Q&A: The FDA's challenge in regulating evolving digital health tools

David Rosen, a partner and public policy lawyer at Foley & Lardner, discusses the agency's recently wrapped Software Precertification (Pre-Cert) Pilot Program and what it means for the future of digital health regulation. In late September, the FDA released its final report on the Software Precertification Pilot Program, which it launched in 2017 to explore different regulatory approaches for digital health tools. "We are not fully capitalizing on these capabilities and approaches for software in the current statutory and regulatory framework for medical devices," the FDA wrote in its report. David Rosen: The whole idea behind the Pre-Cert program was to look at different regulatory approaches to try to assist companies in developing software for use as a medical device. Again, the whole idea behind the pilot Pre-Cert program was to help companies and help the FDA better understand the design and development and management of digital health products. But I think the bottom line is that the FDA decided that the current regulatory paradigm isn't going to work for this, and that they need a different FDA regulatory pathway and review process to deal with software as a medical device. And I think that we have to be very circumspect, and the companies have to be very circumspect, and they need to work and educate the FDA on how their program works and why the metrics are appropriately valid to come up with some sort of treatment decision. MHN: I also wanted to ask about the FDA's recent guidance on clinical decision support software qualifying as medical devices.