Biopharma Breakout Goals Review progress and explore more details on priority use cases for repurposing EHR data for research and drug safety Explore additional high-value use cases for pharma and regulatory science (e.g., use of Real World Evidence, Safety Review and REMS, patient-originated data and protocol execution). Discuss implementation tasks and future plans, including connectathon experience, collaborating with EHR vendors, and testing and validation. 01/15/2015

Breakout Discussion Topics Use Cases (old and new) Data Flows Report on the FHIR Connectathon Lessons from Argonaut Experience with FHIR Apps Lessons from Clinicians on FHIR Validation and Testing Next Steps and Plans 01/15/2015

Breakout 1 Discussion Topics Review Priority Use Cases from April Meeting Review Data Flows for Clinical Data Capture (April's Top Priority) Report on the FHIR Connectathon experience: Pre-populating EDC forms from EHR eSource Implementing FHIR:  Lessons from Project Argonaut (Micky Tripathi) 01/15/2015

Takeaways from April Meeting High Interest in FHIR among attendees What opportunities and use cases did we identify for improving interoperability? Align with the clinical research process: Study design/planning; recruitment; Data collection; aggregation Which are the top 3 priorities? - Next Slide What systems and processes need to be introduced or changed internally to use HL7’s FHIR to improve interoperability? -TBD 01/15/2015

Use Case Priorities Opportunity Area Opportunity Importance Actionable in 1 year Total Design Protocol Feasibility - counts of potential subjects who meet eligibility criteria 3 20 23 Recruitment Apps to support Subject Recruitment and consent 16 19 Data Collection Harvesting EHR data that already exists for study databases 12 14 26   Collection of patient provided data (ePro Questionnaires, etc.) 11 5 Collecting additional CRF data not typically in EHRs 7 Accessing EHR bulk data for secondary research purposes (e.g., drug safety) Data Aggregation & Sharing Making research data accessible to patients 6 Sharing aggregate study results with patients and research community 10 Enabling aggregation of data from multiple sites and multiple studies Mapping patient data to CDISC formats 01/15/2015

Breakout 2 Discussion Topics Use Case: A FHIR Immunization app Iron out issues and gaps; collaborative projects, pilots FHIR Resources and profiles and the Clinicians on FHIR experience Replicate with focus groups of investigators, reviewers Streamlining Validation and Testing Managed continuous automated testing; collaborative acceptance Testing of investigative site implementations of FHIR API Regulatory Use Cases Applying lessons to Regulatory Use Cases for NDA Safety Review and REMS 01/15/2015

Breakout 3 Discussion Topics Regulatory Use cases – Awareness building at FDA – post-market research, advancing public health, REMS, CDRH, Oncology Next Steps: Planning Clinical Research Track for January FHIR Connectathon Feasibility of protocol eligibility Plans for March Partners Meeting CDC participation, VAERS, public health surveillance Other Interactions Further interactions with TransCelerate eSource. 01/15/2015

More Feedback from April Increase awareness of FHIR among pharma – reach key decision makers Provide collaboration tools Define Use cases Attract FDA participation Look for opportunities where Pharma companies can share apps Work on Adverse Events resources Work with Transcelerate eSource Project Develop FHIR/CDISC mappings Explore use of Structured Data Capture approach Explore traction in Europe (EMA, IMI EHR4CR)