IHE SDC/eCC on FHIR

2. Sponsoring Group(s) / Project Team

3. Project Definition

4. Products (check all that apply)

5. Project Intent (check all that apply)

6. Project Logistics

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2.a. Primary Sponsor/Work Group

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

2.c. Project Team

3.a. Project Scope

3.b. Project Need

3.c. Security Risks

3.d. External Drivers

3.e. Project Objectives / Deliverables / Target Dates

3.f. Common Names / Keywords / Aliases

3.g. Lineage

3.h. Project Dependencies

3.i. HL7-Managed Project Document Repository Location

3.j. Backwards Compatibility

3.k. External Vocabularies

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

5.b. Joint Copyright

6.a. External Project Collaboration

6.b. Realm

6.c. Stakeholders / Vendors / Providers

6.d. Project Approval Dates

Warning:

Do not launch ANY of the links while your are in create or edit mode. There is a good chance all of your work will be gone.

Template Usage Information:

Submit template change requests to PMO@HL7.org
For Reaffirmations, please refer to the FAQ in Hl7 Project Scope Statement Instructions for a list of which sections and fields should be completed

IHE SDC/eCC on FHIR


Enter the name of the project here: IHE SDC/eCC on FHIR
Project ID:	1700
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: 2021-02-23
	- 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.

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

Orders and Observations

Co-sponsor Work Group(s): (Enter co-sponsor approval dates in Section 6.d Project Approval Dates)		FHIR-Infrastructure
Indicate the level of involvement that the co-sponsor will have for this project:
	Request formal content review prior to ballot	Yes
	Request periodic project updates. Specify period	Monthly
	Other Involvement. Specify details here:	N/A

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

Project facilitator (1Mandatory)	Alexander Goel (CAP)
Other interested parties and their roles	Sandy Jones (CDC), David Jones (CDC), Jeffery Karp (CAP), Fred Marsh (CAP), Tim Davison (CCR), Joel Francis (CHI), Peter Mello (mTuitive)
Multi-disciplinary project team (recommended)
Modeling facilitator	Joel Francis
Publishing facilitator	Alexander Goel
Vocabulary facilitator	Ask for a Vocab Name (otherwise Alexander Goel)
Domain expert rep	Sandy Jones
Business requirement analyst	Alexander Goel
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) CDC
2) CAP

Describe the project; include what is expected to be accomplished/delivered along with specified features and functions. Include whether the deliverable(s) are universal, realm specific or applicable to various realms. Be sure to spell out all acronyms as these are carried forward to the NIB (Notice of Intent to Ballot) for ballot announcements.

Original Project Proposal: PSS-1683 - Getting issue details... STATUS

This project will aim to port over the Simplifier IG IHE SDC on FHIR, which describes how to convert a CAP electronic Cancer Checklists (eCC) and other IHE SDC forms to FHIR Observations. The guide also describes how to transport IHE SDC forms using the DocumentReference resource, similar to a C-CDA document or PDF. The original Simplifier IG does not use DiagnosticReport, but this resource would be added as part of this project. The current Simplifier IG also only describes transformation to Observation, and this project would expand this to include a definition based extraction which will be leveraged by PSS-1682 Cancer Electronic Pathology Reporting. PSS-1688 - Getting issue details... STATUS

The Integrating Cancer Reporting Scenario in the Public Health Connectathon Track has tested these transformations and transport methods in several FHIR and IHE Connectathons and found them to be viable with the existing and planned future use cases for eCCs and North American Association of Central Cancer Registry (NAACCR) use cases.

The following text is background modified from: https://simplifier.net/guide/SDConFHIR/Introduction

This implementation guide will describe how to use IHE Structured Data Capture (SDC) Forms with FHIR. Specific resources used include the DocumentReference, Observation, and DiagnosticReport. The aim of this proposal is to create a specified format for IHE SDC to be transported through FHIR, using the DocumentReference, and/or transformed into FHIR resources using the Observations and DiagnosticReport. IHE SDC primarily supports pathology use cases, and would enable access to a large amount of structured data.

This project will deliver descriptions of how to attach IHE SDC forms to DocumentReferences, and mappings for data extraction to other resources including the Observation and DiagnosticReport. It will also include further development of the IHE SDC on FHIR parser to better enable these transformations. These deliverables will be usable by anyone who has or intends to implement any products that use the IHE SDC technical framework and enable better interoperability with FHIR SDC.

Note:

IHE Structured Data Capture (SDC) on FHIR uses a form driven workflow to capture and encode data by creating FHIR Observations from the captured data. The primary use case for this implementation guide is point of care reporting for clinicians using structured forms to capture high quality data for care and reporting purposes. Structured data can enable easier auto-population of future medical documents, easily queriable data, and high quality reporting for quality measurement and evaluation, and research.

The SDC initiative was established by the ONC in 2013 to develop two implementation guides:

On March 30, 2017 both initiatives transitioned into community led projects focused on data capture. The ideal scenario is that data captured in any manner can exist in FHIR for maximum interoperability. Both initiatives focus on improving data capture within healthcare. The CAP has already developed and implemented IHE SDC for their collection of electronic Cancer Checklists (eCCs), and being able to extract data from these cancer checklists to create FHIR Observations will enhance interoperability.

This information is required by ANSI for all ballots. Briefly explain the reason behind the need for this project. This may be related to legislative requirements, industry need, or similar justifications.

IHE SDC is the format of the College of American Pathologists (CAP) electronic Cancer Checklists (eCC). These checklists are used to capture essential information about cancer diagnosis for patient care, registry, and research use cases. Consistently representing this information in FHIR resources is essential for interoperability and processing by larger entities such as cancer registries. Ultimately this guide could be used to develop new methods of submitting data to cancer registries, most of which currently rely on HL7 2.5.1 North American Association of Central Cancer Registry (NAACCR) Volume V. Using FHIR will enable easier use of modern tooling, better search capabilities, and closer alignment to new CMS rules.

This project provides an opportunity for better alignment across the pathology space through FHIR and increased interoperability between different formats used in pathology, and other medical domains, such as radiology. Improved coordination through FHIR could facilitate better information sharing and therefore improve patient care.

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.	X	Yes
		No
		Unknown

Describe any external schedules or calendars which may not be known outside of the project team that are driving target dates for this project..

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)	2022 May Ballot
Complete STU Reconciliation	2022 Sep WGM
Submit for 2nd STU Ballot (if needed)	2022 Sep Ballot
Request STU Publication	2022 Dec
STU Period – 12 months	2023 Jan - 2024 Jan
Submit for Normative Ballot	2024 May Ballot
Complete Normative Reconciliation	2024 Sep WGM
Submit Publication Request	2024 Oct
Receive ANSI Approval	2024 Nov
Project End Date (all objectives have been met)	2024 Dec

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.

IHE SDC on FHIR

eCC on FHIR

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:

Enter any dependencies or the name & Project Insight ID of project(s) that this project is dependent upon to achieve its objectives:

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

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. 

https://build.fhir.org/ig/HL7/ihe-sdc-ecc-on-fhir/

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.

Will this project include/reference external vocabularies?	X	Yes		No		Unknown		N/A
If Yes, please enter the vocabularies: CAP C-keys/IDs

	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)
X	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)
X	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:

This project will continue work on the IHE SDC on FHIR parser, which transforms IHE SDC into FHIR resources.

https://github.com/IHE-SDC-WG/IHE-SDC-FHIR-Parser

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

R4

Create new standard				Supplement to a current standard
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:
- 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.)

If necessary, add any additional ballot information here. If artifacts will be jointly balloted with other SDOs, list the other groups.

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

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?	60%
Was the content externally developed ? :	Y	Alexander Goel, Joel Francis
Is this a hosted (externally funded) project? (not asking for amount just if funded)	X	Yes	No

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.

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		Pharmaceutical	X	Clinical and Public Health Laboratories
		Immunization Registries	X	EHR, PHR		Emergency Services
X		Quality Reporting Agencies		Equipment	X	Local and State Departments of Health
X		Regulatory Agency	X	Health Care IT		Medical Imaging Service
		Standards Development Organizations (SDOs)	X	Clinical Decision Support Systems	X	Healthcare Institutions (hospitals, long term care, home care, mental health)
		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
	Other: Indicate other stakeholders, vendors or providers not listed above.

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

2021-01-25 (for proposal)

20220210 for PSS

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date

List each Co-Sponsor and their Approval Date - FHIR-I

2021-10-25

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

N/A

FHIR Projects: FHIR Management Group

FMG Approval Date

2021-03-24

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

N/A

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

Comment (aka Comment-Only)

Joint Ballot (with other SDOs)

Informative

N/A (project won’t go through ballot)

STU to Normative - OR -

Normative (no STU)