Applying Data Science Principles to FDA’s PreCert Program: Some Scary Stuff


Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, authored an article in MobiHealthNews, in “Applying Data Science Principles to FDA’s PreCert Program: Some Scary Stuff.”

Following is an excerpt:

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 of the FDA, the agency has a rather broad plan to advance and indeed lead the use of data science in healthcare through these regulatory reforms. Last summer, FDA released a midyear report describing the agency’s progress in developing the PreCert Program for regulating “software as a medical device” (SaMD). Presumably toward the end of this year, FDA will release a final assessment of its pilot work for the year, and its proposals for the future. Based on Abernathy’s comments, FDA has very ambitious plans for the PreCert Program.

But not everyone is enamored with what FDA is doing. On October 30, 2019, three US senators including presidential candidate Elizabeth Warren wrote FDA a follow-up letter (to their 2018 letter on the same topic) expressing concern over how: effectively the PreCert Program would protect patients, whether FDA had legal authority for the program, and how exactly FDA planned to make use of real-world evidence collected through the program.

So this seems like an appropriate time to discuss the criteria that stakeholders should use to evaluate the desirability of the PreCert Program. In this article, from that same data science perspective that FDA champions, I will review some of the key criteria that stakeholders should think about when they see the next iteration of the planned program.