Applying data science principles to FDA’s PreCert Program: Some scary stuff

MobiHealth News November 1, 2019
Bradley Merrill Thompson

Let’s say I could show you, through reliable data that is statistically significant, that children from wealthy families on average make much better employees in very meaningful ways. Do you think companies ought to adopt policies — perhaps embedded in algorithms — that favor hiring from wealthy families? That sounds pretty un-American.

So why is everyone so excited about creating an easier pathway through FDA for projects that come from certain incumbent companies that have a pedigree demonstrating that they have been more successful in the past? In a nutshell, that’s FDA’s PreCert Program presently under development.

Throughout FDA’s recent work in digital health and beyond, as recently explained by Dr. Amy Abernathy, the principal deputy commissioner and acting CIO...

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