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Template Usage Information:

  1. Project Name and ID



An ID will be assigned by Project Insight

Enter the name of the project here: Pediatric Care Health IT Functional Profile

Project ID:

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:  Submission 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)

Electronic Health Record 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)

PC WG

CIC WG

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 (1Mandatory)

Pele Yu, MD MS

Other interested parties and their roles

Drummond Group (Tim Bennett – lead)

Multi-disciplinary project team (recommended)


     Modeling facilitator

N/A

     Publishing facilitator

John Ritter, Michael van der Zel (Tooling)

     Vocabulary facilitator

N/A

     Domain expert rep

John Ritter

     Business requirement analyst

N/A

     Conformance facilitator (for IG projects)

N/A

     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) 

2) 

3. Project Definition

3.a. Project Scope

This project will establish the HL7 Pediatric Care Health IT Functional Profile and Standard that will support the Recommendations for the Voluntary Certification of Health IT for Use in Pediatric Care settings, as published by the 21st Century Cures Act: Interoperability, Information Blocking, and the U.S. ONC Health IT Certification Program (45 CFR Parts 170 and 171 RIN 0955-AA01). At minimum, the scope of the project will include the ten (10) recommendations described in the federal register:

  1. Use biometric-specific norms for growth curves and support growth charts for children
  2. Compute weight-based drug dosage
  3. Ability to document all guardians and caregivers
  4. Segmented access to information
  5. Synchronize immunization histories with registries
  6. Age- and weight- specific single-dose range checking
  7. Transferrable access authority
  8. Associate maternal health information and demographics with newborn
  9. Track incomplete preventative care opportunities
  10. Flag special health care needs

This is developed based on US regulatory recommendations but can be universally applicable to other realms.


3.b. Project Need

To support the requirements included in the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program’s Recommendations for the Voluntary Certification of Health IT for Use in Pediatric Care settings, it is vital to develop a standard set of pediatric functional requirements that can guide health IT vendors, decision makers, and pediatric health providers to support the health care of children.


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

21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program

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’)

Enter objective/deliverable here.

All planned ballots and their target dates should be included

The example below is a "STU to Normative" path

Enter Target Date

2021 September WGM Ballot Cycle

Example: Submit for Informative Ballot(First Ballot Cycle)

2021 September Ballot

Example: Complete Informative Ballot Reconciliation

N/A

Example: Submit for 2nd STU Ballot

N/A

Example: Request STU Publication

N/A

Example: STU Period – 12 months

N/A

Example: Submit for Normative Ballot

N/A

Example: Complete Normative Reconciliation

2022 January WGM

Example: Submit Publication Request

2022 February

Example: Receive ANSI Approval

2022 March

Project End Date (all objectives have been met)

Note:  For PSS-Lite/Investigative Project, End date must be no more than two WGM cycles, e.g. project initiated at January WGM must complete investigation by September WGM.

Enter Project End Date

2022 May HL7 WGM


3.f.   Common Names / Keywords / Aliases


What common name does your group use to refer to the product(s) produced?  What alternative names, aliases and keywords does your group use to refer to the product(s) that will be produced?  Some examples: C-CDA, LRI, eDOS.  
Pediatric, Child Health, health IT, 21st century cures act


3.g. Lineage


If your project creates a Post-Release 1 version; indicate the name of the prior product and if it is supplanting, replacing or coexisting with a previous release: This will be complementary to CHFP Release 1 (2008, 2019)

3.h. Project Dependencies


Enter any dependencies or the name & Project Insight ID of project(s) that this project is dependent upon to achieve its objectives:
No dependencies. This project supports the advancement of pediatric health IT functionality in the electronic health record.

Projects and their Project Insight IDs can be found via http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?ref=common


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://


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: LOINC, CPT, SNOMED, RxNorm, CVX, NCPDP, HCPCS


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

X

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


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?



5. Project Intent (check all that apply)



X

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;





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)











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)


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)











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?


X

Yes

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. Drummond Group, US Agency for Healthcare Quality and Research (AHRQ), US HHS Office of the National Coordinator (ONC)

For projects that have some of their content already developed:

How much content for this project is already developed?

50%

Was the content externally developed ? :

Y

See above

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

Yes

X

No


6.b. Realm


Universal 

- OR -

 X

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.

US Realm, but it may be universally applicable to other realms


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.

Accredited Certification Bodies for ONC; any provider who cares for and treats children.









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

2020-10-20

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date


List each Co-Sponsor and their Approval Date



Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

CIMI MG Approval Date

CDA Projects: CDA Management Group

CDA MG Approval Date

FHIR Projects: FHIR Management Group

FMG Approval Date

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

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

USRSC Approval Date

Affiliate Specific Projects: Affiliate Approval Date

Affiliate Approval Date

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

Last PBS Metrics Score:


 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

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

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1 Comment

  1. Hi - is the plan that one informative document cover the 10 recommendations, or would there be one informative document per recommendation (or some logical grouping).  Does the team know about this document?  https://www.healthit.gov/sites/default/files/page/2020-06/Pediatric-Health-IT-Developer-IR-06102020.pdf