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Template Usage Information:

  1. Project Name and ID



HL7 Attachments Supplemental Guide for the Exchange of C-CDA Based Documents

Project ID: 1212

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.

 X

TSC Notification:  Informative/STU to Normative 

Date:  7/28/2020

 

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

 

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

N/A

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

 X

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)

Payer/Provider Information Exchange WG

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

Co-sponsor Work Group(s):

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

Structured Documents

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 periodAt WGMs
X Other Involvement. Specify details here: Publish meeting schedules to SDWG listserv

2.c. Project Team

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

Project facilitator (1Mandatory)

Laurie Burckhardt

Other interested parties and their roles


Multi-disciplinary project team (recommended)


     Modeling facilitator


     Publishing facilitator

Russell Ott

     Vocabulary facilitator


     Domain expert rep


     Business requirement analyst


     Conformance facilitator (for IG projects)


     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) Blue Cross Blue Shield Companies

2) National Government Services (NGS)

3. Project Definition

3.a. Project Scope


Create a new testable Implementation Guide with defined requirements and conformance language for the exchange of Attachments between a provider or their agent and a payer or their agent. Definition of Attachment is, 'supplemental documentation needed about a patient(s) to support a specific health care-related event (such as a claim, eligibility, prior authorization, referrals, and others) using a standardized format.'

The guide will define requirements for
1) Identifying attachments (including LOINC codes)
2) sending attachments
3) requesting attachments
4) responding to requests for attachments
5) use of common transports
6) required metadata associated with each transport


3.b. Project Need


This project is required to meet industry needs for a testable implementation guide by defining conformance statements for the exchange of Attachments. It is intended for potential inclusion as part of the HIPAA 'Attachments' rule.


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


There has not been an Attachment rule issued by CMS, and a guide such as this one would be necessary if such a rule were to be issued for the healthcare community.  Even without a CMS rule, the guide will allow the industry to implement the submissions of attachments consistency across the industry.


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

Submit for STU Ballot(First Ballot Cycle)

2016 May Ballot

Initial STU Publication

2017 Aug

Submit for 2nd STU Ballot

2021 Jan Ballot

Request 2nd STU Publication

2021 May WGM

Submit for Normative Ballot

2023 Jan Ballot

Request Normative Publication

2023 May WGM

Project End Date (all objectives have been met)

2023 May


3.f.   Common Names / Keywords / Aliases


Attachments Supplement
Supplemental Guide for Attachments
Attachments Exchange
Attachments Exchange Implementation Guide


3.g. Lineage


N/A

3.h. Project Dependencies


N/A


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.

HL7 Attachments Supplemental Guide


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


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


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)

X

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:


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



5. Project Intent (check all that apply)




Create new standard



Supplement to a current standard

X

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:HL7 CDA® R2 Attachment Implementation Guide: Exchange of C-CDA Based Documents, Release 1
-    Date it was published (or request for publication, or ANSI designation date)August 2017
-    Rationale for revisionAdditional guidance has been requested by the community, and some existing guidance has become outdated and needs to be revised.
-    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.)Release 2 and beyond will replace prior versions.


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



Comment (aka Comment-Only)



Joint Ballot (with other SDOs)


Informative



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

X

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?



Yes

X

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.

For projects that have some of their content already developed:

How much content for this project is already developed?


Was the content externally developed ? :

N


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


U.S. - the guide is specific to regulatory requirements and practices in the US



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

X  

Regulatory Agency

  

Health Care IT

  

Medical Imaging Service

  

Standards Development Organizations (SDOs)

  

Clinical Decision Support Systems

 X 

Healthcare Institutions (hospitals, long term care, home care, mental health)

X  

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

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

2020-08-11

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date


List each Co-Sponsor and their Approval Date

Structured Documents

2020-09-03

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

2020-09-09

FHIR Projects: FHIR Management Group

FMG Approval Date

N/A

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

N/A

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

2020-12-15, 

Approved change in scope

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