The Food and Drug Administration announced an initiative in June, which would ramp up regulations in the digital health space. The announcement comes close after the 21st Century Cures Act which, among several proposals, starts to outline the role of FDA in overseeing digital health.
It further clarified its plans with regard to regulation of digital health technologies in a new blog post last July. The most notable announcement was the new Pre-Cert for Software Pilot Program.
The pre-cert program has important inclusion criteria that limit participants to those developing a “software product that meets the definition of a medical device”.
Forthcoming clarification on the treatment of clinical decision support software, multifunctional products, and regular software updates seem as though they will offer a wide array of exclusions for digital health companies that might otherwise have fallen under FDA purview – narrowing the scope of regulation instead of broadening it.
By building a program focused on firms, not products, as well as post-market data instead of lengthy pre-market trials, FDA appears committed to accelerating the digital health innovation engine rather than stifling it.
Earlier it would take manufacturers years to get any medical device ready for regulatory approval. FDA reviewers managed to keep up.
But then computer code was able to take on more complex tasks. Software developers needed months instead of years to make it to the market. It got harder for the FDA to keep up.
Today, new innovations opened the gateway for machine learning, powering more and more medical device software. And because it is always learning and improving, it is constantly changing products on the fly.
Apart from the above plans, to keep up, the FDA is creating a new unit dedicated strictly to digital health. Associate Center Director for Digital Health at the FDA, Bakul Patel will be hiring 13 engineers—software developers, AI, and cloud computing experts—to prepare the agency to regulate a future in which healthcare is increasingly mediated by machines.
Technology giants are moving into the health care sector aggressively. Google’s venture capital arm has subsidiary companies like Calico and Verily that are pursuing ambitious projects like smart contact lenses and Project Baseline. IBM is employing its artificial intelligence engine, Watson, to do everything from treating cancers to discovering new drugs.
Over the last year, FDA has put out a number of documents describing the agency’s current thinking on digital health. These guidances help developers understand what FDA does and what it doesn’t regulate as a medical device (i.e. a hands-off approach). The FDA is focusing its limited resources mostly on high-risk products, and the most recent of its proposed rules address software as a medical device—a category that would include medical apps, which remain largely unregulated.
The approval process will most likely evolve in form, and it will fall to the new digital health unit to oversee and coordinate it between different offices within the FDA. Right now, those efforts are fragmented by specialty. The goal for the new group is to break out of rigid specialties as the same technologies will increasingly apply to products that overlap specialties. The new group is seeking new recruits from Silicon Valley’s finest.
One big hurdle to overcome is whether talented people will be willing to leave their corporate gigs for a job in the new digital health unit in Washington, under the new Trump administration. It was not a big issue when Obama’s Federal government was in power and talent kept moving between them and tech giants like Google, Facebook, and Apple.