PSS - Update and Separate the HL7 V2 Conformance Methodology Specification

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

Page tree

2.a. Primary Sponsor/Work Group

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

2.c. Project Team

3.a. Project Scope

3.d. External Drivers

3.e. Project Objectives / Deliverables / Target Dates

3.f. Common Names / Keywords / Aliases

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

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

Project Name and ID

Enter the name of the project here: Update and Separate the HL7 V2 Conformance Methodology Specification
Project ID:	1396
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
x	- 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 X
Select the unit of measure used in the standard; if no measurements are in the standard, select N/A			N/A X	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)

Conformance WG

Co-sponsor Work Group(s): (Enter co-sponsor approval dates in Section 6.d Project Approval Dates)		Infrastructure and Messaging
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:	Review working material

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

Project facilitator (1Mandatory)	Rob Snelick
Other interested parties and their roles	HL7 V2 - all other chapter owners
Multi-disciplinary project team (recommended)
Modeling facilitator	n/a
Publishing facilitator	Rob Snelick, Frank Oemig, Brian Pech
Vocabulary facilitator	n/a
Domain expert rep	Rob Snelick, Frank Oemig, Craig Newman, Hans Buitendijk, Ioana Singureanu
Business requirement analyst	n/a
Conformance facilitator (for IG projects)	n/a
Other facilitators (SOA, etc)	n/a

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)

The intent of the project is to update the conformance methodology used to profile message definitions and to separate (divorce) the conformance chapter (currently Chapter 2B) from the “main” HL7 v2 standard.

Provide an independent (separate) HL7 v2 Conformance Methodology standard.
Update the conformance constructs and profiling mechanisms used for implementation guide creation
Update the profile schema that supports the XML computable representation for implementation guides and message profiles
Deprecate by means of an errata the Conformance chapter/section from all prior V2 versions. (our expectation is that the content of conformance testing of existing IGs will not change, but going forward any new specification will use this updated conformance methodology). To be clear, the proposal is an updated method of how to specify conformance for new IGs.
Identify opportunities to encourage adoption by external implementation guide developers (e.g., IHE) to use the same conformance definitions and constructs.

There are many versions of the HL7 v2 standard. An explicit conformance methodology was introduced into the standard in version 2.5 and revised in subsequent versions of the standard. The conformance methodology was part of chapter 2 initially and later became a subchapter (Chapter 2B Conformance). This document serves to replace (override) the conformance methodology in these earlier versions and it is intended to be applied to any HL7 v2 version. That is, if a developer is seeking to constrain a version 2.5.1 message event, they should use the conformance methodology prescribed in this document and not the conformance methodology given in version 2.5.1.

3.b. Project Need

HL7 v2 implementation guide specification has historically been ambiguous due to the lack of sufficient conformance profiling mechanisms and guidance. In recent years many updates and improvements have been developed and used in the creation of HL7 v2 implementation guides. However, these practices have not been formally documented in the HL7 v2 conformance chapter. Additionally, the profile schema that provides the format of the computable XML profile has not been updated. The need is to provide a formal specification for both the narrative and machine representation of current best practices of the HL7 v2 conformance methodology.

Conformance and profiling of message definitions is independent of any one version of the HL7 v2 standard. Profiling activities should use the current conformance mechanisms for creating implementation guides. Currently, the conformance methodology is embedded in each v2 version. The need is to create and promote a process to use the latest profiling constraint mechanisms irrespective of the version of the HL7 v2 implementation guide. Considering that v2 is expected to be relevant due to the global install base, and it has been recognized that consistent, clear implementation guides are essential to the success of any wide ranging interoperability initiative, maintaining current conformance definitions and practices is critical.

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

Project is being tackled now on the heels of work to support various certification efforts from ONC, HIMSS, IHE, etc. where implementation guides became a critical tool to drive consistency and clarity. Creation of certification testing tools revealed the lack of clarity in the HL7 v2 implementation guides being used, and better defining conformance will help v2 implementation guide authors to write consistent, concise and clear requirements. Project is related to the HL7 effort to use IGAMT (Implementation Guide Authoring and Management Tool) to create and publish HL7 v2 implementation guides. The conformance methods implemented in IGAMT will follow the requirements specified in this document.

Submit draft for comment Ballot (First Ballot Cycle)	2019 Sept Ballot
Complete ballot Reconciliation	2019 Nov/Dec WGM
Submit for Normative Ballot	2020 Jan Ballot
Complete Normative Reconciliation	2020 May WGM
Submit Publication Request	2020 June
Receive ANSI Approval	2020 July
Project Close	2020 Aug

V2 Conformance

3.g. Lineage

n/a

There are no project dependencies. However, the relationship between this PSS and HL7 v2.9 and HL7 v2.+ warrants discussion. The specification being created in this PSS replaces conformance sections and chapters (chapter 2B) in previous and future versions of HL7 v2. The section or chapter in previous versions will be deprecated; this applies to all versions prior to and including version 2.8.2. The timeline of this specification and version 2.9 is not yet fully determined. It is estimated that v2.9 will be published first and therefore chapter 2B will be deprecated upon completion of this specification. This specification will be completed before v2.+ and v2.+ will reference it (as will all releases of v2.+).

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://

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?		Yes		No		Unknown	x	N/A
If Yes, please enter the vocabularies:

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)	x	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		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?

	Create new standard			x	Supplement to a current standard
x	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
		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	Project will impact how v2 implementation guides can be written independent of the HL7 version they are written in. Particularly it will request implementation guide writers to express profiling constraints using this specification.
- 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

n/a

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 ? :	Y/N
Is this a hosted (externally funded) project? (not asking for amount just if funded)		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	Clinical and Public Health Laboratories
x		Immunization Registries		EHR, PHR	Emergency Services
		Quality Reporting Agencies		Equipment	Local and State Departments of Health
x		Regulatory Agency	x	Health Care IT	Medical Imaging Service
x		Standards Development Organizations (SDOs)		Clinical Decision Support Systems	Healthcare Institutions (hospitals, long term care, home care, mental health)
		Payors	x	Lab	Other (specify in text box below)
x		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. Anyone implementing HL7 V2 or affected by HL7 v2 implementations

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

2018-01-29

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date

InM

2018-02-14

Family Management Group Approval Date(s)

CDA Projects: CDA Management Group

CDA MG Approval Date

n/a

FHIR Projects: FHIR Management Group

FMG Approval Date

n/a

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

2019-03-08

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:

Infrastructure SD

2018-05-14

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)

ARB Approval Date

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

2019-04-01

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)