1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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)