Description

DCI Network Keynote – Future directions for real-evidence data generation

FDA Perspectives - Dr. Hilary Marston, U.S. Food & Drug Administration https://www.linkedin.com/in/hilary-marston-ab348/

This presentation provides

1. Overview of the FDA RWE Framework  

2. Notable RWE Approvals & Awards

3. Future Directions

Description

DCI Network presents our latest webinar "AI in Healthcare: Real World Data Generation and the Regulatory Perspective"

The pervasive integration of AI into every facet of our lives is an indisputable trend, and its most profound ramifications are notably pronounced within the healthcare domain. This influence came to the forefront at the HIMSS meeting held in April, where practically every prominent company in attendance at the trade show was showcasing their advancements driven by AI technology. This notable upsurge in the adoption of AI holds a range of far-reaching implications for the healthcare industry.

In the wake of this rapid expansion, it becomes imperative to raise and address pertinent questions regarding the data utilized for training AI systems. Considerations extend to the policy and regulatory dimensions of these decisions, along with the strategies regulatory bodies can employ to uphold trust and safety in this new era.

Description

The emergence of EHR data at scale affords the opportunity to leverage vast amounts of real-world data in observational clinical outcomes research.  The paradigm of observational research introduces limitations in data completeness, and requirements for data integration and harmonization.  This talk will address the basic issue of harmonization pipelines for integrating data across multiple clinical organizations, using the National COVID Cohort Collaborative (N3C) as a demonstration use case.

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