HL7 v2 Conformance Methodology Project Scope Statement (PSS)

 

Date: January 23, 2018

Sponsored by: Conformance WG

Draft 1.0

 

 


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

Update and Separate the HL7 V2 Conformance Methodology Specification

Project ID:

 

 

TSC Notification Informative/STU to Normative          

Date : 

 

 

 

Investigative Project (aka PSS-Lite)

Date : 

 

  1. Sponsoring Group(s) / Project Team

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

1.a. Primary Sponsor/Work Group

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

Conformance WG

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

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

1.c. Project Team

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

Project facilitator ( 1 Mandatory )

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

Business requirement analyst

n/a

Conformance facilitator (for IG projects)

n/a

Other facilitators (SOA, etc)

n/a

 

 

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. Project Definition

2.a. Project Scope

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

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.
  • 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.

 

2.b. Project Need

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

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 improvement s 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 upd ated. 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 definition s 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 v 2 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.

 

2.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 Appendix A for additional instructions.

 

 

Yes

 

X

No

 

 

Unknown

2.d. External Drivers

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

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.

2.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’)

Submit for STU Ballot (First Ballot Cycle)

2018 May Ballot

Complete STU Reconciliation

2018 Sep WGM

Request STU Publication

201 8   Sep WGM

STU Period – 12 months

201 8   Sep - 2020 Jan

Submit for 2nd STU Ballot

2018 Sep Ballot

Request STU Publication

2019 Jan WGM

STU Period – 12 months

201 9   May - 2020 May

Submit for Normative Ballot

2019 Sep Ballot

Complete Normative Reconciliation

2020 Jan WGM

Submit Publication Request

2020 Feb

Receive ANSI Approval

2020 Mar

Project Close

2020 Apr

On-going updates to the specification—independent of HL7 v2+ versions

TBD

2.f.    Common Names / Keywords / Aliases

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

v2 Conformance

2.g. Lineage

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

n/a

2.h. Project Dependencies

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

N/A

2.i.    Project Document Repository Location

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

Conformance WG Confluence (URL to be established)

Projects must adhere to the TSC's guidelines (which were approved on 2016-04-04 and summarized in Appendix A ).

Enter the SPECIFIC URL where supporting project documents , deliverables , ballot reconciliation work and other project information will be kept . A template to create a Project Page on the HL7 Wiki is available at: http://wiki.hl7.org/index.php?title=Template:Project_Page .

2.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:

2.k. External Vocabularies

Will this project include/reference external vocabularies?

 

 

Yes

 

 

No

 

 

Unknown

 

X

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 Context Object Workgroup (CCOW)

 

 

V2 Messages - Clinical

 

Domain Analysis Model (DAM)

 

 

V2 Messages - Departmental

 

Electronic Health Record (EHR) Functional Profile

 

X

V2 Messages – Infrastructure

 

FHIR Extensions

 

 

V3 Domain Information Model (DIM / DMIM)

 

FHIR Implementation Guide

 

 

V3 Documents – Administrative (e.g. SPL)

 

FHIR Profiles

 

 

V3 Documents – Clinical (e.g. CDA)

 

FHIR Resources

 

 

V3 Documents - Knowledge

 

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

 

 

V3 Foundation – RIM

 

Logical Model

 

 

V3 Foundation – Vocab Domains & Value Sets

 

New/Modified/HL7 Policy/Procedure/Process

 

 

V3 Messages - Administrative

 

New Product Definition (please define below)

 

 

V3 Messages - Clinical

 

New Product Family (please define below)

 

 

V3 Messages - Departmental

 

Non Product Project - (Educ. Marketing, Elec. Services, etc.)

 

 

V3 Messages - Infrastructure

 

White Paper

 

 

V3 Rules - GELLO

 

 

 

 

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.

X

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;

 

Withdraw an Informative Document

 

 

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)

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.

4.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)

X

STU to Normative     - OR -

 

Normative (no STU)

 

 

 

4.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

5.a. External Project Collaboration

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

N/A NIST – National Institute of Standards. Federal agency with mutual interest; no formal MOU.

For projects that have some of their content already developed:

How much content for this project is already developed?

3 0%

Was the content externally developed (Y/N)? 

No

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

 

 

 

 

 

 

 

 

Yes

 

X

No

5.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

 

 

5.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

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

X

Other (specify below)

 

 

 

 

 

N/A

 

 

Anyone implementing HL7 v2 or affected by HL7 v2 implementations.

5.d. Project Approval Dates [SRD(1]

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

Affiliate Approval Date (for Affiliate Specific Projects):

N/A

US Realm Steering Committee Approval Date
(for US Realm Specific Projects):

N/A

Sponsoring Work Group Approval Date:

WG Approval Date CCYY-MM-DD

Co-Sponsor Group Approval Date

(Copy this entire row for each co-sponsor; indicate the specific cosponsor that issued approval)

Co-Sponsor Approval Date CCYY-MM-DD

FHIR Project: FHIR Management Group Approval Date:

N/A

Architectural Review Board Approval Date:

(required for externally developed content)

N/A

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

[SRD(2]

Technical Steering Committee Approval Date:

TSC Approval Date CCYY-MM-DD

TSC has received a Copyright/Distribution Agreement (containing the verbiage outlined within the SOU), signed by both parties.

 

 

 

 

 

 

 

 

Yes

 

No

 

N/A

 


[SRD(1] To be entered as completed.

[SRD(2] Need to complete.