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
Project Name and ID
Enter the name of the project here: Lower Extremity Skin Wound Assessment FHIR IG
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: February 20, 2020
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.
Select the unit of measure used in the standard; if no measurements are in the standard, select N/A
Investigative Project (aka PSS-Lite)
Date : February 20, 2020
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
2.b. Co-sponsor Work Group(s)
Co-sponsor Work Group(s):(Enter co-sponsor approval dates in Section 6.d Project Approval Dates)
Clinical Information Modeling Initiative (CIMI)
Payer/Provider Information Exchange Work Group (PIE)
Orders and Observations (OO)
Patient Care (PC)
|Indicate the level of involvement that the co-sponsor will have for this project:|
|YES||Request formal content review prior to ballot|
|YES||Request periodic project updates. Specify period||WGMs plus on request|
|X||Other Involvement. Specify details here:|
Clinical Information Modeling Initiative (CIMI) - CIMI plans to have a representative at the weekly telephone calls. Also note that CIMI is co-sponsor for a related Patient Care PSS for a Skin Wound Assessment Profile. Others on this PSS are also on the Patient Care PSS team. In contrast, this PSS is for a FHIR IG for a conformance-testable specification for an exchangeable object containing FHIR 4.0 trust attributes, more detailed than the clinical content in the Patient Care Profile. The Profile and the FHIR IG teams have leveraged complementary interests while maintaining substantially different development paths.
Orders and Observations (OO) - OO will participate through Working Group Meeting updates.
Payer/Provider Information Exchange (PPIE) - PPIE has overlapping membership with implementers and co-sponsors
Patient Care (PC)- PC has overlapping membership with implementers and co-sponsors
2.c. Project Team
All names should have confirmed their role in the project prior to submission to the TSC.
Project facilitator (1Mandatory)
Michael L. Brody, DPM,
Other interested parties and their roles
Pharmacy Work Group
Multi-disciplinary project team (recommended)
Richard Ettema (AEGIS.net, Inc.)
Richard Ettema (AEGIS.net, Inc.)
Domain expert representatives
American Podiatric Medical Association (APMA)
- Seth Rubinstein DPM (Podiatrist in Private Practice)
- Diane Tower DPM – Staff Member
American College of Foot and Ankle Medicine (ACFAOM)
- Michael Warshaw DPM (Podiatrist in Private Practice)
Podiatry Insurance Company of America – Malpractice Carrier
- Linda McSmith Director of Risk Management
Tissue Analytics, a Net Health Company - Wound Measurement Device Manufacturer
- Joshua Budman, VP Wound Care Analytics
Biomedix – Manufacturer of Vascular Analysis Device
- John Romans CEO
ICS Software – EHR Vendor
- Ken Katz CEO
MedXpress – Qualified Clinical Data Registry
- Michael L Brody, DPM Chief Medical Officer
Anthem Prior Auth Workgroup
- Mary Jo Baughman, Business Strategy Planning Director, E-Solutions Management and Admin
ARANZ Medical, LTD - Device Manufacturer
- Bruce Davy, PhD
Trustworthy EHR, LLC - Compliance and U.S. Domain Records Expert
- Reed D. Gelzer, MD, MPH
Business requirement analyst
Michael L. Brody, DPM, Reed D. Gelzer, MD, MPH
Conformance facilitator (for IG projects)
Richard Ettema, AEGIS.net, Inc.
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) Registry Clearinghouse
2) Tissue Analytics
|3) AEGIS.net, Inc.|
|4) ARANZ Medical, LTD|
3. Project Definition
3.a. Project Scope
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..
The goal of this project is to develop a Lower Extremity Skin Wound Assessment Template Implementation Guide in FHIR 4.0 with clinical value, defined as minimum necessary utility according to our domain expert representatives and implementers.
Per the project experts and implementers, select clinical content is aligned with and mapped from the CIMI Skin Wound Assessment IG. Select Data Quality elements are incorporated from the Record Infrastructure section of the HL7/ISO EHR System Functional Model, Release 2.01 (EHR FM R2.01, RI Section) as represented in its source reference, ISO 21089. (ISO 21089 is also represented in FHIR 4.0)
The template will be useful to lower extremity wound care in any domain, including Podiatry practice by addressing clinical data accuracy and consistency for lower extremity wound patients' care quality assurance and continuity of care and care quality assurance. Accuracy attributes are designed to reference Data Quality assurance requirements and U.S. realm law and legal process requirements pertaining to those domains’ definitions of accuracy and authenticity.
The scope of Podiatry in the United States is substantially broader than in other countries and the Accuracy attributes (and their Authenticity validation) reference U.S. law; therefore, this is, at this stage, a US Realm project.
US Core: This FHIR implementation guide will use the US Core profiles. If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.
CIMI Alignment: This FHIR IG has been and will remain closely coordinated with CIMI's clinical content modeling and resulting CIMI Profiles. This specific project references the Profiles within the CIMI Skin Wound Assessment IG. For the latter's current build, see http://build.fhir.org/ig/HL7/cimi-wound-assessment/branches/master/index.html
3.b. Project Need
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.
Podiatry is the sub specialty that focuses on the treatment of the foot and lower extremity. The needs of the profession are unique for several reasons. First, there are specific examinations and documentation elements that are not currently supported by the current EHR-S Functional Model, in addition there are elements of the EHR-S Functional Model that do not apply to the practice of Podiatry. Second, the Podiatry community is relatively advanced in its recognition that data and information trust can be operationalized due to recent years’ advances in Standards development. Operationalized trust will have substantial and measurable benefits for increasing clinical effectiveness, operational efficiency, and patient care quality and safety. All will substantially increase patient benefit and reduce provider burden.
Additionally, while the EHR-S Functional Model provides data quality-relevant functional conformance criteria, it does not provide technical detail sufficient to build templates and establish validation schema. It also references an earlier version of ISO 21089, whereas FHIR 4.0 captures attributes relevant to Data Quality, Accuracy, and Authenticity referencing the newer ISO 21089 (2018-04) Health informatics — Trusted end-to-end information flows.
This project will therefore demonstrate the utility of advancing HIT into conformance with these resources. Normalization of Data Quality, Accuracy, and Authenticity attributes will improve interoperability from its current state of exchanging data objects agnostic to and without representation of trust or value.
Among the issues identified are:
- Improved data normalization and trust for documentation of wounds of the lower extremity, improving continuity of care and interoperability
- Improved ability to support trust-oriented exchange in Electronic Submission of Medical Documentation, Electronic Determination of Coverage, and clinical documentation supporting quality reporting, advanced payment models, and revenue cycle compliance.
- Ability to support the differentiation of data sources according to conformance with defined specifications that include higher order Data Quality requirements. For example, capturing reliable, accurate, reproducible automated wound measurements, extremity vascular sufficiency measurements, and other attributes with end-use sensitivity and specificity requirements. This latter may include, for example, readiness states for armed forces personnel at higher risk for lower extremity injuries and limitations. Ability to support communication of accurate data and authentic records with all appropriate stakeholders including specialty care referrals, payers, risk insurers, and care quality managers in special clinical populations (ex: diabetics) or with unique Social Determinants limitations (ex: distant from care access).
- Ability to support communication of accurate data and authentic records with all appropriate stakeholders including specialty care referrals, payers, risk insurers, and care quality managers in special clinical populations (ex: diabetics) or with unique Social Determinants limitations (ex: distant from care access).
- Ability to support communication of quality measure data with all appropriate stakeholders.
- Increasing industry need as exemplified by trends in evidence with currently unknown timelines (see 3d. External Drivers)
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.
3.d. External Drivers
Describe any external schedules or calendars which may not be known outside of the project team that are driving target dates for this project.
Rising demand for trusted information in patient care is likely to produce new initiatives but, at this time, “when and how” are unknown. For example, extensive interest in clinician burden related to trust assurance uncertainty in EHR systems may produce new ONC guidance. Increasing number of solutions vendors seeking SDO support for means to validate conformance with data quality specifications may produce accelerating market demand. Recent findings in Department of Health and Human Services reports and Department of Justice reports of extensive variability in EHR system data quality may produce new regulations.
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.
Enter Target Date
Submit for STU Ballot(First Ballot Cycle)
2020 September Ballot
Complete STU Reconciliation
2021 January WGM
Request STU Publication
2021 January WGM
STU Period – 12 months
2021 January - 2023 January
<<NOTE: Per FHIR MG, FHIR Policy stipulates 2 year STU for FHIR IG>
Submit for Normative Ballot
2023 May Ballot
Complete Normative Reconciliation
2023 September WGM
Submit Publication Request
2023 September WGM
Receive ANSI Approval
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.
3.f. Common Names / Keywords / Aliases
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.
Skin Wound Assessment (SWA) FHIR 4.0, Skin Wound Assessment , SWA, Wound Assessment and Treatment Template, WATT
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:
3.h. Project Dependencies
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
3.i. HL7-Managed Project Document Repository Location
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.|
Link to the FHIR IG development site: https://build.fhir.org/ig/HL7/fhir-skin-wound-ig/branches/master/index.html
Link to the repository for meetings and intermediate work products: https://confluence.hl7.org/pages/viewpage.action?pageId=55935319
OR Click on this hyperlink: Podiatry THEN Click on links for "Meeting Minutes, Agendas for Wound Template work" and "WATT Content, Data Quality/Record Accuracy References"
3.j. Backwards Compatibility
Are the items being produced by this project backward compatible?
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)
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?
If Yes, please enter the vocabularies: SNOMED, LOINC and other ontologies that deal with clinical data. We will also submit codes to SNOMED and LOINC for consideration to fill any identified gaps in coding for Podiatry.
4. Products (check all that apply)
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)
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
V3 Foundation – RIM
Guidance (e.g. Companion Guide, Cookbook, etc)
V3 Foundation – Vocab Domains & Value Sets
V3 Messages - Administrative
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
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
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 -
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)
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?
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: None
How much content for this project is already developed?
Was the content externally developed ? :
Is this a hosted (externally funded) project? (not asking for amount just if funded)
- OR -
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
Clinical and Public Health Laboratories
Clinical and Public Health Laboratories
Quality Reporting Agencies
Local and State Departments of Health
Health Care IT
Medical Imaging Service
Standards Development Organizations (SDOs)
Clinical Decision Support Systems
Healthcare Institutions (hospitals, long term care, home care, mental health)
Other (specify in text box below)
Other (specify in text box below)
Other (specify below)
Other: Indicate other stakeholders, vendors or providers not listed above.
Podiatrists - American Podiatric Medical Association
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 and Approval Date
|EHR Feb. 18, 2020|
Administrative review – in parallel with Work Group Approval
Co-Sponsor Group Approval Date
List each Co-Sponsor and their Approval Date
1) Clinical Information Modeling Initiative (CIMI)
Approved: January 23, 2020
2) Payer/Provider Information Exchange Work Group
Approved: February 18, 2020
3) Orders and Observations (OO)
Approved: February 27, 2020
4) Patient Care (PC)
Approved: April 27, 2020
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
ARB and Steering Division approval may be in parallel
Architectural Review Board Approval Date:
(required for externally developed content)
ARB Approval Date
If applicable, TSC has received a Joint Copyright/Distribution Agreement (containing the verbiage outlined within the SOU),
Technical Steering Committee Approval Date:
TSC Approval Date