1. Structured Data Capture (SDC) All Hands Meeting April 4, 2013

2. Meeting Etiquette 2 Remember: If you are not speaking, please keep your phone on mute Do not put your phone on hold. If you need to take a call, hang up and dial in again when finished with your other call o Hold = Elevator Music = frustrated speakers and participants This meeting is being recorded o Another reason to keep your phone on mute when not speaking Use the “Chat” feature for questions, comments and items you would like the moderator or other participants to know. o Send comments to All Panelists so they can be addressed publically in the chat, or discussed in the meeting (as appropriate). From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute All Panelists

3. Agenda TopicTime Allotted Welcome and Announcements Meeting Reminders & Announcements Join the Initiative SDC Roadmap 10 minutes Use Case Timeline Review SDC Use Case Comments & Disposition Review Functional Requirements 40 minutes Next Steps / Homework5 minutes Community Presentation: Aster-D Demonstration30 minutes 3

4. Meeting Reminders & Announcements Structured Data Capture (SDC) Initiative holds weekly community meetings on Thursdays at 3:25 pm EST. –Next meeting is scheduled for April 11, 2013 from 3:25 pm – 5:00 pm Eastern. –Next meeting will focus on the Candidate Standards List –See the SDC Wiki Page for meeting information –http://wiki.siframework.org/Structured+Data+Capture+Initiativehttp://wiki.siframework.org/Structured+Data+Capture+Initiative 4 Please check the meeting schedule weekly as the meeting link and call in numbers will change.

5. All Hands Meetings Extended Spring Concert Series Continues –Demonstrations by SDC relevant community members and stakeholders All Hands Meetings has been extended by ½ hour to accommodate these presentations. –3:25 to 4:30 pm Eastern: All Hands Community Working Meeting –4:30 to 5:00 pm Eastern: Scheduled Presentation Today’s Presentation –ASTER-D Upcoming Presentations –11APR13: Candidate Standards Presentation (confirmed)

6. Join the SDC Initiative To join the Structured Data Capture (SDC) Initiative, go here: http://wiki.siframework.org/Join+Structured+Data+Capture+Initiative. http://wiki.siframework.org/Join+Structured+Data+Capture+Initiative Joining the initiative ensures that you are included on initiative communications and announcements. You may join as an Interested Party or a Committed Member. (More information about these two options is on the Join page.) Thank you! Your commitment and participation are critical to our success.

7. Pilots & Evaluation after September Standards & Harmonization Use Case & Functional Requirements Pre-Discovery Pre-Planning Structured Data Capture (SDC) Initiative: Proposed Standards & Harmonization WGs and Timeline Dec ‘12Apr ‘13Jan ‘13Feb ‘13Mar ‘13May ‘13Jun ‘13Jul ‘13Aug ‘13Sept ‘13 Initiative Kick Off: 1/23/13 Pilots & Testing Evaluation Standards SWG - (3) EHR Interaction Standard - (4) Auto-populate standard Form SWG - (1) CDE Standard - (2) Structure Standard Technical Work stream Content Work stream SDC All-Hands WG Use Case WG Common Formats SWG… AHRQ Lead PCOR Content SWG… NLM Lead Standards & Harmonization WG

8. Week Target Date All Hands WG Meeting Tasks Homework due Tuesday COB 12/28 Use Case Kick-Off & UC Process Overview Introduce: Assumptions, Pre/Post Conditions Review: Charter content, Context Diagram, Assumptions -3/7Cancelled for HIMSS 23/14 User Stories, Pre/Post Conditions Finalize: Context Diagram, Assumptions Draft: User Stories Review: Actors & Roles, Pre/Post Conditions 33/21User Stories, Actors & Roles Review: User Stories Finalize: Actors/Roles, Pre/Post Conditions Review: User Stories 43/28Base Flow, Activity DiagramFinalize: User StoriesReview: Base Flow, Activity Diagram 54/4Functional Requirements Finalize: Base Flow, Activity Diagram Review: Functional Requirements 64/11 Functional Requirements, Sequence Diagram Review: Functional Requirements, Sequence Diagram 74/18Data Requirements Finalize: Functional Requirements, Sequence Diagram Review: Data Requirements, Risks, Issues, & Obstacles 84/25 Data Requirements, Risks, Issues, & Obstacles Review: Data Requirements, Risks, Issues, & Obstacles 95/2Finalize: Data Requirements, Risks, Issues, & ObstaclesNone 105/9Full ReviewEnd-to-End Review (5/10-5/20) 115/16End-to-End Review (5/10-5/20)End-to-End Review due 5/20 125/23Consensus (5/24-5/29)Cast consensus vote FINAL CONSENSUS Structured Data Capture Initiative Proposed Use Case & Functional Requirements Development Timeline

9. SDC Use Case Comments See spreadsheet.

10. SDC Use Case Functional Requirements See word document.

11. Next Steps HOMEWORK –Provide comments to all posted content on wiki –http://wiki.siframework.org/Structured+Data+Capture+Use+Case+Commentshttp://wiki.siframework.org/Structured+Data+Capture+Use+Case+Comments Next Work Group Meeting –Will focus on the Candidate Standards List –Thursday, April 11, 2013 from 3:30pm – 5:00pm Eastern http://wiki.siframework.org/Structured+Data+Capture+Initiative Reminder: All SDC Announcements, Meeting Schedules, Agendas, Minutes, References, Use Cases, and Project Charter are posted on the SDC Wiki page –http://wiki.siframework.org/Structured+Data+Capture+Initiativehttp://wiki.siframework.org/Structured+Data+Capture+Initiative

12. Community Presentation Topic: ASTER-D

13. * ASTER-D Project Overview and Demo

14. * ASTER-D Team Project Sponsor: FDA CDRH - Terrie Reed; Director, Informatics - Leslie Tompkins; Informatics Team Project Contributors: Quintiles – Outcome - Dan Levy; Vice President, Information Technology - Tom Taylor; Sr. Project Manager Mercy - Joe Drozda; MD - Project Team includes: Paul Helmering, James Roach, Karen Call, Ben Graf, Pallavi Chandak, Mark Ramach Children ’ s National - Brian Jacobs; MD - Lorenzo Nicholson; Project Manager

15. * ASTER-D Goals Increase the number and quality of device adverse event reports, currently being under- reported, by streamlining the time it takes to complete and submit a 3500A form. The project also supports an FDA initiative to collect Unique Device Identifiers (UDI). The Adverse Spontaneous Triggered Events Reporting (ASTER) study demonstrated that facilitated, “triggered reporting” increased the number of adverse events reported by clinicians. CDRH is piloting ASTER-D to facilitate the use of hospital EHRs and Incident Reporting Systems to detect and automatically report select devices associated adverse events to the FDA. The creation of systems that facilitate triggered or automatic reporting of selected device- related adverse events via the EHR to the FDA as part of a clinician’s normal work flow is likely to increase the number and quality of adverse event reports, decrease under-reporting, and more regularly alert the FDA of potential device-related concerns. * * Source: Center for Devices and Radiological Health, U.S. Food and Drug Administration. Strengthening Our National System for Medical Device Postmarket Surveillance, (Sept. 2012).

16. Method: Enable the 3500A form within an EHR / incident reporting system via RFD at a determined trigger to: a)Pre-populate appropriate data into the 3500A, reducing the data entry burden. b)Improve data quality by adding edit checks and warnings. Current Status: Mercy implemented an AE reporting interface with pre-population of data, including UDI, from their EHR and incident reporting systems. Outcome has developed a Safety Information Exchange (SIE), a set of cloud-based services, which host the 3500A form. RFD has been enabled to serve the form within Mercy ’ s interface. 3500A data are collected and transformed to the HL7 ICSR format for submission to FDA. Next Steps: Dry-run testing of Mercy. Incorporating Children's National into the project. 3-month data submission by each partner. Publication of final findings. * ASTER-D Project Overview

17. 3500A to HL7 ISCR

18. SDC & * ASTER-D Synergy SDC Use Case Model:

19. A potential Adverse Event occurs. Via RFD (Retrieve Form for Data Capture), the 3500A form is surfaced within the EHR (or other form filler). After review of the AE, with the potential for manual entry of additional data, the completed AE is ready for submission to FDA. A complete and approved 3500A form is transformed to HL7 ICSR and transmitted to the FDA’s eMDR (Electronic Medical Device Reporting). The AE data are ultimately stored in MAUDE (Manufacturer and User Facility Device Experience Database). 1 Selects form/template 2 Finds form/template 3 Converts, populates and displays form 4 Inputs data 5 Caches data 6 Stores/transmits data 7 Extract, transform & load data by form/template SDC & * ASTER-D Synergy EHR (Form Filler)External Data RepositoryForm/Template Repository

20. * ASTER-D Demo

21. Q & A Thank You!

22. Contact Information For questions, please contact your support leads –Initiative Coordinator: Evelyn Gallego (evelyn.gallego@siframework.org)evelyn.gallego@siframework.org –Project Manager: Jenny Brush (jenny.brush@esacinc.com)jenny.brush@esacinc.com –PM Support: Zachary May (zachary.may@esacinc.com)zachary.may@esacinc.com –Use Case/Requirements Lead: Jennifer Sisto (jennifer.t.sisto@accenturefederal.com)jennifer.t.sisto@accenturefederal.com –Standards Development Lead: Caryn Just (caryn.k.just@accenturefederal.com)caryn.k.just@accenturefederal.com