Structured Data Capture (SDC) All Hands Meeting

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

2. Meeting Etiquette From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute  All Panelists • 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 • Hold = Elevator Music = frustrated speakers and participants • This meeting is being recorded • 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. • Send comments to All Panelists so they can be addressed publically in the chat, or discussed in the meeting (as appropriate).

3. Agenda

4. Meeting Reminders & Announcements Please check the meeting schedule weekly as the meeting link and call in numbers will change. • 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+Initiative

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

8. Structured Data Capture InitiativeProposed Use Case & Functional Requirements Development Timeline

9. SDC Use Case Comments See spreadsheet.

10. SDC Use CaseFunctional 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+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+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. *ASTER-D Project Overview Method: Enable the 3500A form within an EHR / incident reporting system via RFD at a determined trigger to: • Pre-populate appropriate data into the 3500A, reducing the data entry burden. • 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.

17. 3500Ato HL7 ISCR

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

19. SDC &*ASTER-D Synergy EHR (Form Filler) Form/Template Repository External Data Repository 1 Selects form/template 2 Finds form/template Converts, populates and displays form 3 4 Inputs data 5 Caches data • 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). 6 Stores/transmitsdata Extract, transform & load data byform/template 7

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) • Project Manager: Jenny Brush (jenny.brush@esacinc.com) • PM Support: Zachary May (zachary.may@esacinc.com) • Use Case/Requirements Lead: Jennifer Sisto (jennifer.t.sisto@accenturefederal.com) • Standards Development Lead: Caryn Just (caryn.k.just@accenturefederal.com)