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  1. Project Name and ID

 

Click here to go to Appendix A for more info regarding this section including guidance on naming conventions .

An ID will be assigned by Project Insight

Reaffirm

HL7 Version 3 Standard: Regulated Studies – Reaffirmation Ballot of Annotated ECG Waveform Normative Message, Release 1 (aECG)

 

Project ID: 1439

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: 

 

X

- or -                     Direct to Normative (no STU) (includes reaffirmations)       

 

Identify ISO, IEC or ISO/IEC standard to be adopted in text box below

 

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 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

Click here to go to Appendix A for more information regarding this section.

2.a. Primary Sponsor/Work Group

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

BR&R Work Group

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

Co-sponsor Work Group(s)

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

 

 

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: 

 

 

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 ( 1 Mandatory )

Edward Helton

Other interested parties and their roles

 

Multi-disciplinary project team (recommended)

 

Modeling facilitator

 

Publishing facilitator

Myron Finseth

Vocabulary facilitator

 

Domain expert rep

 

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) 

2) 

  1. Project Definition

3.a. Project Scope

Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

Reaffirm

HL7 Version 3 Standard: Regulated Studies – Reaffirmation Ballot of Annotated ECG Waveform Normative Messag, Release 1  (aECG)

which expires 12/12/2019

 

3.b. Project Need

Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

A HL7 normative message required by CDER at the US Food and Drug Administration

3.c. Security Risks

Click here to go to Appendix A for more information regarding this section.

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

Click here to go to Appendix A for more information regarding this section.

Pharmaceutical industry and FDA and world regulatory authorities

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).

Click here for further information, FHIR project instructions, and an EXAMPLE

Target Date (in WGM or ballot cycle format, e.g.

‘2017 Sept WGM’ or

‘2017 Jan Ballot’)

 

 

Reaffirmation ballot cycle

May 2019 or Sept 2019

Project End Date

Jan 2020

3.f.    Common Names / Keywords / Aliases

Click here to go to Appendix A for more information regarding this section.

 

3.g. Lineage

Click here to go to Appendix A for more information regarding this section.

 

3.h. Project Dependencies

Click here to go to Appendix A for more information regarding this section.

 

3.i.    HL7-Managed Project Document Repository Location

Click here to go to Appendix A for more information regarding this section.

 

3.j.    Backwards Compatibility

Are the items being produced by this project backward compatible?

 

x

Yes

 

 

No

 

 

Unknown

 

 

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:

 

3.k. External Vocabularies

Will this project include/reference external vocabularies?

 

 

Yes

 

X

No

 

 

Unknown

 

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

If yes, please list the vocabularies:

 

  1. Products (check all that apply)

Click here to go to Appendix A for more information regarding this section

 

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

 

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

 

 

V3 Foundation – Vocab Domains & Value Sets

 

Logical Model

 

 

V3 Messages - Administrative

 

New/Modified/HL7 Policy/Procedure/Process

 

x

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)

 

 

  1. Project Intent (check all that apply)

Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

 

Create new standard

 

 

Supplement to a current standard

 

Revise current standard (see text box below)

 

 

Implementation Guide (IG) will be created/modified

X

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)

 

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

Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

 

Comment (aka Comment-Only)

 

 

Joint Ballot (with other SDOs)

 

Informative

 

 

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

 

STU to Normative     - OR -

X

Normative (no STU)

 

 

 

 

5.b. Joint Copyright

Click here to go to Appendix A for more information regarding this section

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

Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

 

For projects that have some of their content already developed:

How much content for this project is already developed?

 

Was the content externally developed (Y/N)? 

 

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

 

 

 

 

 

 

 

 

Yes

 

 

No

6.b. Realm

Click here to go to Appendix A for guidelines regarding choosing Universal or Realm Specific.

X

Universal     - OR -

 

 

Realm Specific

 

 

 

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

 

 

6.c. Stakeholders / Vendors / Providers

Click here to go to Appendix A for more information regarding this section

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

x

Pharmaceutical

 

Clinical and Public Health Laboratories

 

Immunization Registries

 

EHR, PHR

 

Emergency Services

 

Quality Reporting Agencies

X

Equipment

 

Local and State Departments of Health

x

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

 

 

 

6.d. Project Approval Dates

Click here to go to Appendix A for more information regarding this section.
Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date:

2019-01-25

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date

 

N/A
 

Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

N/A

CDA Projects: CDA Management Group

N/A

FHIR Projects: FHIR Management Group

N/A

V2/Publishing Projects: V2 Management Group

N/A

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

N/A

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 2019-03-115

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)

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 CCYY-MM-DD