This week I am talking to Amy Abernethy, MD, Ph.D. (@DrAbernethyFDA) the Principal Deputy Commissioner & Acting CIO for the FDA (@US_FDA). We had talked in January at CES about the forthcoming meeting focused on the FDA’s Technology Modernization Action Plan (outline here) but as a result of the COVID19 pandemic, the meeting was postponed to Jun 30 (details for the new date here).
We explore the original premise of the FDA that is looking to encourage innovation in a modern digital system and balance safety and oversight with the need to allowing for the accelerated pace of innovation. The SARS-CoV-2 disease had an existential effect on the planning and execution of the principles of modernization
We discuss the acceleration felt by the team to apply some of the proposed principles today to allow rapid acquisition of data that included an intriguing concept of accompanying “Nutrition Label” quality indicators for each of the data sources and how to ensure confidentiality and privacy while scaling everything up
The importance of these timely data sets that were close to real-time even more so as our healthcare system and monitoring capabilities try to unlock insights to help guide decisions in the new world we now all inhabit.
We discuss the future potential of this data strategy including details on what this might mean from a scientific method and Randomized control studies (as detailed by Chris Anderson (@cr1sa) in this article The End of Theory: The Data Deluge Makes the Scientific Method Obsolete) that challenges the notion of modeling which the more we learn about biology, the further we find ourselves from a model that can explain it.
Listen in to hear the most compelling message about our future and what COVID19 means to all of us going forward (hint – it’s *all* about community and all of us pulling in the same direction)
It has been amazing how people have come together with a sense of purpose and a sense of contribution. That same sense of community that really is about how do I build for a better future with data that doesn’t bring a whole bunch of personal needs and ambitions but actually rather community and, and multi-stakeholder? Because I think there’s such an urgency around this and I think it’s really important to have many lenses and many voices to bring more to the table – here are important use cases, capabilities and best ideas that are synergistic. This is what moves us forward. And one of the amazing things about COVID-19 is that what we’re seeing this in real time as people figure out how to work together solve this problem.
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