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Template Usage Information:

  1. Project Name and ID



Enter the name of the project here: Clinical Data Exchange (CDex)

Project ID: 1495

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 tscpm@HL7.org); this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.

 X

TSC Notification:  Informative/STU to Normative 

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.

Yes

 

No

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

 

N/A

 

U.S.

Metric

 

Both

 

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)

Patient Care

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

Co-sponsor Work Group(s):

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

Attachments

Structured Documents

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 periodWGMs

 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)

Lisa Nelson, Rick Geimer

Other interested parties and their roles

Viet Nguyen (technical FHIR support)

Multi-disciplinary project team (recommended)


     Modeling facilitator

Rick Geimer

     Publishing facilitator

     Vocabulary facilitator

Viet Nguyen

     Domain expert rep

Lisa Nelson, Rick Geimer, Gay Dolin

     Business requirement analyst

Robert Dieterle, Linda Michaelsen

     Conformance facilitator (for IG projects)

Rick Geimer

     Other facilitators (SOA, etc)




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) United Health

2) Humana 

3. Project Definition

3.a. Project Scope


The Clinical Data exchange (CDex) is part of the larger Da Vinci use case for Health Record exchange (HRex).



After careful evaluation, the eHRx project was decomposed into four independent efforts (and tied to 4 separate PSSs). The exchange of Quality Measures was included in the existing work on the Data Exchange for Quality Measures (DEQM) that is sponsored by the CQI workgroup. The exchange of Payer Data (PDex) is sponsored by Financial Management. The overall HRex Framework is planned to be sponsored by the Clinical Interoperability Council (CIC) and we looking to a combination of Structured Documents, Patient Care and Attachments to sponsor the work on e Clinical Data exchange (CDex).

The scope of the CDex project is to defined combinations of exchange methods (push, pull, subscribe, …), specific payloads (Documents, Bundles, and Individual Resources), search criteria, conformance, provenance, and other relevant requirements to support specific exchanges of clinical information between provider and other providers and/or payers. The goal is to identify, document and constrain very specific patterns of exchange so that providers and payers can reliably exchange information for patient care (including coordination of care), risk adjustment, quality reporting, identifying that requested services are necessary and appropriate (e.g. should be covered by the payer) and other uses that may be documented as part of this effort. Clinical data payloads will include C-CDA, C-CDA on FHIR, compositions, bundles, specific resources, and bulk data exchange. This list is intended to be illustrative and not prescriptive. The project will address patient consent where appropriate. 

This project will reference, where possible the "standards" defined by the Health Record exchange (HRex) Framework Implementation Guide which in turn will utilize prior work from Argonaut, US Core and QI Core effort for FHIR DSTU2, STU3, and R4. The following diagram depicts the anticipated scope of the HRex Framework IG.



The ultimate goal is to support the exchange of provider data on specific patients/members for better patient care with other providers and payers using technology that support FHIR DSTU2, STU3, and R4 releases of the FHIR standard.

The project team plans to work with existing FHIR artifacts where possible. If changes are necessary, the project team will work with the responsible Work Group to review and implement (via tracker items or new PSS) any necessary enhancements to base FHIR resources, extensions, and/or profiles.


3.b. Project Need


Providers and Payers need access to provider information regarding current and prior healthcare services planned for or received by the patient/member to more effectively manage the patients care. Currently, no FHIR implementation guides exist to standardize the method of exchange (push, pull, triggers, subscription, etc.) and the formal representation (e.g. Documents, Bundles, Profiles and Vocabulary) for the range of exchanges between providers and providers or providers and payers of current and emerging interest to the involved parties. This implementation guide will provide a standard for adoption by both payers and providers for the exchange of provider originated information.


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. 

Yes

X

No

Unknown


3.d. External Drivers


None


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’)

Ballot for Comment (First Ballot Cycle)

2019 May Ballot

Submit for STU Ballot (Second Ballot Cycle)

2019 Sep Ballot

Complete STU Reconciliation

2020 Jan WGM

Request STU Publication

2020 Jan WGM

Submit for STU 2 Ballot (Third Ballot Cycle)

2020 Sep Ballot

Complete STU 2 Reconciliation

2021 Jan WGM

Request STU 2 Publication

2021 Jan WGM

STU Period

2021 Jan -2022 Jan

Submit for Normative Ballot

2022 May Ballot

Complete Normative Reconciliation

2022 Sep WGM

Submit Publication Request

2022 Oct

Project End Date (all objectives have been met)

2022 Dec


3.f.   Common Names / Keywords / Aliases


Clinical Data exchange, CDex, Da Vinci


3.g. Lineage


n/a

3.h. Project Dependencies


HealthRecord Exchange Framework



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: http://wiki.hl7.org/index.php?title=Template:Project_Page.

Enter the SPECIFIC URL of the HL7-MANAGED SITE where supporting project documents, deliverables, ballot reconciliation work and other project information will be kept
HTTP: //confluence.hl7.org/pages/viewpage.action?pageId= or above this link.


3.j.   Backwards Compatibility


Are 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 Vocabularies


Will this project include/reference external vocabularies?

X

Yes

No


Unknown

N/A

If Yes, please enter the vocabularies: HCPCS, SNOMED, CPT, ICD, RxNorm, LOINC


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)

X

FHIR Extensions


V3 Documents – Administrative (e.g. SPL)

X

FHIR Implementation Guide (enter FHIR product version below)


V3 Documents – Clinical (e.g. CDA)

X

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?

DSTU2, STU3, R4


5. Project Intent (check all that apply)



Create new standard


Supplement to a current standard

Revise current standard (see text box below)


X

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 -

?

Endorsed


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)


X

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 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?

10%

Was the content externally developed ? :

Y

Da Vinci

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

X

Yes

No


6.b. Realm


Universal 

- OR -

 X

Realm Specific



 

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

U.S.

Includes IG references, vocabulary and profiles that are specific to the US healthcare system

Support US Healthcare workflows


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

 

Stakeholders

 

Vendors

 

Providers

X
 

Clinical and Public Health Laboratories

 X
 

Pharmaceutical

  

Clinical and Public Health Laboratories

X
  

Immunization Registries

X
  

EHR, PHR

X
  

Emergency Services

X
  

Quality Reporting Agencies

X
  

Equipment

  

Local and State Departments of Health

X
  

Regulatory Agency

 

Health Care IT

X 

Medical Imaging Service

  

Standards Development Organizations (SDOs)

X 

Clinical Decision Support Systems

 

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

X
  

Payors

X
  

Lab

  

Other (specify in text box below)

X 

Other (specify in text box below)

  

HIS

  

N/A

  

N/A

  

Other (specify below)


 

 


  

N/A

 

 


Other:  Federal Healthcare Agencies (e.g. CMS), Providers (e.g. Physicians)










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

Sponsoring Work Group Approval Date:

WG Approval Date

1/17/2019

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date


Attachments (need to verify date)

Structured Documents


1/17/2019

1/17/2019

Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

CIMI MG Approval Date

N/A

CDA Projects: CDA Management Group

CDA MG Approval Date

N/A

FHIR Projects: FHIR Management Group

FMG Approval Date

2/27/2019

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

N/A

US Realm Projects: US Realm Steering Committee Approval
(Email WG approved PSS to: tscpm@HL7.org)

USRSC Approval Date

2/26/2019

Affiliate Specific Projects: Affiliate Approval Date

Affiliate Approval Date

N/A

Submit PSS to Steering Division after all of the above approvals are received

Steering Division (of Primary Sponsor WG) Approval Date:

SD Approval Date 

2019-03-22

Last PBS Metrics Score:

X

 Green

 Yellow

 Red

PBS Metrics Reviewed? (required for SD Approval if not green)

 Yes

 No

ARB and Steering Division approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date

N/A

TSC Approval

If applicable, TSC has received a Joint Copyright/Distribution Agreement (containing the verbiage outlined within the SOU),
signed by both parties.

Yes

No

 N/A


Technical Steering Committee Approval Date:
(Email SD WG approved PSS to: tscpm@HL7.org)

TSC Approval Date