JunSubmit for Normative Ballot 2019 May BallotComplete Normative Reconciliation 2019 Sep WGMSubmit Publication Request 2019 OctReceive ANSI Approval 2019 Nov 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.

2019 Dec

3.f. Common Names / Keywords / AliasesQI Core, QUICK, FHIR Quality, QUICK Logical View

3.g.LineageQI Core V2

3.h.Project DependenciesThis project will depend on other projects related to aligning the Product Family related to Health Quality. It is also dependent on maintaining currency with the FHIR version in effect at the time of the QI Core balloting.

3.i. Project Document Repository Locationhttp://www.hl7.org/implement/standards/fhir/qicore/qicore.htmlhttp://hl7docs.appspot.com/quick/index.html

3.j. Backwards CompatibilityAre the items being produced by this project backward compatible?

Yes No Unknown X N/A

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)

Yes No Unknown X N/A

If you check 'No' please explain the reason:

If desired, enter additional information regarding Backwards Compatibility.

3.k.External VocabulariesWill this project include/reference external vocabularies?

Yes No Unknown X N/A

If yes, please list the vocabularies:

4. Products (check all that apply)Arden Syntax V2 Messages – AdministrativeClinical Context Object Workgroup (CCOW) V2 Messages - ClinicalDomain Analysis Model (DAM) V2 Messages - DepartmentalElectronic Health Record (EHR) Functional Profile V2 Messages – Infrastructure

document.docx 2017 Release Page 3 of 5© 2023 Health Level Seven® International.  All rights reserved

FHIR Extensions V3 Domain Information Model (DIM / DMIM)FHIR Implementation Guide V3 Documents – Administrative (e.g. SPL)

X FHIR Profiles V3 Documents – Clinical (e.g. CDA)X FHIR Resources V3 Documents - Knowledge

Guidance (e.g. Companion Guide, Cookbook, etc) V3 Foundation – RIMLogical Model V3 Foundation – Vocab Domains & Value SetsNew/Modified/HL7 Policy/Procedure/Process V3 Messages - AdministrativeNew Product Definition (please define below) V3 Messages - ClinicalNew Product Family (please define below) V3 Messages - DepartmentalNon Product Project - (Educ. Marketing, Elec. Services, etc.) V3 Messages - InfrastructureWhite Paper V3 Rules - GELLO

V3 Services – Java Services (ITS Work Group)Creating/Using a tool not listed in the HL7 Tool Inventory V3 Services – Web Services (SOA)

5. Project Intent (check all that apply)Create new standard Supplement to a current standard

X Revise current standard (see text box below) Implementation Guide (IG) will be created/modifiedReaffirmation of a standard Project is adopting/endorsing an externally developed IG:New/Modified HL7 Policy/Procedure/Process Specify external organization in Sec. 6 below;Withdraw an Informative Document Externally developed IG is to be (select one):White Paper (select one): Adopted - OR - Endorsed

Balloted Informative OR

Non-balloted WG White Paper

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

Revision Rationale:- Harmonization of Health Quality Information Models – FHIR (Also known as QI

Core, QUICK, QI Core and QI Core Logical View)- December 2016- Rationale – update to be consistent with new FHIR release (v3) and to evolve

the model to CIMI detailed clinical models incrementally over time- The new DSTU ballot will evolve the QI Core model to replace the current

standard consistent with the new version of FHIR and to be synchronized with CIMI modeling efforts.

5.a.Ballot Type (check all that apply)Comment (aka Comment-Only) Joint Ballot (with other SDOs)Informative N/A (project won’t go through ballot)

X 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? Yes X No

6. Project Logistics6.a.External Project CollaborationThis effort will consult with activities of the US Clinical Quality Framework Initiative for piloting efforts.

For projects that have some of their content already developed:How much content for this project is already developed? Indicate % hereWas the content externally developed (Y/N)? If Yes, list developersIs this a hosted (externally funded) project? (not asking for amount just if funded) Yes No

6.b.RealmUniversal - OR - X Realm Specific

document.docx 2017 Release Page 4 of 5© 2023 Health Level Seven® International.  All rights reserved

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

U.S. QI Core is to be compatible with US Core

6.c.Stakeholders / Vendors / ProvidersThis section must be completed for projects containing items expected to be ANSI approved, as it is an ANSI requirement for all ballotsStakeholders Vendors Providers

Clinical and Public Health Laboratories Pharmaceutical Clinical and Public Health Laboratories Immunization Registries EHR, PHR Emergency Services Quality Reporting Agencies Equipment 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) Payors Lab Other (specify in text box below) Other (specify in text box below) HIS N/A N/A Other (specify below)

N/AOther: Indicate other stakeholders, vendors or providers not listed above.

6.d.Project Approval DatesAffiliate Approval Date (for Affiliate Specific Projects): “N/A”US Realm Steering Committee Approval Date (for US Realm Specific Projects):

USRSC Approval Date

Sponsoring Work Group Approval Date: WG Approval Date 2017-01-18Co-Sponsor Group Approval Date(Copy this entire row for each co-sponsor; indicate the specific cosponsor that issued approval)

Co-Sponsor Approval DatesCIMI – 2017-01-18CDS – 2017-01-18

FHIR Project: FHIR Management Group Approval Date: FMG Approval Date Architectural Review Board Approval Date:(required for externally developed content)

ARB Approval Date CCYY-MM-DD or “N/A”

Steering Division (of Primary Sponsor WG) Approval Date: SD Approval Date Last PBS Metrics Score: x Green Yellow RedPBS Metrics Reviewed? (required for SD Approval if not green) Yes No

Technical Steering Committee Approval Date: TSC Approval Date CCYY-MM-DDTSC has received a Copyright/Distribution Agreement (containing the verbiage outlined within the SOU), signed by both parties. Yes No N/A

document.docx 2017 Release Page 5 of 5© 2023 Health Level Seven® International.  All rights reserved