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Podcast: A Pivotal Moment for the FDA & Digital Health


After the resignation of FDA Commissioner Scott Gottlieb, Data Book examines agency history & welcomes Duke Law’s Arti Rai to discuss its digital health future.

Now that FDA Commissioner Scott Gottlieb, M.D., has resigned, questions linger about the future of digital health. After nearly two years of the FDA trying to catch up to innovation in data, artificial intelligence, digital health and even cybercrime, the regulator stands at a crossroads: Will efforts like the software precertification program continue? Or will the FDA retreat from its goal of better nurturing healthcare innovation?

Simply put, Gottlieb’s resignation from the FDA means that we don’t know what’s next for digital health regulation.

This week on Data Book, we welcome Arti Rai, J.D., Elvin R. Latty Professor of Law and faculty director of Duke Law’s Center for Innovation Policy, to discuss Gottlieb’s legacy, the state of innovation inside the FDA and what the agency needs to do going forward. Rai is an expert in innovation policy and health law, and artificial intelligence has consumed much of her time as of late. For her, healthcare is at an inflection point, and it’s critical that the FDA get its next steps right — and that means pushing the software precert program forward.

While Gottlieb has his critics, few will argue that he’ll leave the FDA the same as he found it. During his tenure, prescription digital therapeutics, AI diagnostic systems and real-world evidence took centerstage. These two years represented, by most accounts, a drive toward digital health.

But to better understand how the FDA might evolve, this episode of Data Book starts by examining how it has evolved.

Less than 100 years ago, innovation at the FDA meant something far different than cybersecurity and mobile health apps. For starters, the regulator as we know it wasn’t even born until the 1930s. And throughout much of the 1900s, the FDA’s authority was less encompassing, especially regarding medical devices.

Many turning points — dramatic moments of death and innovation, horror and hope — occurred for the public and Congress to take the actions that created today’s FDA. So, tune in for a condensed look at how this FDA came to be and what the regulator could look like tomorrow.

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