Dr. Scott Gottlieb just outlined his new “Digital Health Innovation Plan,” focused on fostering innovation at the intersection of medicine and digital health tech. What does the plan entail, and what are the potential implications for the industry?
The FDA had a busy 2016 in digital health, issuing groundbreaking draft and final guidance, and recordbreaking medical device approvals. Signing of the 21st Century Cures Act in December was welcomed by the industry, but concerns have lingered regarding the specific regulation of clinical decision support software.
In his June 15 post, the new FDA commissioner mitigates these fears while stoking considerable excitement. Dr. Gottlieb seems committed to soon publish guidance that clearly differentiates devices requiring clearance, while offering new protocols for expediting approvals, plus clarifying the use of real world data in health apps.
Citing the proliferation of digital health and its ability to transform healthcare, Gottlieb insists the FDA is behooved to provide policies and regulatory tools that encourage safe and effective innovation. Central to that goal is eliminating any ambiguity that could discourage investment and prolong processes in a rapidly changing market.
To encourage innovation, FDA should carry out its mission to protect and promote the public health through policies that are clear enough for developers to apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development.
Low Risk to High Risk
As part of that goal, Gottlieb promises to issue new guidance further clarifying what falls outside the scope of FDA regulation, such as low-risk clinical administrative support software and mobile apps intended only for maintaining or encouraging a healthy lifestyle, while explaining how new statutory provisions affect pre-existing FDA policies.
Understanding that a more efficient, risk-based regulatory framework for managing these adaptive medical technologies is also necessary, the new commissioner also outlined a third-party certification program designed to expedite approvals. Analogous to TSA pre-clearance. the idea dovetails off concepts shared by the new, dedicated Digital Health unit.
Special certification for software as a medial device (SaMD) would be issued to those companies proving they consistently and reliably engage in high quality design, validation, and maintenance. The prior vetting would help expedite approvals, and encourage innovation by getting products faster to market while ensuring their safety.
Real World Data
The use of real-world data was outlined in the 21st Century Cures Act, but the devil is always in the details. To help expedite and manage post-market collection of such data to support new and evolving digital health innovation, Dr. Gottlieb proposes a strategic alliance with the National Evaluation System for Health Technology (NEST).
Designed to expedite market entry and expansion of indications, NEST would aggregate data from registries, EHRs, payer claims, and other sources. Working with the Medical Device Innovation Consortium (MDIC), the FDA will align with stakeholders from across the health system, including patients, physicians, providers, payers, and other agencies.
A New Era at the FDA
By adopting a firm-based rather than product-based approach, Dr. Gottlieb hopes to evolve the FDA to meet the needs of today’s digital realities. The end goal is to create market incentives for greater investment, in turn resulting in more rapid deployment of and updates to safe digital health tech that benefits millions of patients.
Through these and other steps, FDA will help innovators navigate a new, modern regulatory process so that promising, safe and effective developments in digital health can advance more quickly and responsibly, and Americans can reap the full benefits from these innovations. These efforts are just one part of a much broader initiative that FDA is currently undertaking to advance policies that promote the development of safe and effective medical technologies that can help consumers improve their health. Our goal is to make sure that FDA has the most modern and efficient regulatory approaches when it comes to evaluating new, beneficial technologies.
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