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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

 

 

Establish IGAMT as the HL7 V2 IG Publication Tool

Project ID:

 

 

TSC Notification Informative/STU to Normative          

Date : 

Check this box when the project proceeds from Informative to Normative or STU to Normative status.  Forward to the TSC for notification, as this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.  

 

 

Investigative Project

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 and Scope, 2-Sponsoring Group(s)/Project Team, 3a-Project Scope, 3b-Project Need, 3g-Project Objective, 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)

Publishing

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

Co-sponsor Work Group(s)

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

 

Conformance

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

 

Request formal content review prior to ballot

 

Request periodic project updates. Specify period: 

 

X

Other Involvement. Specify details here: 

Participate fully

Co-sponsor Work Group(s)

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

 

Vocabulary

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)

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

 

Electronic Services

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

 

Request formal content review prior to ballot

 

Request periodic project updates. Specify period: 

Monthly, at WGMs, etc .

X

Other Involvement. Specify details here: 

Participate fully

Co-sponsor Work Group(s)

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

 

Education

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

 

Request formal content review prior to ballot

 

Request periodic project updates. Specify period: 

 

X

Other Involvement. Specify details here: 

Participate fully

2.c. Project Team

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

Project facilitator ( 1 Mandatory )

Rob Snelick

Other interested parties and their roles

OO, PH, InM, and EST as primary IG authors

Multi-disciplinary project team (recommended)

 

Modeling facilitator

 

Publishing facilitator

 

Vocabulary facilitator

 

Domain expert rep

Frank Oemig, Brian Pech, John Garguilo, Craig Newman, Hans Buitendijk

Business requirement analyst

 

Conformance 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)  PH

2)  OO

  1. Project Definition

3.a. Project Scope

Establish IGAMT (Implementation Guide Authoring and Management Tool) as V2 Publishing Tool

  • Review of IGAMT capabilities
  • Identify/implement minimum enhancements before wider use
    • Best Practices Guide
    • On-Line Help
    • Link to V2+ (depends on enhancements to V2 Chapter 2B Conformance constructs.)
    • Other features tbd.
    • Outreach to regulatory agencies on input/suggestions on minimum IG requirements to enable regulatory references.
  • Tooling
    • Establish hosting approach (NIST, HL7, Other)
    • Determine how to store/link web publication
    • Link to V2+
  • Create IGAMT training program
    • Primary Users (future publishing facilitators)
    • General Users
  • Establish and train/educate IGAMT publishing facilitators for each work group
  • IGAMT Support
    • Establish support process/structure
    • Establish enhancement and issue reporting, prioritization process
  • Create a roadmap to establish IGAMT from an optional tool to a required tool for HL7 V2 based IGs.

Outreach to other IG developers (CDC, IHE, etc.) to gauge interest to join project.

 

IGAMT is one tool in a tool set supporting HL7 v2 specification development, test plan development (including test data creation), and message validation (conformance testing). Artifacts created in IGAMT are essential in the test plan and validation tools, however, these are out of scope and will be addressed through other projects.

 

As the IGAMT tool is developed and maintained by a US Federal Agency (NIST – National Institute of Standards and Technology) we need to address how the tool can be supported for non-US users.  This requires further consideration beyond the scope of this project, while we will not restrict use cases to US-Realm.

 

We also recognize that NIST funding is not guaranteed, thus we need to consider contingency plans for adopting the tool in the event that NIST needs to withdraw its support.  We note that the tools are open-source, providing some level of continuity in such an event.

 

It is not in scope to clarify IP at a universal, realm, or jurisdiction level.

 

To support introduction of IGAMT we need various updates to Chapter 2B Conformance constructs, which will be addressed through a separate PSS.

 

The scope is limited to IGs moving forward rather than retrofitting old IGs, although.  workgroups may decide to create a new version to reap the benefits to the tools.

3.b. Project Need

 

  • Improved quality of HL7 V2 based IGs
  • Improved consistency across IGs
  • Creation and re-use of IG components (building blocks), e.g., data types.
  • Embed computable conformance constructs into the IG to improve on clarity and reduce ambiguity while reducing the burden on IG developers.
  • Simplify IG maintenance, enhancements, and publication
  • Enable national level IGs using the same tool set to easily customize to local requirements
  • Establishes the groundwork to create unambiguous, encoded test criteria, including requirements traceability.
  • Raises the level of rigorous and more complete conformance testing
  • IGAMT export when paired with any testing framework, e.g., NIST, Gazelle, provides an immediate conformance testing tool (at “no cost”)
  • The tooling capabilities is not limited to US Realm, rather be universally applicable and jurisdiction

 

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

 

 

No

 

 

Unknown

 

3.d. External Drivers

National programs, e.g., ONC Certification programs, that require consistency and clear, unambiguous implementation guidance to measure conformance.

3.e. Project Objectives / Deliverables / Target Dates

 

Target Date

(Dependency on Chapter “2B.A” Conformance updates)

Assume May Draft

Final September

Optional Use Phase

Immediately

Apply Chapter “2B.A” requirements to IGAMT

2018-08-01

Improve IGAMT Help (on-line/otherwise)

2018-09-01

Establish Training Program for IGAMT Users

2018-09-01

Offer Training Sessions

2018-09-01 – 12-31

Start Mandatory Phase

2019-01-01

“Integration” of V2+ with IGAMT

2019-TBD-TBD

3.f.    Common Names / Keywords / Aliases

IGAMT, IGAMT on V2

3.g. Lineage

Not Applicable

3.h. Project Dependencies

Chapter 2.B Conformance Updates

 

3.i.    Project Document Repository Location

Confluence: http://52.42.5.44:8090/display/PUB/V2+Implementation+Guide+tooling

 

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

 

 

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?

 

 

Yes

 

 

No

 

X

Unknown

 

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

If yes, please list the vocabularies: VSAC and others depending on what we prepopulate.

 

  1. Products (check all that apply)

 

Arden Syntax

 

 

V2 Messages – Administrative

 

Clinical Context Object Workgroup (CCOW)

 

 

V2 Messages - Clinical

 

Domain Analysis Model (DAM)

 

 

V2 Messages - Departmental

 

Electronic Health Record (EHR) Functional Profile

 

 

V2 Messages – Infrastructure

 

FHIR Extensions

 

 

V3 Domain Information Model (DIM / DMIM)

 

FHIR Implementation Guide

 

 

V3 Documents – Administrative (e.g. SPL)

 

FHIR Profiles

 

 

V3 Documents – Clinical (e.g. CDA)

 

FHIR Resources

 

 

V3 Documents - Knowledge

 

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

 

 

V3 Foundation – RIM

 

Logical Model

 

 

V3 Foundation – Vocab Domains & Value Sets

 

New/Modified/HL7 Policy/Procedure/Process

 

 

V3 Messages - Administrative

 

New Product Definition (please define below)

 

 

V3 Messages - Clinical

 

New Product Family (please define below)

 

 

V3 Messages - Departmental

 

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

 

 

V3 Messages - Infrastructure

 

White Paper

 

 

V3 Rules - GELLO

 

 

 

 

V3 Services – Java Services (ITS Work Group)

X

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

 

 

V3 Services – Web Services (SOA)

 

  1. 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;

 

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

 

X

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

-          

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

 

Comment (aka Comment-Only)

 

 

Joint Ballot (with other SDOs)

 

Informative

 

X

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

 

STU to Normative     - OR -

 

Normative (no STU)

 

 

 

 

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

 

 

  1. Project Logistics

6.a. External Project Collaboration

NIST, Frank Oemig

For projects that have some of their content already developed:

How much content for this project is already developed?

Indicate % here

Was the content externally developed (Y/N)? 

If Yes, list developers

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

 

 

 

 

 

 

 

 

Yes

 

 

No

6.b. Realm

X

Universal     - OR -

 

 

Realm Specific

 

 

 

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

 

Enter “ U.S. ” or name of HL7 affiliate(s) here.  Provide explanation/justification of realm selection. For projects producing deliverables applicable to multiple realms, document those details here.

For Investigative projects, indicate if the project is planned to be Realm Specific or Universal, if known. Work Groups are encouraged designating project a Universal project initially, and discover which Realms can contribute to the work effort during the discovery phase of the project.  Note: This status is subject to change during the investigative process.  

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

 

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/A

 

 

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

 

6.d. Project Approval Dates

Affiliate Approval Date (for Affiliate Specific Projects):

Affiliate Approval Date CCYY-MM-DD or  indicate “N/A”

US Realm Steering Committee Approval Date
(for US Realm Specific Projects):

USRSC Approval Date CCYY-MM-DD or  indicate “N/A”

Sponsoring Work Group Approval Date:

WG Approval Date CCYY-MM-DD

Co-Sponsor Group Approval Date

(Copy this entire row for each co-sponsor; indicate the specific cosponsor that issued approval)

Co-Sponsor Approval Date CCYY-MM-DD

FHIR Project: FHIR Management Group Approval Date:

FMG Approval Date CCYY-MM-DD or “N/A”

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 CCYY-MM-DD

Last PBS Metrics Score :

 

Green

 

Yellow

 

Red

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

 

Yes

 

No

Technical Steering Committee Approval Date:

TSC Approval Date CCYY-MM-DD

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

 

 

 

 

 

 

 

 

Yes

 

No

 

N/A