Pleased with the Food and Drug Administration’s (FDA) focus on reimagining digital health oversight, industry stakeholders have some thoughts about how the agency should move those efforts forward.
One of those ideas includes the creation of an “integrated online collaboration capability,” a cloud-based platform where manufacturers could submit applications and allow other participating companies to access information on approvals and adverse events.
That approach was fleshed out in a report released by Deloitte this week based on a two-day session with industry stakeholders, startups, patient advocacy groups and FDA regulators. A potential framework emerged from that discussion that emphasized the need for regulators to provide a clear regulatory pathway that uses a risk-based approach and the ability to analyze real-world data from multiple sources.
The ideal solution, the report concluded, would be the creation of a secure cloud-based platform that would house the FDA’s regulatory development kit, the new software precertification program and data from a variety of stakeholders, all of which would be accessible by the entire ecosystem. While individual companies would have access to their own proprietary information and application process, broader data sharing on approvals, user adoption and product quality would help organizations navigate the new paradigm.
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“As SaMD [Software as a Medical Device] technology becomes cheaper, more accessible and more sophisticated, it is likely to play an increasingly important role in healthcare delivery, personalized medicin, and medical research,” the analysts wrote. “To realize its full benefit, however, regulation of these devices will need to radically change to accommodate new SaMD manufacturers and the technology’s rapid evolution, and to harness SaMD’s ability to capture RWD to create a collaborative, innovative SaMD community.”
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Whether the FDA will adopt those suggestions remains to be seen. Last month, FDA Commissioner Scott Gottlieb said if the agency receives an additional $473 million outlined under President Donald Trump’s budget proposal, he plans to create a new Center of Excellence on Digital Health that would oversee the agency’s new regulatory paradigm and include a new cybersecurity unit.
Under Gottlieb, the FDA has made significant changes to the way it plans to regulate digital health tools, launching a new precertification pilot program that includes some of the country’s largest tech companies. Gottlieb has said the agency will remain focused on digital health throughout the year.