FDA Digital Health Framework Raises Questions: Post
A Health Affairs blog post says that the recently announced FDA Digital Health Innovation Action Plan raises as many questions as it answers. The plan signals two major shifts in agency policy toward digital health, the post says: from premarket review to postmarket review of digital health products and from agency oversight to oversight by independent, non-government certifiers.
The first issue raised by the post is that the 21st Century Cures Act doesn’t seem to support the major shifts announced by [FDA commissioner Scott] Gottlieb. Although an earlier version of the bill included authority to implement a new regulatory framework for software, the version that passed did not, focusing instead on clarifying FDA’s jurisdiction over software. “Thus,” the report says, “the new plan will likely be implemented through non-binding guidance, a weakness previously identified by scholars and by Gottlieb himself. In fact, Gottlieb’s announcement hinted that third-party certification may be difficult to introduce under FDA’s current statutory authority.”
The second issue raised is that although there remains significant demand among users and payers for reliable evidence to substantiate claims made by digital health products, it is not clear that the new plan will generate much evidence prior to market introduction. “Currently,” the authors write, “the absence of robust premarket review by FDA for most digital health products creates an environment of caveat emptor, which can depress both demand and adoption of these new technologies. Such efforts will have more teeth if FDA retains the authority to use traditional regulatory enforcement tools when necessary. Moreover, if the shift from premarket to postmarket evaluation is to be meaningful, it would be useful to specify a mandatory reevaluation by FDA at some regular interval, as is being contemplated in other countries.”
Finally, the post says there are “serious questions about the effectiveness of third-party certification.” It notes that a certification process for electronic health record “meaningful use” standards “had decidedly mixed results” and also says that an early digital health certification effort was suspended “after serious flaws were discovered in some of the apps that had been certified.”
The analysis concludes that the policy changes proposed by FDA “represent an experiment in medical product regulation, with important ramifications for patients, clinicians, hospitals, payers, and product developers. Under a new administration, FDA is experimenting with a new way to balance innovation and risk with emerging medical technologies. The big question is whether the experiment will generate evidence that potential users can rely on.”