The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, in collaboration with Jeff Shuren, MD, JD, director of the Center for Devices and Radiological Health, recently published a blog post on the agency’s efforts to work with the tech industry to spur innovation in digital health.
The agency addressed the progress it has been making over the past few years to promote development and innovation in the digital health space.
“With the launch of our Digital Health Innovation Action Plan last summer, we committed to implementing policies, adding expertise, and exploring a software precertification pilot program to bring clarity and efficiency to how we regulate digital health products,” the post read.
As part of this, Gottlieb and Shuren proposed to create a Center of Excellence for Digital Health in the FDA’s Fiscal Year 2019 Budget. The center would aim to advance the modernization of the agency’s regulatory approach to “help this industry grow and reach its full potential, while protecting patients.”
According to the FDA, the center would help establish more efficient regulatory paradigms, consider building capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit.
John Reites, partner and chief product officer at Thread said he is excited about the potential Center of Excellence. “This continued focus will only help to propel regulation clarity, evaluation quality, and standards for our industry,” he told us.
Reites commented that the FDA is clearly supportive of digital health innovation, as is demonstrated in its publications and presentations over the last few years.
“The timing is critical as the digital health industry is receiving more press, funding, and opportunities than I have ever seen before,” he said.
With technology now an essential feature for consumers, Reites said the need to keep pace with change to enable modern health care and clinical research is essential.
“I believe the industry, including the FDA, understands the balance we must strike between speed of review and proper quality evaluation,” he said, adding that initiatives such as the Digital Health Innovation Action Plan, which included the launch of the pre-certification pilot program and new guidances, are providing a clearer understanding of regulations.
Reites said, “These publications are helping to remove some of the innovation barriers by providing more clarity on the requirements for digital health organizations to understand their business pathway.”
At Thread – which provides a platform to design, launch, and manage remote clinical trials – the FDA announcements and increasing acceptance of the use of digital health in Phase II-IV studies have promoted steady growth.
The company’s biopharma, contract research organization (CRO), academic, and non-profit customers are all using apps, devices, sensors, telehealth, and other digital health technologies in their research, Reites explained.
“As these digital health-focused regulations continue to mature, the opportunities for more and new clinical research endpoints will increase,” he added.
As one recent example, USC Center for Body Computing (CBC) and Dr. Leslie Saxon, founder and executive director of CBC, are working with Apple Watch and Thread’s patient app in studies with the Marine Corp’s Basic Reconnaissance Course.
Reites said, “These new regulations and supportive messages from the agency are enabling digital health companies of all sizes to see a more clear path to potentially becoming a standard in health care.”