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All names should have confirmed their role in the project prior to submission to the TSC.
Project facilitator (1Mandatory1Mandatory) | Anita Walden and Ed Hammond |
Other interested parties and their roles | National Institute of Health-NCATS Will provide guidance on project direction and scope Federal Drug Administration (FDA): conduct audit of the sites to evaluate the methodology of using FHIR to collect data for clinical research. Vanderbilt will participate on pilot demonstration project |
Multi-disciplinary project team (recommended) | |
| FHIR Facilitator | Ed Hammond (Jean Duteau) |
Modeling facilitator | Michael Rutherford |
Publishing facilitator | James Topping |
Vocabulary facilitator | Julie James |
Domain expert rep | Meredith Zozus |
Business requirement analyst | Anita WaldenJames Topping |
Conformance facilitator (for IG projects) | Michael Rutherford |
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 implementer specific to your work group’s resources if you know of any. | |
1) Duke University | |
2) University of Arkansas for Medical Sciences | |
| 3) Vanderbilt University | |
3. Project Definition
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Phase II - Develop standards, prototype and demonstrate automated single internal review board (sIRB) data and document exchange. Where needed the following standards will be developed. Existing FHIR resources will be utilized when appropriate, FHIR documents to support the following data collection and exchange (1) Structured (IRB) Reliance Agreement Determination Letter based on National IRB reliance models, (2) Study protocols, (3) Structured recruitment materials and (4) Structured informed consent documents and (5) Reportable medical (Unanticipated events, Adverse Events and Serious Adverse Events) and non-medical events and (6) Continuing Review and Final Progress Report form. FHIR resources will be utilized when appropriate. Implementation Guides will be created.
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Describe any external schedules or calendars which may not be known outside of the project team that are driving target dates for this project.. |
Federal Policy Change- The Common Rule
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. | Target Date(in WGM or ballot cycle format, e.g. | |
Submit Project Scope Statement | 2019 May 23 | |
Gap analysis between needs and existing standards | 2019 March2020 February | |
Development of Implementation Guide/s | 2020 March | |
| Host Connect-a-thon | 2020 | FebruaryMay |
Notification of Intent to STU Ballot of Implementation Guide | 2019 December2020 July | |
Ballot Implementation Guide STU | 2020 Jan/MayJuly | |
Ballot Reconciliation | 2020 JanJuly/MayAugust | |
Request for Publication | 2020 JuneOct | |
Project End Date (all objectives have been met) | 2020 JuneOct |
3.f. Common Names / Keywords / Aliases
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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. |
sIRB Project
3.g. Lineage
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: |
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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? Not sure yet.R4 |
5. Project Intent (check all that apply)
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Create new standard | x | 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 | X | Non-balloted WG White Paper | N/A (Project not directly related to an HL7 Standard) | |||||||
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Comment (aka Comment-Only) | Joint Ballot (with other SDOs) | ||||||
x | Informative | N/A (project won’t go through ballot) | |||||
x | STU to Normative - OR - | Normative (no STU) | |||||
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If necessary, add any additional ballot information here. If artifacts will be jointly balloted with other SDOs, list the other groups. |
| We will ballot Informative first then once we receive feedback will move to STU. We are also open to doing a "Comment Only" ballot in January because this is a unique application and our main objective this phase is to demonstrate progress and feedback as we move forward. |
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Universal | - OR - | X | Realm Specific | |
| Check here if this standard balloted or was previously approved as realm specific standard | |||
US - because because this project is supported by the National Institute of Health | 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. "U.S." 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. "U.S." | |||
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| Stakeholders |
| Vendors |
| Providers | |
| Clinical and Public Health Laboratories | X | Pharmaceutical |
| Clinical and Public Health Laboratories | |
| Immunization Registries |
| EHR, PHR |
| Emergency Services | |
| Quality Reporting Agencies |
| Equipment |
| Local and State Departments of Health | |
X | Regulatory Agency |
| Health Care IT |
| Medical Imaging Service | |
X | Standards Development Organizations (SDOs) |
| Clinical Decision Support Systems | X | Healthcare Institutions (hospitals, long term care, home care, mental health) | |
| Payors |
| Lab | X | Other (specify in text box below) | |
| Other (specify in text box below) |
| HIS |
| N/A | |
| N/A |
| Other (specify below) |
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| N/A |
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Other: Indicate other stakeholders, vendors or providers not listed above. Academic Medical Centers (clinical sites), | ||||||
6.d. Project Approval Dates
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Sponsoring Work Group Approval Date: | WG Approval Date | 2019-05-21 | ||||||||||||||
Administrative review – in parallel with Work Group Approval | ||||||||||||||||
Co-Sponsor Group Approval Date | List each Co-Sponsor and their Approval Date | CIC: 2019-05-07 | ||||||||||||||
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 | 2019-05-22 | ||||||||||||||
V2/Publishing Projects: V2 Management Group | V2 MG Approval Date | N/A | ||||||||||||||
US Realm Projects: US Realm Steering Committee Approval | USRSC Approval Date | 2019-06-18 | ||||||||||||||
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 CCYY-MM-DD | 2019-11-22 | ||||||||||||||
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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 | 2019-12-02 | ||||||||||||||
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