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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: Vocabulary Binding Concepts, Principles, and Practices | ||||||||||
| Project ID: | An ID will be assigned by Project Insight | |||||||||
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 | |||
2. Sponsoring Group(s) / Project Team
2.a. Primary Sponsor/Work Group
Primary Sponsor/Work Group | Vocabulary |
2.b. Co-sponsor Work Group(s)
Co-sponsor Work Group(s): (Enter co-sponsor approval dates in Section 6.d Project Approval Dates) | Conformance | |
| 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) | |
Other interested parties and their roles | |
Multi-disciplinary project team (recommended) | |
Modeling facilitator | N/A |
Publishing facilitator | |
Vocabulary facilitator | N/A |
Domain expert rep | |
Business requirement analyst | N/A |
Conformance facilitator (for IG projects) | N/A (Not an IG) |
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) N/A | |
2) N/A | |
3. Project Definition
3.a. Project Scope
Develop and publish an architectural foundation for vocabulary binding including concepts, principles and best practises in a product family agnostic way i.e. not in conflict with particular models, designs and paradigms in product families, coding systems, or related product family specific models. As annex describing how to apply the best practices to HL7 Fast Healthcare Interoperability Resources (FHIR) Release 4 (R4). Additional annexes may be added to cater for other product families (e.g. HL7 Version 2 and Clinical Document Architecture) in order of demand and use. |
3.b. Project Need
Binding terminology artifacts (code systems, value sets, codes) to data elements which may carry coded values is commonplace in health informatics. However, few resources exist to describe the concepts, principles, and best practice for doing so which may lead to poor and unpredictable implementations. Further, FHIR which is seeing widespread adoption internationally, supports and extensively uses binding, in particular binding to value sets. Without appropriate guidance and a source of best practice when binding the risk of “not getting right” is much higher in the FHIR ecosystem. Accordingly, this project seeks to provide sound foundational knowledge and guidance to implementers as well as describing the correct application of the guidance using the FHIR standard. V2 and CDA have done binding in a way that is not compatible with each other nor necessarily conducive to the current and near term needs of FHIR. |
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
None. |
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 |
Example: Submit for STU Ballot(First Ballot Cycle) | 2018 Jan Ballot |
Example: Complete STU Reconciliation | 2018 May WGM |
Example: Submit for 2nd STU Ballot | 2018 May Ballot |
Example: Request STU Publication | 2018 Sep WGM |
Example: STU Period – 12 months | 2019 Jan - 2015 Jan |
Example: Submit for Normative Ballot | 2019 May Ballot |
Example: Complete Normative Reconciliation | 2019 Sep WGM |
Example: Submit Publication Request | 2019 Oct |
Example: Receive ANSI Approval | 2020 Nov |
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 |
3.f. Common Names / Keywords / Aliases
Binding |
3.g. Lineage
N/A |
3.h. Project Dependencies
N/A |
3.i. HL7-Managed Project Document Repository Location
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: | ||||||||
3.k. External Vocabularies
Will this project include/reference external vocabularies? | X | Yes | No | Unknown | N/A | |||
SNOMED CT 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) | V3 Documents – Clinical (e.g. CDA) | ||
X | FHIR Profiles (enter FHIR product version below) | V3 Documents - Knowledge | |
X | 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: N/A |
For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?
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5. Project Intent (check all that apply)
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 | ||||||
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) | |||||
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? | 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. | ||||
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 | ||
6.b. Realm
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. | ||||
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 | |
X | 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 |
|
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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 | |||||||||||||||
Administrative review – in parallel with Work Group Approval | ||||||||||||||||
Co-Sponsor Group Approval Date | List each Co-Sponsor and their Approval Date |
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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 | 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 | |||||||||||||||
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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), |
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Technical Steering Committee Approval Date: | TSC Approval Date | |||||||||||||||