Structured Data Capture (SDC) FHIR SDC Pilots Template This template is designed to help you document the scope and plans for a pilot project with the SDC Initiative, focused on implementing the latest version of the FHIR SDC Profile (http://hl7.org/fhir/iglist.html - scroll down to see links in the table to the two Structured Data Capture implementation guides) Insert the Name of Your Pilot / Organization Here MM/DD/YYYY

Pilot Team (Lead Organization) Identify the members of your organization who will be supporting this pilot. If possible include the role he/she will play in the pilot and contact information Name Role Email

Full Disclosure? Please document any items you believe should be shared with the community or other pilot and project teams, in the spirit of ‘full disclosure’. You may also use this section to document any other risks or concerns you may have.

Goal of the Pilot Pilot proposals should focus on implementing and testing the published standards in order to evaluate and update the standard in preparation for the normative publication of the FHIR SDC Profile standard through HL7. Please download and review the FHIR SDC Implementation Guides: Latest version of the FHIR SDC Implementation Guide can be found here: https://www.hl7.org/fhir/sdc/sdc.html Latest version of the FHIR SDC Data Element Implementation Guide can be found here: https://www.hl7.org/fhir/sdcde/sdcde.html Please include a write up and create a diagram (e.g. high level workflow) of what you intend to show/prove/support during the pilot process. Make this an actionable statement with specifics. Also include in this description what you hope to gain from this pilot. Note that two example SDC Workflows and How SDC Leverages the FHIR Resources are provided as references in the next three slides.

Structured Data Capture Structured Data Capture Workflow Metadata CDE Library Sends request for form/template 1 Form/Template Repository Form Library Metadata Source Sends requested form/template 2 SDC Scope EHR System Specified Form/Template 3 Converts, populates and displays form 4 Fills, stores/transmits structured data Please create your own high-level workflow for how you envision using the FHIR SDC Profile. External Data Repository Displayed Form Actor Key Extract, Transform, and Load Data by form/ template 5 Forms Filler Structured Data Capture Forms Manager External Repository DRAFT: Not for distribution

SDC FHIR Workflow Example Please create your own high-level workflow for how you envision using the FHIR SDC Profile. 6 DRAFT: Not for distribution

How SDC Leverages FHIR Resources SDC FHIR Profile makes use of the following FHIR Resources: DataElement is used to define data elements that can be referenced in questionnaires, and can be used to auto-populate form data. Questionnaire is used to define form definitions that may be downloaded for manual and/or automatic population. QuestionnaireResponse is used to share instance data captured using questionnaire forms. ValueSet is used to define allowed values for data elements and for questions in questionnaires. FHIR Resource List: http://hl7.org/fhir/resourcelist.html Data Element Resource: http://hl7.org/fhir/dataelement.html Questionnaire Resource: http://hl7.org/fhir/questionnaire.html Questionnaire Response Resource: http://hl7.org/fhir/questionnaireresponse.html Value Set Resource: http://hl7.org/fhir/valueset.html

Pilot Team (Roles) Please use this section to identify which role your organization (and any partner organizations) will take on. Please also include any organizations you may partner with who could fill additional roles. Role Description Organization Name Form Filler Retrieves forms from a Form Manager as and when required. When requesting a form, the Form Filler can optionally provider EHR context information by providing pre-population xml data in the request for use by the Form Manager. Form Manager Supplies forms to Form Fillers based upon form retrieval requests. May return a form, or the returned form may be selected or constructed based upon context information supplied in the form retrieval request. Form Receiver Receives and processes completed or partially completed forms instance data from a Form Filler.

What Relevant Purpose (from the Use Case) does your Pilot support? Please read the SDC Use Case and identify what area your pilot will focus on. Link to download Consensus Approved Use Case: http://wiki.siframework.org/Structured+Data+Capture+Use+Case Clinical Research Patient Centered Outcomes Research Patient Safety Reporting Public Health Reporting Determination of Coverage Other: ____(Please specify)

Minimum Configuration What is your current technical / infrastructure set up? What systems / applications will you be using to conduct the pilot? Examples: Ambulatory Electronic Health Record (EHR) system Form/Template repository External database (which one/type) Existing interfaces New interfaces (to be developed as part of the pilot)

Timeline What is your proposed timeline? Guidance: ~6 months minimum / ~1 year maximum Evaluation: starts @ 6-9 months / final evaluation when pilot is complete Milestones/Activities are examples. Please feel free to edit as needed. Milestone / Activity Target Date Responsible Party Kickoff Design Development QA and Test Demonstration Evaluation

Success Criteria What will you/your organization use to determine the success of this pilot? This needs to be quantitative and not subjective in as much as possible. Example: Establish a process within your organization where XX% of their Incident Reports are completed electronically.

In Scope / Out of Scope If you already know what will be in and out of scope for your pilot (beyond the Implementation Guidance (IG) or the Use Case) please document it here.

Risks & Challenges Please identify any risks or challenges. Be sure to include proposed mitigations/solutions for each risk.

Resource Estimates Please provide an estimate of the resources you believe will be required to complete the proposed pilot activities. At a minimum, please provide the labor categories, rates, and estimated number of labor hours for each team member for the period of performance, along with any additional, non-labor costs you anticipate. IMPORTANT: cost information should be provided along with this proposal template to Ms. Farrah Darbouze (farrah.darbouze@hhs.gov)

Questions Please include those items you wish to consider any questions you have or hope the pilot addresses.

Useful Links Structured Data Capture Wiki http://wiki.siframework.org/Structured+Data+Capture+Initiative Structured Data Capture Use Case http://wiki.siframework.org/Structured+Data+Capture+Use+Case Introduction to the FHIR Standard https://www.hl7.org/fhir/index.html FHIR SDC Implementation Guide can be found here: https://www.hl7.org/fhir/sdc/sdc.html FHIR SDC Data Element Implementation Guide can be found here: https://www.hl7.org/fhir/sdcde/sdcde.html FHIR Resource List http://hl7.org/fhir/resourcelist.html

Submission Instructions Submit completed proposal presentation templates and cost information to the ONC Lead Farrah Darbouze (farrah.darbouze@hhs.gov) Submit any questions you may have to both the ONC Lead: Farrah Darbouze (farrah.darbouze@hhs.gov) and the Project Manager, Jenny Brush (jennifer.brush@esacinc.com).