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MDE MDEpiNet PPP PPP Annual nnual Mee eeting ing: Op Opening R g Rema marks
Harlan M. Krumholz, MD Yale School of Medicine Yale-New Haven Health System
Twitter: @hmkyale
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Twitter: @hmkyale
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MDE MDEpiNet PPP PPP Annual nnual Mee eeting ing: Op Opening R - - PowerPoint PPT Presentation
MDE MDEpiNet PPP PPP Annual nnual Mee eeting ing: Op Opening R - - PowerPoint PPT Presentation
MDE MDEpiNet PPP PPP Annual nnual Mee eeting ing: Op Opening R g Rema marks Harlan M. Krumholz, MD Yale School of Medicine Yale-New Haven Health System Twitter: @hmkyale 1 Toward Collective, Collaborative Intelligence via
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Status quo is woefully inadequate to keep up with the information needs of patients, clinicians, administrators, payors, and policy makers
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Too slow, too expensive, too uninformative
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Errors of false negatives and false positives
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Opportunities: We do not learn from experience.
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Opportunities: We do not work together.
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Opportunities: We are polarized.
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Learning from experience Collaboration across disciplines and stakeholders
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Putting the interest of patients and the public first
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Th Themes…
Device and technology lifecycle
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Th Themes…
FDA has a greater freedom to consider a large range of methods and approaches
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Th Themes…
Devices and technologies evolve in their use and performance
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Th Themes…
Devices and technologies evolve in their use and performance What changes: population, application, expertise, context, software
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Th Themes…
Technology, computational power, digital transformation, consumerism, and business models are positioning us to create platforms for learning from experience and translating that knowledge into benefit for patients and the public.
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ICOR, ICCR, ICVR, ICTVR, Ortho CRN, VISION, SPARED, Robotic Surgery, DAISI, Women’s Health Registry Initiative, SMART, BUILD, AUDI, IDEAL-D, PASSION, DELTA, BD2K, Claims Validation, CBRI, HIVE, TMJ, AEDs, Methodology
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NE NEST and and MD MDEpiNet
Coordination, Integration, Progression Demonstration, Investigation, Invention
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NEST T and MD MDEpi piNet
Complementary and Essential
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Jou Journey y to
- a Critical Ju
Junct cture
Untenable Status Quo Ample Opportunities Infrastructure to Support Change
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Fu Future