US FDA: Digital health remains at top of agenda for 2018

After what was widely viewed in the US as a groundbreaking year for digital health oversight, the country’s Food and Drug Administration (FDA) plans to maintain its focus on easing the pathway for innovative technology and devices.


Advancing digital health is one of several priorities for the FDA in the coming year, according to a 2018 Strategic Policy Roadmap (PDF) released by the agency last week, which identified four priority areas “that will be the focus of additional policy activity in 2018.”

In particular, the FDA plans to publish finalised guidance clarifying when digital health technology falls under the FDA’s regulatory purview and when the agency plans to exercise enforcement discretion. Unsurprisingly, the agency also plans to advance its software pre-criticisation programme after launching a pilot program in September involving nine companies including Apple and Fitbit.

“By monitoring and managing chronic health conditions and dietary needs using consumer directed mobile apps and other mobile health tools, or using medical devices to connect digitally with medical professionals, consumers can take more effective control of their care and their medical information and clinicians can provide better medical care,” the roadmap stated. “Well-validated, digital technologies provide a significant opportunity to achieve all of these and similar goals.”

“Today, new medical breakthroughs are profoundly altering how we view and treat disease in ways that seemed inconceivable just years ago,” said Scott Gottlieb, MD, Commissioner at the FDA. “In this modern medical setting, FDA is evaluating all aspects of its policies to make sure we’re protecting consumers, while promoting beneficial innovation that has the potential to effectively treat disease for human and animal patients, and improve public health.

“As scientific understanding of disease advances and the practice of medicine becomes more tailored to individual patient needs, we also are modernising how we work with innovators throughout the development process to bring products to patients more efficiently, using the best available science,” he continued.

For example, FDA recently co-ordinated the approval of a novel diagnostic device that can detect hundreds of genetic mutations in a single test, thereby facilitating earlier access to the product.

The Agency also advanced new draft guidelines that address better ways to develop treatments that address the underlying molecular changes that often cause or contribute to disease. “The framework could lead to more consistent development and approval of targeted therapies for patients who are likely to benefit from them,” said Gottlieb.

The FDA is coming out of a year in which it unveiled a Digital Health Innovation Plan that was met with enthusiasm from industry experts, released new guidance on clinical decision support software and began recruiting a team of entrepreneurs to “help identify requirements and input for a new digital health paradigm.”


Tonya Stewart

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