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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: Health Record Exchange (HRex) Framework | ||||||||||
| Project ID: | 1494 | |||||||||
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. | ||||||||||
X | TSC Notification: Informative/STU to Normative | Date | ||||||||
| - 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 | |||||||
Select the unit of measure used in the standard; if no measurements are in the standard, select N/A |
| N/A |
| 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. | ||||||||||
2. Sponsoring Group(s) / Project Team
2.a. Primary Sponsor/Work Group
| Primary Sponsor (may only be one) | Clinical InteroperabilityCouncil |
|---|
2.b. Co-sponsor Work Group(s)
Co-sponsor Work Group(s): (Enter co-sponsor approval dates in Section 6.d Project Approval Dates) | Patient Care Attachments Financial Management | |
| Indicate the level of involvement that the co-sponsor will have for this project: | ||
| Request formal content review prior to ballot | ||
| X | Request periodic project updates. Specify period | WGMs |
| 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) | Lloyd McKenzie, Rick Geimer |
Other interested parties and their roles | Viet Nguyen (technical FHIR support) |
Multi-disciplinary project team (recommended) | |
Modeling facilitator | Rick Geimer |
Publishing facilitator | |
Vocabulary facilitator | Viet Nguyen |
Domain expert rep | Lisa Nelson, Rick Geimer, Tony Benson, Mark Scrimshire |
Business requirement analyst | Robert Dieterle, Linda Michaelsen |
Conformance facilitator (for IG projects) | Rick Geimer |
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) United Healthcare | |
2) Humana | |
3. Project Definition
3.a. Project Scope
The Health Record exchange (HRex) Framework is part of the larger Da Vinci use case for Health Record exchange (HRex). After careful evaluation, the HRex project was decomposed into four independent efforts (and tied to 4 separate PSSs). The exchange of Quality Measures was included in the existing work on the Data Exchange for Quality Measures (DEQM) that is sponsored by the CQI workgroup. The exchange of Payer Data (PDex) is sponsored by Financial Management. The exchange of provider originated data or Clinical Data exchange (CDex) is sponsored by Patient Care. The overall HRex Framework described in the PSS is planned to be sponsored by CIC as a US Realm specific framework that defines common elements and interactions necessary for the other implementation guides.
The following depicts the relationship of the multiple Da Vinci use cases developed during 2018 and planned for 2019. Many of these will use the HRex Framework as their basis for defining the use of specific FHIR artifacts.
The scope of the HRex Framework project is to defined combinations of exchange methods (push, pull, subscribe, CDS Hooks, …), specific payloads (Documents, Bundles, and Individual Resources), search criteria, conformance, provenance, and other relevant requirements to support specific exchanges of clinical information between: 1) providers, 2) a provider and a payer, 3) a payer and providers, and/or a provider and any third party involved in value based care (e.g. a quality management organization). The goal is to identify, document and constrain very specific patterns of exchange so that providers and payers can reliably exchange information for patient care (including coordination of care), risk adjustment, quality reporting, identifying that requested services are necessary and appropriate (e.g. should be covered by the payer) and other uses that may be documented as part of this effort. The specific use case driven implementation guides will inherit the HRex Framework to avoid defining the same exchanges, profiles, constraints in multiple guides with slightly differed variations. This project will reference, where possible, the prior work from Argonaut, US Core and QI Core effort for FHIR DSTU2, STU3, and R4. The following diagram depicts the anticipated scope of the eHRx Framework IG.
The ultimate goal is to provide a framework from which specific implementation guides can be developed with reduces effort and potential conflicting definitions to support the exchange of provider and payer data on specific patients/members or groups of patients/members to reduce provider and payer burden, and improve patient care using technology that supports FHIR DSTU2, STU3, and R4 releases of the FHIR standard. The project will address patient consent where appropriate. The project team plans to work with existing FHIR artifacts where possible. If changes are necessary, the project team will work with the responsible Work Group to review and implement (via tracker items or new PSS) any necessary enhancements to base FHIR resources, extensions, and/or profiles. |
3.b. Project Need
Providers and Payers need to exchange information regarding prior and current healthcare services planned for or received by the patient/member to more effectively manage the patients care. Currently, no FHIR implementation guides exist to standardize the method of exchange (push, pull, triggers, subscription, etc.) and the formal representation (e.g. Documents, Bundles, Profiles and Vocabulary) for the range of exchanges between providers and providers or providers and payers of current and emerging interest to the involved parties. To satisfy this need, a number of specific implementation guides will need to be created, each of which will span multiple version of FHIR (DSTU2, STU3, R4,...) and multiple methods of exchange. To avoid defining the same profiles and exchanges multiple times, we propose to create a US Realm focused Framework Implementation guide for use by Da Vinci and other FHIR standards development efforts to defined the appropriate use of the exchange methods, specific FHIR resources, profiles, values sets, etc. once and allow them to be reference by each of the specific implementation guides. This implementation guide will provide a standard framework for inclusion in multiple use case specific implementation guides focused on the exchange of provider and payer originated information to improve patient care and reduce provider and payer burden. |
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’) |
Ballot for Comment (First Ballot Cycle) | 2019 May Ballot |
Submit for STU1 Ballot(Second Ballot Cycle) | 2019 Sep Ballot |
Complete STU1 Reconciliation | 2020 Jan WGM |
Request STU1 Publication | 2020 Jan WGM |
Submit for STU2 Ballot(Third Ballot Cycle) | 2020 Sep Ballot |
Complete STU2 Reconciliation | 2021 Jan WGM |
Request STU2 Publication | 2021 Jan WGM |
STU Period | 2020 Jan -2022 Jan |
Submit for Normative Ballot | 2022 May Ballot |
Complete Normative Reconciliation | 2022 Sep WGM |
Submit Publication Request | 2022 Oct |
Project End Date (all objectives have been met) | 2022 Dec |
3.f. Common Names / Keywords / Aliases
Health Record exchange, HRex, Da Vinci, Framework |
3.g. Lineage
n/a |
3.h. Project Dependencies
US Core for R4, CCDA on FHIR for R4 |
3.i. HL7-Managed Project Document Repository Location
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: //confluence.hl7.org/pages/viewpage.action?pageId= or above this link. |
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: | ||||||||
If desired, enter additional information regarding Backwards Compatibility. | ||||||||
3.k. External Vocabularies
Will this project include/reference external vocabularies? | X | Yes | No | Unknown | N/A | |||
If Yes, please enter the vocabularies: HCPCS, SNOMED, CPT, ICD, RxNorm, 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) | ||
X | FHIR Extensions | V3 Documents – Administrative (e.g. SPL) | |
X | 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: |
For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? DSTU2, STU3, R4 |
5. Project Intent (check all that apply)
Create new standard | Supplement to a current standard | ||||||||
Revise current standard (see text box below) | X | 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)
X | 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) | ||||
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 | X | 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? | 15% | |||
Was the content externally developed ? : | Y | Da Vinci | ||
Is this a hosted (externally funded) project? (not asking for amount just if funded) | X | Yes | No | |
6.b. Realm
Universal | - OR - | X | Realm Specific | |
| Check here if this standard balloted or was previously approved as realm specific standard | |||
U.S. | Includes IG references, vocabulary and profiles that are specific to the US healthcare system Support US Healthcare workflows | |||
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 | |
X | Clinical and Public Health Laboratories | X | Pharmaceutical |
| Clinical and Public Health Laboratories | |
X | Immunization Registries | X | EHR, PHR | X | Emergency Services | |
X | Quality Reporting Agencies | X | Equipment |
| Local and State Departments of Health | |
X | Regulatory Agency | X | Health Care IT | X | Medical Imaging Service | |
| Standards Development Organizations (SDOs) | X | Clinical Decision Support Systems | X | Healthcare Institutions (hospitals, long term care, home care, mental health) | |
X | Payors | X | Lab |
| Other (specify in text box below) | |
X | Other (specify in text box below) |
| HIS |
| N/A | |
| N/A |
| Other (specify below) |
| ||
|
| N/A |
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Other: Federal Healthcare Agencies (e.g. CMS), Providers (e.g. Physicians) | ||||||
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 | 1/24/2019 | ||||||||||||||
Administrative review – in parallel with Work Group Approval | ||||||||||||||||
Co-Sponsor Group Approval Date | Patient Care Financial Management Attachments | 2/5/2019 | ||||||||||||||
Family Management Group Approval Date(s) | ||||||||||||||||
CIMI Projects: CIMI Management Group | CIMI MG Approval Date | N/A | ||||||||||||||
CDA Projects: CDA Management Group | CDA MG Approval Date | N/A | ||||||||||||||
FHIR Projects: FHIR Management Group | FMG Approval Date | 2/27/2019 | ||||||||||||||
V2/Publishing Projects: V2 Management Group | V2 MG Approval Date | N/A | ||||||||||||||
US Realm Projects: US Realm Steering Committee Approval | USRSC Approval Date | 2/19/2019 | ||||||||||||||
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: | SD Approval Date | 2019-03-22 | ||||||||||||||
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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 | N/A | ||||||||||||||
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 | |||||||||||||||