Scott Gottlieb, commissioner of the U.S. Food and Drug Administration, kicked off the 2018 Health Datapalooza conference in Washington, D.C., on April 26 by announcing several new efforts at FDA to both streamline regulation of digital health tools and incorporate digital technology into the drug and device review processes.
In the first-ever presentation by an FDA commissioner to the Datapalooza conference, Gottlieb began by quoting Stanford University computer scientist Roy Amara, who said that we tend to overestimate the impact of a new technology in the short run, but we underestimate it in the long run. Although there has been a lot of hype around the promise of digital health, “the long run is now from where we sit at the FDA,” he said.
The FDA commissioner said the FDA is taking steps to make sure that beneficial technology can be made available much more quickly. “The FDA’s usual approach to regulation is not always well suited to digital health’s rapid pace of change,” he said. “The FDA must be as nimble as the technology we are asked to regulate.”
He then gave an update on the Software Precertification (Pre-Cert) Pilot Program, which was created last year to help inform the development of a regulatory model to assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies. The FDA has been working on a pilot to create the building blocks of the program. Now, he said, it is making available a draft of the working model and a roadmap for how to develop it further. The next critical piece needed is input from software developers and the public. The program is expected to launch by the end of 2018, Gottlieb added, and be further refined in 2019.
Gottlieb said the FDA is opening a docket to create guidance concering how it would regulate software to be used with prescription drugs, building off the approach it has taken with medical devices. For instance, mobile devices could help confirm patients have taken medications or monitor side effects to classify pain or cognitive performance. All of that information could be incorporated into the EHR.
The FDA also is working to keep pace with the rapidly advancing field of artificial intelligence and machine learning, starting with medical imaging, Gottlieb said.
The agency also is starting to apply digital tools to update its own practices. A detailed examination of how it tracks submissions found a lot of inefficiencies from analog work flows, he said. Trial sponsors were submitting information via PDFs or paper. Medical offices at the FDA were mostly reviewing and track them individually. “Internal surveys found they spend 16 percent of time managing paper-based reports,” Gottlieb said, and a big portion of that time was spent on administrative file management tasks.” That makes it difficult for reviewers to focus on monitoring the safety of patients, and precludes analytics. “It is a fragmented workflow badly in need of change.” He said there have been successful pilots of digital submissions of data sets that can be visualized and analyzed in ways that can improve accuracy and efficiency.
Gottlieb also mentioned a new tech incubator at the FDA called Information Exchange and Data Transformation (INFORMED). It is a multidisciplinary initiative anchored in the FDA Oncology Center of Excellence designed to harness the power of big data and advanced analytics to improve disease outcomes.
He closed by noting that one of the biggest barriers to the advancement of digital health innovation is thecost and risk of new product development. “New digital tools can reduce these costs and break down artificial barriers,” Gottlieb said. We are rethinking our own mandate. Wee share your urgency and are committed to doing our part.”
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