1. Data Access Framework All Hands Community Meeting 1 April 6, 2016

2. 2 If you are not speaking, please keep your phone on mute DO NOT place your phone on hold, if you need to take another call or step away, please hang up and dial in again Hold = Elevator Music = Frustrated Speakers and Participants Feel free to use the “Chat” feature for any questions, comments or any items you would like the moderator or participants to know Meeting Etiquette NOTE: This meeting is being recorded and will be archived on the DAF Wikipage, under “Materials”  “Past Meetings” From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute

3. 3 Agenda TopicEstimated Time General Announcements2 minutes Pilot Kickoff Presentation with REACHnet30 minutes Next Steps & Questions2 minutes

4. 4 General Announcements DAF All Hands Community Meeting Our next All Hands meeting will be on Wednesday, April 20, 2016 at 12:00 PM (ET). The meeting details can be accessed on the homepage: http://wiki.siframework.org/Data+Access+Framework+Homepage http://wiki.siframework.org/Data+Access+Framework+Homepage DAF Pilot Wikipage To track the latest Phase 3 pilot activities, please visit: http://wiki.siframework.org/Data+Access+Framework+Pilots http://wiki.siframework.org/Data+Access+Framework+Pilots Past Meeting Materials To access materials and meeting recordings from the All Hands meetings and technical WG calls, please visit: http://wiki.siframework.org/Data+Access+Framework+Meeting+Artifacts http://wiki.siframework.org/Data+Access+Framework+Meeting+Artifacts DAF Functional Requirements The draft functional requirements for capabilities 1-4 can be accessed here: http://wiki.siframework.org/Data+Access+Framework+Pilots#DAF%20Functional% 20Requirements http://wiki.siframework.org/Data+Access+Framework+Pilots#DAF%20Functional% 20Requirements

5. REACHnet 5

6. Agenda Introduction Goal of Pilot DAF Capabilities to Be Piloted Pilot Approach Standards and Technologies Under Consideration Ecosystem Defining Success Logistics Resources/References

7. Introduction REACHnet is a Patient-Centered Outcomes Research Institute (PCORI) funded clinical data research network (CDRN) of health systems containing clinical records for more than 1.7 million active patients (2+ encounters in the last 2 years) in Louisiana and Texas, facilitating patient-centered comparative effectiveness research (CER). Funded by the Patient-Centered Outcomes Research Institute (PCORI) and made possible through collaboration between the REACHnet Coordinating Center and the following partners: Resources and Services Pragmatic Trial App Suite Common Data Model Prep-to- Research Querying Longitudinal Data Linkage Collection of Patient- Generated Data Streamlined IRB and Contracting Partnerships with LA CaTS and LTR Health in Our Hands (HiOH) Patient Network Stakeholder Engagement

8. Ecosystem Introduction GPID Matching Secure Environment Health System Partner A Health System Partner B Health System Partner C Live CDM Live CDM Live CDM Frozen SAS CDM Data Mart Pragmatic Trial App Suite Study Specific Data Marts (aggregated clinical and other data types) Sync App Data Lake Secure Environment Combi ned CDM (Longi- tudinal patient records linked by GPID) Secure Connections Quality Checks Daily transfer Quarterly transfer Condition Specific Cohort A GPID i2b2 Longitudinal Data Sources ( claims, vital records, hospital discharge data, etc.) Use case-specific ad hoc transfers Condition Specific Cohort B Condition Specific Cohort C I2b2 & analysis tools Data cleaning, Derivations, Transformations REACHnet Infrastructure Frozen SAS CDM Data Mart TriNetX i2b2 LA CaTS Genomics PGD GPID Hashing Quality Checks TriNetX i2b2 TriNetX i2b2 PopMed Net PTR Queries

9. Introduction CONTINUED DAF Pilot Team – Eliel Oliveira, MS, MBA: eoliveira@lphi.org, Principle Investigator, Data Access Framework pilot, Director of IS & Analytics, Research Action for Health Network (REACHnet--formerly the LaCDRN); Associate Director, Health Services Research, Louisiana Public Health Institute (LPHI)eoliveira@lphi.org – Thomas Carton, MS, PhD: tcarton@lphi.org, Principal Investigator, Research Action for Health Network (REACHnet--formerly the LaCDRN); Director, Health Services Research, Louisiana Public Health Institute (LPHI)tcarton@lphi.org – Kristin Lyman, JD, MHA: klyman@lphi.org, Operations Director, Research Action for Health Network (REACHnet—formerly the LaCDRN); Associate Director, Health Services Research, Louisiana Public Health Institute (LPHI)klyman@lphi.org – Rahul Jain, MPH, CPHIMS: rjain@lphi.org, Project Lead, Data Access Framework pilot, Digital Health Analytics Manager, Health Services Research, Louisiana Public Health Institute (LPHI)rjain@lphi.org – Prasad Patil: prasad_patil1@persistent.com, Technical Lead, Data Access Framework pilot; Solutions Architect, Persistent Systemsprasad_patil1@persistent.com

10. Goal of Pilot Twofold – To efficiently add data partners to the network; – Provide researchers with a streamlined analytics cohort data access solution. Business Driver – The primary drivers for this pilot is the achievement of optimized ways to ingest and expose data to/from data partners using ONC’s interoperability roadmap recommendations and more effectively expand the research capabilities of the network; – Contribute to and learn about FHIR-based tools that can be used for distributed querying and analysis. Use Cases (data warehouses) – Tulane Data Lake; – Greater New Orleans Health Information Exchange.

11. DAF Capabilities to Be Piloted REACHnet intends to work with the DAF/FHIR team to design, implement and test C1-C3. REACHnet will also pilot C2-C4 in collaboration with other pilot sites. CapabilityDescription: C1 Standardize data extraction mechanism from clinical data sources to populate data marts. C2Standardize metadata about data marts, CDRN’s, PPRN’s and data sources. C3Standardize Query Distribution mechanism. C4Standardize Query Results for returning aggregate data.

12. Pilot Approach ETL (extract, transform, load) processes are built for REACHnet’s partners that generates files and later place into a common data model using Hadoop tools. The pilot will transform this file based ingestion to a real-time FHIR based one. REACHnet is using PopMedNet to expose datamarts to PCORnet, since that is what PCORnet uses. A FHIR enabled PopMedNet server and Datamart client will be piloted by REACHnet. The PCORI common data model is mapped into i2b2 currently. REACHnet researchers use i2b2 as the local query tool so that they can build queries easily. However, there is no way at this time to control what results researchers receive once access to i2b2 is provided. The pilot will expose data to PopMedNet Server using FHIR enabled PopMedNet Datamart client providing researchers with an web-based query tool to not only build their queries easily but also follow governance policies in terms of query responses.

13. Standards & Technologies Under Consideration REACHnet has active interest in FHIR and working on standardized ETL (C1) to accelerate adding data sources. REACHnet will use DAF implementation guides and standards on any systems that are required to be developed or adapted by REACHnet for this pilot. REACHnet plans to convert data from a specific data partner into CDM using FHIR technologies. To onboard any clinical system, REACHnet would create a ingestion pipeline as part of C1 to load the data into CDM data-mart. This data-mart metadata would be exposed via FHIR enabled PopMedNet client (C2). REACHnet will also use the standardized query creation and distribution mechanism provided by PopMedNet tools (C3-C4). REACHnet intends to work in collaboration with other pilot sites to implement capabilities 2, 3 and 4. As PopMedNet is the standard set of tools used by PCORI, it would be critical to deploy the PopMedNet portal and pilot the execution of standardized queries within REACHnet. We believe there is a great value in testing the new tools developed by the other pilot sites in a real CDRN environment.

14. Current partners are Ochsner, PATH, BSWH, LSU/Pennington, Tulane/HCA. REACHnet is continuously engaging new data partners to become part of the data network. Advance negotiations are currently with BCBS, DHH-OPH, and CHRISTUS Health. REACHnet has a PI board composed of data partners leaders that meet biweekly and a clinician board that meets monthly to discuss the research priorities of the network. REACHnet continuously engage additional researchers within its network to grow its research capacity. Details available at: http://www.reachnet.org/research/.http://www.reachnet.org/research/ REACHnet has partnered with existing data partner (Tulane/PATH) to construct FHIR enabled CDM for this pilot. REACHnet currently uses the PCORI CDM ingested through a SFTP file based Hadoop ecosystem along with PCORI’s query tool PopMedNet. Additionally, REACHnet uses i2b2 for its internal querying needs. REACHnet has active interest in FHIR and working on standardized ETL (C1) to accelerate adding data sources and standardized ways to distributed and respond to queries that use FHIR resources. Ecosystem

15. REACHnet has piloted data collection queries using i2b2 and also with PopMedNet. REACHnet maintains datamarts for its data partners in its datacenter along with all application tools needed for the PCORI project to query and analyze cohort data. All systems are replicated to a secondary datacenter for redundancy and high availability. Data ingestion from partners takes place nightly and data is exposed to researchers tools real-time. REACHnet has several domain experts in staff along with the technical team that can engage in this pilot to accomplish the goals established. REACHnet whishes to receive assistance in guiding its team on the use of the required documentation and standards developed in Phases 1 and 2 of DAF. Ecosystem CONTINUED

16. REACHnet would like to focus on developing capabilities to onboard a clinical system in FHIR enabled CDM standard, and piloting the capabilities developed by PopMedNet for data querying and extraction. REACHnet would like to benchmark against number of patients integrated through FHIR enabled data extraction and number of standardized queries responded. REACHnet will consider how more efficiently new data partners can be integrated using DAF piloted solutions. Additionally, REACHnet will consider the adoption of tools that use FHIR resources to query and allow for the analysis of data that will be adopted through this pilot. REACHnet has significant experience with policy issues arising from PCORI activities that will be considered while determining the feasibility of implementing DAF solutions. REACHnet will document all activities performed and technical details of systems adopted throughout the pilot. The high level architecture diagram, list of goals and costs prepared in this plan will serve as the baseline for documenting and completing the work for this pilot. Defining Success

17. Timeline Kick off: Feb 2016 - Completed Identification of Partners/Providers/eco-system: March 2016 - Completed Project plan: Apr 2016 – In Progress Development work: Apr 2016 - Started Completion of Pilots: Sep 2016 Documentation of IG based on pilot findings: Nov 2016 Logistics

18. Draft C1, C2, C3 DAF Architecture ETL Data Quality HIPPA Compliance Data Masking IRB EDW Data Standardization De-identification Mapping FHIR CDM Connector FHIR to CDM Batch Processor FHIR Client Processed EDW Workflow and Scheduling HAPI Server FHIR Convertor CDM + Metadata EMR Data Partner Reachnet Datamart client Server PMN API Server PMN Webserver Researcher

19. Questions and Answers? Contact Information for DAF Pilot Team: – Eliel Oliveira, MS, MBA: eoliveira@lphi.org, PI, DAF pilot, Informatics Director, REACHnet, LPHI;eoliveira@lphi.org – Thomas Carton, MS, PhD: tcarton@lphi.org, PI, REACHnet, Director, Health Services Research, LPHI;tcarton@lphi.org – Kristin Lyman, JD, MHA: klyman@lphi.org, Operations Director, REACHnet, LPHI;klyman@lphi.org – Rahul Jain, MPH, CPHIMS: rjain@lphi.org, Project Lead, DAF pilot, REACHnet, LPHI;rjain@lphi.org – Prasad Patil: prasad_patil1@persistent.com, Technical Lead, DAF pilot; Solutions Architect, Persistent Systems.prasad_patil1@persistent.com

20. Upcoming Meetings Pilot TWG 2 (C2-C4): Monday, April 11, 2016 at 3:00 PM (ET) Pilot TWG 1 (C1): Wednesday, April 13, 2016 at 10:00 AM (ET) All Hands Community Call: Wednesday, April 20, 2016 at 12:00 PM (ET) 20 Next Steps

21. DAF Project Team  ONC Sponsor: Farrah Darbouze Farrah.Darbouze@hhs.govFarrah.Darbouze@hhs.gov  S&I & DAF Initiative Coordinator: Johnathan Coleman jc@securityrs.comjc@securityrs.com  Support Team: Project Management: o Jamie Parker jamie.parker@esacinc.comjamie.parker@esacinc.com o Gayathri Jayawardena gayathri.jayawardena@esacinc.comgayathri.jayawardena@esacinc.com Project Support: o Nik Reineke nikolas.reineke@esacinc.comnikolas.reineke@esacinc.com o Swapna Bhatia swapna.bhatia@esacinc.comswapna.bhatia@esacinc.com Technical SME: o Nagesh (Dragon) Bashyam nagesh.bashyam@drajer.comnagesh.bashyam@drajer.com Standards SME: o Brett Marquard brett@riverrockassociates.combrett@riverrockassociates.com o Ed Larsen ed_larsen@comcast.neted_larsen@comcast.net Software Developer: Douglas Harley douglas.andrew.harley@gmail.comdouglas.andrew.harley@gmail.com Privacy and Security SME: o Glen Marshall gfm@securityrs.comgfm@securityrs.com Standards Development Support: o Angelique Cortez angelique.j.cortez@accenturefederal.comangelique.j.cortez@accenturefederal.com 21

22. Additional DAF Resources 22

23. Useful Links DAF Homepage – http://wiki.siframework.org/Data+Access+Framework+Homepage http://wiki.siframework.org/Data+Access+Framework+Homepage DAF Initiative Signup – http://wiki.siframework.org/Data+Access+Framework+Join+the+Initiative http://wiki.siframework.org/Data+Access+Framework+Join+the+Initiative DAF Charter – http://wiki.siframework.org/Data+Access+Framework+Charter+and+Members http://wiki.siframework.org/Data+Access+Framework+Charter+and+Members DAF Standards, Harmonization and Implementation Activities – http://wiki.siframework.org/DAF+Standards+Harmonization+and+Implementa tion http://wiki.siframework.org/DAF+Standards+Harmonization+and+Implementa tion DAF HL7 FHIR IG – http://hl7.org/fhir/dstu2/daf/daf.html http://hl7.org/fhir/dstu2/daf/daf.html DAF IHE White Paper – http://ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_White_Paper_DAF_R ev1.1_2014-10-24.pdf http://ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_White_Paper_DAF_R ev1.1_2014-10-24.pdf 23

24. 24 SDO Updates DAF Publications  DAF FHIR IG DSTU (HL7) On September 23, 2015, Health Level Seven® International (HL7®) published Release 2 of the HL7 Fast Healthcare Interoperability Resources (FHIR®) Draft Standard for Trial Use (DSTU). Additionally, we are pleased to announce that the DAF FHIR Implementation Guide, a US-realm specific implementation guide, has also been published!! The DAF FHIR IG identifies and recommends standards for the interoperable representation and transmission of data using the notion of a Query Stack which modularizes the various layers of the Data Access Framework.DAF FHIR Implementation Guide  DAF Document Metadata Based Access IG (IHE) On September 24, 2015, the Integrating the Healthcare Enterprise (IHE) Patient Care Coordination (PCC) Technical Committee published The Data Access Framework (DAF) Document Metadata Based Access Implementation Guide. This US National Extension provides requirements and guidance on accessing clinical documents created during clinical workflows. The guide accomplishes this using RESTful resources based on HL7 FHIR® and the more traditional SOAP based IHE Profiles.The Data Access Framework (DAF) Document Metadata Based Access Implementation Guide