2020-02-19 Lower Extremity Skin Wound Assessment FHIR IG

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

1. Project Name and ID

2. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

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

2.c. Project Team

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

3. Project Definition

3.a. Project Scope

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

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

3.d. External Drivers

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

3.f.   Common Names / Keywords / Aliases

Skin Wound Assessment (SWA) FHIR 4.0, Skin Wound Assessment , SWA, Wound Assessment and Treatment Template, WATT

3.g. Lineage

None

3.h. Project Dependencies

None Known

3.i.   HL7-Managed Project Document Repository Location

3.j.   Backwards Compatibility

3.k. External Vocabularies

4. Products (check all that apply)

5. Project Intent (check all that apply)

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

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.

6. Project Logistics

6.a. External Project Collaboration

6.b. Realm

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

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