INVESTING IN A COORDINATED DATA NETWORK INFORMING THE VISION OF NEST THROUGH PARTNERSHIPS ACROSS THE INDUSTRY A PARTNERSHIP TO ACCESS REAL-WORLD DATA TO GENERATE RELIABLE REAL-WORLD EVIDENCE 1
KEY CHALLENGES FACING REAL-WORLD DATA BUILDING ON PAST LEARNINGS, ACKNOWLEDING KEY CHALLENGES KEY GOALS AND FACTORS FOR SUCCESS AREAS FOR COLLABORATION DATA ACCESS: Front-end and back-end data and Technical Requirements for Data Capture, IT standardization and centralization Extraction, Transformation and Analysis DATA USAGE: Reliable and meaningful data Data Modeling and Testing Expectations dictionaries and data capture workflows + Cross-functional collaboration, innovative, Policies, Processes and Methodologies entrepreneurial mindset, and supportive regulatory environment Data access for execution capability; data usage for meaningful and reliable evidence generation - partnership across stakeholders is critical 2
MERCY PROGRAM DEEP DIVE
PROGRAM GOALS DEFINE REQUIREMENTS FOR RWD NETWORKS THROUGH FULL EXECUTION OF OUR PROCESS Our Data Extraction Process § Establish technical infrastructure and requirements that will enable access and use of clinical, claims, purchasing and administrative data across Mercy IHS DATA ACCESS 1. Sourcing § Assess the data asset value in terms of data 2. Mapping quality/reliability as well as the extractability and usability of 3. Extraction unstructured data DATA USAGE § Define and modify clinical systems and workflows to 4. Quality Assurance 5. Modeling & Testing maximize data standardization, quality and completeness 6. Consumption Preparation § Define gaps and opportunities in the current regulatory environment 4
PROGRAM GOALS DEFINE REQUIREMENTS FOR RWD NETWORKS THROUGH FULL EXECUTION OF OUR PROCESS Our Data Extraction Process WHY MERCY DATA ACCESS 1. Sourcing 2. Mapping Connection /Collaboration across Industry UDI Adoption & 3. Extraction Leadership DATA USAGE 4. Quality Assurance 5. Modeling & Testing Recognized Leader in Advanced Analytics Standardization & Workflow Mgmt 6. Consumption Preparation $2.5M total $1.8M+ at Mercy | $700k+ at Medtronic Mercy has innovation track-record combined with willingness to learn and to dedicate resources to act 5
OUR USE CASE ESTABLISHING A METHODOLOGY FOR THE FUTURE HEART FAILURE CRT USE CASE • De-Identified Dataset with 80,000+ Heart Failure patients • From across the Mercy Health System (40+ sites, 700 clinics), 2011-today • Medtronic and non-Medtronic patients (the latter will be masked) • Specific focus on data elements that help assess the effectiveness of CRT devices HF Patient Care Continuum Patient Cohort Data extraction Prospective real-time 1 HF Diagnosis start 3 years prior data extraction on to 1 and/or 2 identified cohort 2 CRT Implant OUR GOAL : Application of the use case to inform a scalable methodology for the responsible access and usage of EHR data 6
OUR TIMELINE ESTABLISHING A METHODOLOGY FOR THE FUTURE MILESTONE A M J J A S O N D J F M Ø Manual aggregation & extraction of data Ø Transfer of test file Ø Test file data assessment, refine data needs Ø Extract final data list & automate data flow Ø Establish data cloud access (refresh daily) Ø Execute use case analysis, apply advanced analytics Ø Execute policy gap analysis Ø Disseminate findings and learnings across industry stakeholders Ø Define next steps ü Data sourced across health system and linked at patient level ü NLP programmed, SAP/HANA cloud and analytics established ü Monthly calls with leaders from FDA KEY WINS TO DATE: ü NEST demonstration project award ü Validation of frameworks and templates ü Strong operating model 7
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