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HL7 Project Scope Statement v2018.2_Provenance 20190312_v02_FMG_Security_Update.docx

dNOTE : Please spell out all acronyms the first time the acronym occurs. 

For Reaffirmations, please refer to the FAQ within Appendix C of the PSS_with_instructions template for a list of which sections and fields should be completed.

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

 

 

Provenance Basics for C-CDA and FHIR

Project ID: 1492

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 

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

 

X

No

 

 

 

 

 

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

 

 

N/A

 

X

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 in bold outline are mandatory for project approval of an investigative project; all other sections are optional. 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.

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.

  1. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

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

Security

 

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

Co-sponsor Work Group(s)

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

 

Patient Care

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.

X

Other Involvement. Specify details here: 

Analysis involvement in the use cases

Co-sponsor Work Group(s)

Co-sponsor Work Group(s)

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

 

Community Based Care and Privacy (CBCP)

 

Indicate the level of involvement that the co-sponsor will have for this project:

X

Request formal content review prior to ballot

X

Request periodic project updates. Specify period: 

Monthly

 

Other Involvement. Specify details here: 

 

Co-sponsor Work Group(s)

Co-sponsor Work Group(s)

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

 

EHR

 

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

 

Other Involvement. Specify details here: 

 

 

Co-sponsor Work Group(s)

Co-sponsor Work Group(s)

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

 

Structured Documents (C-CDA)(2019-01-24)

 

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: 

Regular updates on our conference calls

x

Other Involvement. Specify details here: 

Project meeting announcements to SDWG list

 

 

1.a. Project Team

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

Project facilitator ( 1 Mandatory )

Brett Marquard and Russ Ott

Other interested parties and their roles

 

Multi-disciplinary project team (recommended)

 

Modeling facilitator

Brett Marquard

Publishing facilitator

Mike Davis

Vocabulary facilitator

Kathleen Connor

Domain expert rep

 

Business requirement analyst

Michael Clifton, Drew Torres, Mike Davis

Conformance facilitator (for IG projects)

 

Other facilitators (SOA, etc)

John Moehrke (FHIR)

 

 

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) US Department of Defense, Military Health System

2) US Department of Veterans Affairs, Veteran’s Health Administration

3) Cerner

4) Epic

  1. Project Definition

2.a. Project Scope

Develop an Informative document in the US Realm to specify functional and technical guidance on what constitutes minimal “provenance”. This guidance should inform future implementations of the data class identified in the US Core Data for Interoperability published by the Office of the National Coordinator.

 

Specifically, the IG will include technical guidance for C-CDA 2.1, and US FHIR Core (based on R4). Guidance will be limited to the set of data classes identified in the US Core Data for Interoperability, and any additional information needed to convey those data classes within C-CDA and FHIR.

 

Full technical guidance for Version 2 is out of scope for the first phase of this project.

2.b. Project Need

The Draft U.S. Core Data for Interoperability and Expansion Process, published by ONC on Jan 5, 2018 indicated 22 “data classes” in the list of Draft USCDI Version 1 Data Classes. While many of those data classes have already been well defined within the C-CDA and FHIR standards, “provenance” has not been. For interoperability to be achieved with this data class, functional and technical guidance are needed regarding what details constitute “provenance”, which data classes should be conveyed including provenance information, and technically how provenance information should be represented in the C-CDA and FHIR standards.

2.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

 

2.d. External Drivers

N/A

2.e. Project Objectives / Deliverables / Target Dates

 

Target Date

Develop priority use cases

2019 May WGM

Submit for Informative Ballot(First Ballot Cycle)

2019 Sep Ballot

Complete Informative Reconciliation

2019 November WGM

Request Informative Publication

2020 Jan WGM

Project End Date

2020 Feb

2.f.    Common Names / Keywords / Aliases

Provenance, Data Provenance 

2.g. Lineage

Will review prior projects on Provenance, including HL7 DPROV CDA. For a full listing see project presentation.

2.h. Project Dependencies

N/A

2.i.    HL7-Managed Project Document Repository Location

Confluence location underneath Security

2.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.

2.k. External Vocabularies

Will this project include/reference external vocabularies?

 

 

Yes

 

 

No

 

X

Unknown

 

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

No modelling is anticipated as part of this effort.

 

  1. 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

X

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:

N/A

 

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

  1. Project Intent (check all that apply)

 

Create new standard

 

X

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 -

 

Endorsed

 

X

Balloted Informative OR

 

Non-balloted WG White Paper

 

 

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

 

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

 

Comment (aka Comment-Only)

 

 

Joint Ballot (with other SDOs)

X

Informative

 

 

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

 

STU to Normative     - OR -

 

Normative (no STU)

 

 

 

 

4.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

 

 

  1. Project Logistics

5.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?

0%

Was the content externally developed (Y/N)? 

N

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

 

 

 

 

 

 

 

 

Yes

 

X

No

5.b. Realm

 

Universal     - OR -

 

X

Realm Specific

 

 

 

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

 

U.S

 

This Informative guide is related to anticipated regulatory requirements in the US.

5.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

X

Clinical and Public Health Laboratories

X

Immunization Registries

X

EHR, PHR

X

Emergency Services

X

Quality Reporting Agencies

 

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

 

Other (specify in text box below)

 

Other (specify in text box below)

X

HIS

 

N/A

 

N/A

 

Other (specify below)

 

 

 

 

 

N/A

 

 

 

 

5.d. Project Approval Dates

Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date:

Security 2019-01-15

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date

 

Patient Care 2019-01-14

CBCP 2019-01-15
EHR 2019-01-16

SDWG 2019-01-24

Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

N/A

CDA Projects: CDA Management Group

CDA MG Approval Date 2019-02-27
 

FHIR Projects: FHIR Management Group

FMG Approval Date 2019-02-27
 

V2/Publishing Projects: V2 Management Group

N/A

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

USRSC Approval Date 2019-01-29

Affiliate Specific Projects: 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 2019-03-06

Last PBS Metrics Score :

 

Green

 

Yellow

 

Red

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

 

Yes

 

No

ARB and SGB approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date CCYY-MM-DD
or “N/A”

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 Steering Division approved PSS to: tscpm@HL7.org )

TSC Approval Date CCYY-MM-DD