PSS for Patient Data Exchange for Value-Based Care

2. Sponsoring Group(s) / Project Team

3. Project Definition

4. Products (check all that apply)

5. Project Intent (check all that apply)

6. Project Logistics

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Project Name and ID

2.a. Primary Sponsor/Work Group

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

2.c. Project Team

3.a. Project Scope

3.b. Project Need

3.c. Security Risks

3.d. External Drivers

3.e. Project Objectives / Deliverables / Target Dates

3.f. Common Names / Keywords / Aliases

3.g. Lineage

3.h. Project Dependencies

3.i. HL7-Managed Project Document Repository Location

3.j. Backwards Compatibility

3.k. External Vocabularies

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

5.b. Joint Copyright

6.a. External Project Collaboration

6.b. Realm

6.c. Stakeholders / Vendors / Providers

6.d. Project Approval Dates

Warning:

Do not launch ANY of the links while your are in create or edit mode. There is a good chance all of your work will be gone.

Template Usage Information:

Submit template change requests to PMO@HL7.org
For Reaffirmations, please refer to the FAQ in Hl7 Project Scope Statement Instructions for a list of which sections and fields should be completed

Project Name and ID


Enter the name of the project here: Patient Data Exchange for Value-Based Care
Project ID:	1518
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.
	TSC Notification: Informative/STU to Normative
	- 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.

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

Patient Care (3-27-2019)

Co-sponsor Work Group(s): (Enter co-sponsor approval dates in Section 6.d Project Approval Dates)		Attachments Orders and Observations
Indicate the level of involvement that the co-sponsor will have for this project:
X	Request formal content review prior to ballot	WGMs
X	Request periodic project updates. Specify period	WGMs
	Other Involvement. Specify details here:

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

Project facilitator (1Mandatory)	Robert Dieterle, Viet Nguyen
Other interested parties and their roles	Orders and Observations (interested party because of specific resources), Viet Nguyen and Lloyd McKenzie (technical FHIR support)
Multi-disciplinary project team (recommended)
Modeling facilitator	Lloyd McKenzie
Publishing facilitator	Paul Knapp
Vocabulary facilitator	Viet Nguyen
Domain expert rep	Lenel James, Robert Dieterle,
Business requirement analyst	Christol Green, Mary Kay McDaniel, Linda Michaelsen, Nick Radov, Amit Shah, Mary Lynn Bushman, Durwin Day
Conformance facilitator (for IG projects)	Lloyd McKenzie
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) CMS
2) United Healthcare

This PSS will focus on closing the loop with patients direct involvement with home treatment. This will include, but not be limited to:

1) reporting the receipt and use of home equipment

2) reporting the success or failure of prescribed treatments/interventions

3) reporting the measurements taken by monitoring devices

The intended source of the information is from smart phone applications and certain appropriately equipped devices.

Payers and providers need information on the delivery, use and treatment success for ordered devices and services. This will close the loop with the patient to ensure that the ordered/prescribed devices/treatments were delivered, used and effective. The failure to have the devices delivered and or used can have significant care implications and the early determination of effectiveness is critical to early modification of treatment to address urgent and chronic conditions.

This IG will define one or more simple exchange methods between patients and their responsible provider and payers.

Note: the project will coordinate with efforts regarding patient reported data, including (where appropriate): patient devices, IHE, CARIN, care planning, etc.

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

The ultimate goal is to support the exchange of patient data to the responsible payer and provider in real-time to allow effective clinical and administrative decision making.

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.

Patients need the ability to communicate directly with Payers and Providers to report specific information that can be used for care management. Payers and providers need to know if a patient has received specific devices or services that were ordered by a provider and will be covered by the responsible payer. In addition, providers and payers need to know if the specific device is being used and if the device or treatment is making a difference in the patients reported symptoms. The need is for a FHIR-based approach to enable patients to use an application on their smart phone or a smart device to report specific information to any appropriate payer or provider that is needed to help to manage their care.

This PSS builds on existing implementation guides for the automation of requests to a payer for coverage information (Coverage Requirements Discovery – CRD), definition of documentation and payer rules (Documentation Templates and Payer Rules) access to provider information (Clinical Data Exchange – CDex) and the Health Record Exchange Library/Framework (HRex).

Currently, no FHIR implementation guide exists to standardize the method of requesting reporting patient sourced information to both responsible payers and provider to improve the patient's care. The resulting IG will be a standard for adoption by payers, providers and patients to improve the exchange of patient originated information.

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

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’)
Standard For Trial Use (First Ballot Cycle)	2019 September Ballot
Complete STU Reconciliation	2020 January
Request STU Publication	2020 January WGM
Submit for STU 2 Ballot (Second Ballot Cycle)	2021 May Ballot
Complete STU 2 Reconciliation	2021 Aug
Request STU 2 Publication	2021 Sept WGM
STU 2 Period	2021 Sept -2023 May
Submit for Normative Ballot	2023 May Ballot
Complete Normative Reconciliation	2023 Sept WGM
Submit Publication Request	2023 Oct
Project End Date (all objectives have been met)	2023 Dec

Da Vinci, Patient Data Exchange

n/a

Health Record Exchange Library/Framework

Projects must adhere to the TSC's guidelines (which were approved on 20 16-04-04 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. 

https://github.com/HL7/davinci-pdev

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.

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

	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?

R4, STU3, DSTU2

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.)

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

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

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?	0%
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

Universal

- OR -

X

Realm Specific

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

U.S.

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

Support US Healthcare workflows

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	X	Clinical and Public Health Laboratories
		Immunization Registries	X	EHR, PHR	X	Emergency Services
X		Quality Reporting Agencies	X	Equipment	X	Local and State Departments of Health
X		Regulatory Agency	X	Health Care IT	X	Medical Imaging Service
		Standards Development Organizations (SDOs)	X	Clinical Decision Support Systems	X	Healthcare Institutions (hospitals, long term care, home care, mental health)
X		Payors	X	Lab	X	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)

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

2019-03-27

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date

Attachments

Orders and Observations

2019-03-12

2019-03-28

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

2019-03-27

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

2019-03-26

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 CCYY-MM-DD

YYYY-MM-DD

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

2019-04-15

Comment (aka Comment-Only)

Joint Ballot (with other SDOs)

Informative

N/A (project won’t go through ballot)

STU to Normative - OR -

Normative (no STU)